heprat

Six Months Later…Viral Breakthrough

2012-02-08T21:09:00.000-08:00

I recently had six month after treatment blood test to determineif I achieved a sustained viral response or SVR. The results came back todayand the Hep C virus is back. My viral load is currently at 1 million IU/ml. This completelysucks. 18 months of interferon and ribavirin including 5 months of anexperimental polymerase inhibitor RG7168 aka RO5024048 that produced the side effects of weightloss, depression, inability to concentrate, lack of energy, memory going tohell, anemia, and I'm sure others, that the memory problems prevent me fromremembering; all of this to achieve nothing. It is getting hit by the million pound shit-hammer all over again.

I knew at thebeginning that the traditional therapy only resulted in a 45% chance ofclearing the virus. So when I had the chance to get into the trial of the RG 7128 aka RO5024048 polymerase inhibitor which, inearly-stage experiments had demonstrated a rate of clearing the virus of up to75%, I jumped at it. I'd hoped that the experimental drug would clear thevirus. Even after the viral breakthrough that resulted in my expulsion from the test group Istill thought that transitioning to standard therapy after the initialsuccess of the experimental drug might give me a small leg up on clearing thevirus.

Perhaps the fact that it took 12 weeks for the traditionalinterferon/ribavirin therapy to bring my viral load down from only 40,000 IU/ml to clearshould have tipped me off. Maybe it should have shown me that the strain of virus that I have wouldbe resistant to my own immune system and traditional therapy and I wouldperhaps be more likely not to clear the virus then to succeed, but no one wantsto face that possibility. When you have already been in a process for sixmonths and you've already faced the side effects and found that, to a point,you can handle them; and you believe you have a chance of clearing the virus;and you don’t know what your health insurance is going to be like in anotheryear or two or whenever a new therapy might come online; and the fact that youhave insurance now; and you’re stubborn and you're optimistic; it all putsyou in a mind to say I'm going to see if sticking this out will succeed inbringing me to a sustained viral response and a cure.

Well it didn't. So in a sense I look at the last two yearsof my life, the 18 months on the therapy and the six months beginning torecover from it until the day of the test, as being wasted. I did not get muchaccomplished during those two years. While I was able to do very good things atwork (including expanding the scope of my operation, systematizing and streamliningall of the processes, integrating a part-time person and training them inhandling the basics of the operation, and increasing sales and average of 25%per year), that is cold comfort. Just doing that, just functioning on aday-to-day basis and going to my job eventually took so much energy that itleft little time and little energy for any part of a personal life. My work andefforts as a sculptor were minimal, my ability to do things with my friends andfamily were cut way down by the fact that it was exhausting to do anything forvery much time at all. It all infuriates me even though I knew that it was onlya 50% chance at success. I don't think anyone ever enters a situation like thisthinking that they're going to fail and I certainly didn't. The fact that thetherapy did not work leaves me feeling somehow cheated. It's not rational, but there it is. You feel that if you spent that much time, that much energy (or lack of it) invested that much hope and effort, something better should have happened. It didn't and I feel somehow empty.

All that being said, on the good side all my liver functions are normal. My doctors tell me that the results that they're gettingfrom the liver tests would indicate that the time that I spent clear of thevirus during the therapy, (which totaled about 12 to 14 months out of the 18),allowed my liver to begin to heal itself. The swelling is reduced. It isfunctioning well and I have bought additional time with a healthy liver. I alsolearned that I can handle the therapy. I learned that the side effects I gotwith the standard interferon ribavirin chemotherapy and with the RG7128 are ones that I can manage. I know thata lot of people have a much more difficult time than I ever did during thetraditional therapy. There are people who are so exhausted they can barelymove; people whose anemia is frighteningly intense; people who have much more severedepression; people who lose even more weight than I did; people who have evenless energy and people whose cognitive facilities and memory decline evenfurther than mine. I realize that the ones who have it far worse than I didmust feel even more empty or betrayed or depressed when they find out that itdidn't work. Because as difficult as it was for me, if I had gone through even12 months of the sort of difficulties that others with this disease undergoingthe same therapy went through, I don't know if I could ever face doing itagain.

I'm sure at somepoint I will do it again. I don't like the idea of managing this disease. Idon't like the idea of having something in my body that is gradually destroyingmy liver, breaking down my cognitive functions and creating in the long run aless energetic less mentally sharp individual. I don’t like the possibility ofdeveloping serious liver problems that might include liver cancer, cirrhosis andresult in the need for a transplant. Though my doctors told me that given my liver results I am the sort of personwho is more likely to die with hepatitis C than from hepatitis C, I don't wantto have it at all. The idea that a lifeless particle of protein wrapped aroundsome DNA is working its way through my body destroying my liver doesn't fit mydisposition. So I will try again at some point.

I don't know thatI will ever try interferon therapy again. It is extremely devastating and Idon't know if I can face it even though I do suffer it better than many otherpeople. There is a tremendous amount of research going on and a lot of that isoriented towards non-interferon drug combinations to attack the virus. There'sa lot to look forward to and I know that I'm in good shape to see where itleads.

It's still depressing, it still sucks but you buck upand handle it the best you can. Even though I've been whining for most of thispost, I know that my life is a hell of a lot better than a lot of other people in the world and especially a lot of other people with Hep C. Besides, Spring Training is right around the corner and how can you stay depressed when pitchers and catchers report in only six weeks,

Sierra Vacation One Year Later

2011-09-14T20:20:00.000-07:00

At right about the halfway point in treatment last year, I took a short vacation to Camp Mather near Yosemite. It was a real challenge, particularly regarding side effects and was described in this post. Having actually enjoyed it despite the difficulties, my wife and I decided to do it again this year. It was a vastly different experience.

Right off the bat, we didn’t need to take refrigerated drugs and the daily dose of pills was down to two (a thyroid pill and Celexa). Remembering last year’s difficulty breathing at altitude, I injected my last dose of Procrit a few days before we left. We then threw enough gear for a two month safari into the back of the pickup (it was a five day vacation – in a cabin) and headed up to Camp Mather.

The biggest difference was the energy I had this year. Even being off the treatment drugs for only 10 weeks created a noticeable difference. There was a lot less exhaustion – I only needed to take one short nap every day – and I had the energy to do a lot more walking. I even played catch, Frisbee golf and kicked around a soccer ball with my wife during the stay. We even stayed up in the evening and played board games with some of our friends, though I crapped out on the late night wine and ranting sessions that are de rigueur for any vacation. It was wonderful to enjoy physical activities without gasping, nausea and spacing out.

It’s great to feel some actual progress in recovering from treatment. I even pretend to see my hair growing back (I’m sure those dark hairs weren’t there before, both of them). Of course, after driving back to San Francisco, I went to bed and slept for 12 hours, then took an afternoon nap for two more. I guess I’m not quite yet the physical powerhouse I thought I was.

Seeing More Clearly After Treatment

2011-09-06T21:13:00.000-07:00

Vision changes are a big part of the side effects of both standard treatment and several of the additional drugs either approved (boceprevir, telaprevir) or under study for treating Hepatitis C (RO5024048 RG7128). They can include blurry vision, changes in the strength of your vision, sparkles or light shows within or at the edge of your visual field and worst of all macular degeneration. The effects can vary in intensity during the course of treatment. Most of the visual side effects reverse after treatment is ended save for macular degeneration, which is permanent. In my case, the effects seem to be slowly reversing themselves.

In this post (about 6 paragraphs down) there is a description of the onset of the visual side effects when treatment began. At the time the primary effect seemed to be a reduction in my ability to focus on things that were close-up in my visual field. I lost most of my natural monocular vision in which the left eye focused up close the right eye focused at a distance. It eventually progressed to the point that, at the end of treatment, there was little difference between the two eyes. The left still focused a touch better close up and the right a touch better at a distance, but there was no longer a significant difference.

There was also some variation in the strength of vision. It seemed that from month to month there were variations in the amount of short sightedness I was victim to. Sometimes, it seemed my glasses were not nearly strong enough and other times they were far too strong. I took to not wearing them most of the time and carrying around reading glasses for when there was a need to focus closely (for those of you in the San Francisco Bay Area, Ichiban Kan the Japanese discount store has reading glasses for $1.50 per pair; and stylin ones at that). I decided not to get new glasses or even try to determine my prescription until the treatment was over.

Several months after I had been dropped from the experimental study and was on the standard treatment, I began to notice that there were sparkles in my visual field. They were not large nor were they particularly intrusive, but they were apparent when I wasn’t focusing on a specific area. They were also apparent at the edges of the visual field, particularly in low light. I kept thinking that I saw something out of the corner of my eye and when I tried to turn and focus on it, there was never anything there. It took a while to realize that it was due to the sparklies and not to flies, birds, mice, rain, ghosts or any of the other things that appear in the corners of your vision.

Now that 9 weeks have passed since finishing the interferon and Ribavirin treatment, there has been some reversal of the visual side effects. The sparklies in the visual field and at the corners of my eyes are mostly gone. They still appear when I am very tired, but they may have always done that and I wouldn’t know it given the state of my memory. The variations in my strength of vision have stabilized as well. There are no longer times when I cannot wear glasses because they make my eyes hurt. Perhaps it is time to visit the eye doctor and get a new prescription and even new glasses (Costco here we come). There has been no change in the loss of monocular vision. My two eyes remain slightly different, but the old ability to read with the left eye and focus long-distance with the right seems to be gone permanently.

The side effect of the eyes getting tired rapidly during reading and watching a movie, TV or computer screen has also begun to reverse. So much so that this past weekend my lovely wife and I were able to take in two movies in two days. These were not “films” either with long static takes of characters talking or meditative pans across beautiful scenery. These were eye-taxing action films with rapid changes in focus, explosions, chase scenes and all the things you watch movies on the big screen for. Yes, we saw “Cowboys and Aliens” and “Rise of the Planet of the Apes” - two brilliant examples of all that is right in Hollywood filmmaking. At least with Hep C, the treatment doesn’t make apes smarter and people dead. We got that going for us…

Leaving the Support Group

2011-08-22T20:26:00.000-07:00

As discussed previously in this post, support groups are an excellent program for HEP C sufferers. They provide a safe and secure environment to talk about the disease. They are a useful pool of knowledge about the side effects, the strategies for coping with them and, of course they provide a wealth of information about treatment. The sheer relief of finding people who have had similar trials, successes, and failures is worth attending in itself. All that being said, I stopped going to my support group in January of 2011.

Some of the reasons are the same as the ones described in this post, some are more personal. The overall tone of the group began to seem as though it was a group therapy session for folks with social interaction deficits rather than a support group dedicated to dealing with HEP C. The amount of time spent discussing the relationships and personal difficulties of the people in the group began to outweigh the time spent discussing the effects of HEP C on their lives and the sharing of knowledge about facing and treating the disease. While this kind of discussion was clearly important to those who initiated it, it seemed to me to be a case of too much information and too much bitching. It never bothers me when someone bitches about the difficulties the disease or its treatment creates in their lives, it does not seem relevant to here repeated complaints about their fathers, mothers, brothers and others in their lives. This may very well be an example of my being selfish and not caring enough about my fellow HEP C sufferers. I fully admit this. But I would rather spend the time talking about the disease, the treatments, the knowledge others have about these things and the general state of the HEP C community, research and public awareness of the disease. All of these concerns can be personal and can intersect with the personal lives of the folks with the disease; I just don’t want to hear about their landlord having a problem with their cat.

It came to a head when I realized that I had to take an Ativan before going to the meetings in order to get through them without becoming anxious and upset. It seemed that the requirement to be tranquilized to go the meeting was probably a sign that they had outlasted their usefulness. I still remain in contact with a few of the people in the group, but the dynamics of the actual bi-weekly meetings just became more than I could stand.

I still believe that support groups are a great resource. If you have one in your area you should definitely check it out. The chances are that it will be a great source of emotional support and information. Everyone with HEP C deserves all the support they can get and a support group is a great place to seek it. Perhaps those of us who are surly loners just can’t handle all that good feeling. Ah well…

A Shout Out to Gregg Allman

2011-08-21T21:59:00.000-07:00

The television was tuned to one of those deep cable cultural stations which was running a German film from the thirties when they went to commercial. The ad started out with a voice over from Gregg Allman mentioning the Allman Brothers Museum in Macon, Georgia. Then it morphed in a completely different direction. In a full-face statement, he announced that in 1999 he had been diagnosed with Hepatitis C. He said that on his doctor’s advice he eventually acknowledged the reality of the disease and sought help. He said that he was glad he did and that doing so allowed him to not just have memories of the past, but to continue to make memories today. He urged people to go to tuneintohepc.com for more information and to get tested.

Even though a number of prominent people in various walks of live have contracted HEP C, (list here) there have not been a correspondingly large number who have spoken out about their disease. Natalie Cole, a fellow musician who is featured on the tuneintohepc.com website talked about the disease, how she got it and what the treatment was like in 2008. A link to one of the articles is here. Pamela Anderson has talked about her disease as well. Allman talked to Sanjay Gupta on CNN about the disease, his cancer and his liver transplant earlier this summer (link here). He also made the TV public service commercial noted above. I’m sure there are others, but just the fact that it is hard to identify them means that HEP C sufferers have not had the same celebrity support that folks with many other diseases have had.

Folks who have HEP C, whether celebrity or no, have no obligation to reveal their health information to anyone. To assume that they bear greater responsibility to advocate for the disease is wrong. All of us may choose how we deal with the fact that we have it. Still, it would do a great deal for raising the awareness of HEP C if all of us who have it, especially celebrities, speak out about the disease, advocate for more research, and for those of us who have undergone treatment, inform people about what to expect if they decide to be treated.

For now, though, I would like to thank Mr. Allman for making his public service announcement, for going on CNN and for being out front and straightforward about the disease. Let’s hope it leads a lot more people to be tested and to be able to consider treatment while their liver can still be saved.

New Drugs, New Treatments, New Hype

2011-08-18T19:54:00.000-07:00

In mid-June of this year while at a baseball game watching my childhood hometown Minnesota Twins defeat my adopted home town team San Francisco Giants, a friend asked if I was excited about the news in the paper that morning about the new cure for Hepatitis C. He said that it cured 80% of all patients in clinical trials and that the treatment might last only 24 weeks instead of the standard 48 week therapy. The news was stunning. Which drug was it? I had been keeping up with the various new drugs in the FDA approval pipeline and had never heard of one with a viral clearance rate of more than 65%. Of course he couldn’t remember the name and none of us had a smart phone with us, so it took until after game and back at home before I could do any research.

This article appeared in the San Francisco Chronicle. It stated that about 80% of HEP C patients “with the most common strain” and relapsers from previous treatment were cured by the new drug. The drug was the protease inhibitor telaprevir, brand named Incivek by its developer Vertex Pharmaceuticals. Imagine the amount of money they must have paid a naming company to develop that brand name; rolls right off the tongue. The results from earlier studies had indicated that telaprevir increased the Sustained Viral Response (SVR) in genotype 1 HEP C, the most common genotype infecting US residents, to 65%. It seemed prudent to search out the source material to sort out all these percentages. A quick search of the web found this press release. In the fourth paragraph of the release it stated that “The sustained virologic response for patients treated with Incivek across all studies, and across all patient groups, was between 20 and 45 percent higher than current standard of care.” This seems to indicate that the low end of the SVR rate was indeed 65% and the high end might be almost 90%. The article and press release also indicated that 60% of treatment naïve patients achieved a rapid viral response (RVR) in 4 weeks and these folks not only would only be in treatment for 24 weeks, but had a 90% chance of achieving an SVR as well. It is not clear what the SVR rate for the folks who don’t achieve a RVR and continue for 48 weeks of treatment has been in the tests. It is also unclear whether there is a difference in SVR rates between genotype 1a and 1b. Folks who had relapsed after previous treatments had a 32% SVR rate when treated with the telaprevir, interferon and Ribavirin cocktail. This is very good news indeed for HEP C patients.

A month earlier, this article appeared in the NY Times announcing the debut of Victrelis the brand name of boceprevir (again where do these brand names come from) another protease inhibitor, this one developed by Merck. This drug, which is taken for either 24 or 48 weeks in combination with interferon and Ribavirin, has an SVR rate for treatment naïve genotype 1 HEP C patients of 65-70%. The SVR rate for patients who relapsed after previous treatment is about 40%. Boceprevir is a bit different in that the patient starts with 4 weeks of standard treatment and then adds the boceprevir for either an additional 24 or 48 weeks depending on the viral response. So we have two competing drugs available whose addition to the standard of care treatment increases the SVR rate by a range of 20 to 40 percent. Good news indeed but what is the rest of the story.

The rest of the story has several chapters from side effects to cost of treatment. Looking at side effects first, both boceprevir (Victrelis) and telaprevir (Incivek) have additional side effects to add to those caused by interferon and Ribavirin and both can somewhat intensify the interferon and Ribavirin side effects as well.

Boceprevir can increase the risk of anemia and neutropenia, cause strange taste sensations and cause intestinal tract issues.
Telaprevir also increases the risk of anemia, causes diarrhea, and most importantly can cause an itchy rash. The rash can be serious enough to require that the patient stop taking the telaprevir.

The new drugs are very much like the established treatment in that those with lower viral loads at the beginning of treatment have a better chance of success than those with high viral loads. Also like the established treatments, anyone who has ever tried a treatment, whether standard or experimental, and failed also has a considerably lower chance of success.

Both drugs are protease inhibitors. This means that they inhibit the action of an enzyme that the virus needs to reproduce. They are similar to the protease inhibitors developed to fight the AIDS virus. This means that they must be taken on a fairly rigid schedule: three pills per day, one every eight hours. If that means waking up to take it, wake up you must. They also need to be taken with food, so you cannot pop a pill and run off. You have to have certain types of food with the dose of the drug. This means that for 12 weeks (telaprevir) or 24-48 weeks (boceprevir) your life will be scheduled around your drug dosing.

Both drugs are vastly expensive as discussed in this article. Boceprevir/Victrelis will cost $1,100 per week making the cost of a full course of the drug either $26,400 (24 weeks) or $52,800 (48 weeks) depending on your viral response. Telaprevir/Incivek has been priced at $49,000 for the 12 week course of treatment. This cost is in addition to the $15,000-$20,000 (24 weeks) or $30,000-$40,000 (48 weeks) for the interferon and Ribavirin with which they must be taken. This also does not count the cost of the Procrit to fight anemia ($500 per week) or the Neupogen to fight neutropenia (also about $500 per week) should you need them. There are also the costs involved with antidepressants, sleep medications, thyroid medications, pain medications and whatever you will be using to deal with the rash and itching in the case of the telaprevir.

It is also not clear how quickly insurance plans will add them to their drug formularies. Kaiser Permanente, my HMO here in California, has added both to its formulary. I do not know which other insurance providers have done the same. Even if they are added, it is not clear what the requirements will be for a patient to be eligible to be prescribed and how easily insurance companies will make them available. From an economic point of view they should make them easy to get as even at these prices the cost of treatment is still much less than the cost of a liver transplant.
For those without insurance, I do not know how anyone but the wealthy could afford the additional cost. The cost of standard of care treatment is by itself so high as to exclude many HEP C sufferers from being treated. There are programs to assist those with low resources to get treatment but even with the drugs deeply discounted the ability to come up with as much as $20,000 for a course of treatment would seem impossible.

Despite all these potential problems, the advent of new drugs to combat HEP C is excellent news. Ramping up the SVR rate to a range of 60% - 80% is a vast improvement over the standard of care treatment rate that topped out at 45%. Psychologically, it is far more encouraging to go into a course of treatment thinking you have a 2-1 shot at beating the virus than to go in thinking you have just under a 50-50 shot. These drugs are also only the leading edge of a wave of new drugs and new therapy approaches that are under research and testing. There are new polymerase inhibitor drugs that have SVR rates similar to telaprevir, but with fewer and less severe side effects. Testing on the holy grail of finding a treatment regimen that does not have to include interferon is also underway with early stage results coming in soon. Within the past year, scientists have discovered a method of growing the HEP C virus in the lab. This means that future early stage testing of drugs can be done directly on the virus instead of with animal models. This should increase the pace of research dramatically. In all it is a good time to have HEP C if you are one of us infected. There are established treatments, there are promising new treatments and there are drugs and treatments in the research and development pipeline that seem to point to future in which HEP C can be attacked and treated with a high expectation that it will be successfully cleared from the human body.

Perhaps we can believe the hype surrounding these new drugs. Despite the problems of determining the actual efficacy of the drug in your own case, the potential difficulties in obtaining and paying for the treatment and persevering through the side effects, they have advanced the cause of combatting Hepatitis C.

The more cures, the fewer pig livers will have to be implanted in humans (sorry, I’ve been reading far too many science fiction novels during treatment).

Changes In Visualizations During Treatment

2011-08-16T21:12:00.000-07:00

There is a great deal of evidence that creative visualization can influence the actual physical and mental performance of people in the real world. Studies have been done on academic test performance and athletic performance to use two examples and the evidence has indicated that if one group spends a specific amount of time visualizing successfully completing a task and another group spends the same amount of time practicing the task, the two groups have similar results upon undertaking the task. There is also evidence that the same sort of creative visualization influences recovery rates and treatment outcomes in disease situations.

It was with that in mind that I created my own visualization when I started HEP C treatment in the RG7128, RO5024048 clinical trial. I imagined that the polymerase inhibitor RG7128 was an armored division of fast moving powerful tanks that struck quickly and with lethal force at the HEP C virus. The interferon and Ribavirin were the methodical infantry units that followed the tanks and mopped up the remaining resistance from viruses that were either entrenched or bypassed by the fast moving armor. I visualized that image often throughout the clinical trial. After being tossed out of the clinical trial because of a viral breakthrough, my visualization metaphor changed. My tanks had run out of gas and were now abandoned by the side of the road.

After transitioning into Standard of Care therapy I still used a military image when I thought about my battle with the HEP C virus, but now it had switched to an image of slogging trench warfare with my infantry (interferon and Ribavirin) in hand-to-hand combat with the virus. It was going to be a 12 month struggle but they were attacking an already weakened foe and had strength of numbers and better supplies on their side. I used this image for several months and sure enough, after 14 weeks the numbers came back negative indicating my infantry were winning.

Then there was the possible viral breakthrough in December after six months of treatment and the subsequent return to being virally negative in January. The metaphor was fairly tattered by then but I tried to hold to it. As the months of treatment ground on and I eventually went on disability, the only military image that seemed to fit was the battle of Stalingrad; except I didn’t know which side I was on. Holding on till the end of treatment was the only concern. This carries on the military metaphor quite well actually. At the end of a long tour of duty on the front lines, the primary concern a soldier has is surviving until it is over.

At the end of treatment, the viral load was undetectable and the viral activity was negative so we can assume that the visualization was either successful and contributed to the treatment or at least did not inhibit the effectiveness of the treatment. I would recommend the technique to anyone undergoing any kind of treatment for disease. There is no need to use a military image, whatever is vivid and emotionally engaging will work. It is no doubt easier to maintain the metaphor for shorter treatments than longer ones, but anything that can help healing is worth pursuing. Just hope your metaphor doesn’t run out of gas on the side of the road. There is nothing sadder imaginarily speaking than watching your elite troops quit the battlefield.

Night Sweats Redux

2011-08-12T19:53:00.000-07:00

After finishing 18 months of treatment involving powerful, side-effect laden drugs one’s expectations are that once you are no longer taking the drugs, you no longer experience the side effects. This does not exactly seem to be the case. Shortly after the first week following the end of treatment, I began to experience night sweats again.

Within a few months of beginning the drug trial in 2010, I started to experience night sweats, as related in this post. The night sweats were intense with heavy sweat soaking through sleeping clothes and even requiring changing the sheets in some cases. These went on for several weeks until my body seemed to adjust to the various drugs and they receded to only an occasional event. This was the norm for about a year until they became a bit more common during the final 8 weeks of treatment. They were still not the heavy sweats that characterized the early part of treatment, but they did happend a few times a month toward the end.

About ten days after finishing treatment, I woke up on my back with a pool of sweat on my concave abdomen (did I mention that I had lost a bit of weight?). After a change of shirt and going back to sleep, I awoke later to the same condition. This happened three times during the night and by morning there were damp shirts hung all over the bedroom. It was unclear why it might be happening. My wife had recently had the flu and I was a bit feverish before retiring for the night so perhaps it was related to that. When it happened each night for the next week, it occurred to me that it might be related to the HEP C treatment. The heavy sweats have stopped, but in a milder form they have remained an event that occurs about 3 times a week.

It is not clear what the cause is. In my darkest moments, I remember that the symptoms for the onset of acute HEP C are flu-like, including fever, sweating and muscle aches. I felt some of them at the start of this round of sweats but it does not seem likely the sweating would have continued on for several weeks after the other symptoms disappeared. In talking to folks who have had relapses after treatment, they report that they relapse within the first month, which would fit the scenario, but they do not report having symptoms. It could also be related to stopping the other drugs being taken to alleviate the side effects of the standard treatment. Ambien was something I was taking every day for the final 2-3 months of treatment as sleep was not something that came easily or often. Ambien is not something that should be taken daily and even Dr. Sue had been more worried about the addictive nature of that than of any of the other drugs I was taking. There are some withdrawal symptoms that are noted for Ambien, but they do not indicate that they would go on for weeks after stopping. It could be that the long term use of interferon and Ribavirin has reset my internal thermostat. It always ran cold before as witnessed by the pile of covers on my side of the bed every night. Perhaps now it is more like my wife’s internal temperature gauge. She often sleeps covered only by a sheet on nights when I am swathed in blankets.

I hope it is something as benign as my body permanently running warmer than it used to. If nothing else, surviving summers in San Francisco will be easier if running hot, than if constantly cold. Until more evidence is gathered, the jury is out. In the meantime I am busy brainwashing myself that it is NOT because of any recurrence of HEP C.

Money Saved Is Money Earned

2011-08-11T19:55:00.000-07:00

In one of the last posts I did before I lost the energy to continue writing, I talked about the differences in care between a centrally administered health care organization (in my case the Kaiser HMO) and a health insurance model of care. One of the biggest differences is in the way drug prescriptions are handled. While under health insurance, the copayment for commonly prescribed drugs and drugs with generic equivalents was $15 for each prescription. Uncommon drugs or drugs whose patent had not yet run out or there were no generic equivalents available had much higher copayments depending on which supply store or agency you used. In the case of HEP C, the high-copayment drugs needed for treatment were Interferon (Pegasys), Procrit and Neupogen. My copayment for each of these was $100 for a 4 week supply. These drugs had to be ordered many days in advance from an out of state specialty pharmacy that delivered them via express mail. When you added in Ribavirin, the thyroid meds, the Ambien for sleep, Celexa for depression and the Vicodin for the weekly bought of muscle pain, the copayments added up to $375 every 4 weeks. During the 7 months of Standard of Care treatment while covered by health insurance the grand total was roughly $2800 in copayments for the meds.

Under the Kaiser HMO model of care, it is very different both in cost and the ease of getting the necessary meds. Kaiser has all the drugs available through their pharmacy. The is no longer any need for ordering interferon, Ribavirin, Procrit and Neupogen through an out of state mail order pharmacy; a pharmacy that had to send the stuff in an insulated carton with freeze packs and once mistakenly sent the meds to Canada. It can now be picked up at the local Kaiser pharmacy without the necessity for ordering many days in advance to make sure all the necessary approvals are in order. Kaiser also considers a standard order to be larger for some of the drugs than do the health insurance people which means there is more bang for the buck. The copay for the Ribavirin, Celexa, thyroid meds, Ambien and vicodin are still $15 but the prescriptions are for greater numbers of pills each. The interferon, Procrit and Neupogen all have a $25 copayment. In the case of the interferon and Procrit it covers a 4 week supply, for the Neupogen it covers an 8 week supply. Thus a 4 week supply of the necessary meds adds up to about $120. The savings amount to about $1500 for the length of treatment done while at Kaiser. This is not a trivial amount for the folks in my pay grade.

There are a lot of other differences large and small, good and bad, between the two methods of supplying health care and I hope to go into them more in the near future. This difference however, is nothing but good. $1500 saved covers a full month of expenses in my world and that is the same as $1500 earned.

The Disability Two-Step

2011-08-10T20:50:00.000-07:00

Applying for Disability as mentioned in an earlier post, should be a relatively straightforward process. Contact your doctor and tell them you would like to go on disability and give them the reasons you feel it is necessary. With Hepatitis C, it is generally pretty standard for your doctor to have a very clear idea of what you are going through and why disability would help. You contact the state for a form, fill it out, take it in to your doctor, they fill it out, it is mailed back to the state. Then the state contacts your employer to confirm that you work there and what your salary is. You are sent a notification of the amount of money you will receive and within a few weeks of the start of your disability period, you begin to receive your benefits. Like all purportedly simple processes, the difference between the ideal and the real, the concept and the reality are far different. Such was the case with my claim as well.

After being advised by my friend Dr. Sue that I should go on disability, I approached my Human Resources department to get some basic information. They described the process, exactly as above, and that was the only thing they got right. They informed me that I would get between 75% and 95% of my normal pay but that I had to use up all my sick time before my benefits could start. Both of these statements were wrong. California SDI pays you 55% (in my case that meant $492/week) of your standard pay up to a maximum of $975 per week. So if you make $150,000 per year you would still only get $975 week. However, the benefits you receive from SDI are tax free, which makes them stretch further. You do not have to use up all your sick pay, if your employer grants you any that is. You only have to inform them if you are using any of it during the term of your disability claim. The HR folks also did not know what the status of my health insurance would be during the term of my disability. The moral here is check out everything for yourself, the professionals paid to assist you in these matters may not know what they are talking about.

I filled out the forms and took them to my doctor. He filled them out and they mailed them in to the state. The disability benefits start to accrue 9 days after the last day you work. I put down that my last working day was the 23rd of April. I also told them that I would be using 6 days of paid sick time to bridge the gap between my last day of work and the date my benefits began to accrue. This was fine with them and the said my benefits would start to accrue on May 1. The first payment would come 14 days after the benefits started to accrue. On May 2nd I received my official notice from the state of the amount of my benefits. Things seemed to be moving along well. On May 12th I received a notice that my benefits were not going to be granted and I could file an appeal if I so desired. The heartburn started on the spot. I called the included number and the courteous state employee told me that the notice of denial was a standard form they sent out when they had not yet received all the necessary paperwork. They had attempted to contact my employer 3 times by phone to no avail and had sent a form to them to fill out but had not yet received it back. He then told me to file an appeal to protect my rights and contact my employer to find out what was going on. I contacted them and was told that the form had been sent to the state the day before and they had no record of any phone calls about the matter.

A phone call to the state 5 days later to find out whether the form had arrived yielded the information that it had not. A different, but equally courteous, state employee said that employers failing to send in paperwork was the single biggest problem his agency had in processing claims. He said that the second most common problem they had in claim processing was doctors filling out the forms in completely unreadable handwriting. He mentioned that it was not uncommon for forms to be handed around the entire office in an attempt to find someone able to decipher what doctors had written on claim forms. He also said that filing an appeal was something I should do immediately. I filed an appeal that afternoon.

Two days later another courteous state employee called to inform me that they had received my appeal but still no paperwork from my employer. He then took my employment information over the phone and after asking me to swear that it was correct told me he would process the claim that afternoon. Seven days later I received my first payment. It was 25 days after my last day of work.

The form of the payment itself was another slight curveball. Rather than pay via check or direct deposit of funds into a bank account, the state of California now provides people who receive benefits with a debit VISA card. The disability account attached to that card is replenished by the state every two weeks with your payment. This is ostensibly to provide those without bank accounts an easier way to access their funds than taking a check to a check cashing shop. For anyone with a bank account it involves transferring money from the card to your account in order to pay your bills. VISA, of course, extracts small transaction fees for the various money movements. I can just imagine the VISA lobbyists talking to the state bureaucrats to get them to make this change. How many dinners, free trips and outright bribes did it take to get this deal done? Who knows, but credit VISA for seeing it through.

Things went swimmingly right up until I was about to finish up my treatment at the end of June. I contacted my doctor to confirm the end of my disability term and was astonished to hear that it was over on July 1. After asking how a patient who had been in treatment for 18 months and for whom the side effects were severe enough to eventually require a stint on disability could be considered fit to return to work full time 24 hours after the last dose of their treatment medication, they averred that they have made a mistake. After running some more forms back and forth and sending them in to the state, an extension till August 1st was granted.
An issue of primary importance when considering disability is what the status of your health insurance will be during the time you are disabled. Your employer is not required to pay your health insurance. They may if they choose, but they do not have to. My employer cut off my health insurance and offered my COBRA while I was on disability. Given that COBRA payments would have been in the neighborhood of $750 per month, it would have used up about 35% of my benefits just to pay health insurance. Without health insurance I could not afford to continue treatment, so this is a crucial consideration. Luckily, my wife has health insurance under which the spouse can be covered. If this had not been the case, I could never have taken advantage of the disability benefits on which I had been paying premiums the past 10 years.

Disability is definitely something that anyone in treatment should look in to if it is available to you. The rest you get helps your mental attitude, you physical condition and leaves you in far better shape to survive and prosper from your treatment. Treatment can be brutal and disability benefits can relieve some of that brutality for you.

Writing Checks My Body Can’t Cash

2011-08-08T19:56:00.000-07:00

I was tired all weekend and am tired today. It appears that while the old mind thinks that I can work full-time with no problems, the body is more difficult to convince. There are a number of reasons that contribute to this fact.

The first is that 18 months of interferon and Ribavirin just wear down your body. It is hard to understand just how pervasive that effect is until you try to return to your old activities. The body has to get used to the idea that it can do these things again. It also has to continue to rid itself of the toxins built up over the months of treatment.

Another is that the months of treatment that wore down the body also brought about an enormous lack of energy. This created a situation in which it was extremely difficult to exercise. Walking, stairs, lifting and carrying all leave you so exhausted that you have no incentive to keep attempting to be physically active. So the muscle you have left atrophies and leaves you weak as a kitten.

A third is that recovery from the anemia brought on by the Ribavirin is much slower than expected. A month after finishing treatment and even though I have been injecting Procrit weekly, my hemoglobin is only at a little over 11. Given that it was at 15 at the start of this whole shebang, there is still quite a ways to go to get back to normal.

Finally, as I mentioned a bit earlier, I am genuinely weak as a kitten. A week after I stopped treatment, I began to do some light exercise to try to build up my strength and muscle tone. The amount of various exercises that I could (or more accurately, couldn’t) do was astounding. Just to give the most embarrassing example let’s consider lunges. These are the exercise in which you step forward with one leg, drop the opposite knee down until it touches the ground and then straighten up. I could do 3 on each leg or six total. In all the years I have ever done any of these sorts of exercises it was always possible to do 10 on each side or 20 total even when my condition was terrible. The worst part was that after doing the 6 I could do, my legs were stiff the next day. Yes, I just turned 58 and have had a long bout of drugs but still, that’s damn disappointing.

All this contributes to the fact that 5 full time days equals a full time weekend of rest and even then there is not enough time to revive.

Hungry

2011-08-05T18:24:00.000-07:00

At the end of Hepatitis C treatment on June 30, 2011 I weighed 166 lbs. (75 kilos), a loss of 35 lbs. (15.5 kilos) from my weight before the trial started. Granted, my lovely wife had been assiduously packing the weight on to me before the drug trial began so it wasn’t as if I lost only muscle, but still 15% of your body weight is nothing to sneeze at. The great majority of the weight loss, 25 lbs. (11 kilos) came in the first 5 months of the drug trial. It held steady for the first 6 months of standard treatment, then there was another quick 5 lb. drop. It plateaued again for another 4 ½ months and then there was another steady 1lb. per week drop till the end of treatment. It was as if the body dropped weight until the metabolism adjusted to the drugs, then held steady until the drugs broke through the plateau then dropped more weight until another adjustment was made and balance was achieved again.

The first week after I finished treatment was the same as being in treatment. My weight was steady, my appetite was suppressed, my energy very low. After about 10 days, it was as if a switch was thrown in my metabolism. I was hungry constantly. Breakfast in the late morning (I was trying to bring my sleep cycle into line with the rest of the world and not having a great deal of success), then a sandwich an hour later. Some sort of lunch at around 2 p.m. and again something to eat ever hour or so until supper; after supper, more grazing until bedtime. I even woke up hungry in the middle of the night and had to eat an apple or banana so I could get back to sleep. This continued day after day for about 2 weeks. I was astonished at how much I was eating after 18 months of trying to convince myself to eat anything. The only problem was that my diet hadn’t made a change from the on treatment period. My doctor had encouraged me to eat whatever seemed appealing in order to keep my weight up. This meant ice cream, baked goods, cheese etc. The problem now was that these foods were being consumed in large quantities. Two weeks after the eating began, I had gained 7 lbs. (3 kilos). That’s a lot of weight, especially when you look in the mirror and realize it went straight to your abdomen.

Some changes were made to the diet after that realization, cutting down on the ice cream especially and trying to manage the urge to eat. I am down to 3 meals a day without much between meal eating, but am still eating a great deal more at each sitting than during treatment. One month after my metabolism decided it wanted food again, I am 10 lbs. (4.5 kilos) heavier than at the end of treatment. My head likes to believe that the weight gain has begun to change to muscle instead of fat, but convincing my waist of that is a bit harder to do. Still, it is a wonderful thing to enjoy food again. There is nothing like enjoying fresh tomatoes on lettuce and toasted bread, grilled ribs, asparagus and a wonderful ripe peach. This sort of talk is making me hungry again and luckily it is just about time for dinner. So on that note, I will sign off and fulfill my task of gaining more weight. It is a difficult job, but someone has to sit down and do it.

Disability

2011-08-04T18:11:00.000-07:00

We went down to Los Angeles around April 1st this year for my fantasy baseball draft. We always follow the auction with a stay at our old friends Carol and Steve’s place in Santa Monica. While we were whiling away the weekend in the backyard (we might have done something else but I was too tired to do much of anything except whiling time away) our friend Sue came by to hang out. Sue is a doctor and works at a public health clinic. She has a lot of experience with chronically ill patients. After about a half hour of general chat, she turned to me and asked if I had ever considered going on disability. I told her I had been thinking about it, but hadn’t formally started the process. She said that she thought it would be good for me to do it. It seems my life had narrowed down to work, disease and sitting at home. She did not see that as a life and told me that disability would allow me to rest, be in better condition to help my treatment, and allow me to do some of the things that made life worthwhile. My wife agreed with her completely and between the two of them had convinced me to start the process by the time the weekend was over.

The process is relatively straightforward. You get a form from the state, fill it out, give it to your doctor to fill out and sign, and send it in to the state offices that handle disability. They contact your employer to determine if you actually work there and what your pay is and a certain number of days after your last day of paid work, you begin to accrue your disability benefits. They send you a check every two weeks once you have been accruing benefits.

State disability insurance or SDI is a short term program that is administered by the state and paid for by insurance premiums that are taken out of your pay. Therefore it is administered by the state and bound by state regulations. It can last up to a year. If you are disabled for longer than that you switch to Federal Long Term Disability that is administered by the Social Security Administration. For HEP C it is a standard process because HEP C is one of the conditions that are covered in the state regulations. Your doctor can just write in the definitions from the state manual on your form and it will be processed routinely. This is not to say there won’t be screw-ups, because there will, but at least you will be fixing problems in the process and not be trying to convince the state agency that they should be covering a non-standard condition. The bumps on the road to my approval will be discussed in an upcoming post.

I stopped working on April 23rd and started accruing benefits on May 3rd. It made a world of difference. I was able to rest. I slept 11-12 hours a night the first few weeks and took naps in the afternoon. I was able to get out of the house for brief excursions. I didn’t have to deal with the stress of work wearing me down. As I was mildly to seriously anemic during the last several months of treatment, being able to rest was hugely important. Dr. Sue and my wife were right, it definitely helped make life better and treatment easier to handle. I wish I had done it sooner. If I had, I might be less exhausted now that I am back to work.

World Hepatitis Day – Who Knew?

2011-08-03T20:48:00.000-07:00

Thursday July 28, seven days ago, was World Viral Hepatitis Day. The day was dedicated to raising awareness of all types of viral hepatitis and the populations they affect throughout the world. Did you know it was happening? If not for the efforts of the San Francisco Hepatitis Task Force, no one in my city would have known, myself included. Were it not for an email sent out by the task force recruiting volunteers for some boots on the ground outreach at transit stations in the city, it certainly would have passed me by. As it was about 50 hardy souls wore t-shirts, held up banners and handed out information cards during the morning and evening commute hours. Over 2500 cards were passed out during the day and thousands of other folks saw the signs and heard our pleas that they find out about HEP C and get tested. We tried out numerous catchphrases such as: “Do your liver a favor, get tested,” “Seven out of ten people don’t know they have it,” “We never thought we had it,” “If you have a tattoo, you might be infected.” “I never knew I had it,” etc. I irresponsibly came up with a few others such as “If you have a tattoo you are already dying,” “If I have it, so could you,” “Don’t die not knowing what killed you,” “What you don’t know can kill you,” and others. Anything to break through the iPod, cell phone and traffic noise clutter. It was a worthwhile though exhausting effort but it left me wondering why we don’t have better outreach about Hep C.

If you remember the beginning of the AIDS epidemic, the gay community did a fantastic job of organizing to demand research about the disease, research about a cure, better treatment by medical professionals, and fairer treatment for infected individuals. They had the same problem as the HEP C community in that AIDS was seen as a disease that affected mainly people who the mainstream of society saw as deviants. With AIDS the victims were defined as promiscuous, drug using men who engaged in “perverted” behavior. With HEP C victims are seen as drug using losers. (There is a rumor in San Francisco that the local Hepatitis B community decided not to ally with the HEP C community in a previous outreach program because they did not want their cause associated with drug use.) The AIDS community worked hard and eventually triumphed over that stigma (though suburban white folks starting to get the disease via contaminated blood certainly moved America toward the realization that the disease was not the wrath of god, but rather and dangerous virus). They now get vastly more attention than the HEP C community even though there are 4 times as many HEP C sufferers as people infected with HIV/AIDS. Our community of infected people needs to start becoming a lot more aggressive in publicizing HEP C and the fact that is one of a family of viruses that can infect people who have never used drugs or indeed engaged in any behaviors mainstream Americans look down upon.

We can certainly learn some lessons from the AIDS community and lose our apathy, shyness or indifference. It is the only way we are going to get the treatments for HEP C widely distributed at an affordable price so we can save the lives of people who don’t need to die from HEP C.

Speed Bump On The Road Back

2011-08-02T19:12:00.000-07:00

Just in case I didn’t get the memo that it was going to be a long slow road back to full mental functioning, there was a reminder for me this morning. We had ordered a Chicago-style pizza for dinner last night and, as expected, there were leftover slices after we gorged ourselves. The plan was to take one of these massive wedges of dough and cheese to work for lunch. A good plan: easy, quick and needing minimal effort in the morning to prepare. Things did not quite work out that way.

I got up, did my stretching, drank my green tea (this is California after all) and took out the container with the pizza and set it on the counter. After a quick bathroom break, I returned to the kitchen and realized lunch still needed to be made. After moving aside an annoying plastic container, I laid out bread, cheese, roast beef, tomato and lettuce. Just at the point of finishing the sandwich and putting it into the waxed paper bag, I looked down and saw the pizza sitting right there on the counter were it had lain, forgotten (indeed, even shoved aside) during the process of making the sandwich. It turns out that my brain is just as capable of being distracted and forgetful 4 weeks after finishing treatment as it was during the height of treatment. You could say that there is nothing like the feeling of foolishness that accompanies this sort of brain lock, but I have felt it so many times during the past many months that it has become all too familiar. Here’s hoping that the brain fog starts to burn off in the near future.

The silver lining was that the pizza was just as good for dinner as it would have been for lunch.

Coming Back To Life

2011-08-01T17:58:00.000-07:00

I finished my course of treatment for Hepatitis C on June 30, 2011. The last 6 weeks were particularly tough with bouts of nausea, some dizziness, decreasing red blood cell counts, consistent exhaustion and increasing mental fog. Eighteen months of interferon and Ribavirin apparently do a number on us humans. The good side is that at the end of the treatment cycle, the viral load was undetectable with negative viral activity. Now we wait for 6 months until January of 2012 for the follow-up test to determine if I have stayed negative and thus qualify for having a true Sustained Viral Response or SVR. It brings to mind the song from the Mel Brooks movie “The Twelve Chairs” with the chorus:

“Hope for the best, expect the worst
Some drink champagne, some die of thirst,
No way of knowing which way you’re going,
Hope for the best, expect the worst.”

By the way, did you know that Mel Brooks wrote the music and lyrics for the songs in his movies.

So we are hoping for the best over the next six months (though the thought that the next test occurs in 2012, the year of the end of the world certainly tempers the enthusiasm).

We return to the subject of the post after that small digression. On about the 8th or 9th of July, I was lying on the sofa catching up on the episodes of “Mob Wives” I had missed, when I thought about unloading the dishwasher and tidying up the kitchen counters. For months, this sort of urge was met with the thought that it could be put off until later that night or tomorrow or to some indefinite time in the future. But on this occasion, I arose from the sofa, walked to the kitchen and actually unloaded the dishwasher and wiped down the counters. It was the first sign that some mental and physical energy was returning. Over the next few days, I began to do a bit more. It was a great feeling to experience energy as opposed to lethargy. It genuinely felt like I was rising from the depths back to life. It’s going to be a long, slow struggle back to normalcy by all accounts, but as the old saying goes, “every journey begins with a single loading of the dishwasher.”

Puzzling Evidence

2011-03-09T20:25:00.000-08:00

Viral Load Blips Up and Then Back Down

What I feared came to pass at the end of December; I did indeed have a viral breakthrough. My viral load blipped up to 430 IU/ml. This is a relatively small number, though it is a log scale rise from the less than 43 that is undetectable.

It happened at the end of the year, during our open enrollment period when I was not sure whether I would still have the same insurance that would allow me to stay at California Pacific Medical Center (CPMC).

It happened while some of my health care team was taking some well-deserved time off from work.

It happened while I was scrambling to make sure I would have continuity in my medications as all my meds were running low. (While we are told at length not to let our prescriptions run low, the insurance companies will not let you renew expensive meds early.)

This led to three decisions about the disease.

One, there was not a follow-up test to determine whether the breakthrough was real or a false positive. No one knew whether I was going to be covered and no one wanted to be out of pocket the expense of a confirmatory test.

Two, Dr. Bzowej decided that it might be best to discontinue treatment. This was the second time I had a viral breakthrough at 24 weeks on two separate types of therapy (the RG7128 test and the Standard of Care therapy). She felt that I might be the sort of patient that needs 3-drug therapy.

Three, I had finally gotten my meds renewed just before my coverage changed and since I had a month’s worth of Interferon and Ribavirin left, I thought that I might as well keep taking it until it was gone. There was also a brief period of time when I thought I would continue at CPMC, so I thought that I should keeping taking it until the monthly test at the end of January and see what was happening.

I kept up my medication schedule through the month. Though by the end of January, I knew that I would not be covered for CPMC after February 1st, I went in for the viral load test anyway. By the time the results came back, my coverage had expired but the Nurse Practitioner at CPMC, bless her heart, called my with the results anyway. I was back to undetectable. Good news but what did that make the December test, true viral breakthrough (not good) or false positive (not bad)? We’ll never know

When I started at Kaiser, they tested my viral load on February 10^th. I came back undetectable in that one as well, though they said there was qualitative detection. That means that there is some evidence that there is still viral activity, but it is so low that it cannot be counted. I am not completely sure what that portends as depending on what you read it is either very bad or indeterminate.

I have been keeping to the medication schedule and go in tomorrow for another viral load test. We’ll keep moving forward.

As a final note, the TV show Royal Pains comes back this summer for another season. Write in and let the producers know we want to see more of “Fisherman Jim” so we can follow the course of his treatment for Hepatitis C. I believe he is the only character on a prime-time TV show with Hep C. I hope he recovers well on the show, but given that he is still running a fishing boat while undergoing interferon and ribavirin treatment, he sure makes me feel like a wuss. That’s the magic of television…

Health Care versus Health Insurance

2011-03-01T17:20:00.000-08:00

When last I wrote, I was just about to institute a change from the good people at California Pacific Medical Center (CPMC) through Blue Shield insurance to the Kaiser Permanente Health Maintenance Organization. Our organization changed its insurance policies and the only affordable option was to go with the Kaiser HMO. From my first appointment with my new Primary Care Physician (PCP) it was clear that Kaiser’s approach is very different from standard insurance. It is the difference between a Health Care Organization and a Health Insurance Organization.

I made an appointment to see my new PCP - which appointment I was able to get for only two days after I called. I picked my new doctor from a roster of available doctors because she had been working in the Chinese community on some Hepatitis B projects and thus was already familiar with Hepatitis cases. When I went in to see my PCP, I brought along my lab reports and health summary updates from my doctors at CPMC. I gave her my data and she began asking questions and typing lots of information into my medical record via the computer in the examining room. My biggest single concern was making sure that my meds, which were running low, would be able to be continued and that I would not miss doses in my treatment regimen. She started entering in my various medication and doses, checking instantly to see if the same drugs were available and in stock at the pharmacy. On her own authority she was able to prescribe all my meds and send the prescriptions through to the pharmacy via computer. This included pegasys and ribavirin as well as the thyroid medicine, the antidepressant and the sleep aids. You could have knocked me over with a feather. She then forwarded my records over to the gastrointestinal department and told me that someone would be calling me that afternoon to go over my information and set up an appointment. She also made instant referrals to the psych department to set up a neuropsych evaluation as per Dr. Bzowej’s recommendation and to some various other departments to handle some other health issues unrelated to the Hep C. This all happened in a 40 minute appointment in which, despite her working at top speed – especially in data entry, never felt rushed. She then gave me her card with email and phone contact info and told me to call her with any further questions. I walked out of the appointment in shock.

Compare that to what Blue Cross (or Blue Shield, Healthnet, Aetna – I’ve had them all over the years) would have done. I would have seen my PCP. They would have had to write a referral to a Hepatologist. The referral would have to have been approved. I would have seen the Hepatologist. That doctor would have had to prescribe the meds I need for treatment. The prescriptions would have had to be approved by the insurance company. I would have had to go through a specialty pharmacy to get the meds. I have no idea how long that might have taken even if there was an attempt to expedite the process due to my ongoing condition.

It is all due to the difference in business model that each type of organization has. Kaiser’s model is that I pay a monthly fee for my health care. They make money (they are a non-profit corporation, but they need to at least break even for all this to work) through efficiency and by rationing care. If you are seriously ill they are on the job, if you have a sore throat you had better have had it for a long time before they are going to set you up with a doctor’s appointment. The whole implementation of computerized records and paperless referrals means that they save beaucoup bucks in paperwork costs. They also are proactive with immunizations and diagnostic tests because they are aware that early detection of disease means that treatment is easier and cheaper. They have their problems to be sure, but they offer good care.

The insurance company model is that you pay a monthly fee for insurance against illness. They make money by limiting your care. They do this by making referrals and authorizations for treatment difficult to get. They also are very careful in how much they pay to doctors and hospitals for treatment and frequently deny payment or portions of payment for treatment. They are less likely to emphasize preventive care because that costs money out of pocket and you might never get that particular illness while insured by them. On the other had they offer considerably more flexibility in whom you can see and where you can see them for care.

Going forward will be an interesting journey, but the first experience has been very good and at least I was able to continue uninterrupted treatment.

P.S. The gastroenterologist really did call me back that afternoon and he set up an appointment for only three days later…

More Dread – Heath Insurance Woes

2011-01-26T23:57:00.000-08:00

Insurance Plan Change Forces Change Of Doctors

The new year continues its run of good news as I found out that none of the health care options (the ones I can remotely afford anyway) that are available to me under our organization’s new health insurance plans, allow me to continue with the team that has been currently treating my Hepatitis C.

As several of the recent posts have detailed, our organization changed its health insurance broker and plans for the upcoming year. In order to save money (and I can’t really argue with this as the insurance costs for the organization have risen 40% for this year), they subscribed to Blue Cross “Select” and Heathnet “Silver” insurance plans in addition to the standard Kaiser Permanente plans that have been offered for years. While initial and even follow-up research indicated that my doctors were contracted with both Blue Cross and Healthnet the final determination that came through the brokers was that, while they are contracted to both Blue Cross and Healthnet, they are not contracted with the two stripped-down plans that our organization subscribes to. I could subscribe to a PPO that includes my doctors, but the monthly cost would total more that $4,000 per year, plus the $4,800 in yearly drug co-payments, plus very high deductibles on any medical procedures and hospitalizations that might occur and I just can’t afford to pay those kinds of fees on my income here in one of the most expensive cities in America.

On the positive side, I still have health insurance. It will be through Kaiser Permanente and will be funded by my employer. Kaiser does good work and has good doctors. Even the treatment nurse who has been handling my care at California Pacific Medical Center, was hired away by Kaiser and he is top-notch. The only problem is whether I can manage the transfer of my treatment to Kaiser during the relatively small window of time until my prescriptions run out. I have to get a primary care doctor, have him refer me to a hepatologist, have my records transferred and have my meds continued during a time period of about 20 days. I get to find out how much stress and complication I can handle with a Swiss cheese brain and a 30-day supply of anti-depressants. But that’s the modern world we all have to cope with, so the best thing to do is buckle down and dive in, to mix up some metaphors.

There are lots of people in much worse shape than I am. There are folks with the disease and no health insurance who depend on the largesse of drug companies or aid programs. There are people on waiting lists for liver transplants that are watching their window of opportunity close on them. There are people even with health insurance who are paying huge chunks of their income or going into debt to get access to treatment. I am in none of those positions and I appreciate that more than I can say. I would just like to get some good news at the start of the year. Maybe the Giants will trade for a right-handed bat, the Niners will sign a quarterback, or the Warriors will make the play-offs. I can feel my immune system recharging already.

A Creeping Sense of Dread

2011-01-24T20:01:00.000-08:00

Holiday Stress Equals Erratic Meds

I’ve been in treatment for 57 weeks and have been negative since the end of September, but I am approaching my upcoming viral load test with a great deal of trepidation. The month since the last test has been very difficult. The holidays were not a happy time for my wife and I as there were job problems, family problems and the general high stress levels that the holidays can bring.

The combination of all the stress with my growing inability to concentrate and remember resulted in my missing 3 afternoon doses of my meds during the 10 day period following Christmas. This makes me very edgy as it was the combination of skipped interferon and lowered Ribavirin doses that led to the viral breakthrough that bounced me out of the RO5024048, RG7128 study last June.

In this case, I did not miss any interferon doses, but I did miss 3 partial doses of Ribavirin in a relatively short period of time. This was effectively similar to the lowered Ribavirin doses of late May before the breakthrough. Ribavirin by itself does not seem to have a strong direct antiviral effect on the Hep C virus, but it does contribute a great deal to continuing to hold the virus in check once the interferon has pounded it into undetectability. Therefore reducing the dose, whether deliberately or through simply forgetting to take the drug, can have a significant negative effect on continuing to be undetectable.

The strange thing is that I cannot remember forgetting to take two of the doses (I realize how silly that sounds given the state of my brain by this point but nonetheless…). I can only remember the sick feeling of getting up the next morning, going to take my meds and finding the closed container labeled Monday p.m. that still contained my previous evenings dose. It was bad enough the first time, but two days later on Thursday, exactly the same thing happened. I thought I had done my duty, got up the next morning and found the container with the dose on the table. I knew that it was serious, that I had to stay on schedule and yet I had forgotten again. The thing that knots your stomach is the knowledge that you have screwed up and you can’t go back and make it right. The opportunity to stay on the schedule is gone and the best you can hope for is that it hasn’t compromised your treatment.

Several days later, I missed the third evening dose. This time I figured out what happened and decided that yet another behavior modification was necessary. I went to take my evening dose, sat down and opened the container with the meds in it and then my cell phone rang. It was someone to whom I rent space in my studio so I took the call. It took a while to figure out the problem and by that time I had forgotten to take the dose. However, since I had specifically gone into the room to TAKE the dose, when I thought about it later that evening, I confabulated the memory of actually taking the meds. Again, the increasingly sick feeling in the morning when I found the open but full container on the table. I decided at that point that I would immediately take my doses the moment I thought of them from that point on and it has worked excellently since then. It doesn’t matter if the phone rings, my wife is talking to me or I have to run to the bathroom; when the thought of my evening dose crosses my mind, I get up right then and go take it.

I cannot stress enough the importance of keeping your dosing schedule (your doctors, nurses and everyone else all stress the same thing, so I know I am preaching to the choir). If you have to put signs all over your home, rubber bands on your wrist or tattoo it to your forehead; do whatever it takes to stay on your schedule and not miss a dose.

I hope it doesn’t screw me up, but it was a bad end to last year and a tough start to this one, so I am looking at this test the same way you look at the door into the dark basement in the horror movie – don’t go down there and don’t split up.

Heprat’s Coverage Is In The Health Insurance Twilight Zone

2011-01-05T20:52:00.000-08:00

The following story is sadly not unique to my situation.

The phone call came from the HR director of our organization. He told me that our health insurance broker had called him with the information that my primary care physician (PCP) only had a contract with Anthem Blue Cross (world’s scariest health insurance company) as a specialist, not as a primary care physician. Therefore I would have to find a new PCP. I had been going to my PCP for 12 years through 4 insurance carrier changes. For the entire time he had been affiliated with a physician group that has contracts with every major health insurance company. Something did not smell right about this ruling.

My PCP had written all my referrals to specialists for my Hep C treatment. He had written several of the prescriptions for the drugs to manage my Hep C side effects. If I had to find a new one, the new doctor would have to get up to speed on my condition, reinstitute all my referrals and prescriptions and do it all by the 10th of January when my supply of Ribavirin would start to run out.

Heprat, man of panic and desperation, sprang into action. I called my PCP’s office. They told me in no uncertain terms that they had a PCP contract with Blue Cross as many of their patients had Blue Cross insurance. I went to the Anthem Blue Cross website, searched for PCP physicians within 2 miles of my home and my doctor appeared on their list of Primary Care Physicians. Not only that, but the doctor code for his PCP status was listed and it said that he had an open practice and was currently accepting patients. Armed with this information, I called the insurance broker for our organization. I explained my situation and they repeated that according to the website of the insurance broker they used, my doctor was only contracted as a specialist; they even went online and checked it while we talked. I told them that I was looking at the Blue Cross website and on that site it clearly stated he was a contracted PCP. I reminded them that the broker website they used for their information had been wrong about the Blue Cross drug formulary and wrongly stated that my hepatologist was not a Blue Cross doctor. They grudgingly admitted that the Blue Cross website might be more accurate than their broker website and agreed to resubmit the paperwork with the codes I provided them from Blue Cross. Now we wait on Blue Cross to process the paperwork.

The Ribavirin runs out on the 10th of January. The interferon runs out on the 14th of January. My thyroid medication runs out on the 9th of January. The Celexa runs out on the 17th of January.

I suspect my neighbors think I am either insane or being brutally beaten as I have spent several minutes the past few afternoons walking around the house and screaming. It sounds terrible but it really does help relieve the stress. For all of you out there in this same situation, I recommend screaming. It lets out your feelings and leaves you so damned tired that you don’t have enough energy for an anxiety attack.

The Magic Bullet Theory

2010-12-21T21:42:00.000-08:00

Waiting for the “Next Best Thing”

Last Tuesday was the annual Holiday Pot Luck for the twice-monthly Hepatitis C support group that meets in the California Pacific Medical Center Pathology Conference room. There were about two dozen people there and, in the tradition of potluck dinners everywhere, enough food for twice that number. Best of all, there were plenty of desserts.

Of the two dozen people or so people attending, about half were either currently in treatment or had successfully completed treatment; another quarter had undergone treatment and either failed to respond or the virus had reappeared after the completion of treatment and the last quarter had yet to make a decision about treatment. About half the folks who had successfully completed treatment and never had a recurrence of the virus were people with Hepatitis C genotype 2. This genotype has about an 80% chance of clearance, and excellent prospects of a sustained viral response, with 24 weeks of standard interferon and ribavirin treatment.

After people had settled down with their plates of food and glasses of non-alcoholic libations (ginger potions of all sorts were quite popular), everyone reported on their general state of health, how they felt and any significant issues they had that might be caused or intensified by the disease or their treatment status. Several common themes emerged as people told their stories.

The people who had successfully completed treatment reported that by and large they felt they were back to normal functioning (one individual reported that she felt that after 2 years she still did not feel she was back to her previous cognitive function level). They felt their energy had returned, they no longer had shortness of breath, their strength was back and generally they were physically in good condition. Most felt that their mental faculties and their memory had returned to pre-treatment levels as well. To a person, they reported that it took considerably longer to return to full function than the time that is considered standard by the medical establishment. The usually quoted time to recover from the effects of interferon, ribavirin and the other associated drugs used in treatment is 3 to 6 months. Everyone reported that the time it took them to recover from treatment was in the range of 6 months to 1 year with a few reporting longer times than that.

The people currently in treatment (and for that matter, the folks who had completed treatment) reported two side effects as most debilitating: fatigue and brain fog. The fatigue ranged from merely difficult to extreme with no one reporting only mild fatigue. That said, person after person stated that the most irritating and frustrating side effect was the cognitive deficit associated with interferon brain fog. It was not just the increased memory difficulties, it was the inability to concentrate, the ease of distraction, the loss of train of thought that drove everyone crazy. Most folks also reported nausea of varying degrees, insomnia, sweats etc.; but those paled in comparison to the frustration of brain fog and the annoyance of being tired all the time.

The rest of the people at the meeting, the non-responders to treatment and the people yet to attempt treatment, all had the same outlook: they were waiting for the new and better drugs to become available. They had very different reasons for this viewpoint, but it was surprising to see the uniformity of their point of view.

The non-responders and fail-to-sustainers had all failed at the standard interferon and ribavirin treatment. They and their doctors had come to the conclusion that the two drug standard treatment was not going to successfully defeat the virus in their bodies. They need the additional punch of one of the new drugs in order to have a real chance at success. You can’t argue with that conclusion, when what is available has failed, you have to await further developments to move forward.

The people who had not done any treatment had different reasons for waiting for the next new and better drugs. Many were afraid of the side effects but most were looking for a therapy with a better chance of success that the standard therapy. The standard treatment has about an 80% chance of clearing genotype 2 Hepatitis C. It has a 40-45% chance to clear genotype 1 Hepatitis C. The drug most likely to be approved next is Telaprevir, a protease inhibitor (Boceprevir, a similar protease inhibitor is supposedly not far behind). Telaprevir has demonstrated in research testing that, in combination with interferon and ribavirin, it has a genotype 1 clearance rate of about 60-65% (Boceprevir has similar test results). On the surface the reasons for waiting for the new drugs are clear-cut, 60% is a much better chance than 40%. There are a lot of other factors to consider before pinning one’s hopes on the next best thing, however.

First is the discovery of variations in the IL28B gene and how these variations affect response to treatment. If you have the CC variant of the gene, the evidence indicates that your chances of responding well to standard treatment rise to the 60% level, or about the same as the telaprevir response rates. The test to determine which variant you have is available, not extremely expensive and clearly gives information you can use to make a decision about treatment. For a more info the link is here.

Secondly, the new drugs are not assured of either approval or timeliness. The latest Telaprevir application was submitted to the FDA in November, 2010 which means a decision is 6 to 10 months away. Boceprevir has not even reached the “it’s coming in the next x months stage of rumor yet.” There is also the, admittedly small, chance that Telaprevir is never approved. I have many friends who are in the gene-splicing and drug development fields who report a number of instances when companies were extremely confident of FDA approval only to be turned down during the final application. The FDA might come back with concerns that require further testing or additional data submissions, all of which could move the timeline much further out. The promising new polymerase inhibitors (RG7128 and RO5024048 for example) are only just beginning phase II trials which means they are at least 3-5 years away from any sort of approval and only if they succeed in further trials. There are other drugs even further away, etc.

Thirdly, these new drugs are expensive. They project to be about twice as expensive as the current interferon and ribavirin. The plan is that you only need 24 weeks of treatment, but it will be a very expensive 24 weeks. Therefore the question of once the drugs are approved how long it will take for them to be added to insurance company drug formularies so they will be covered by your insurance becomes extremely important. As we all know, insurance companies can be quite recalcitrant about approving new therapies.

Finally, there are all the considerations about your personal situation. What stage is your liver disease? What is your viral load? What is your general health? How old are you? These questions only start to list your issues. What is your financial situation? What is your insurance coverage? What is your work situation? Do you have solid family support? If you have to go on disability, how would that affect your job future? Can you even tell your employer, family, friends and coworkers that you have the disease? All of these and more are considerations that may be more important than the rates of viral response of the various drugs.

Remember two things as think about all the ramifications of when and how to deal with your Hepatitis C: first, there is always a newer, shinier, more promising therapy in the future and second, the best is the enemy of the good.

Ode to California Pacific Medical Center Hepatology Center

2010-12-15T21:59:00.000-08:00

Today was my bi-weekly blood test. It was a quick and dirty one-tube wonder that measured the standard blood chemistry, hemogloblin, neutrophils, white and red cell counts, etc. It was a screening day for folks who were applying to be in one of the upcoming drug trials, so there was a bit of a wait at the Hepatology Center lab. They have a TV in the waiting room playing nature DVDs on a continuous loop with the sound turned way down. Anyone who has read much of this blog knows how much I like watching concentration free video, so it was not a burden to sit in a comfortable chair and wait my turn.

While waiting my managing nurse from the Roche drug trial (RO5024048 or RG7128 depending on which company you favor) AVB saw me and stopped by to chat me up. Actually she just sat down to ask how I was doing but we older guys can always dream. We talked for a bit and she asked if I was still on treatment, how much longer it was to last, if I was negative, whether I was still working and how I was coping in general. (I asked about her mother and she told me that she was fine, but probably needed to have somebody to talk to outside her family).

I gave her the lowdown on how I was doing – still on treatment, 54 weeks in 24 to go, I have been negative for 12 weeks now, I am still working 4 days a week and aside from feeling very tired all the time and stupid some of the time I felt I was doing okay. Like many people with experience in either undergoing or administering Hepatitis C treatment, she was surprised I am still working. She urged me to make sure that working was not taking too much out of me. She emphasized that if work wore me out too much, it could inhibit my ability to succeed at treatment and that I have to remember to think of my own health first. She reiterated something that she told me several times when I was in the experimental trial, that they would write the papers for a disability claim for me whenever I felt it was necessary. We talked briefly about our holiday plans; she patted my knee (see what I meant about chatting me up…) and went about her business.

I mention that meeting because it is characteristic of the vast majority of interactions I have had with the staff of the CPMC Hepatology Center. From the folks at the front desk to the people who draw blood, to the nurses, technicians and the doctors themselves, they all exhibit genuine concern and care for their patients. I am a relatively relaxed patient in most circumstances, but I have seen them show tremendous patience with difficult, disturbed, confused and unresponsive patients. They are gentle with the physically challenged, explain in great detail the nature of diseases and care, are helpful with the people for whom English is not a first language and generally kind and concerned with those under their treatment.

When they are dealing with me personally, I never feel that they are rushing me through our appointments. They answer my questions (and in fact are more than willing to grill me about how I am reacting and whether previously reported symptoms are still present) and explain medications and procedures until they are sure I understand what is going on. My nurse Alex (who, sadly, is leaving for a better paying job with another health organization) goes so far as to leave messages on all my various phones and then insists I call him back to make sure that his information has gotten to me. Dr. Bzowej has first-rate knowledge of the field and has a warm manner that is a great comfort during a trying time.

There are folks I know (a few in the local Hep C support group) who have not had experiences as positive as mine at CPMC. My wife claims that some of my experience is because I am a good person and that difficult people tend to have difficult experiences but she is not exactly unbiased in her analysis. Nonetheless, I have to say that the CPMC Hepatology Center and the people who staff it have been great to me and a huge reservoir of support for the past year. Let’s hope they only have to play that role for me until next May and that they never have to treat me again after that.

Another Day Another Insurance Functionary

2010-12-08T20:59:00.000-08:00

It is amazing how exhausting phone conversations with health insurance bureaucrats can be. After composing and sending several emails, I hit the phones to try for more direct answers concerning the details of the potential coverages available to me. I talked to a number of folks who ran the gamut from clueless, bewildered, helpful but clueless, helpful but wrong and helpful and possibly correct. The problem is that determining the difference between the final two types, helpful but wrong and helpful but possible correct is neither easy nor readily apparent.

After sending a set of detailed questions to my HR department, they punted me further on to the insurance broker who handles our account. They were nice folks and quite helpful, but the insurance plan drug formulary comparison tool on their website indicated that Neupogen and Ribavirin were not in either the Blue Cross or the Healthnet formularies. I found that a bit hard to believe as both are large health care providers and must have more than a few Hep C patients. I managed to track down the pdf file of the actual Blue Cross formulary updated as of November, 2010 and all the drugs I am taking are in their formulary. Naturally, this does not raise one’s confidence level about the quality of the answers to the other questions I asked.

The two other questions I asked were about the drug copays for specialty drugs and any special tasks I needed to complete to insure continuity of care. The drug co-payment information they provided was straight out of the handbook and concerned the difference in co-payments between generic and brand name drugs, it did not address the specialty drug question. It may not even be an issue, but, again, it’s all up in the air until the actual paperwork goes through.

As far as continuity of care: heck, not a problem. Just let everyone know as soon as possible that the change in plans is occurring, get them to write new prescriptions for everything you take, get authorizations from the insurance company for all of them and have it all happen before any of the current scrips run out. Oh, and have it all happen during the highly productive holiday season.

If only they could switch the open enrollment period to some other time of the year...Ho! Ho! Ho!

The Joy of American Health Insurance

2010-12-07T18:08:00.000-08:00

Two days ago the employees in my organization entered our annual health insurance open-enrollment season. While this has always been a pain in the butt process, it assumes greater importance given my current situation. Considering that I have 22 weeks left to complete my course of Hepatits C treatment, continuity of care becomes an issue of primary importance.

I currently have Blue Shield insurance. I enrolled in Blue Shield when my organization’s health care broker dropped my previous insurance company. This year, they have dropped Blue Shield from their list of available plans. They have substituted Anthem Blue Cross, one of the more notorious insurance companies in the country and Healthnet, one of the most expensive. Just the sort of additional stress one looks forward to at this most wonderful time of the year.

I am currently enrolled in an HMO under the Blue Shield umbrella. This is not an HMO in the traditional sense of Kaiser Permanente or Group Health; that is a company that owns it’s own medical facilities. Instead Blue Shield contracts with physician groups and hospitals that provide the same services as a HMO. My physician group is associated with both Blue Shield, Healthnet and Blue Cross, so I should – emphasis should – be able to transfer my care over to one of the other umbrella payment plans without a great deal of difficulty. Even if that is the case, however, there is no guarantee of consistency in the drugs each organization has in their drug formularies and particularly in the amount of co-payment they charge for the more exotic drugs necessary for treatment: Pegasys (interferon), Neupogen, Procrit and Ribavirin. Currently my co-payments for these bad boys run about $315.00 per month. Will the number go up, down, sideways? Inquiring minds want to know.

I have begun my research, of course. I have a series of questions in to my HR department, such as it is; I have called my specialty pharmacy to initiate inquiries as to their knowledge of co-payment differences; I have talked to my doctors about the necessary paperwork I will have to produce to ensure that I will have uninterrupted care. Oh yes, I have ten days to make my decision.

Would that our country was a sane one and health care was viewed as both a necessity and something citizens could expect from the taxes they pay. Thank heaven I at least have an employer that provides health insurance plans or I might be living in a box right now – the actual retail cost billed to the insurance company for the drugs I take on a monthly basis is just over $7,000, quite a bit more that I make in pay.

Soon enough information will come pouring in and decisions will be made, I can hardly wait for the conversations with insurance functionaries, Joy To The World, eh?

Science Café About Hepatitis C Research

2010-11-23T21:01:00.000-08:00

San Francisco has a thriving science and nerd community. A symptom of that is the wide array of science events that occur throughout the Bay Area every month. One of them is a monthly series titled “Science Café” in which a scientist or two is inveigled to come to a local café and talk for a few hours about their area of expertise. The most recent event was about Hepatitis C.

The Atlas Café was the scene and the scientists were Dr. Melanie Ott of the Gladstone Institute who researches the reproduction cycle of the Hep C virus and Dr. Todd Frederick a Hepatologist at the California Pacific Medical Center who treats Hep C patients. As a disclaimer I must mention that Dr. Frederick has examined, palpated and prescribed for me as part of the Polymerase Inhibitor study I was in.

Dr. Frederick gave an overview of the scope of the Hep C epidemic and the nature of current treatments available to combat it. He talked about the new protease inhibitors Telaprevir and Boceprevir that are awaiting FDA approval to be used in combination with interferon and ribavirin. He also gave a hint at possible future therapies using polymerase inhibitors with interferon and ribavirin and the possible combination of polymerase and protease inhibitors with ribavirin to create a treatment regimen that does not use interferon.

Dr. Ott gave us a basic yet thorough crash course in the reproductive cycle of the Hep C virus. She revealed its dependence on fat molecules in human cells and the promising area of research involved in using fat disabling compounds to interfere with the ability of the Hep C virus to reproduce itself. She also had a very cool animation that illustrated the reproductive cycle of the virus. She was quick to state that this was still basic, in the petri dish research and many years away from demonstrating efficacy in living organisms. It was fascinating stuff and the crowd of 30 was intent throughout both presentations.

A few of the questions asked in the Q & A were about the new compounds being developed and particularly about the issue of deciding whether to treat now or wait for new developments. Dr. Frederick clearly attempted to be balanced in his answers, but as a doctor involved in clinical trials of promising new compounds he is really exited about the possibilities of the new treatment combinations and he showed a bit of a bias towards waiting for new developments.

I respect Dr. Frederick’s viewpoint a great deal, but I think if you are seriously considering entering treatment, you need to consider a wide range of factors beyond the simple consideration of treatment outcome percentages. The condition of your general health, the condition of your liver, the amount of impact the disease is having on your quality of life, your family situation, your housing situation, your work situation, your insurance situation, your financial situation, the quality of support you can expect, all of these are important factors to consider in your decision. We still don’t know when the new drugs will be approved, how quickly they may be included in insurance company covered drug rosters, and how much they will cost (though we do know they will be expensive). So think it all through thoroughly and carefully before making a decision. While the future may be so bright we gotta wear shades, the shades might be very expensive and the future a bit further off than we would wish.

Personal Evidence of Cognitive Deficits from Hepatitis C Treatment

2010-11-17T21:51:00.000-08:00

I am writing this piece having finally managed to tear myself away from the television after watching almost 90 minutes of the Adam Sandler vehicle “You Don’t Mess With The Zohan.” If that is not evidence enough that 46 weeks of treatment have eroded my mental capacities, let me add this nugget: I had to get up, go downstairs, turn the television on and check the listings to remember the name of the movie. Having walked away from the TV not 3 minutes earlier, I could only remember that the movie had the word Zohan in the title but could not recall the complete title.

In the past 6 months of treatment, my critical capacities have deteriorated to the point that I have descended from watching “Celebrity Rehab” through “Jersey Shore” and “Basketball Wives” and now am watching, and more embarrassingly being entertained by, Adam Sandler movies. I have 26 weeks to go in my Hep C chemo regimen, what will I be watching by next June, “Jackass 7, Stupid Geezers in 3D”?

The sad part is that I cannot help myself and neither it seems, can other Hep C chemo veterans. Almost everyone I have talked to about their treatment has admitted that the same thing happened to them. The lucky ones were finally so tired and concentrationally challenged they could not even muster the energy to pay attention to television and just sat staring into space. I suspect that would be preferable to Rob Schneider, Johnny Knoxville, Dane Cook or whatever else might be passing in front of my eyeballs by the end of this.

It is disconcerting to think that this result has a tiny chance of remaining permanent. While I might end up being perfectly happy as a drooling idiot for the rest of my life, I suspect my wife would find that less charming.

But, looking on the bright side, when I finally stop the interferon I can document in painful detail the increase in brain function, the gradual increase in my boredom threshold and the return of my memory. Given that I’ll be approaching 60 by the time I fully recover from all this, I wonder how I will be able to tell if my memory is back or not…

I admit that all of this is anecdotal evidence from a small set of treatment-experienced individuals and does not attain the level of statistical validity, but it is nonetheless disturbing. I’m not sure what would happen if I started to bug my wife to come with me to the latest Adam Sandler classic on opening night.

Managing Serotonin Update

2010-11-09T20:52:00.000-08:00

It’s been just over 4 weeks since I cut down on the drugs that affect the serotonin levels in the brain. I was taking trazadone for sleep, tramadol for pain and daily doses of Celexa for depression. I cut out the tramadol and the trazadone and, after consultation with my hepatologist Dr. Bzowej, replaced them with Ambien and Vicodin. The results have been significant.

I have noticed that I am physically calmer. My hands are steadier and the random muscle twitching I have been experiencing has receded a bit. I still have all the hyperactivity behaviors I’ve had all my life (leg bouncing, pacing, etc.) but I am not as physically tense and tight as I was 4 weeks ago. My teeth-clenching and grinding have both subsided and the tendency to get caught in negative mental feedback loops (or to put it another way, become obsessed with other people’s irritating behavior) has also declined. Not to be continually catching myself thinking about other people and their foibles really reduces the stress load.

Among the downside to the change is that I am now using Vicodin for pain. Tramadol was relatively mild in its mental effects compared to vicodin. The days I have to take two doses to relieve the aching and allow sleep leave me loopy while I’m taking it and groggy the next morning. Given that serotonin overload can result in seizures and occasionally death, I’ll deal with vicodin’s side effects, it’s just that losing even more mental acuity while I’m taking it means I have even less to work with.

Ambien works differently as well. It is not as strong as trazadone. That means that I don’t wake up groggy, but I also wake up much more during the night. Trazadone would generally allow me to get at least one stretch of 3-4 hours of sleep during the night. The ambien puts me to sleep more gently but also not as deeply and I generally sleep for no more than 2 hours at a time. I wake up feeling rested so it is apparently having the desired effect, it just accomplishes it differently.

The change in medications has done me good. This reinforces the fact that you have to pay close attention to your own physical state and close attention as well to your drugs, their doses and their interactions. Don’t be afraid to talk to your doctor about any symptoms you think may be related to any of your drugs. They can’t help you if you don’t talk to them. Make sure that you get your questions and concerns are answered in any meetings you have with your doctors and nurses.

Now that my mental state is calmer and steadier and my energy is returning after the emotional roller coaster of the San Francisco Giants World Championship drive, I hope to have more frequent postings. Thanks to all of you who have commented and offered support. I hope the rally thong ends up in Cooperstown…

Memory Deficit Side Effects May Be Permanent

2010-10-30T14:50:00.000-07:00

There was a guy I knew years ago who had the talent of entering a conversation about almost any subject with the line, “let me tell you a story about that.” Strangely enough, the story was relevant to the subject an uncanny amount of the time. I don’t have that same talent, but that won’t stop me from starting off with a story.

The day that I got the news that my viral load was undetectable or “negative” in the parlance of the hepatology folks, I wrote an entry about the motivation that gave me to pay special attention to my drug dosing regimen so as to give myself the best chance to succeed at having a sustained viral response at the end of treatment. Motivated though I was, I forgot both my evening Ribavirin dose and my evening injection of interferon on that very day. This was not disastrous as I had already taken 600 mg of ribavirin in the morning and I was able to give myself the interferon the following day. Nonetheless, it shows the power that interferon brain fog has to confuse even in the face of sincere dedication.

The following week I had my regular appointment with my hepatologist Dr. Bzowej. We discussed my test results, my general state of health and how I was reacting to the medications I was taking. I went over the various physical reactions I was having to the drugs and how those reactions had changed over time. She then quizzed me about my mental state. I told her that my memory had deteriorated quite a bit over the course of treatment and that my ability to concentrate and solve problems had also taken a hit. These are expected side effects of the interferon and ribavirin drug combination, but Dr. Bzowej had some new information about them that is quite disturbing.

The memory and cognitive deficits that Hep C treatment inflicts on those who are undertaking it have been believed to be temporary. When the patient stops taking the drugs, those side effects gradually disappeared and the patient returned to the same mental acuity they had before treatment began. This is apparently not always the case. Dr. Bzowej related that in the past year, she has had two patients whose symptoms have not improved. Their memory and concentration problems have remained over a year after no longer taking interferon and ribavirin. She is concerned enough that she referred me to a neuro-psychology specialist for a set of tests to determine my current memory and cognitive abilities. She will then have me tested in anther 3 months to check whether there has been further deterioration and if so, what course of action we should take.

This scares the crap out of me. The one thing I have always been able to rely on is my brain. I have neither dazzling good looks nor great athletic ability or physical strength. I have some amount of personal charm, but certainly not enough to depend on for a living. Nor do I have vast amounts of physical or moral courage. What I do have is a good brain. I have intelligence, creativity, the ability to learn new skills relatively quickly and the ability to solve problems. This has always been the rock I could depend on, and if it crumbles, I don’t know where it leaves me. A pile of sand on the beach maybe; certainly it changes who I am and what I can do.

The same applies to anyone else considering entering treatment. Talk to your hepatologist about this issue. Ask if it is possible to be tested for memory and cognitive function before treatment begins to establish a baseline for future reference. While in treatment keep your doctor informed of the symptoms of memory and concentration loss. You have to decide if being cleared of the Hep C virus is worth the small possibility of permanent brain function damage.

I’m still glad I entered the study and am now in standard treatment, but I don’t want the price to be permanent memory disability no matter how small the chances of that happening.

Undetectable

2010-10-21T21:31:00.000-07:00

There is a certain sort of mild agony that accompanies waiting for medical test results. You want to know the results, but at the same time you don’t want to learn anything negative. It is a feeling of “please let me know the results as quickly as possible, but only if it is good news.” If the results are delayed, the tension slowly increases until you don’t care what the results are; you just want to hear something definite. I was in that holding pattern until yesterday when I finally got the first viral load numbers I have seen in a month. The tension turned to relief when I learned I was back to undetectable.

Finally, after 16 weeks of Standard of Care chemo, I am officially back to where I was after 6 weeks of the RO5024048 study. I have definitely been undetectable (under 43 IU/ml by this test) since October 6th. I may have been undetectable since September 23rd, but that was the test the lab screwed up. This means that, among other things, my liver is getting a break from the tissue damage that occurs while fighting the Hep C virus. It can begin to heal and regenerate once again.

It also means there is now a date certain (as the politicians would say) for the end of my Standard of Care chemotherapy. The hepatologists at California Pacific Medical Center (CPMC) continue interferon and ribavirin therapy for 36 weeks after the patient reaches undetectable level. That means that June 15th, 2011 will be the end of treatment. Now I can start crossing off weeks on my calendar (or maybe I can start carving marks into my desktop for each week completed) until it is over.

This is all based on the fact that I stay undetectable in each test from now until then, but I have even more motivation now to adhere as closely as possible to the “Best Practices” of the chemo regimen. (Sorry for the corporate terminology in the last sentence, but I was at our strategic planning staff meeting today where I was bombarded with bureaucratic mumblespeak up to and including “creating cross-functional workgroup plans”)

I have a deadline. There is real evidence that the interferon and ribavirin regimen is working. I will hold these facts in front of me like talismans whenever the night sweats get too wet, nothing seems worth eating and getting up the steps of the stadium to the cheap seats leaves me exhausted. It is working and there is an end in sight. It was worth the wait to hear those things.

Managing The Serotonin Complex

2010-10-14T21:33:00.000-07:00

My previous post discussed the problems I have been having because I am taking Celexa, Trazadone and Tramadol to manage side effects of my chemotherapy. I had a scheduled appointment with my hepatologist this past Friday and decided to bring these issues up at the meeting.

That plan was derailed from the start. When I got to the doctor’s office, my appointment had been cancelled. It was irritating as hell, but they did immediately contact my nurse practitioner Alex who called in the overall Hep C treatment nurse Tammy for a three-way consult. I explained my symptoms and my worries about serotonin overload. Tammy agreed with me that my symptoms could be some level of serotonin syndrome and she and Alex both said I should stop the Tramadol. I told them that the only effective means I had of dealing with the muscle pain I get each injection cycle was to take 800 mg of Ibuprofen every 4 hours. I said it worked fine, but that I had been told it was bad for my kidneys. They agreed but said that in the hepatology department they do not prescribe any opiate-based painkillers. I would have to talk to my primary care doctor in order to get anything prescribed. This sets me up for a great meeting with Dr. K to engage in some classic drug-seeking behavior. I need that stress like I need another hemorrhoid.

I also told them I wanted to change from Trazadone to something else for sleep. They were both resistant to that suggestion. Apparently Trazadone is prescribed along with Celexa and other antidepressants fairly commonly and without problems. I explained that my nervous system is sensitive to drugs and perhaps we should cut back to only one serotonin reuptake inhibitor. They told me that we should eliminate one at a time. Not a bad idea, but then they don’t feel as jumpy as I do.

That was five days ago and it has been a nasty five days indeed. I decided to stop the trazadone as well as the tramadol to try to get my serotonin levels done more quickly. The first 3 days were especially rough at night. My legs were so twitchy that I had to keep getting out of bed to walk around and tire them out. When I got back to be, I had a ten minute window to fall asleep before the twitching would start again and I would have to start pacing, It was a great deal like the symptoms described in this post, but they lasted longer and were more intense. I managed to get about four hours of sleep a night.

The past few days have been better. I have less general jumpiness, irritability and nervousness during the day. The nights are still difficult, but I have been able to get five to six hours of sleep. I am going to try some over-the-counter sleep stuff of some kind if this goes on much longer.

I think I made the right choice to get off the tramadol and the trazadone, but I certainly wish I had a better idea of how long it’s going to take for my body to settle down a bit. I have dealt with restless leg syndrome all my life, but if this goes on much longer I’ll need stronger drugs than celexa to keep me sane…

Minding Your Drug Interactions

2010-10-09T19:03:00.000-07:00

Among the disadvantages of being in a drug research study is the tendency for discontinuity in your medical care. The RO5024048 Roche study that I participated in was run by Dr. Natalie Bzowej. It was administered by the Hepatology Center at California Pacific Medical Centers (CPMC). CPMC is a first rate institution and they do cutting edge Hepatitis C research. The doctors are excellent, but as is true with specialists everywhere, they are busy people with many patients. When I screened for the study, I was examined by Dr. Frederick. For early symptoms of rash, sweats etc, I was examined by Dr. Merriman. When I had difficulty with pain issues I was examined by Dr. Bonacini and prescribed Tramadol. Later, when I was having trouble with sleep, I was examined by Dr. Frederick and prescribed Trazadone. When depression issues cropped up, I was examined by Dr. Bzowej and prescribed Paxil. and added Ativan for use as needed. After I reported difficulties with the Paxil, I was seen by Dr. Frederick again and he changed the antidepressant to Celexa Finally, my thyroid function was affected by the research meds and I was put on Levothyroxine by my primary care doctor.

Over time, this can add up to a significant number of medications creating their own set of interactions with each other that have to be carefully attended to. This is something that you should not be leaving solely to the doctors treating you. All the doctors in the hepatology center work on the same team. They are all involved in doing research and, to the limits imposed by patient and study confidentiality restrictions, they communicate with each other and share patient information. However, each doctor has preferred medications they are familiar with and prescribe regularly. This creates a situation in which each doctor is thoroughly familiar with certain meds and they may not be conversant in the effects and interactions of meds preferred and prescribed by the other doctors. You have to do your own research on the drugs you are taking and the potential interactions between them all. I found the drug interaction database at drugs.com to be particularly helpful. If you find something, contact your doctor and get their response. If you feel you need to change drugs, tell them. Keep at it until you get answers that satisfy you.

In my case, I was prescribed tramadol, trazadone and celexa. All have the effect of inhibiting serotonin reuptake in the brain. While this is a good thing for combating depression, if it results in an overabundance of serotonin in the brain, it can cause serious problems: irritability, confusion, tremor, stronger reflex reactions, sweats and potentially even seizures. I do not think these would have been prescribed together if all my symptoms had manifested at the same time. But as each was prescribed for a symptom that was occurring at separate times in the study, I ended up taking them all. There are days when I have to take all three and it is on those days that I have been noticing an increase in my some of my symptoms.

I have increased irritability, a general increase in physical tension and in activities like rubbing my hands, pacing, grinding my teeth, etc. This is all symptomatic of serotonin syndrome which I thought I experienced a few months ago. I am seeing both my primary care doctor and my hepatologist this week and will bring this all up with them both. I would like to see another painkiller substituted for the tramadol and perhaps another sleep aid substituted for the trazadone. I am not sure which way the doctors will want to go but I am tired of feeling this way and need a change.

The latest Viral Load Results – Sort of

2010-10-03T21:31:00.000-07:00

When I checked the mailbox Saturday, I saw the envelope with my latest test results. Two weeks ago when my last test numbers came in the mail, I did some serious magical thinking. I implored nature to be on my side, I beseeched luck and karma and I chanted to myself all the way into the house. This time, the site of the envelope made me queasy. I was so close to undetectable last time and want so much to finally be undetectable with this test, that fear was the main emotion I felt. I want good news. I want the prize and I don’t know how I will react if the numbers don’t back up what I want to happen.

I take the envelope into the house, tear it open and scan down the page past the white and red blood cell results to the RNA quantitative numbers. There I see this statement: “test cancelled, coding error, resubmitted to LIS.” I have been either in the RO5024048 study or in Standard of Care chemotherapy for 10 months. During that time I have had over 40 separate blood draws with hundreds of tests done on the blood. Never during all that has a test failed, been cancelled or had faulty results. But this week, when I may see the result I have been waiting for since I got bounced out of the study by the viral breakthrough, something was wrong with either the blood or the test. To say it is torture would be an insult to those who have actually undergone torture, but mental agony, yes indeed.

I will call my nurse on Monday to check if the test was redone and there are any updated results, but I have the sickening feeling that I won’t see any updated viral load numbers until the results of the test scheduled for this coming Wednesday come back in a couple of weeks.

When you are in chemotherapy your focus tends to narrow. Test results become the mileposts by which you judge your progress. They are regular points of data that you use to chart the fight against your disease. You have cycles of drug taking, cycles of side effects and cycles of results that mark your life. Missing test results have a serious psychological effect on your treatment in the same way that missing drug doses have a serious physical effect. This was the week I was going to celebrate (or weep with fear that the chemotherapy wasn’t going to be effective). Instead I am left hanging for another two weeks until I find out whether it’s hope or fear.

On the bright side, the Giants won the Western Division today and are going to the post-season. So life really is good after all…

The End Of The Season – Baseball, That Is.

2010-10-01T19:34:00.000-07:00

Fantasy Team Disappoints, Actual Baseball Exhilarates

The Vincent Black Shadows, a fantasy baseball franchise operated by your correspondent for the past 25 years in five different fantasy leagues in three different cities in two different time zones, are limping to a sixth place finish in the Tri-Tip League of Santa Barbara. It was a year that saw the team crippled by injuries, players traded out of the National League and players underachieving due to sloth, pigheadedness and the insistence of playing while injured.

The Shadows pitching staff was particularly disappointing. Young pitchers failed to develop (Paul Maholm, Chris Volstad). Veterans regressed (Aaron Harang, David Bush). Speculative signings failed to pan out (Sean Gallagher, Sammy Gervacio).

The position player side of the roster entered the season weak in power hitting. My plan to leverage my excellent farm system (Starlin Castro, Jose Tabata, Devaris Gordon) as trade bait to acquire sluggers from other teams was scotched by the unexpected early promotions of Castro and Tabata to the big leagues. Adding to my loss of trade leverage were injuries to two key players (John Baker, Mark DeRosa) and the trade to the American League of another (Conor Jackson) leaving my team with holes I could not fill.

Even with this bad luck, I was still in the hunt until late July. I was unable to negotiate the needed trades however, and even my prescient signing of new Milwaukee closer John Axford and the late season additions of Kevin Corriea and Joe Blanton could not generate the necessary momentum for a run at the money. The foundation for next year’s team is very solid, but it is cold comfort indeed here at the tail end of my third year in a row finishing out of the money.

I like to think that the brain fog produced by Hep C and interferon contributed to the Shadow’s disappointing season by impairing the decisions made by the team’s “baseball people.” In fact, now that I think of it, I went symptomatic right about the time that the Shadow’s began their decline…

Major League baseball, on the other hand, has been a delight. My old home team, the Twins are in the playoffs, the Texas Rangers managed by one of my favorite people in baseball, Ron Washington are in the playoffs and Your San Francisco Giants, with a win tonight against the Padres, will win the National League Western Division Championship. The postseason is almost upon us and I have several rooting interests and a friend who has scrambled around and secured tickets.

I am optimistically awaiting my latest viral load results, and the Giant’s game is starting up on the TV and life is good enough for now…

Less Anger, More Irritation

2010-09-27T21:17:00.000-07:00

Today was more placid than the past several days. The book sale was over save for the cleanup. We made more money than we projected we would. Even though not nearly enough people showed up to help with the load out, it still managed to get done without driving any of us to total exhaustion. Close, but not quite all the way there.

The inner dialogue today was primarily one of irritation and disgust instead of rage and fury. That is a big win from my perspective. Even though none of the dialogue ever reaches spoken form to be judged by others hearing it, it still makes me feel better that, were it to slip out, it would not sound quite so insane as it would have this past weekend.

I still set up an appointment with the difficult Dr. K, my primary care guy to sort out the thyroid situation, as it could not hurt to know the score on those meds. He can check assorted plumbing as well so we will all know just how things look from the bottom up.

Still keeping the knives sequestered and the ammo separated from the firearms by stairs, but the trigger finger is much less itchy today…

Anger Management Revisited

2010-09-26T21:21:00.000-07:00

I have noticed that anger management issues are cropping up once again as my chemotherapy drags on. In an earlier post, I talked about the first bout of it I had several weeks into the RO5024048 study. It’s coming back again, though with a decidedly different twist. I am not having problems dealing directly with irritating people, but I am having extended arguments with them in my head. I think this could be attributed to one of two side effects or a third cause that is due my current circumstances.

The first would be depression. I am on Celexa and do not feel that I am depressed. I remember what I felt like before I started on the antidepressants and this doesn’t feel like that. I am a bit tenser than I have been and I have a theory about that I am going to check out this week. I noticed that once I started on levothyroxine for my low thyroid function, I became more jittery than I had been before. There was a bit of an adjustment period when I started on antidepressants but that had leveled out a bit by the time I started on the thyroid meds. I then noticed a definite step up in nervousness when I started taking the thyroid meds. I wonder if my thyroid is working better now and my dose is too high and whether the thyroid meds might be interacting with the antidepressants to make me a bit too edgy. I am calling my primary care doctor tomorrow to set up an appointment to test my thyroid hormone levels and perhaps adjust my dose.

The second possibility is the mental problems that can be caused by interferon and ribavirin themselves. It is a known side effect of this combination of drugs that can include irritability, depression, aggressive behavior, suicidal behavior and suicidal or homicidal thoughts. I have not been thinking about killing myself or anyone else. I have indeed thought about letting a few individuals know what I really think about their attitude and behavior and doing it in no uncertain terms. I have imagined these (admittedly one-sided) conversations in vivid detail. I have not, however, actually done any of this and I have not noticed that my behavior towards others has become more aggressive. I am trying to keep a close watch on this and am going to wait for the results of the thyroid tests and any dose adjustments before I address the issue of whether my antidepressants need to be adjusted.

I do note that my behavior has become more decisive, but no one has mentioned that I have been abusive or angry toward them, and I have been asking for feedback if that happens. I find that in situations start to degenerate into indecisive dithering, I am becoming more apt to step in and tell people what to do. This does not seem to me to fall under aggressive behavior in the way they mean in the side effects description, but I am definitely wary of my reactions and behavior.

The third possibility is that some of this is the result of a long hard seven days of dealing with our organization’s biggest event of the year. I have been working longer hours than usual, in more crowded and chaotic circumstances than usual, doing more stressful work than usual. There is nothing like dealing with the sort of obsessive, picky and occasionally barking mad people that populate a used book sale to drive stress levels to the stratosphere. I don’t believe it is entirely due to this circumstance that I am noticing my inner dialogue moving more to “that stupid little prick” sorts of expressions than usual, but it must have something to do with it.

So until I get to see all my doctors about my meds, the knives stay in the drawers and the guns and ammunition on separate floors of the house…

Brain Fog x Fatigue = Say What?

2010-09-22T21:20:00.000-07:00

The longer one takes interferon, the more significant the cognitive and memory deficits become. It’s a gradual process whose creeping nature means that you some definite “oh crap,” moments can pop up and catch you unawares. The farther into a task you go in any one day, the more like you are to be hit with a OC moment.

The organization I work for puts on a big used book sale every year. Picture a large airplane hanger with 550 banquet tables and 400,000 books open for sale for 5 days to a total of 12,000 customers. This requires some high level organization to pull off successfully, which is why the people who know us are annually astonished that we can do it.

It also means an early start the first day to make sure the logistics are all mapped out (literally) before the army of volunteers and the truckloads of tables and books start to arrive. I was there at 6:30 a.m. to mark out the floor of the hangar for table and book placement. This involves chalk, long tape measures and lots of walking; as in 20 trips up and down the 600 foot building and lots of side-to-side walking, and conferences, and rechecking, etc. By about 10:00 a.m, my dogs were barking and my brain was fogging. I noticed that I was having trouble reading my map and making calculations on my tape measure. I had to mark a 48-foot length of tables on the floor and I was standing at the 59 foot mark on my tape measure. I could not for the life of my figure out that 59 plus 48 equals 107 feet. I made enough wrong marks on the floor (which I did a bad job of scuffing out) that the volunteers had to track me down and make me show them where the damn tables were supposed to go. Suddenly, I just couldn’t think clearly. Taking a break helped a bit as did water, a snack and periodic rests, but once the brain fog started, the rest of the day was not a good one for our hero.

Twelve hours of sleep helped, but another long day the next day meant that I needed another ten hours of sleep today, a three hour nap in the afternoon and restricting myself to menial tasks around the house. Ten hours more tonight and I should be ready to exhaust myself again tomorrow.

Of course I will be most aware of my situation and be extra careful to rest adequately and not overextend myself in stressful situations, of course…

Latest Viral Load Count – So Close…

2010-09-16T20:53:00.000-07:00

When I checked the mailbox on the way home from work today, the envelope with my latest test results was there. The other two envelopes were my paycheck and my wife’s paycheck, but I didn’t register that until later. I wasn’t thinking about money. The only thing I was thinking about was whether those results would show my viral load was undetectable.

In situations like these (preparing to open the envelope bearing important news), you find that you’re still mentally a primitve creature. I’m not a god-botherer, as the Brits would say, but as I walked in the house I was chanting to myself, “Yes, this is it. Please be undetectable. Yes, this is the week. Come on, let’s see undetectable results.” I sat down at the kitchen table (okay, it was the table on the back porch but you get the picture), held the envelope, took a deep breath and opened it up.

My viral load numbers since the viral breakthrough have been: 40.000; 10,000; 5,000; 1,500; 990; 310 and 110 IU/ml. I was really hoping that I would get that final bump down but it didn’t quite happen. The number was 60 IU/ml. Undetectable on this test is 43. It’s been 13 weeks since I went back on full interferon dosing after the breakthrough and I’m not quite there yet. Seventeen of those little bits of viral DNA per milliliter are still hanging on in various nooks and crannies of my bloodstream.

Objectively, this is not the best news. The longer it takes you to reach undetectable levels the lower your percentage of having a sustained viral response at the end of your chemotherapy. But I’m going to keep the same attitude that I had at the beginning of the RO5024048 polymerase inhibitor trial just under ten months ago. Back then I refused to believe that I would not get the test drug and would end up in the placebo arm of the trial. Now, I refuse to believe that I will not be one of the 25% or so who obtain an SVR as slower responders.

I’m not as stubborn as my wife’s Irish ancestry allows her to be, but I have my own stubborn Polish fatalism going for me and I’m going to ride it to the finish. Primitive mentality yes, but it’s the only one I have.

Vacation In The Sierras

2010-09-14T22:43:00.000-07:00

Vacationing while on chemotherapy for Hep C has a number of factors to take into consideration even for a short jaunt to the seaside. Adding a few days and several thousand feet of altitude to your relaxing getaway and a whole new set of issues get added to the mix. It is not really that difficult to arrange, but you can count on being sideswiped by an unknown effect or two graciously provided by your medical situation.

I just spent 5 days at Camp Mather in the Sierras of California. Camp Mather is a piece of property owned by the City of San Francisco that is located between Yosemite and Hetch-Hetchy Valley. It was acquired in the early twentieth century through a combination of political hardball, backroom dealing, convenient crafting of legal provisions, and the judicious application of money. It has about 75 cabins, a small lake, a pool, trails, stands of ponderosa pine and incense cedar, tent camping sites, bathhouses and a mess hall. Each cabin has a couple of beds, two plastic chairs, lights and a picnic table. It’s not tent camping, but is rustic enough to be only a step up. It is also at 4500 feet above sea level.

The specifics of the Hep C planning required bringing all three injectable drugs along in a cooler as my dosing schedule occurred during the vacation. I brought along a fully loaded daily drug-dosing carrier that had all my daily meds broken down into morning and evening doses. I also brought the ancillary drugs along in case I couldn’t sleep, became anxious or the pain in my muscles flared up.

The drug dosing all went swimmingly, but the thin air really did me in. The simple act of unloading our stuff out of the car and into the cabin and setting it up, let me gasping and exhausted. Nothing a quick nap didn’t fix, but it certainly caught me off guard. A bit of clear thinking on my part could have predicted this, but hey…
A trip to Glacier Point in Yosemite (one of the most spectacular views of granite domes and glacial valleys that exists in the USA), which is at the 7200-foot level, was even more daunting. As I walked up the slope to the overlook I was constantly being passed by fit, trim, healthy people in their 60s, 70s, and even tough old birds in their 80s. You nod cheerfully, gasp out a hello and plod along.

The thin air also makes keeping properly hydrated something you have to pay particular attention to. You have to drink water constantly to maintain your normal hydration level and stave off nausea and queasiness. Combine this with my walnut sized bladder and enlarged prostate and it’s not a pretty picture. For surviving the nights I have two words: gallon jug.

The third factor is really a combination of the first two. The thin air and tendency towards dehydration leave you even more susceptible to fatigue than usual. Don’t plan on cramming too much activity into your day or you will spend the next day doing nothing but sleeping.

This is not to say I did not have a good time. It was a delightful long weekend. We got together with old friends, met interesting new people, saw places we had never seen before, revisited old favorites and simply lounged around. Even the food was good. I will stand in a cafeteria line any time for turkey dinner, tri-tip steak or spaghetti with meat sauce. The staff and volunteers who keep the place going are great folks.

So by all means head out the mountains whether you are on chemo or not. Just prepare to be surprised by how you body reacts to your brain’s idea of a good time.

It Is Chemotherapy; It Is Not “Treatment.”

2010-09-08T22:52:00.000-07:00

The statistics speak for themselves. Over 4,000,000 people are credibly estimated to have Hepatitis C in the USA. The research money devoted to finding a cure for Hepatitis C is about $20 per infected individual. As a counter example, about 500,000 people have HIV/Aids in the USA. The research money devoted to finding a cure for Aids is $2700 per infected individual. You do the math, research money in the USA for Aids: $1,350,000,000; research money in the USA for Hepatitis C: $80,000,000; fourteen times the money for ¼ the total number of patients.

I do not begrudge the money granted to research on AIDS. I do not begrudge the money granted to research cancer or heart disease or tuberculosis or any other life-threatening disease. All these diseases merit serious study. I am interested in why Hep C is so underrepresented in the research funding arena. A few thoughts have been knocking around my head concerning that area.

The closest disease example I can think of to Hep C is HIV. Both groups of people infected by the particular disease are stigmatized to one extent or another. The AIDS community was painted from the very beginning as promiscuous, drug using homosexuals – hard to beat that for a stigma in American society. Hep C has been characterized as a disease of drug users and needle sharers, another big no-no in the USA. Yet after about 3 or 4 years the AIDS community was well organized, aggressive, public and effective in lobbying the drug companies and the FDA. It took a long time and a lot of hard work, but they got a lot of attention, a lot of money and some effective treatments leading to a high rate of long-term survivors. One of the reasons that they were effective was that they were a unified, identifiable community, stigmatized or no, that was able to leverage their movement for gay rights onto the movement for HIV research and treatment. The out of the closet gay community led the way in publicizing the disease and the need for research.

Individuals infected with Hep C are spread across wider segments of society. They are present in larger numbers across various sexual, gender and racial segments of society and a lot of them are still in the closet, as it were, regarding their disease. While there are advocacy groups, support groups, web sites, etc. There is not a tight, vocal, aggressive group lobbying loud and hard for additional funding. We need to have an out of the closet group of Hep C infected being in your face about the situation regarding research and treatment.

Another problem we have is that Hepatitis C patients undergo “treatment” or enter “standard of care” or are in a “study” or are utilizing “alternative therapies.” We need to call a spade a spade here. Hepatitis C is fought using chemotherapy, not “treatment.” Calling it what it truly is magnifies the significance of what people with Hep C are going through. Everyone knows someone who has undergone chemotherapy for breast cancer or colon cancer or leukemia or prostate cancer and they all understand how serious and invasive it is. By referring to Hep C treatment as treatment or Standard of Care or therapy diminishes the seriousness of the disease itself and the regimen used for attacking the virus. We need to stop minimizing it. What we go through is not treatment; it is hard-core chemotherapy with all the attendant problems and side effects.

To use myself as an example once again, I am 9 months into chemotherapy for Hepatitis C. I inject 3 drugs on a weekly basis: Pegasys, Procrit and Neupogen. I take four additional drugs on a daily basis: Ribavirin, Celexa, Levothyroxine and Folic Acid. I take three additional drugs on an as needed basis: Trazadone, Tramadol and Ativan. I am using 10 different drugs to attack the Hep C virus and to manage the side effects of the drugs that are attacking it. If that does not qualify as chemotherapy, what the hell does?

I have side effects ranging from nausea, fatigue, hair loss, muscle pain, joint pain, fevers, rashes, night sweats, low white blood counts, anemia and brain fog (because of the brain fog, I’m sure I have forgotten some of the side effects). If that array of side effects does not indicate I am undergoing chemotherapy, again, what the hell does?

It is time to call what we endure to fight the Hepatitis C virus what it is: Chemotherapy. It is invasive, disruptive and long lasting. In fact Hep C chemo generally lasts for 48 weeks. That is considerably longer than the chemo and radiation regimens for a number of cancers and other diseases. This is a serious process.

Our disease is serious and ultimately fatal, our method of attacking it is a long course of difficult chemotherapy. It does neither our disease, our treatment or ourselves as patients any favors to be less than open about the seriousness of our disease and the long, difficult and exhausting regimen of chemotherapy we undergo to fight it. Let’s do ourselves the justice of calling it what it is.

Thanks for listening to the rant. I am on vacation for the next week and will have more bile when I return...

A Nice Soft Belly

2010-09-04T23:05:00.000-07:00

It turns out that my status as a research study participant who morphed into a standard of care hepatology patient created a bit of a black hole in my medical records. Since all of my records from the study are confidential the hepatology department discovered that even though I was 12 weeks into treatment, they did not have basic paperwork on me. To solve this problem, they brought me in for a meeting with another nurse practitioner, TL, to gather the necessary data. Unfortunately, they did not tell me why I was meeting with her and thus I left my medical history documents at home.

When I arrived, they handed me a twelve page questionnaire detailing my medical history, most of which I can never remember in normal circumstances much less when my brain is in a fog. It worked out well enough in the end as TL and I went through it together and puzzled out the details. It was reassuring as well that when I recounted the timeline of my study participation, dose reductions and subsequent viral breakthrough, TL was firmly convinced that the dose reductions were indeed the cause of the breakthrough. It is powerful reinforcement to hear another experienced person express the opinion that it was not the intractability of the virus that caused the problem, but rather the variability in dosage dictated by the study protocols. It reinforces my optimism going forward through the rest of the treatment.

TL informed me that the rest of the treatment would total nine additional months after I became undetectable. Given the nine months I have been on meds, it will make a total of 18 months of interferon, ribavirin and the other assorted drugs I am taking. It is going to be an even longer grind than I assumed at the beginning of the process lo those many months ago.

My viral load is down to 110 IU/ml. after twelve weeks and I am hoping to see it go undetectable (under 47 IU/ml.) in my next test on the 10th of September. That would put the end of my treatment in June of 2011 when I turn 58. If it works and I am still undetectable six months after the end of treatment, I will have gone from diagnosed to cleared of the virus in three years. A dream perhaps, but it’s the one I am sticking with.

The meeting ended up with TL adding some additional monthly blood draws to my schedule and a brief physical exam. TL checked my legs for swelling, listened to my lungs, checked for any rashes and then palpated my stomach to check for ascites. “Oh, you have a nice soft belly,” commented TL, “no evidence of fluids at all.”

That is the best medical comment I may have ever received. From this point forward, anyone who comments on what is left of my spare tire is going to be told that my medical team has complimented me on my soft belly and far be it for anyone else to criticize its texture. In fact, I am patting it now as I finish this missive, so soft…

Careful Planning Meets Chaos Theory

2010-09-01T20:43:00.000-07:00

When Chaos Theory first became widely discussed years ago, there was a quick and dirty example of it that made the rounds: Chaos Theory can be illustrated as your typical day. You wake up in the morning with a certain plan or pattern for your day. You have places to be and tasks that need to be accomplished and you think that they can all fit into your day. Then your day happens.

As you get dressed, your shoelace breaks and you realize you don’t have any spares. You unthread one from another pair of shoes and go to make breakfast. You find that someone has used the last of the ground coffee and you have to grind some. There is no orange juice for your smoothie, so you have to hustle up some English muffins for breakfast. You find that the deli meat and tomato you were going to use for your lunch sandwich are gone and that means you have to buy something for lunch. All this combines to get you out the door a touch late and there is a bus stall on your way to work. You are late to work and that pushes back your first meeting. The meeting runs long. There is not enough time to complete the spreadsheet work you were going to do before you need to check in with the contractor working on the office. Lunch gets pushed back and you have to take additional time to go out and get food. All this shortens your afternoon and you absolutely have to be at little league practice (you’re the coach) or 16 kids will be standing around. Etc, Etc, Etc. By the end of the day, the resemblance to your morning plan may be only a passing one.

The same thing occurs when you attempt to plan your activities around your treatment regimen. Chaos has the same domino-like effect. It ambushed me just two days ago.

I had a fairly heavy day at work, packing and moving many boxes of books, rearranging inventory and working through floor plans for a 400,000-book sale. I felt all right when I got home, but I realized I had pushed it and decided to stay home instead of making a run to my studio. I knew that my wife worked late the next day and I could handle what I needed to do tomorrow evening. At 1:30 a.m. that night however, tired as I was, I was wide awake. I had to get some sleep and broke down and took a Trazadone. I took about an hour to work, so I managed to get 4 hours of sleep and woke up with a logy feeling from the sleeping pill. By the time I got home after work, I went right to bed and slept for 3 hours. I was still tired enough that I went to bed early and slept for 8 hours (as treatment veterans know, 8 hours sleep can be a miracle). I did not even manage to get much done at work much less do any of the small tasks I had hoped to accomplish in the evening. The lack of accomplishment that day affected the next and it is only now that I can plan to get what I wanted to do yesterday done tomorrow evening, if all goes well.

Planning is good, lists are good, notes to yourself to remember that you forget are good, but the best-laid plans can definitely be put paid by a bout of treatment-derived chaos…

Fatigue Vs. Normal Life

2010-08-30T20:26:00.000-07:00

One of the situations that develop after an extended period of Hepatitis C treatment is the onset of a pervasive fatigue. It is not that you feel tired all the time, it is that your ability to bounce back after exertion becomes much more problematic. This reduced level of recuperation can also extend for several days after the event that brings it on. If you combine that effect with the fact that brain fog makes you forget you have this recovery deficit, it creates for some bouts of exhaustion that can take you completely by surprise.

This sort of fatigue is one of the most widely reported effects of long-term treatment on interferon. The drug seems to eventually saturate your cells at some level and large numbers of patients report effects ranging from extra tiredness at the end of the day, to barely being able to get themselves out of bed without exhaustion.

Several recent examples in my own case come to mind as illustrations of this effect. A few weeks ago I took a week vacation from work. I did not travel anywhere as my wife was working during my time off. I caught up on my sleep, my reading and did one project around the house that had been on my mind for about 10 years. (This is the nature of home ownership, after you do you initial renovations – in our case very extensive – you tend to let the small items slide until you just can’t stand it anymore). Our house has lath and plaster walls that are cracked in several areas and I made it my project to fix cracks in the entryway and stairwell. The first day took about 7 hours of scraping, filling vacuuming and cleaning. I was tired the next day, but it didn’t seem bad. It took about 4 hours that day to finish up and after cleaning and replacing rugs, etc. I felt good about getting the job done, finally. The following day I slept till noon, woke up tired, lasted till about 2 p.m., slept till 5 p.m., was able to stay up and visit with my wife and then was in bed at 10 p.m. and slept till 10 a.m. I was exhausted from the two days of physical activity that had gone before.

A few days after that I went to the baseball game referenced in this post. It was a long game, in mid-week and I followed it up by working the next day. The day after that, I again slept till noon, did a bit of reading and went to bed early in the evening. The mere fact of dropping a 10-hour day (which was primarily recreation) into the middle of the work week flattened me.

The final example occurred last week when I work five straight days instead of my usual four. This didn’t seem like a big deal to me and indeed on off day of Friday, I did not feel terribly tired. Saturday I went to a reunion of a group of folks I have know for over 20 years who used to take long weekends together in the California gold country. It was a relaxing day of eating, talking and sitting around on the deck. The addition of these 5 or 6 hours of excitement and attention to the extra-long work week left me out on my feet the next day. I found myself dozing off reading the paper; riding in the car and just about any time I sat down to take a break from our not-very-strenuous walk.

In each of these cases, I had completely forgotten the previous bout of exhaustion by the time the next one came on. If I had enough energy to remember the fatigue or enough memory to remember the lack of energy, it would make planning my exertions go much smoother…

Normal Life vs. The Brain Fog

2010-08-27T21:16:00.000-07:00

The single most difficult aspect of Hepatitis C as a disease and of the treatment for Hep C is the combination of memory loss, concentration loss and cognitive loss known as brain fog. Hep C sufferers consistently comment that it is the most troubling and hard to handle aspect of the disease. Hep C itself has a side effect in many of its victims of varying forms of memory and thinking difficulties and when you combine the effects of the Hep C virus with the side effects of taking interferon you get the syndrome they call interferon brain fog. It affects all aspects of your life to one degree or another.

It goes beyond merely forgetting where your keys are or what the name of a movie you saw in the past is. It extends to trying to remember what you walked into the room to do, what it is you were trying to say a moment ago, what you were going to make absolutely sure you got done today or even what you sat down to write about. Perhaps the most troubling aspect of brain fog is that it can actually make you forget the fact you have brain fog, a classic lose-lose situation.

You forget that you have noticed very particular situations that you made note of in the past with an eye towards either avoiding in the future or not entering in to without a plan to make the situation go as smoothly as possible. You find yourself unable to concentrate even though you know you are in a situation that absolutely requires that you pay attention. You discover that you cannot think through and solve the type of problem that you have been able to handle in the past. It drives you to distraction and, unfortunately, you are already there.

This past week my wife and I went to the Roots of Impressionism exhibition at the DeYoung Museum in San Francisco. In the preparations to go to the show, it completely slipped my mind that since the beginning of my treatment crowd situations make me anxious and irritable. The show was only moderately crowded but shortly after entering the galleries, I realized two things: I was starting to get really jumpy and I had forgotten to bring along my Ativan which does a very good job of calming me down in those situations. By the time we finished our tour of the exhibition I was edgy enough that when some friends we had happened upon at the show suggested going to the café for a chat, I had to decline and head home to calm down.

As an aside, I think that the person who invented the audio tour for art exhibitions should be tarred and feathered. Bad enough in the normal sort of exhibition that you have to navigate around the clumps of people reading the labels and the explanatory posters, but at least their ebbs and flows are predictable. The people walking around with audio headsets on are a nightmare. They stop and start erratically. They make sudden turns and movements and they are completely unaware of the people around them. It is the same sort of behavior as automobile drivers on cell phones and just as much of a pain in the ass.

Returning to our previously scheduled disquisition…

Two days after the jaunt to the museum, a friend who had an extra ticket invited me to a Giants baseball game. I laid out a checklist for the game that included sunscreen and a long sleeve shirt to counteract the extra sensitivity to sunlight caused by interferon; several bottles of water, some fruit, and an extra T-shirt in case the fog came in and dropped the temperature 20 degrees. I forgot entirely that baseball games draw large crowds, especially on beautiful summer afternoons. The mere act of getting through the crowd to get to my, excellent, seat already had me twitching. I had once again forgotten to bring the Ativan that allows me to handle crowds more easily. The only thing that saved the day was that the people immediately on either side of our seats decided not to attend that day and there was enough extra personal space to let me relax. It was a great game, even though the Giants lost, but it could have been a really tough day.

You would think that the dodgy experience I had at the museum only 48 hours earlier would have left an indelible mark, but even that could not penetrate the fog…

Heading Towards Undetectable

2010-08-21T21:34:00.000-07:00

As I walked in the door from doing some grocery shopping today I picked up the mail which included my latest set of lab results (10 days old actually, but still the most recent I have). My viral load number is down to 310 IU/ml. Yes! Woohoo, etc.!

Since my viral breakthrough my numbers have run 40,000; 10,000; 5,000; 1500; 990 and now 310. In ten weeks I have achieved a log 2.2 reduction in my viral load. With any luck, my test this Wednesday will put me very close to undetectable.

Yes, it’s getting ahead of myself to think about hitting undetectable (under 47IU/ml by this test method) but optimism is what fuels successful treatment and I remain resolutely optimistic.

So there, the graph is going down, the interferon is hunting out and killing the remnants of the Hepatitis C viral horde that was infesting my body and now I am going to go take some drugs and watch a terrible Sci-Fi channel movie with my wife.

I hope your evening is as exciting as mine…

Trophy Geezer

2010-08-19T23:53:00.000-07:00

I was deep in the throes of TV inertia. Anyone who has gone through Hep C treatment or chemotherapy knows the drill. You are home from work, or have done some work around the house or have just managed to drag yourself through the day and you are tired and you couldn’t concentrate on anything to save your life. You flop (or gracefully settle) down onto the sofa, grab the remote and turn on television, the great savior of the addled, befuddled and fatigued.

Luckily, the brave new world of cable (or satellite or internet) television gives one an almost infinite set of choices of worthless time wasters to choose from. Celebrity Rehab: B, C, D and E list “celebrities” try to get off drugs and use the show to rebuild their careers at the same time; Holmes on Homes: Canadian contractor makes you feel that any work that was ever done on your home was probably both substandard and outright dangerous; Whale Wars: Sea Shepherd staff and volunteers demonstrate a belief that their self-righteous conviction to the cause of saving whales means they do not have to practice or prepare in anyway for their maneuvers until they are in the middle of the Antarctic Ocean (oh, and never bring any spare parts either); Comedy Central Presents: an endlessly supply of comedians you have never hear of doing the same 30 minute set on travel, life in the city, health and grooming habits, how their girlfriend-husband-wife-boyfriend are impossible and then the windup about the perils of sex; all these hits are available for your delectation.

The other day none sufficed until I flipped by John Stewart’s The Daily Show just as he was introducing his guest, Emma Thompson. The lovely Ms. Thompson is my favorite actress and the only woman intelligent, loony and sexy enough that I would leave my wife for her. She was delightful and indeed completely loony during the interview. She went on about the narcissism of Mary Poppins (she was promoting her new Nanny McPhee movie), the practice of raising British children in boxes and never letting them outside when the sun was shining and how she did her scriptwriting longhand and indeed only wrote one letter per page so that her finished scripts were huge stacks of paper. Okay, you had to watching – but I was and it was fabulous.

Later that evening I was describing this to my wife and, for the umpteenth time mentioning that Emma was the only women I would leave her for while adding that there was no danger the attraction would be mutual (did I mention certain saint-like characteristics of my wife), To which my wife replied why not? Why wouldn’t Emma Thompson find me attractive? Flattering I said, but I’m older than Emma, have bad teeth and thinning gray hair and am not a wealthy guy and movie stars generally go for the good looking fit younger sorts, especially if those sorts don’t have money (the trophy wife, boy toy thing). So she suggested that I play the anti-boy toy card. That I be the intelligent, amusing, somewhat eccentric older guy; that indeed, I be the trophy older guy.

That’s when it hit me. I could start a career as Emma Thompson’s trophy geezer, her partner in inspired, insane lunacy. She would have to pick up all the bills of course as whatever talents I posses have never led to money, but she can afford it. And to think, I have my wife to thank for this brilliant idea. My trophy geezer facebook page and twitter accounts should be going up soon as well as the trophygeezer.com website where you can sign up for courses on becoming a trophy geezer and share you experiences on the various trophy geezer forums. And I owe it all to Hepatitis C…

Disclaimer: The events, ideas and descriptions described in the above post may have occurred due to the interactions among the panoply of drugs I am currently taking in my treatment…

Feeling Better On Standard Of Care

2010-08-16T23:04:00.000-07:00

Being treated on Standard of Care as opposed to in a drug research trial can make a big difference in your general feeling of health. It allows you to use drugs that directly counteract the characteristics of interferon and Ribavirin that depress your red and white blood cells. The use of Procrit to keep the hemoglobin level up and Neupogen to boost the white blood cell counts can have effects that go beyond the specifics of maintaining minimum levels of blood components.

Having more hemoglobin to carry oxygen around your body can mean a lot less shortness of breath after exertion. It can help your muscles recover faster and mean you can do more before you get that tired, wobbly-legged feeling. It also means that you feel a bit less fatigued overall and perhaps means that you don’t need quite as much nap time during the day to keep you functioning.

With higher white blood cell counts, you are less likely to suffer from minor infections and more able to fight off any illnesses, like cold and flu, that might be going around.

My own experience has been an example. Since beginning to administer Procrit my hemoglobin level is up to 11.4. This is higher than at any time since I began the drug study 33 weeks ago. I have definitely noticed that I am not as fatigued at the end of the day and that I can do more physical work without gasping and breathlessness. The down side is that I am not as exhausted a night which means falling asleep is even harder than normal leading to a bit more insomnia. No good result goes unpunished, I guess.

My neutrophil counts are consistently holding at around 800 since I started on the Neupogen. While I haven’t noticed a direct effect on my energy or mental state, I haven’t gotten sick since then either and I’ll take that result any time.

I am not noticing that either better hemoglobin or white cell counts have increased my ability to concentrate or improved my memory however. You might imagine that a bit more oxygen to the brain would be helping those sorts of things, but in my case you would apparently be wrong.

The other area the extra hemoglobin does help though is in the late-night laps around the house. I can walk a half-mile back and forth easily now before going back to bed and finally falling asleep…

Which Side Effects Matter…and to Whom

2010-08-10T21:40:00.000-07:00

When you begin the process of considering whether to apply for a research drug trial or enter treatment, one of the things that you give a lot of thought to is the side effects that accompany the various drugs you will be taking. These side effects fall into two categories, the side effects that are physical symptoms affecting your comfort level and the side effects that directly alter your body’s operating systems. Those two types of side effects matter in very different ways to you and to the doctors and/or researchers supervising your treatment.

Those of us participating in a study or standard treatment tend to be very concerned with how the treatment is making us feel. The doctors tend to be very concerned with how the treatment is affecting our body’s ability to function. These concerns definitely overlap, but the primary focus is very different between patient and doctor.

When the patient first examines the information about experimental drug trials or the standard of care treatment, they tend to focus on the potential side effects of the medications and especially the side effects that manifest themselves as physical reactions: nausea, vomiting, diarrhea, fatigue, muscle pain, dizziness, headache, rash, irritability, hair loss, sore throat, depression, confusion, itching, etc. The patient also generally makes a note of the potential long-term side effects like changes in thyroid function that may be permanent and the possibility of macular degeneration. A lot of the patient’s focus is definitely on the comfort related side effects.

The doctors are aware of all these as well, but primarily as an issue of whether the patient will be able to continue through to the completion of the treatment. Will some of these become so serious that the patient will have to discontinue either the study, if they are in one, or the standard of care treatment? Can they be managed successfully to keep the patient on course?

The set of side effects of primary concern to the doctors are the ones that directly affect the body’s systems: Anemia (low red blood cell counts), Neutropenia (low white blood cell counts), thyroid function changes, depression and insomnia. Anemia can put stress on the heart and circulatory systems and contribute to fatigue; Neutropenia affects the body’s ability to fight off infection successfully; changes in thyroid function can lead to a host of metabolic problems; depression and insomnia can both lower the body’s ability to fight off disease and function successfully. For the patient in a research study, the side effects just mentioned can lead to the doses of their meds being reduced or suspended to the point that the treatment loses its effectiveness. That is unfortunately what happened to me. For the patient under standard of care treatment the doctor may be forced to prescribe additional drugs to counteract those effects in order to keep them on the course of treatment.

It was interesting to realize, after the fact, that the long list of side effects I was originally concerned about, were not the ones most important to my successful treatment. The nausea, chills, headaches, dizziness, irritability, rash, back pain and the rest were not, in the long run, the side effects that negatively effected my treatment. The tremendous reduction in my white and red blood cell counts were what required the reduction in my medication doses that eventually caused the viral breakthrough.

There wasn’t really anything I could have done about it given the requirements of the research study, but it is interesting to note, that I was looking the other way, so to speak, while the virus slipped back in…

Going Camping With Drugs

2010-08-09T21:31:00.000-07:00

Planning getaways and vacations while in a drug study or on treatment can be a bit of a challenge. As a primary concern, you need to plan your vacation around your dosing regimen, particularly if you have a regular cycle of side effects. For instance, if you have nausea or muscle pain or killer headaches at a predictable time after injecting your interferon you might want to wait to start your getaway until those effects have settled down. Who wants to be in a beautiful location feeling crappy if you can avoid that by timing your trip appropriately?

You also need to plan how you will ensure that you maintain your drug-dosing schedule. Depending on how long your trip will be and the number of drugs you are currently taking, you need to make sure you have the necessary amounts of drugs and the equipment to store them properly. If I am going to be gone for more than one week, I need to bring along (and have the proper coolers or refrigeration for) 2 doses of pegasys, 2 doses of neupogen and 2 doses of procrit. That is 6 syringes and enough cold packs to keep it cool for the necessary time frame as well as the appropriate number of ribavirin, celexa, folic acid and levothyroxine pills. And of course, the necessary sleep aids and painkillers should something flare up; do you really want to have insomnia in a tent, after all?

This is perhaps an over elaborate lead-in to our two day “camping” trip this past weekend. My wife and I met a number of old friends at a location called the “Coastanoan” on the San Mateo County coast south and west of San Francisco. It is a “low-impact” lodge development that has a couple of lodge buildings, a small number of wooden cabins and about 80 tent-cabins. A tent cabin, in this case, is a 10 by 12 foot (3 by 4 meter) wood-frame structure covered with waterproof, reinforced tent material. It has a bed, an electrical outlet, windows and a door. The facilities are in centrally located areas scattered throughout the campground and are the only heated buildings outside of the lodge structures. So, you have an unheated, semi-permanent tent like structure that you sleep in and you walk to the bathrooms and showers. They have outdoor fireplaces near the bath facilities and the usual barbeque and picnic areas. It is a short walk (crossing the highway carefully) to the beach.

I am describing all this so you realize that while it is called a campground you are not lying in a small tent, huddled in a sleeping bag with only a thin pad between your tender bottom and the cold ground. Oh no, you are on a futon in a full-sized bed with a HEATED mattress pad to keep you toasty through the chilly night. We were not exactly roughing it, but all those caveats I mentioned earlier apply.

I had to make sure I had injected 36 hours previous to leaving to make sure the majority of the interferon symptoms would be past. I had to bring all my other drugs and make sure I took them on schedule, not always easily when you are running around with old friends and their children. I also had to develop a plan of action to deal with the 3 to 4 trips to the bathroom I would be taking each night, and walking through the cold, foggy, damp night to the bathroom was not the plan I had in mind.

It all went remarkably well and served as a dress rehearsal for our 6 day trip next month to the higher and colder area around Yosemite. It all seems doable, but it requires extra planning and lots of extra blankets because the last thing you want is to catch a chill with a low white blood count.

I wonder if bears will break into cars to get Hep C meds…

Walkin’ After Midnight

2010-08-03T18:17:00.000-07:00

What with the general insomnia that the interferon and ribavirin treatment can bring about, combined with the pure nervous overload of my recent bout of serotonin syndrome, I have found myself pacing around my house in the middle of the night with some frequency in recent days. If I start at the back of the house and walk though the “breakfast room,” the kitchen, the dining room – such as it is, the living room and return on the same track, I walk about 90 feet. If I do ten laps it is 900 feet, twenty makes 1800 and 25 laps is just under a half a mile. It takes about 15 minutes to do 25 laps as I can’t really build up a lot of speed in the dark because the bruising on the shins becomes quite painful if one is not careful to watch where one is going. This pacing generally quiets down the leg jitters and twitches and tires me out enough that I fall asleep after going back to bed.

Unfortunately, I occasionally wake up and can’t fall back asleep necessitating another set of laps until I am tired enough to sleep through the night. Aside from toning up the calves nicely, these late-night peregrinations also allow one to review all the plans one once had for the house. That floor you were going to refinish; the cracks in the plaster that need patching, the new chandelier you were going to install in the dining room about ten years ago. There is nothing like the middle of the night to come face to face with all the grand, and unfulfilled, plans one had for your castle. It’s a good thing the lights are out or the number of flaws and not quite finished details would be overwhelming.

But then I climb the, squeaky, set of stairs to the second floor, climb into bed next to my (gently, gently) snoring sweetie, put my arm around her and think that the new paint on the stairway can wait awhile, it’s perfectly comfortable as it is.

Serotonin Syndrome

2010-08-01T21:16:00.000-07:00

I had a bout of serotonin syndrome during the past several days and it was quite an experience. It began last Wednesday the 27th as I started to feel a bit jittery while at work and had a few episodes of chills that evening when I was going to bed. I continued to feel jittery, nervous and had some muscle twitches on Thursday. I went to the Giants game that afternoon (it was a 4:05pm start) and got quite chilled by the end of the game. Even after arriving home I noticed that I continued to be cold and had a lot of jitters and muscle twitches.

This reminded me a great deal of the physical situation I encountered when I started on Paxil and, to a lesser extend, after I switched to Celexa. It seem unusual that this should be happening several weeks after beginning antidepressants, so I began examining my recent use of meds to determine what might be happening. I believe it was related to the pain medication tramadol.

The past few weeks I have had a bout of fairly serious lower back pain. I have been dealing with this sort of pain for about 20 years as the result of a serious bicycle accident (over the handlebars, on the pavement, laid up for a month sort of thing). It is something I have managed by stretching, core exercises and, occasionally muscle relaxants. It flared up about 10 days ago with pain across the lower back, around the sides of the pelvis and even with some sciatic pain radiating down my right leg. It made it impossible to sleep and even tough to work while sitting up. I immediately started in with my stretching routine and exercises but until they began to take effect I was taking tramadol at least twice a day and on a few occasions 3 times a day.

I remember when I got my prescription for Celexa; the pharmacist took me aside and told me that he noticed I was also taking tramadol. He stated that while tramadol is not a serotin uptake inhibitor specifically, it has a similar chemical construction to Celexa and I should be careful not to take too much of it while taking the Celexa as it could lead to an oversupply of serotonin in the brain which causes serotonin syndrome.

Symptoms may include:
· Restlessness
· Hallucinations
· Loss of coordination
· Fast heartbeat
· Rapid changes in blood pressure
· Increased body temperature
· Overactive reflexes
· Nausea
· Vomiting
· Diarrhea

As soon as I remembered this conversation, I immediately stopped taking tramadol and instead used ibuprofen for any pain. I still took my dose of Celexa but I noticed that it did not get any worse on Friday and by Saturday it had begun to moderate somewhat. After a jumpy night Saturday, Sunday has been okay with a gradual reduction in nerves, chills, sweats, etc. I think it is well on the way to returning to normal over the next few days.

I am definitely going to paying closer attention to my use of tramadol and will be talking to my hepatologist about potentially switching to another pain med for the times I need it. At least I recognized the symptoms as being similar to the range that occurred at the start of the antidepressants and could make the connection with the serotonin.

On the positive side, though I would not recommend it to anyone, I lost four pounds in four days due to the amplified nervous activity from the serotonin. But do not try this at home. It is much better to be fat and happy than slightly less fat and jittery as hell.

Standard of Care Pace vs. Research Pace

2010-07-25T21:04:00.000-07:00

I just got my latest viral load numbers back from the lab today. The viral load has declined to just a bit over 1500 I.U./ml. I have now achieved a log level reduction in viral load since the peak of the viral breakthrough. This is great news but also points up one of the biggest differences between being on the Standard of Care treatment of interferon and Ribavirin and the research trial treatment of interferon, Ribavirin and Polymerase Inhibitor RO5024048. The Hep C virus is definitely harder to kill on only two drugs instead of three.

My viral load progression on Standard of Care has been:

Week 1: 40,000 IU/ml. (peak number of viral breakthrough)
Week 2: 10,000 IU/ml
Week 5: 5,000 IU/ml
Week 7: 1,500 IU/ml (log 1.6 reduction)

My viral load progression on the Research Trial drug was:

Week 0: 12,900,000 IU/ml.
Week 1: 4,260 IU/ml (log 3.48 reduction)
Week 2: 1,110 IU/ml
Week 4: 195 IU/ml
Week 6: undetectable (log 5.83 reduction)

As you can see, the pace at which the virus is destroyed is much slower (though steady) on the interferon and Ribavirin combination. It has taken 6 weeks to get a log 1.6 reduction from the peak breakthrough number when it only took one week to get a log 3.5 reduction from my pre-trial viral load on the polymerase inhibitor. This has taken some getting used to. You get spoiled on the three drug therapy, especially in the case of the polymerase inhibitor because it does not seem to carry major additional side effects along with it. While I steadily heading towards the log 2 reduction in my viral load needed by week twelve after the breakthrough in order to continue treatment, it seems to be happening in slow motion after the knockout blow the RO5024048 dealt the virus while I was on the three drug combination.

While this may pose a few psychological issues for me to deal with, the overall outlook for the polymerase inhibitor plus interferon and Ribavirin mode of treatment is very good. It definitely deals a hammer blow to the virus and so far, most of the individuals I have talked to who are in the trial (admittedly a very small sample) have not reported serious side effects associated with the RO5024048. Also the addition of a new group to the trial which will receive the drug for 24 weeks instead of the 8-12 weeks we got it indicates that the safety issues are not a major concern and that the drug is promising enough to expand the range of patients eligible. This is all very good news for people both awaiting treatment and considering their treatment options. Another effective tool appears to be on the way in the battle against the Hep C virus.

The Little Things…

2010-07-24T20:02:00.000-07:00

Slogging ones way through the cycle of treatment, you really do start to appreciate little things. You have to let go of the level of activity and accomplishment you had before the relentless round of powerful drugs began. It’s either that or drive yourself crazy with frustration and depression. On the other hand, you can begin to appreciate as accomplishments things you either took for granted or viewed as things to get out of the way in the past; for instance: housecleaning.

My wife is the beneficiary of this newfound appreciation of accomplishing small tasks. The house has been a bit cleaner, in some rooms anyway, than it was before I started treatment. Weekends usually find me in the headache, backache, nausea, fatigue, and muscle weakness phase of my injection cycle. This generally means that I don’t get out and do much outside the house on at least one of the weekend days. But I can clean the bathrooms, or degrease the stove, clean the grout, you know, all the delightful tasks that you generally find any excuse to avoid. When you spend the day really getting some part of your environment clean, it makes you feel better. You’ve done something good for yourself and your family. It may not be much, but it does have the feel of accomplishment. And there is always the benefit of having your wife say, “Honey, did you clean the cooktop? It looks like new.” As any married guy knows, a happy wife makes for a happy husband.

Reorganizing is another manageable task that can give you a sense of progress. Over the past several weeks, I have opened cupboards, ventured into closets and examined boxes that have not been opened, ventured into or examined in months (okay years, but that might be revealing too much…). It is amazing how much room you can create just buy arranging things in a logical way instead of the “throw it in and close the door before it can escape” method. The archaeological finds you can make in the back of your closets are quite amazing as well. When did you wear those shoes, where did that shirt come from and I don’t remember that photo at all are the sorts of reactions you can expect. There is nothing like the joy your wife expresses when she discovers that there is now additional room in the closet for more stuff!

After a day of cleaning, reorganizing, weeding, or some other task, there is also the joy of flopping down in front of the TV and discovering that the movie “Juno” just started and you can recover while enjoying a great flick. Small movie, but huge enjoyment.

Another thing I have had to learn to accept and let slide is the effect brain fog has on my ability to write. It’s not hard to sit at the computer and write; I have the energy to do that. It is the frustration of sitting in front of the screen while trying to remember where I was going with a particular story or experience. Combine that with not be able to remember the words for certain thoughts, actions, feelings and even places and things and it really drove me crazy. Now I just sit here and let it slide. It’s still annoying, but the flip side is that I can genuinely say to people, “I have no idea,” or “I don’t remember that at all” in all sorts of situations. Gets you off the hook when your blank look of incomprehension is clearly real.

I would the mindset resembles the one touted in the AA serenity prayer. Unfortunately there is no chance that I will have the wisdom to know the difference…

Co-Pay & Prescription Assistance Programs

2010-07-19T20:34:00.000-07:00

As I am beginning to see the co-payments for my medications mount up, I know that many other people undergoing treatment are facing the same issue. Many of the folks I have met who have Hepatitis C, are putting off the decision to undergo treatment because of the cost of the medications. Others are waiting for the chance to screen for research trials of new drugs because the drug companies running the trials cover the cost of the medications and the monitoring care.

There are resources available to help with the cost of medications. I mentioned a few that are run by the drug companies themselves in this post. There are also a wide range of other programs run by both pharmaceutical companies and private foundations. A list of some of these programs follows. I hope it is useful.

Patient Access Nework Foundation
https://www.panfoundation.org/
1-866-316-7263
Assists patients who cannot access the treatments they need due to out-of-pocket health care costs including deductibles, copayments and coinsurance. Up to 4K yearly in drug/co-pay assistance. Patients can apply on line or call the phone number listed above.

Healthwell Foundation
www.healthwellfoundation.org
1-800-675-8416
Addresses the needs of individuals who cannot afford their insurance copayments, premiums, coinsurance or other out-of-pocket health care costs.

National Organization For Rare Disorders (NORD)
www.rarediseases.org
1-800-634-7207
Assists uninsured or under-insured individuals in securing life-saving or life-sustaining medications.

Partnership For Prescription Assistance (PPA)
www.pparx.org
1-888-477-2669
Offers a single point of access to more than 475 public and private patient assistance programs, including more than 150 programs offered by pharmaceutical companies. Includes assistance for the uninsured.

Patient Advocate Foundation’s Co-Pay Relief Program
www.copays.org
1-866-512-3861
Provides direct co-payment assistance for pharmaceutical products to insuraed patients (including Medicare Part D beneficiaries) who financially and medically qualify.

Chronic Disease Fund
www.cdfund.org
1-877-968-7233
Patient will have to call monthly to see if they have funds. Funds are based off individual donations.

Families USA
www.familiesusa.org
1-202-628-3030
Families USA is a national nonprofit, non-partisan organization dedicated to the achievement of high-quality, affordable health care for all Americans.

Modest Needs Foundation
www.modestneeds.org
(415) 956-9395
Modest Needs is an award-winning public charity with a simple but critical mission: we work to stop the cycle of poverty BEFORE it starts for the low-income workers whom conventional philanthropy has forgotten.

Needy Meds
www.needymeds.org
1-978-281-6666
NeedyMeds is a non-profit with the mission of helping people who cannot afford medicine or healthcare costs. The information at NeedyMeds is available anonymously and free of charge.

Patient Services Inc. (PSI)
www.uneedpsi.org
1-800-366-7741
Assists patients in locating health insurance policies. Provides health insurance premium assistance (including COBRA) and co-payment assistance (including helping satisfy Medicare Part D true-out-of-pocket.

Advocacy Attorney through Crohn’s Foundation
Email: patient_advocate@sbcglobal.net
1-860-674-1370

Patient Advocate Foundation
www.patientadvocate.org
1-800-532-5274
Patient Advocate Foundation is a national non-profit organization that seeks to safeguard patients through effective mediation assuring access to care, maintenance of employment and preservation of their financial stability relative to their diagnosis of life threatening or debilitating diseases.

OTHER FINANCIAL ASSISTANCE PROGRAMS

Chrohn’s & Colitis Foundation of America – www.ccfa.org - 1-800-932-2423

American Cancer Society – www.cancer.org – 1-800-227-2345

Brain Tumor Society – BTS Cares – www.tbts.org – 1-800-770-8287

Cancer Care – www.cancercare.org – 1-800-813-4673

Leukemia and Lymphoma Society – www.LLS.org – 1-800-955-4572

Lymphoma Research Foundation – www.lymphoma.org – 1-800-500-9976

National Brain Tumor Foundation – www.braintumor.org – 1-800-934-2873

National Marrow Donor Program – www.marrow.org – 1-888-999-6743

Since We Were Talking About Side Effects…

2010-07-18T20:47:00.000-07:00

The past four or five days have seen another shift in the nature of the side effects associated with treatment. Generally, I have noticed that the side effects I am experiencing are consistent for an extended period of time. The cycle of flu-like symptoms, fatigue and nausea has consistently started about 14-18 hours after the interferon injection and lasts about 36 hours. The fatigue also continues to moderate through the week after the interferon injection and my best days are usually Wednesday and Thursday, just before my next injection. The headaches and dyspepsia (which they define as an overly full feeling and general stomach discomfort) are intermittent but they happen for a few days each weekly cycle. This experience of side effects has been the same for about 10 weeks. This week saw changes in some of the effects and the resurfacing of one that had disappeared 10 weeks ago.

The last 5 days I have been mildly nauseous for most of my waking hours. This has also been accompanied by a bloated feeling in my stomach. I also had a return of dysgeusia (a change in the taste of food) as well. The nausea didn’t seem like much of an issue to me, although it did keep me from doing some of the things I was planning. I wasn’t running to the bathroom to vomit, I only had to lie down a couple of times and mostly I could ignore it or wait it out. Then I woke up this morning without it and realized how good it felt to just feel normal. There is nothing like suddenly not feeling a side effect to make you realize just how crappy it had been making you feel. I may have been tired all day today but damn, I felt good!

I have also had yet another change in the taste of food. The last one came about the time I started taking antidepressants and resulted in ice cream suddenly tasting good again. This time I have become extremely sensitive to things that taste sweet. I tried to eat a piece of chocolate on Thursday (yes, I shouldn’t be eating chocolate, see here, but I am weak) and it was so sweet I couldn’t finish it. Ice cream has once again become something I just can’t face eating as well as things like fruit preserves. I realized how extreme it had become just this evening. I had bought some sweet corn (25 cents an ear) and after boiling it up to have with sausage and potato salad, I could barely finish eating it as it seemed to be sickeningly sweet. Sweet corn, along with tomatoes, one of the iconic tastes of summer, what is Hep C treatment turning my body into?

I am now injecting 3 drugs per week, interferon, Procrit and Neupogen, so that might have something to do with the change in side effects. It might just be long-term sensitization to the drugs. It could be the changes in white and red blood levels or the interaction of the 7 daily and weekly drugs I am now taking, who knows. It seems my body is reaching a new rapprochement with the drugs I am taking and that it might mean a new cycle of side effects to get used to. It could be worse, the next time it might be grilled sausage that starts to taste like cardboard, anything but that…

RO5024048 Side Effects Reconsidered

2010-07-14T20:14:00.000-07:00

Now that I am out of the study and on the Standard of Care of Interferon and Ribavirin, I have been looking back at the first 8 to 12 weeks of treatment to try to determine whether the RO5024048 polymerase inhibitor had side effects of its own, whether it intensified the side effects of the interferon and Ribavirin or did both.

As I have mentioned before in this post, I believe I received the study drug at the beginning of treatment. My viral load dropped log 3.6 or so during the first week of the drug trial, which is almost unheard of on the standard of care. I have yet to drop a full log number from the peak viral load after my viral breakthrough 5 weeks ago now that I am on Standard of Care treatment. This just reinforces my belief that I was given RO5024048. That said, I do not know either how long I received the study drug, nor the size of the dose I received. I could have received 500 mg for 12 weeks, 1000 mg for 12 weeks, or 1000 mg for 8 weeks. In any case, I believe I received the polymerase inhibitor for either the first 8 weeks or the first 12 weeks of the study.

Looking at the list of side effects from the drugs involved I can draw some conclusions about the variation in them as the study went on.

Nausea: seems about the same throughout the study, mild but occasionally intrusive
Vomiting: only happened once
Diarrhea: definitely more serious at the beginning of the study and gradually disappeared as the study went on
Abdominal Pain: is more noticeable in the past 8 weeks
Anorexia: I don’t believe I had it
Dysgeusia: Didn’t notice it until about 8 weeks into treatment
Dry Mouth & Dyspepsia: consistently present throughout treatment
Anemia: seems worse now that I am on standard of care
Neutropenia: set in about 8 weeks into the study and has been consistently present since
Fatigue: seems a bit better since I have been on only interferon and Ribavirin
Chills: present the first several weeks of the trial has disappeared since
Fever: cyclic with the interferon injection schedule throughout the trial
Muscle Pain: intermittently present throughout treatment up to the present, also a general feeling of muscle weakness and fatigue after exertion
Joint Pain: present during the first few months of the trial not present now
Headache: present throughout the trial, more intense early in the trial and during the past 5 weeks
Rash: Never a big problem, but more noticeable during the first few months
Dizziness: only when taking some of the ancillary drugs
Anxiety: peaked during weeks 12-18
Depression: peaked during weeks 10-18
Insomnia: consistently present throughout treatment
Irritability: very irritable early in the trial, became a problem again in weeks 12-18, not a problem since introduction of antidepressants
Throat Pain: have not had any
Injection Site Redness: has not appeared at any time
Sinus Congestion: tends to occur during the first 4 or 5 days after each interferon injection
Alopecia: Hair loss consistent through first 20 weeks of treatment, has moderated since
Blurred Vision: not specifically noticed, but my close focusing ability deteriorated immediately at the start of the trial and the deterioration has remained
Eye Pain: have consistently had eye pain. It tends to happen when attempting to focus on something relatively close to my eyes. Generally moderates when I relax my eyes and my focus
Blood Sugar Problems: none
Back Pain: tightness occurs within a few days of every interferon injection
Laryngitis: none
Sore Throat: has occurred intermittently since the start treatment
Loss of Concentration: As the treatment progressed, my ability to concentrate noticeably declined at about 2:30 every day
Confusion: my short term memory has declined noticeably since the start of treatment
Liver Problems: I developed a hypothyroid condition starting at about week 10

As I look over the list of side effects I notice only a few that seem like they could be directly related to the RO5024048. Diarrhea is something that was only a problem during the time I was on the test drug. Chills have not really happened since the first 8 weeks either. Fatigue seems to have been amplified a bit by the polymerase inhibitor. Joint pain also seemed to disappear after the first 8-10 weeks of the trial. The rash problem was never more than an annoyance and was more extensive during the first 8 weeks. Irritability was definitely high at the beginning of the trial and has moderated since them, particularly since taking the antidepressants. The vision change happened right away, but I also noticed that there was a bit of change to it when I went back on full interferon doses 5 weeks ago.

Most of these are also side effects of the interferon and Ribavirin so the fact that they have moderated over time might just be that my body acclimated to the drugs. If I had to make the call, I would say that diarrhea, joint pain fatigue and rash were all either caused by or intensified by the RO5024048. It seems that the polymerase inhibitor is an easier to tolerate drug that the protease inhibitors such as Telaprevir and Boceprevir. The research coordinators I talked to all said that the Telaprevir study they had run had been much harder on the patients in terms of side effects (especially rash) than the RO5024048.

Given that it seems to hit the virus like the blitzkrieg hit Poland and that it appears to have a more moderate level of side effects than some of the other new drugs, RO5024048 seems to have a bright future fighting Hepatitis C.

A Good Word For Big Pharma

2010-07-12T22:01:00.000-07:00

Huge multi-national pharmaceutical companies, aka Big Pharma, tend to have a bad reputation among many of the people who study health care issues or are in need of exotic drugs to treat diseases. These companies are often portrayed as greedy, rapacious, and insensitive and that’s just how they are described in polite company. While I understand where the opinions of these folks come from, from the point of view of a Hepatitis C sufferer, my opinion is a bit different.

I am somewhat familiar with the issues of drug research. Several folks I know are gene-splicers involved in medical research working at companies as large as Genentech down to small, privately held startup level concerns. My wife has a science background (MS level) and has worked for research companies and I have a lifelong interest in scientific issues and some familiarity with the protocols and problems of medical research. I admit I have tended to be on the side of the folks with low opinions of Big Pharma in the past, due in no small part to the insider stories I have heard over the years. This has changed since I was diagnosed with Hepatitis C and changed even more so since I entered treatment.

There are two reasons for the change. The first is that private sector drug companies are the drivers for research into new ways to treat Hep C. The taxpayer-funded National Institutes of Health (NIH) does not exactly throw money at Hep C. For instance, while there are estimated to be 4,000,000 people in the USA infected with Hepatitis C compared to a bit over 1,000,000 infected with HIV, the NIH spends only about $20 per patient on Hep C research versus roughly $2,750 per patient for HIV. They have also been known to siphon off bits of that pathetically low amount and send it to other research areas. On the other hand, recognizing that 4,000,000 people is a large market for their products, the major drug companies are funding a wide and ever-increasing range of studies to discover new and more effective treatments for Hepatitis C. This is an example of how the profit motive can result in far more benefits for disease sufferers than waiting around for government funded research projects to begin to address the issues.

The other reason is the benefits that I and other people undergoing Hepatitis C treatment have received from the drug companies researching and selling the drugs to treat the disease. When I moved from treatment on the RO5024048 study to out-patient standard of care treatment, there was a gap between the time when I left the study to the time when my treatment and prescription authorizations cleared the insurance company bureaucracy. The people at Roche provided some samples of both Ribavirin and interferon that allowed me to continue treatment without missing any doses as the paperwork cleared. I don’t know whether the samples “fell off the truck” or are routinely provided so that the people at the Hepatology Center can deal with just such issues as mine, but they were a godsend. Likewise when my prescription for procrit fell through the cracks at the specialty pharmacy for a week and it looked like I might have to drastically cut my Ribavirin dose until it arrived, a sample of procrit was also provided by a drug company to give me the chance to address my red blood count issues more quickly and keep me on the maximum dose of Ribavirin.

Big Pharma also has programs to assist uninsured and underinsured patients to receive the treatment they need. There are programs directly from the companies themselves as well as foundation programs funded in part by drug companies that provide treatment almost entirely for free for low-income patients. One of the people in my support group had their entire treatment paid for this way. The only time they had to pay was if a part of the treatment was done outside of the California Pacific Medical Center.

While Big Pharma is far from perfect, they are the folks that those of us infected with Hep C have to look towards for improvements in treatment. Until the public profile of the disease is raised and the government actually begins to dedicate serious money to research, it is the private sector that will drive the research into new treatments. We 4,000,000 potential customers are all saying, you get something that is highly effective and we will push the insurance companies to get it to us and to cover it.

Treatment Update - 5 weeks along in Standard Therapy

2010-07-10T18:30:00.000-07:00

My latest viral load test results came back and I have a viral load of just a hair over 5,000 I.U./ml. That is a 3.76 log reduction from the 12,900,00 I registered at the beginning of treatment 29 weeks ago. It also shows a trend in the right direction following the viral breakthrough. My numbers from week 24 going forward are 17,000; 40,000; 10,000 and now 5,000. While the 5,000 number is not yet a truly significant reduction from the peak of my breakthrough viral load, it is getting awfully close.

Two other numbers are showing some change as well. My hemoglobin has dropped to 8.2 from the 11.4 it had climbed to after they reduced my Ribavirin dose to 1000 mg. during the final 6 weeks I was in the research study. My neutrophil count has dropped to 500 in the five weeks since they reinstituted a full dose of interferon. The response to these test results by my hepatologist illustrates clearly the difference in being treated outside of a research study. As I discussed in this post, the researchers running the study need to control, as thoroughly as they possibly can, the drugs that are utilized in the study. One of the primary goals of studies like this, after they determine the drug is effective against the virus, is to determine the side effects and potential dangers of the drug. They know the side effects of the standard of care and by adding only the new drug to the treatment, they can see if it amplifies or minimizes or introduces completely new side effects to the standard treatment. So when presented with test results that show that the research subject has anemia or low neutrophil counts they adjust the doses of the standard of care drugs or the research drugs to determine whether this is what is causing the problems. Unfortunately this can result, as in my case, in reducing the effectiveness of the treatment.

Now that I am being treated outside the research study in the standard of care therapy, they have a panoply of treatments they can use to address the problems and keep me on the full doses of the anti-viral drugs. In my case, the hemoglobin count went down fairly quickly and they put me on folic acid to attempt to build up my red blood cells. When that did not have much effect after about 10 days of taking it and my hemoglobin continued to fall, they prescribed procrit, a drug that directly stimulates red blood cell production. It is a drug that has to be injected once a week under the skin, like the interferon. In doing this for the first time, I tried to inject it into a pinched-up roll of fat on the right side of my belly area and discovered that the skin in that part of my body is like rubber. After trying three times to push the needle through this highly resilient and puncture-resistant patch of skin, I gave up and tried my left side. On that side it went right in and the injection was no problem. I’m thinking of offering the skin on the right side of my spare tire as a new material for bicycle tires. Spare tire tires; alligator skin tires; super skin tires; there has to be some money in selling skin outside the skin industry.

They are also attacking the low neutrophil count by prescribing neupogen another injectable drug that stimulates white blood cell production. I am currently in the process of urgent insurance authorization for that drug and should start using it next week. My wife thinks all this is turning me into a pincushion, as I will now be injecting three different drugs every week. I am also taking levothyroxine to stabilize my thyroid function. The change in thyroid function is also a side effect of the interferon. Luckily, this drug is in pill form and I take it once a day. The three drugs mentioned here are all being taken to enable me to continue taking full doses of interferon and Ribavirin to combat the Hepatitis C virus.

So the drug roster being taken either weekly or daily to fight the Hep C or the side effects of the drugs is:
Pegylated Interferon
Ribavirin
Procrit
Neupogen
Levothyroxine
Celexa
Trazadone
Tramadol
Ativan
The final numbers are not in yet as my nurse AR is working to find the cheapest drugs with the lowest copays but so far it works out to be a bit over $375 per month in copayments. This may go up or down some but if it holds at that number it is about $4500 for the duration of the treatment, assuming no additional drugs are needed.

Considering the only drugs I ever really took up until this time were the occasional course of antibiotics; painkillers after surgery or some muscle relaxants after throwing my back out, this level of involvement with the pharmaceutical industry is a whole new world…

Support Group Redux

2010-07-07T21:58:00.000-07:00

In a previous post, I described going to my first support group meeting. It was a good experience and my intermittent appearances at other meetings of the group have been useful both for the emotional support of others who have undergone the same experience and for the information they can pass on about their coping mechanisms for getting through treatment. There are times when the group can be a bit trying and the other day was one of those experiences.

Before mentioning the circumstances that made it an infinitely long 90 minutes, there was one piece of anecdotal evidence we discovered as a group that we have not seen described in the literature as an effect of becoming symptomatic Hepatitis C sufferers. Several of the individuals at the meeting had been diagnosed with Hep C relatively recently. As they related the stories of how they had ended up being tested for Hep C and the symptoms that led them to their doctors, one of the repeated statements was that they had experienced shortness of breath. After the third individual mentioned this, the moderator of the group mentioned that she had that same symptom at the time she was diagnosed and asked the group in general whether that was the case for them as well. Of the eleven people there, eight, including myself, related that previous to and continuing after the diagnosis, they had experienced shortness of breath and some difficulty feeling that they could draw a complete lungful of air. As I said, anecdotal evidence to be sure, but we all wonder whether that is a common experience of Hep C sufferers. You learn something new at every group.

You also occasionally have to suffer through a meeting with a plethora of difficult personalities and this was one of them. The first individual to speak related the experience of undergoing treatment twice and failing both times to clear the virus. It was entirely the fault of incompetent doctors, unresponsive nurses, delayed treatments, bad communication, shoddy lab work, you name it and this individual named it as a reason treatment had failed. After listening to the ranting for about 10 minutes, and knowing the doctors named were among the leaders in the field, we realized that we were experiencing directly some of the reasons this person had not experienced a successful outcome.

Three other individuals at the meeting clearly do not get out much and used the meeting to ramble on about their personal lives before, during and after treatment without offering much information about their experience with the disease. Having worked in retail at various times, I have experienced this before. Individuals often came into the store and, perceiving the clerk as a captive audience, proceed to spend no little time describing their personal problems at length until you find a way to cut them off. In the case of the support group, these individuals are usually not hard to deal with, but the number of folks doing it at this particular meeting just ended up being a bit more than I was prepared for.

Finally we had the new age proselytizer. Every person who related symptoms of the disease or issues of treatment was given an herbal nostrum to try, a meditation regimen to use or a dietary modification to make to help with the preservation of the liver or the mitigation of side effects. I have an open mind about strategies for treating disease. I have investigated a number of alternative therapies for a wide range of conditions and found some of them to be efficacious, but when someone insists that I must drink filtered water in order to lighten the toxic load on my liver but does not seem to understand that vastly more toxins are inhaled by a typical individual every day in any major city than they will ever get through treated tap water, it certainly raises my level of tension. Likewise the insistence on a vegetarian diet, organic foods and particular methods of preparation sounds great until you run into the situation I described as The Everything Tastes Like Crap Diet. Then I think it is far more important to just find things you feel like eating and eat them, than worry overmuch about the specific balancing of your diet.

I could go on, but then I would turn in to individual number one at our meeting. I will continue to go to the support group as it is indeed helpful and there is always new information to discover. Just remember that the occasional meeting can find you clock watching and hoping for the end as opposed to suddenly being surprised by the custodians and realizing it’s time to give them a chance to do their job and wait to continue the discussion till the next time.

Viral Load and Log Numbers

2010-07-02T20:18:00.000-07:00

Viral Load is one of the numbers that folks with Hepatitis C take very seriously. We take it more seriously than we probably should given that the viral load numbers do not directly correlate with whether you are symptomatic, the amount of damage to your liver or the seriousness of the side effects that you may be experiencing. It is, however, the number that is measured to determine the ongoing success of your treatment regimen and to determine in the long run whether you have cleared your body of the virus. Given that, it is followed with a great deal of attention.

The viral load is expressed in the number of copies of the Hep C Virus RNA that are contained in a milliliter (ml) of blood. This is expressed as the number international units (IU) of Hep C RNA per ml. In my case, my viral load number ranged from 3,000,000 IU per ml when I was diagnosed to just slightly below 13,000,000 IU/ml at the onset of treatment.

The changes in viral load that we track during treatment are expressed as logarithmic or log numbers. Log number differences in the amount of virus are differences in amount that are expressed as factors of 10. These log number differences are the numbers that are considered significant in Hepatitis C treatment. Using my case as an example, if 13,000,000 IU/ml is my viral load at the start of treatment, then a drop in viral load to 1,300,000 is a log 1 change. A drop to 130,000 is a log 2 change, to 13,000 is a log 3 change, 1,300 is log 4, 130 is log 5 and going to undetectable, or under 15, is right about a log 6 change in viral load. In treatment, the doctors want to see a log 2 drop in viral load by week 12 or the patient is considered to be non-responsive.

Once we understand that, the changes in viral load that we see at various times during our disease and during treatment and the significance of those changes become easier to understand. For example, the changes in my viral load as I progressed from 3,000,000 to 13,000,000 before starting treatment are actually not significant changes despite the fact that they look like large changes. In order to have a log 1 increase in my viral load, I would have had to see it increase to 30,000,000 and a log 2 increase would mean that I would have had to see a viral load number of 300,000,000 IU/ml. Now that would be a high viral load indeed. Likewise if you had a viral load of 250,000 and saw it jump to 500,000 it would be considered a not significant change in amount even though your viral load doubled.

The same thing applies to watching viral load as it drops. If you have that same 250,000 IU/ml at the beginning of treatment, a log 1 drop would require a change to 25,000 and to achieve the log 2 reduction your doctors will want to see by week 12 you need a drop to 2,500 IU/ml. In order to reach the undetectable level, you would need a drop of somewhat over log 4. In my case, when I went from 13,000,000 to 4,000 after one week of treatment, that was over a log 3.5 drop in viral load. Likewise when I had my viral breakthrough and went from under 15 to 17,000 it was about a log 3.1 increase in my viral load.

Both of these numbers were significant because of the size of the logarithmic change in the amount. When my confirmation breakthrough test came back with a number of 40,000 that was not a significant change from the 17,000 number that signaled my viral breakthrough despite the fact that it doubled. When the first test results I got after going on treatment outside the study came back at 10,000 that was also not a significant change. I was happy to see my number going down, but just to get to a simple log 1 change I would have to drop to 4,000 and the magic log 2 change means I have to drop to 400 IU/ml.

So don’t panic over fluctuations in your viral load numbers that might appear to be quite large if they don’t reach the level of a ten-fold (log 1) change or greater. Even then, it may not be signaling a major change in your illness, but if it doesn’t even reach that level, it probably means little or nothing at all…

World Cup Manifesto

2010-06-29T21:04:00.000-07:00

We take a break tonight from our regularly scheduled disease-ridden maunderings to discuss the most important event occurring in the world today, the 2010 World Cup of Football (or soccer to most US citizens). And we dare to ask the question, “Why is this World Cup so disappointing to the world-wide television audience?”

We are not talking about the football. The play has been interesting and even compelling for the most part. Both of the finalists from 2006, France and Italy, did not make it out of their groups. Combine them with England (also a casualty of group play) and all three looked old, slow and as if the game had passed them by. The upstart nations of Asia displayed quality play and two advanced to the knock-out round. South America reasserted its historic dominance and had the highest percentage of its entries make it clear of group play. Africa fell prey to disorganization and bad luck and sees only one team still alive in the tournament. The USA did as well as it should have winning clear of its group only to go down in defeat in the round of 16. There has been interesting attacking play, the usual number of terrible mistakes by players, refereeing both wonderful and woeful, and a fast-brewing controversy about the intransigence of FIFA regarding the role of instant-replay in international football.

All well and good, but when we are standing amongst a group of strangers in a tavern at 7:00 a.m. on the west coast of the USA, many of whom clearly came directly from their bed without a hygiene stop along the way, we want more than mere great football on the big screen as our reward.

We want cheesecake (and beefcake too for that matter).

What are we getting instead are endless shots of coaches pacing the sidelines, players grimacing after tackles and missed shots and the occasional celebrity fan close-up. Does anyone alive today honestly believe that we want to see a wrinkly Bill Clinton standing next to an even wrinklier Mick Jagger (who is beginning to look like he goes to the same life extension center for the undead as Keith Richard)? Hell No! We want to see beautiful Spanish women agonizing over a missed goal opportunity. We want to see muscular Ghanaian guys with six-pack abs waving their shirts over their head. We want to see bronzed Brazilian babes doing the samba after the best team in the world scores yet another goal. In order to prevent this travesty of television justice from ever happening again at the World Cup, two major areas of concern must be addressed in the most forceful terms.

The first is that the World Cup must never again be scheduled to occur in a country that has cold, or even cool, weather at world cup time. Beautiful young women and cute young guys are still beautiful and cute even when bundled into down jackets and knit beanies, but if that is what we want to see we can tune into the winter X-Games on ESPN. In warm-weather venues we can see the most beautiful men and women in the world in all their skimpily-attired glory. We can see them in the extremes of the agony and ecstasy that sports fans can experience and for this World Cup we could be seeing them in High Definition TV. Instead we see only the faces of the beautiful and handsome peeking out from beneath their wool hats and over the collars of the jackets they are huddling inside. Never Again!

The second is that any television director who allows a stoppage of play to go by without either a beefcake or cheesecake shot should be dismissed from directing the video of any further world cup matches. We are not talking about an out-of-bounds ball that results in a relatively quick throw-in or a foul that allows for a quick replay followed by the free kick, these may continue to be covered in the same way. But when a player is writhing endlessly around on the ground after a trivial foul, or a player is strolling slowly over to the sideline to be replaced or we are enduring the agonizingly exact preparations for a set piece off a free kick, we must be given beauty as a reward. Above all, we must be shown the celebrations in the stands after a team scores a goal. As it is now, we see the players celebrating the goal. Watching yet another striker run to the corner flag, slide on his knees and be mobbed by his teammates without also being shown young women shrieking in joy and young men dancing in the aisles and the celebration of fans who have followed their country’s teams longer than that striker has been alive must never be allowed to happen again. If FIFA will not address this, we need a new international governing body.

Here it is: The Heprat Manifesto for the perfect World Cup:

Warm Weather Venues and Compulsory Cheesecake.

Why Did I Continue Treatment…

2010-06-28T23:01:00.000-07:00

Somebody asked the other day about what the thought process was that resulted in the decision to continue treatment in the face of a viral breakthrough roughly 6 months after the RO5024048 study began. It’s a good question and thinking about the answer made me thoroughly examine why I did decide to go on. After all, why not take a break after 6 months of side effects and wait for new drugs to come online?

It started with the positive initial results I had in the study. My viral load dropped from 13,000,000 to 4,000 (about a log 3.5 drop) in the first week of the study. That’s a pretty impressive result from 7 days of treatment and I was at 195 after 4 weeks of the study. Since I did not become undetectable (less than 15 which is the limit of the test’s detection) at week 4, I was did not have a Rapid Viral Response (RVR) but rather an Early Viral Response or EVR. An RVR means that in the general statistics of Hep C treatment you have about a 60% chance of clearing the virus (also known as a sustained viral response or SVR). An EVR puts you in the 40% range. While these are the cold hard statistics garnered throughout the history of Hep C treatment, the early results for the experimental drug RO5024048, which I believe I was taking, indicate the possibility of a 70% clearing rate. I was undetectable after my 6th week viral load test which means I reached that stage sometime between the 28th and 42nd day of treatment. For all I know my viral load dropped to undetectable the day after my 4th week test putting me tantalizingly close to the RVR cutoff. Sure it’s whistling past the graveyard to think that, but let me carry some illusions through this process.

Both I am my doctors are fairly well convinced that the viral breakthrough was the result of the dose adjustments in my interferon that were mandated by the research protocols. Treatment outside the study under the Standard of Care for Hep C gives me the opportunity to undergo the course of treatment at the full doses of interferon and Ribavirin. This gives the treatment the best chance of working for me.

I was at an undetectable viral load for somewhere around 18 weeks. During this time, my liver enzymes returned to normal and all my liver tests returned results in the normal range. They tell me that this means the inflammation in my liver has subsided and it has had at least a small window of time to begin a bit of healing. My liver disease was between a stage one and two and giving it time to heal will give me a much longer timeframe for the progress of the damage. If continuing treatment returns me to an undetectable level for another 20 plus weeks, this just can’t be a bad thing for my liver.

All things considered, I tolerate the treatment well. I have side effects and some are worse than others, but compared to the treatment issues that many other patients have it is pretty reasonable. I am continuing to work, albeit at a reduced level of hours. I able to keep what food I eat down through the occasional wave of nausea. The flu-like symptoms follow a reasonably predictable cycle and do not overwhelm me. Insomnia is an ongoing issue, but when it gets particularly intrusive, I have drugs that allow me to sleep without a sedative hangover. The most insidious effect the treatment had on me was the gradual onset of depression. However the deployment of antidepressant medication has made that a manageable issue as well. So if I can tolerate the treatment, why not continue to be aggressive in attacking the virus.

My employment situation is good. Both my boss and the Executive Director of the organization are firmly in my corner and are willing to work with me to create a situation which gives me the best chance to do my job and gives the organization some actual benefit from my continuing to work. There is no guarantee that this level of support will continue indefinitely. Either of the individuals might move on or retire and their replacements might not be as supportive.

My benefits are good. My employer pays for my health plan and the plan I have allows access to the CPMC Hepatology Center which has first-rate doctors and is on the leading edge in both treatment and research. I still have accumulated sick time I can use (though every time I look the number seems to have shrunk a lot more quickly than I thought it would) and my organization allows other employees to donate sick time to me. Luckily, I haven’t alienated everyone in the organization yet and several people (who seem to be frighteningly healthy) have offered to donate time to me. Again, this is the sort of thing you can’t count on being there forever, so why not take advantage of it while I can.

I have a pretty grim view of the financial future of the USA. What with huge deficits and unfunded liabilities; high unemployment, several more years of the housing mess in front of us, the treasury printing trillions of new dollars, the states being for all practical purposes bankrupt, etc, etc, etc, I figure I should go for the treatment while I can afford to do it.

Finally, I have the full support of my wife. She has been absolutely unflinching in her support throughout this process. After we talked about all the reasons for and against continuing, she supported the decision to go ahead and continues to believe along with me, that we are going to beat this virus. After all, it’s not even really alive. It’s just a protein coat with some RNA, damn it and if we can’t even beat something that doesn’t even meet the complete definition of being actually alive, what chance do we have…

The Cost of Stress

2010-06-25T20:21:00.000-07:00

The results of the first viral load test since I began treatment outside the study came back yesterday and my viral load numbers are trending back down. This is enormously good news. The first test indicating the viral breakthrough showed a viral load of 17,000. The retest number was a touch above 40,000. Now, one month after the initial breakthrough and two weeks after resuming full doses of interferon, the number has dropped to 10,000. This offers confirming evidence for the theory that the breakthrough resulted from the series of reduced and interrupted doses over the final few months of my participation in the study and not because the Hepatitis C virus had begun to develop resistance to interferon. This also adds weight to the belief that it is indeed worthwhile to continue treatment and potentially clear the virus.

Tracing the path of stress during the past month leading up to this result has been a learning experience of the first order. The initial news of the breakthrough brought a tremendous jolt of adrenaline and anxiety. I was convinced the breakthrough had everything to do with the interferon dosing changes due to my low neutrophil counts and was intent on continuing treatment in some form. The uncertainty of whether or not the study doctors and my doctors would agree and what this would mean for ongoing relations with the researchers resulted in a solid seven days of anxiety. The agreement and support of the doctors involved was an all-too-brief relief as the stress shifted to getting rapid treatment and prescription authorizations from the health insurance company and attempting to secure bridge doses of interferon and ribavirin that would allow no further dose interruptions until the prescriptions were filled. Having accomplished that, the stress shifted to finding the best suppliers for the prescriptions which would result in the lowest possible co-payments so as to make ongoing treatment affordable. Finally, the wait for the first round of tests indicating whether the renewal of full-dose interferon treatment would knock the viral load back down continued the grind.

The first 10 days were actually a period of relatively high-energy as news was received, reactions were dealt with, research was done, meetings were planned for, calls were made and decisions were arrived at. The next 10 days were a marathon of waiting for authorizations, arranging prescriptions and deliveries and generally feeling my physical and mental energy drain away. The final days were a series of forced marches through each day. It became hard to sleep and harder to stay awake. I woke up tired, had to take several catnaps a day at my job to be able to keep any mental focus at all and when not at work found myself falling asleep after any activity that required mental effort.

The relief of seeing the new viral load numbers bestowed the great gift of sleeping through the night for the first time in weeks; and sleeping through the following day, and continuing to doze off throughout the day today. Who knows, a few more days of 16 hours of sleep and I might be able to watch the knock-out round of the World Cup with the attention it deserves.

The Cost of Treatment

2010-06-20T22:03:00.000-07:00

Going on the Standard of Care Hepatitis C Treatment of Pegylated Interferon and Ribavirin that is paid for via your insurance plan or out of your own pocket, causes a major restructuring of you financial budgets. The meds to treat Hep C are not cheap. Pegylated interferon is a relatively new drug and thus does not have a generic version available. It is available only via brand name preparations. As anyone dealing with drugs knows, brand name is always more expensive than generic. Ribavirin is a bit of a different story. It is available in generic form as well as brand name and thus is available at a lower cost, but that lower cost is not necessarily cheap.

None of this is news to anyone who approaches the treatment through their hepatologist and insurance company. For those folks, the cost of treatment has been a major component of their decision whether or not to even begin the process. For people who have been involved in research trials where the drugs are provided free of charge by the drug company sponsoring the research plan, it is a rude shock. Complicating the situation is the fact that people entering treatment through their insurance company or via their hepatologist have been thinking long and hard about the cost of the treatment, they have been making plans as to how to pay for it. They may have contacted the drug companies if they are underinsured or uninsured to see whether they qualify for any financial assistance. In short they have been thinking about it seriously for a considerable time.

When you suddenly make the decision to continue treatment through you insurance or out of your own pocket in order to try to continue the gains you have made during the research trial, the cost issue is thrust upon you without a real chance for reflection and planning. You find out that Pegylated interferon is runs up to $550 per dose; That a months supply of Ribavirin might be $1000; making the monthly bill over $3000 if you are paying for it yourself. Even if your insurance is paying for some of the cost of the drugs, it might not be for the same prescription co-payment you have grown used to with the other drugs you have received over the years.

In my case, I am already on 5 drugs to manage the side effects of the interferon and ribavirin, they are Celexa, Trazadone, Levothyroxin, Ativan and Tramadol. I don’t take all of them every day and the scrips run for various lengths but it is safe to say that the co-payment bill is $60 per month for those 5. As we have hustled to continue the Standard of Care treatment without interruption to the dosing schedule, we have heard several different numbers for the co-payments for Ribavirin and Pegasys (which is the drug that is on my insurance company formulary). It started out being a flat 20% of cost or $450 per month, then was reported to be $165 per month, then a test payment run by the specialty pharmacy supplying the Pegasys reported it at $250 per 4-week supply. The ribavirin will be covered at the standard $15 per prescription copay. So what it looks like is that it will cost from $325 per month for the 7 drugs in question up to $525 per month under the worst-case scenario.

In easy to understand terms, it means from $3900 to $6300 per year for the drugs that will give me at best a 40% chance to clear the virus; about $100 per percentage point of potential success. And this does not include any additional drugs which may be prescribed to counteract the low blood cell counts caused by the interferon and ribavirin. This is yet another reason that some people wait years to undergo treatment. It can be hugely expensive.

More on the personal costs in upcoming posts.

The Rest of the Story…

2010-06-17T20:10:00.000-07:00

What really happened when I formally left the study was, needless to say, much less histrionic, though it had its own brand of drama.

I got a call from AVB in the morning announcing the lab results were back, I had a confirmed viral breakthrough and I had to stop taking the meds belonging to the research study. She was working on getting some medical samples from the Roche representative that would bridge me over until my insurance authorizations went through and my prescriptions for Pegasys and Ribavirin were filled. She told me that when she had some news she would contact me and then I could bring my old meds in and get the bridge meds from her.

Sure enough the call came through at 3:00 p.m. that same day while I was in an event planning meeting. She had arranged the bridge meds and could I get to the hepatology research center no later than 4:30 to pick them up and drop off the old stuff. I was without transportation, but promised to do my best. I excused myself from the meeting by telling everyone I had to go pick up drugs and started walking quickly the 1 ½ miles to my home.

As anyone in San Francisco who relies on the Municipal Railroad system, or MUNI as it is infamously known, schedules are something that are mostly honored in their breach. I walked the distance home along a MUNI route without seeing a bus during the entire 40 minutes. I grabbed my meds, diary, sharps container and fanny pack jumped in my trusty pickup and headed back toward the research center. I went back over the same route and still did not see a bus by the time I had to turn off on other streets.

When I got to the center, I met AVB and she collected my old meds and other materials. I actually got to keep my Roche Logowear. She explained that she had samples of Ribavirin and Pegasys that should tide me over until the insurance authorizations cleared and that she was on her way to Dr. B’s office (who had stayed late to be available) to get the necessary documents signed. She returned with the meds and with the gentleman who would be the nurse coordination for my treatment with Dr. B. She introduced us; he gave me his contact info and he told me he would be in touch with a day or two to follow up on the authorization status. He gave me some lab test request sheets and a preliminary schedule of when I needed to get lab tests done. The he shook my hand and, wished me good luck and said he would contact me soon.

AVB then went over the kit of materials that is given to outpatient treatment subjects and showed me how to use the preloaded syringes that the Pegasys came in. No more vials to fill syringes from, Yay!

At that point she wished me good luck, said that she was still available as well if I had questions or needed to go over any of my previous history on the study. She choked up a bit. I choked up a bit. I thanked her for all the efforts she had made on my behalf, she said don’t worry about that now, just work on having a successful treatment. We shook hands and she put her arm on my shoulder and walked me down the hall to say good-bye.

And that’s the Rest Of The Story…(apologies to Paul Harvey)

Drummed Out of the Study

2010-06-16T20:37:00.000-07:00

The confirmatory test results came in and I got the phone call from AVB formally telling me that I had a viral breakthrough and as per the protocols of the research trial must be taken off research treatment. I was asked to come in with my unused meds and my records.

I gathered together my bottles of Ribavirin both empty and full, my sharps container with all my used syringes, my unused vials of interferon in my insulated Roche fanny pack, my diary with records of the timing and amount of my daily doses of meds, loaded them into a bag and drove to the CPMC hepatology research center.

I trudged, gasping, up the hill to the hospital, rode alone in the clanking elevator to the third floor and was escorted into one of the closet-sized examining rooms. I stood in front of the desk of research coordinator AVB and unloaded my bag. The vials were counted, the pills were counted, the sharps container set aside for the later counting of the used syringes and my never-to-be completed dosing diary was confiscated from me. The Roche logo was ceremoniously cut off my insulated fanny-pack and it was tossed back to me. I was slapped on each cheek with the partially completed diary and as the theme song to Branded played in the background I was marched out of the room. As I walked down the hallway towards the elevator the nurses averted their eyes, the lab tech closed his door and the other patients behaved as though I did not exist. The walk back to my truck became another endless, gasping, uphill climb. What shreds of my dignity I had managed to preserve until that time broke down when I got into my vehicle and I sobbed uncontrollably over the steering wheel until I could gather what composure I could and drive back across the pitiless city to my cold, echoing home.

Tomorrow…The Rest of The Story.

Bad/Good News 3 – Participating in Future Research Trials

2010-06-14T21:30:00.000-07:00

The final item that concerned me about moving out of the research trial and getting treatment through standard channels is one that will concern anyone in the same situation. Does making this decision preclude you from participating in future research trials?

I specifically asked AVB, the research coordinator about that issue. I framed the question to her that “since I am dropping out of the trial to pursue treatment outside the protocols and on my own…” She immediately cut me off at that point. Her statement to me was that I was not dropping out of the study. I was consulting with the medical personnel in the study and my own doctors and making a decision about what was in my best interests as a patient. This decision transcends the study and is about what is best for the patient in their attempt to fight their disease as effectively as possible.

She stated that I have followed all the protocols, come to all appointments, kept accurate records and come in for additional testing as the situation required. Patients who have done these things are considered to be good research subjects. That fact that patients who have been reliable subjects make decisions to pursue courses in the best interests of their long-term health does not preclude them from being included in further studies. She stated that given a history of positive participation in previous trials she would be inclined to include them in future studies for which they passed the screening.

She mentioned that their have been people who have dropped out of this and other studies she has been involved in either due to viral breakthroughs, inability to tolerate side effects or inability to follow the study protocols. Some of these patients have cut off all communication with the study, not returning phone calls, emails and letters and not returning the unused study medications. In some cases they cannot be found and their ongoing health cannot be determined. These are the sorts of patients she would not include in any future trial. They are not reliable subjects.

This was a load off my mind as my percentages are low to clear the virus on continued treatment. While Telaprevir will no doubt be approved soon, there is not guarantee that I would succeed with it either and having the possibility to participate in trials of future promising treatments is another arrow in the quiver, so to speak.

The only real downside is that I am no longer treatment-naive…

Bad News is Not So Bad 2

2010-06-12T20:34:00.000-07:00

The Kindness of Doctors.

All of us who have being living in the American health care system have stories of the system letting people down. Doctors who sleepwalk through their job; insurance companies that find any way possible to deny care; nurses who are surly and hostile; hospitals that warehouse and ignore patients. After a lifetime of these kinds of events, you can become fairly cynical about the motives of healthcare professionals and about their dedication to their jobs and those under their care. The response that has been shown by the folks in the Roche RO5024048 study is the kind of event that can restore your faith in doctors.

In the first phone call to me informing me that I had had a viral breakthrough, AVB the study coordinator told me that I should ask Doctor B, the hepatologist, what she thought about my continuing treatment outside the study protocol. She said there were no guarantees, but I should certainly ask the question. I did not have a lot of confidence in Doctor B’s response. She is the lead doctor on the study. She gets her name on the research paper written about the study and in the interests of gaining research data for the study putting me off-protocol does not help her do that.

When we had our meeting just after the retest blood draws, she went over the viral breakthrough test results and mentioned that, subject to the results of these tests, I would be off the research treatments. AVB mentioned that I had a question for her and I asked about continuing treatment outside the study. Doctor B wanted to look at me test results and most particularly my dosing record. We she examined them in detail and saw that the breakthrough had occurred after 2 skipped doses of interferon due to low neutrophil counts and that I had been on a reduced interferon dose for several weeks before that, her whole personal affect changed. It was a subtle shift from researcher to doctor. She looked closely at my viral load numbers and saw that I had been undetectable for between 12 and 18 weeks even on the reduced dosing and that the dose reductions had all been due to low neutrophil counts (neutropenia). She asked me how I had been handling treatment and the treatment side effects. She told me that outside the research study protocol, she could administer drugs to combat both the neutropenia and the lowered hemoglobin counts. This would allow me to have a good chance to continue treatment on the full doses of interferon and ribavirin, thus giving me the best chance to clear the virus. She mentioned that other drugs were in the pipeline and nearing approval, particularly telaprevir, and did I think I wanted to wait or to continue with treatment now.

I told her I was leaning toward continuing treatment now, but wanted to talk to doctor C, my gastroenterologist before I made my final decision. She immediately told me that she would call him and let him know the latest situation and that I should talk to him and my primary care person as soon as possible so as to be able to get the treatment drug approval process under way with the insurance company as soon as possible. She also volunteered to oversee my treatment if I got a referral to her from my primary care doctor. She also volunteered to call him as well and let him know the situation.

To see the change in view from research scientist to medical doctor determining the best course of care for her patient caught me completely off-guard. It seemed to occur in a matter of an eye-blink. She became completely focused on letting me know the options and the possibilities. It gives me a great deal of confidence in having her as my hepatologist going forward.

My conversation with Doctor C was similar. He wanted to know if I felt I could handle treatment going forward. He also wanted me to know that the percentages of clearing after an event like this are not high. He also emphasized the availability of the drugs to treat the low blood cell counts and the fact that this would allow the higher doses of the Hep C Standard of Care drugs. But the decision is always in my hands.

I am going forward with treatment. It may take a few weeks to get everything set up, but the test results don’t come back until after my usual dosing schedule, so I will have one last dose in my from the Roche study before I forge ahead on my own.

Just as a final note and reality check, I had a meeting with my primary Doctor K. I have some thyroid function issues due to treatment and he needed to prescribe something for that and issue the referral to Doctor B for insurance company purposes. Ah, the reality of being back in the arms of my overworked primary care doctor. Listen, no chance, talk over me, of course, give me confusing instructions, par for the course. It’s good to know something things don’t change…

Bad News Is Not So Bad News 1

2010-06-09T22:13:00.000-07:00

The situation of having a viral breakthrough and the decisions made about treatment in light of that breakthrough is a good illustration of the differences between undergoing treatment under the protocols of a drug trial and undergoing treatment under the Standard Of Care supervised by a hepatologist. There is a bit about that is this post.

I met with Doctor B, the doctor in charge of the Roche RO5024048 study today. I was getting the blood tests to confirm that I indeed had a viral breakthrough and met with her as part of that process. Given that it would be highly unusual for the tests to show that I was again undetectable, I am going to be dropped from treatment under the protocols of the study (the protocol is that if you show any viral activity at week 24, treatment is suspended). That being the case, I asked Dr. B what her opinion was of the value of my continuing outside the study using the standard interferon and ribavirin treatment.

She was initially noncommittal and wanted to see my viral load history and my dosing history for the Pegasys and ribavirin. She saw that my viral load had been undetectable for 18 weeks. She also saw that I had spent 5 weeks on a ¾ dose of interferon, had skipped 2 doses completely due to low neutrophil counts and had just resumed injecting at a ½ dose level. I had also been on a reduced dose of ribavirin for the past 7 weeks. When she saw that the breakthrough had occurred after the two skipped doses of interferon, she warmed to the idea. She asked me how I have been tolerating the treatment. I told her I had a lot of the usual side effects but that the addition of an antidepressant had really made a huge difference in my mental outlook and my mental energy. Then she pointed out the reasons she thought it might be worthwhile to pursue.

If you undergo treatment under normal circumstances, you can be prescribed drugs to reduce the loss of neutrophils (neutropenia). You can also be prescribed meds to help with the hemoglobin loss as well. They don’t do this in drug trials because they are trying to control the number of variables as well as to determine the effect the study meds are having with the interference of other drugs. Being able to take these additional medications means that the full doses of interferon and ribavirin can be maintained for the longest possible time during the course of treatment. It goes without saying that this increases the chances for a successful outcome.

In my case for about 40 % of the time I have been in the study, I have been taking reduced doses of just those standard medicines that have proven so successful against Hep C. Moving forward with treatment under full doses means I have a chance to reach a successful outcome. Given the 6 months I have spent on this so far, I don’t see why I shouldn’t grab that chance.

Ruminating Before The Retest

2010-06-07T20:32:00.000-07:00

I retest tomorrow to determine what my viral load is and, after the study governors review the numbers, find out whether I am bounced off treatment. Until the results come back I’m just drifting along in an indeterminate state. It’s like the experiment in quantum physics where in one instance light behaves like a particle, in another it behaves like a wave. If I’m back to undetectable, I am carried along wavelike in the tide of treatment. If I still have a detectable viral load, I am tossed up particle like onto the shoreline to watch the ocean go by.

As I wait, I’ve been thinking about what I think about the disease. In journalism they ask the questions of Who, What, Where, When, How and Why. As I mentioned back in my very first post about finding out you have the disease, the who, what, when, where and how tend to fade into the background before the fact of being infected with the disease. The question of why remains, but it’s problematic in the extreme to try to come to an answer to that one.

If you believe in an entity or mechanism or power in the universe that somehow keeps track of and balances positive and negative energies, good and evil or grace and disgrace, you may have an answer to they question of why within your belief system. I do not believe in a universal balancing mechanism aside from one that keeps the second law of thermodynamics by conserving energy. I do not pretend to know what is going on at the level of why our universe(s) is the way it is. Most of the models that physicists use to attempt to capture the functioning of the universe have multiple dimensions in them that are beyond are ability as human animals to comprehend directly. Something must be going on in those dimensions; maybe there is some sort of explanation there, maybe not. If anything, I personally believe in a cosmology based on Teilhard de Chardin’s idea that the increasing complexification of consciousness eventually will result in the creation of god. But we are not there yet.

Regardless of the answers you may find for the 6 questions, you are eventually left with only the fact that you have the disease. This fact has a number of consequences. The disease will likely progress in the severity of damage it does to your liver. This may mean you will get cirrhosis and need a new liver. You may or may not qualify for a transplant. Even if you get one, it may not “fix” the disease. The disease may also cause liver cancer. If so, you can also try for a transplant and have a reasonably high survival rate. If you don’t get a transplant, you will likely die within five years. One of the effects that the fact of having Hepatitis C brings home in a remarkably clear way is that we all have an expiration date.

To put the date off a bit, you can chose to fight the disease, but there are no guarantees that treatments either inside or outside traditional western medicine will effectively clear the virus from your body. Methods to manage the symptoms of the disease and attempt to attack the virus that are available outside the traditional medical establishment can run up significant costs in both time and money. Acupuncture, massage, herbal supplements and nutritional consultations are not inexpensive especially when considered over a period of years. There is also no guarantee that they will prevent the progression of the disease. Treatments through traditional medical regimens are both monetarily costly (though this can be mitigated by insurance, participation in research trials, or compassionate use protocols) and physically costly. To many, the treatment is difficult enough that they either cannot complete it or never start it at all. There is also at this point only about a 50-50 chance that the treatment will clear the virus from your body if you have the most common North American genotype of 1a.

Another corollary of the fact that you have Hep C is that you are now someone who can be a hazard to other people. It is certainly at a small level if you are careful how you interact physically with people, but it is a fact. The idea that you are capable of giving someone else this disease just by exchanging a tiny amount of blood is a sobering fact.

Here are my facts: I have the disease. It has gone symptomatic. It affects my quality of life. I have reduced concentration, forgetfulness, depression and fatigue. I can choose symptom management and non-traditional methods to attack the virus. I can choose to attack it aggressively with the methods developed by medical research. I personally chose to attack it with an experimental drug therapy regimen. So far it has bought me about 16 weeks of relatively virus free time for my liver and the knowledge that I can handle the rigors of the treatment regimen. Whether or not I continue on treatment in this study, I will continue to attack the disease aggressively using conventional medical protocols. My wife tells me that I can be very determined when I get my back up over something. I certainly hope she is right.

A final fact that millions of people with this and other communicable, serious diseases have discovered is that having this sort of disease changes your image of yourself at a fundamental level. It has certainly changed mine.

Thoughts From The Nail

2010-06-05T19:23:00.000-07:00

The shock of having a viral breakthrough is wearing off. I have spent some considerable time today mulling over the implications of the virus returning. For anyone in this situation, there are a number of considerations and possibilities.

Is there something that presents itself as a reason that the breakthrough might have happened? Does it appear to have happened despite your best efforts to adhere to the protocol? If it happened in spite of you taking all you meds correctly, your virus might be developing a resistance to the type of interferon you are taking or to interferon in general. There is evidence that changing the brand of pegylated interferon you are taking can change the results against the virus. You can talk to your doctor about the possibility of changing the type of interferon you are taking. Of course some insurance plans only include one company’s pegylated interferon in their formulary which means you are out of luck unless you have the $500+ per dose to cover the change.

I believe there was a specific reason for my breakthrough. I think it resulted from dose adjustments made to my interferon dose dictated by the study protocols. These dose adjustments happen to many patients who are undergoing treatment. They are made to attempt to control side effects for the most part. If your hemoglobin drops, if your neutrophil or lymphocyte counts drop too far a dose adjustment will be made in your interferon or ribavirin. In my case, they reduced my Ribavirin dose from 1200 mg to 1000 mg per day after a week 16 retest showed my hemoglobin had dropped to 9.6. I don’t think this had much to do with it. More importantly, at week 21 my neutrophil count went down to 360 and I was told to skip my interferon dose. The next week the count had not rebounded quite far enough and I had to skip another dose. I had only injected one time before my week 24 tests and that was a half dose. I think the suspension of my interferon for two weeks directly contributed to the viral breakthrough.

Which way is you viral load trending? If you have a breakthrough, they are going to retest you to reconfirm that it is a real event. It could be a lab error, especially if it just blips a bit over the undetectable level, or it could be a one-time event. If the results show that your breakthrough is real and the viral load is rising, you’ve probably got a resistant virus and will need to change your treatment drugs or dosing. If your breakthrough is real, but the viral load is declining, then the continuation of your present treatment regimen might mean you will return to the undetectable level. If the results show you are again undetectable, then perhaps it was a test error or one-time event and you can curse the additional gray hair you got while waiting for the results.

Is adjusting your dosing possible? If your breakthrough occurred after lowering your doses of medications, is it possible to raise them again and safely manage the side effects? Did the side effects, especially the blood counts, mean you absolutely had to reduce the dose?

Do you have the option of continuing treatment through your own insurance or by funding it yourself, or is being in a study the only way you can afford treatment?

Does a viral breakthrough mean you are starting over from week one of the 48 week treatment regimen or, if your viral load is trending downward again, would it mean only a continuation to the end of the original treatment time-frame?

All these are questions to ponder. You can endlessly mull them over in your mind right away, or you can try to get away from them for a bit and start to obsess about them when your get your retest results.

I tend more toward the drive yourself crazy by obsessing about them continuously camp. Luckily I have a bunch of drugs to calm me down and help me sleep, otherwise by late next week, I would be a mere husk of myself. Try not to go down that path.

They may have dropped the MPSH on me, but even that bounces after it hits you…

The Million Pound Shit-Hammer

2010-06-04T17:27:00.000-07:00

It is week 24 of the experimental trial; half down, half to go.

Current Condition:

Hair - Thin and White
Body - Thinner and White
White Cells - Thin but recovering
Red Cells - Thin but stabilizing.
Brain – Stabilized on Antidepressants

Which, as it turns out is a good thing as I got the news today that I had been dreading. The week 24 tests came back and the Hep C virus is Back.

They call it viral breakthrough (HCV-RNA falls with treatment, but then rises even though treatment is continuing). My latest viral load number is about 17,000 IU per ml.

This means that they will retest next week and if I am not undetectable in that test, they will stop my treatment under the experimental trial protocol. Needless to say, I am encouraging my body to kick it into gear over the next several days. I will have had two additional interferon doses since the original test was performed and I am holding myself optimistic that I will remain on treatment in the trial.

I have already emailed my gastroenterologist, the good Dr. C, asking him for his take on the efficacy of continuing on the Standard Of Care treatment of Pegasys and Ribavirin outside of the trial protocol and will ask the same question of Dr. B. the trial hepatologist when I am tested next week.

We’ll see how it all turns out, but I am definitely not giving up. Hep C is not going to win and I am going to keep fighting it until I clear it from my body.

I am still in shock about the news, so this will be short. I want to explore the implications more soon, but now I just want to watch mindless TV.

As an added note, Wednesday was my birthday. I’ll have to change my age to 57…

Give Me A Head With Hair, Long Beautiful Hair…

2010-05-30T15:25:00.000-07:00

Among the plethora of side effects of Hepatitis Treatment that are listed in all the Study documents and online resource sites, nowhere does it mention that undergoing Hep C treatment will turn you into a cat. I realize this may require a bit of explanation so here is the back-story, as the theater folks say.

I have long hair. I have had long hair since my twenties. In fact, it has been about 35 years since I have done more that trim the length of my ponytail every several months and keep my beard trimmed. In years past (as little as 10 years ago), much of my hair was dark brown. It was also present in a reasonable quantity. Sure, there were areas where it was clear that my scalp was encroaching into areas previous covered with hair, but overall, I was doing better than any of the men in my family had ever done before. Over those ten years it has gradually gone increasingly gray; to the point that before treatment started I was more gray than brown.

Then interferon began to exert is magic. First my hair began to turn increasingly white. It is not completely white yet (that would be James Coburn cool), but the strands of gray and brown seem to getting mighty few and far between. Then it began to slowly up and leave my head. It does not fall out in huge clumps as is the case with other forms of Chemotherapy. It just gradually gives up the ghost, hair by hair, and slips away. I track its disappearance by my elastic ponytail band. When I started treatment, I needed three loops of the band to hold my hair securely. Now, when I brush my hair in the morning, I have to loop the band 5 (Five!) times around the few remaining hairs in my ponytail to hold them firmly in its grasp. In fact it’s not really accurate to call it a ponytail anymore, it’s more of a pony strand.

Where does all this hair go? That is where the catlike nature of the situation lies. Any chair that I use regularly – those at work for example - becomes gradually covered with a layer of long gray hairs. The sofa at home, the chair on the back porch, even my pillow, all slowly receive a coating of long gray hair. It is not long enough to be my wife’s and besides, she is clearly not losing any hair. It is mine, or more accurately was mine. My jackets and coats as well all testify to the fact that I am shedding, more rapidly as time goes on, what is left of my hair. To be genteel about the situation, I find it most distressing. To be more straightforward, it sucks.

Everyone involved with the treatment and with our support group tells me it will grow back, but that is cold comfort. Cold being an operative term as the lack of hair definitely points up that it had been keeping my head warm all those years. There are far more serious issues involved with hepatitis C and its treatment, but this one just strikes a nerve. While I like cats, I don’t want to shed my coat until I become a large pink hairless version.

The only thing that saves me now is that my hair is light, my scalp is white and it seems there is more hair than really exists. How much more time I can buy with that before it’s time for the shaved head well, I’ll keep you informed.

Research Leverage – Use It or Lose It

2010-05-28T22:47:00.000-07:00

In the previous post, I discussed at some length the reasons Research Drug Trials are often harder on the patient than Standard of Care (SOC) treatment through you doctor. I also talked about the advantages of being in a research trial not the least of which is the access to new drugs that can increase the chances for successful treatment. There is another aspect of being in a research trial that you can use to help you mitigate the side effects and stress of being in a drug trial, it is the leverage you have regarding the data they are collecting from you body.

Once they move beyond the Phase 1 trials to determine basic efficacy and safety, research trials increase in size and length. The reason is that to determine the effectiveness and side effects of the drugs under study, they need a large enough sample to give them statistical significance. Therefore they recruit hundreds of subjects for the trials. There is another reason for recruiting larger numbers of subjects. The researchers know that a certain number of the patients entering their trial will not finish it. Some will fail to abide by the parameters of the study. Others will consistently miss taking doses of their drugs and be dropped from the study. Still others will have such severe reactions to the drugs that they will not be allowed to continue. There are those who will leave the area and not be moving to a location that has the necessary facilities to allow them to continue and some will just not be able to stay the course for the necessary time to complete the study. So they need to recruit enough people to collect enough data even after the inevitable attrition of subjects.

This is where your leverage comes in. The researchers want your data, they need your data and they need you to complete the trial for that data to become a useful part of their records, reports and papers. Therefore they will go to some lengths to keep you in the study. If you move, they will try to find a lab or medical facility near you that can continue the testing they need for the trial. They will work hard to educate you about what you have to do as far as dosing and record keeping and keep at you to do it correctly. They will also prescribe remedies for some of the side effects to make it possible for you to stay in the trial.

That is why it is important to report side effects to the researchers as they happen. It is also important to tell them how severe they are. If they are interfering with your ability to function effectively tell the researchers that as well. For some of the side effects, they will adjust you research drug dose to attempt to mitigate the situation, for others they will prescribe medications to ease the side effects. It is not necessary to exaggerate any of the information you are giving them. Be factual, but above all be timely. If you report accurately and quickly when you have side effects and when those side effects are becoming a real detriment to your life, they will do what they can to help because they want your data. To get your data, they need you in the study. That is your leverage and if you don’t use it, you lose the advantages it can bring.

To use my case as an example, if I had reported the muscle pain in my sides that the interferon causes as soon as it happened, they would have prescribed Tramadol sooner. I would have been more comfortable and probably better rested earlier in the study than I was simply by reporting the severity of the situation as soon as it was happening. Likewise with the insomnia that is a common side effect. I was sleeping badly for a few weeks before the truly enormous bags and dark circles under my eyes made it plain that I was not getting enough sleep. When it became obvious they moved quickly to prescribe the Trazadone to help me sleep. The same was true with the depression caused by the interferon. If I had been reporting my mental state more accurately, it would have been apparently several weeks earlier that I need help for my mental state. As soon as it was plain that I did, they started on the search for the correct antidepressant.

So even though, they want to watch the progression and severity of the effects and side effects of the drugs and they want to control the variables of drug interactions by keeping what you are taking to a minimum, they also want you to complete the study and get your data. Use that leverage to help make your own treatment as bearable as possible.

Why Research Trials put the P in Pain, the F in Fatigue and the M in Mental Breakdown.

2010-05-26T21:29:00.000-07:00

The pitfall of participating in a research drug trial for Hepatitis C is that it will tax your mind and body more harshly than if you underwent the standard treatment or Standard of Care. The upside of participating in the trial is that you get a chance to take a drug that improves (sometimes drastically) you chance of clearing the virus. In order to do the research necessary and gather the data needed for the study, the subjects of the research are required to enter the study “naked” or without the support of drugs and supplements that can help mitigate the side effects of the anti-Hep C medications, at least until the study doctors decide to administer any such mitigating therapies. (The word “naked” refers to a baseball term reported by Hall of Famer Tony Gwynn of the San Diego Padres. He stated that during his time in the Major Leagues players who took the field without using amphetamines were said to be “playing naked”).

What this means in practical terms is that the subjects of a research study will experience all the side effects of the anti-Hep C medications without the benefits of many of the established remedies that patients who undergo the Standard of Care of Pegylated Interferon and Ribavirin can take advantage of from the very beginning of the study.

Pegylated Interferon is well known to cause depression, fatigue, brain fog, nausea, insomnia and depressed white blood cell counts. Patients undergoing SOC through their doctors are often prescribed antidepressants before the start of the study in order to combat the depression. They are routinely prescribed anti-nausea medications and sleep aids from very early in their treatment to deal with those particular side effects as well. Ribavirin is well known to cause anemia (often severe), itchy rash, nausea and muscle pain. SOC patients are prescribed drugs to combat the anemia, given anti-itch creams (often with steroids), anti-nausea meds and painkillers for muscle and joint pain. These are usually given as the symptoms are reported and continue for the length of the treatment. This is not exactly the case with the subjects of a research study and there are very good reasons for that.

As I discussed in this post, the effectiveness of the Hep C drugs and the results of drug interactions are complex things to parse. Combine that with trying to track the side effects caused by the study drugs and you need to control as many of the variables as you can for an effective study. To that end during the screening process for the study, the study doctors want to know every drug and supplement you are taking. If any of them would interfere with their ability to determine the effects of the study medications, they will ask you to stop taking them or, if you cannot stop taking them for medical or other reasons, they may disqualify you from participating.

The same need for a controlled medical environment applies once the study begins. The researchers need to track the efficacy of the treatment drugs and the number and severity of the side effects. To do this, you need to experience the effect of the drugs and the side effects of the drugs without the interfering effects of other treatments and if there are other compounds you are taking, they need to be able to track their use.

So you are going to experience the side effects in full force. It is when the side effects are either dangerous or interfere with your ability to continue with the study that you may be prescribed something to help you deal with them. To use my case as an example, I have not and will not be prescribed anything to deal with the anemia caused by the Ribavirin. This is because they want to track as clearly as possible whether this new combination of drugs changes the instances and severity of the anemia. Many other individuals I have talked with about their treatment experience were given drugs to stimulate red blood cell production. Rather than do that the researchers have adjusted my Ribavirin dose to try to keep my hemoglobin count above the minimum they require to continue the trial. I have not been given anything to help with my white blood cell counts but have had my interferon dose adjusted and even skipped to attempt to keep my neutrophil and lymphocyte counts above the minimum to continue the trial. When I began to report muscle pain associated with treatment, I was told to take over the counter medications. It was only when I reported that the pain acute enough to interfere with my sleep, that I was prescribed a painkiller.

Interruption of your normal sleep patterns is one area that they respond to fairly rapidly. The researchers believe that getting enough sleep is vital to your ability to be able to complete the study. They want to hear if you are having difficulty sleeping and they want to be the ones to determine what remedy, be it over the counter or prescription you are going to take to combat the problem. It is a matter of controlling the variables again. In my case, about 6 weeks after the had prescribed the pain med Tramadol to deal with the pain that was keeping me awake I reported that I was having difficulty getting any more than 4-5 hours of sleep per night. They immediately prescribed Trazadone to help me sleep.

Depression is another major side effect that gets handled differently in a study. Unless a patient was already taking an antidepressant previous to screening for the study, they generally do not prescribe them until the researchers believe they are necessary to your ability to complete the study. Those of us undergoing the study in San Francisco were all given information on strategies to handle the stresses of the treatment and programs to give support to Hep C sufferers, but we were not prescribed anything for the condition until they were convinced we needed it. In my case it was about 18 weeks into the study before AVB began to believe I needed to be given something. By that time, it took me three weeks to gather my thoughts and energy enough to realize I was beginning to tip over into serious depression. At that point, they moved fast and started me on SSRI antidepressant drugs.

All these discussions and examples are provided to make sure you think about this aspect of a research study. I did not consider it at all. It was not until I had been in treatment for a few months that I went to a support group and talked to people who had undergone the standard treatment, that I found out that they were routinely prescribed things to deal with side effects. It was then that it hit me that as lab rats for Roche, we were going “naked” in the study. I have a bit of background in science and my wife has “A Masters Degree In Science,” as Doctor Science used to say. We both realize that controlling study variables is essential to getting good data and ending up with a useful study. I just didn’t think clearly at the beginning of the study, that I was the one whose variables were being controlled and that might mean the course of treatment might be a bit rougher than the SOC.

Knowing what I know now, I would not choose differently. In my mind, the chance to take a drug that increases my chances of clearing Hepatitis C genotype 1a by 50% is worth the potential of having a harder time in treatment. I wish I had thought it through and prepared myself mentally for the realities of what that would mean, but I would not change my decision.

Your decision is up to you. Think it through; be aware of what entering a research study means and then with the most forethought you can, make up your mind.

New Morning & Another Reason for Keeping Notes

2010-05-24T19:42:00.000-07:00

It is very clear to me now both why doctors prescribe antidepressants and why patients endure the early symptoms until their brain chemistry stabilizes and the drug begins to work. I feel…better. It is a curious state to attempt to describe. As my friend BS says, “You generally don’t notice feeling okay or good, but you do notice when you feel bad.” There is also the fact that as you experience a particular state for an extended period of time, be it either feeling good or feeling blah, you come to take it as your normal state and forget that you used to feel differently.

In my case, I realize now that the treatment regimen had gradually been grinding down my mental energy and state of mind. I had not noticed it as it happened though the folks running the study, and AVB in particular, claimed that they could see it happening to me. They actually had the advantage of seeing me intermittently as opposed to every day. This allowed them to notice the changes more clearly because they showed up as significant differences. It’s like the first time you spend some serious time away from home. When you return you notice real changes in your parents and siblings that would not have been nearly so obvious had you been with them on a daily basis. Likewise with me, my wife and I were immersed every day in the grind of treatment and thus the incremental changes became what were normal as opposed to something we should be paying attention to. If nothing else, the declining number of posts per month to this blog should have been a tip-off that the depression and why-bother attitude induced by the interferon were taking a very real toll.

Now that I have been taking antidressants for about 3 weeks and Celexa in particular for about 10 days, I feel a bit better; a touch more mentally alert; less likely to have the why-bother attitude. I still get tired and lose the ability to concentrate by early afternoon, but now when I get home, I don’t just drop onto the sofa and watch a couple hours of awful television in a kind of passive stupor. I still turn on the TV, but I now get bored after a while and find something else to do. The ability to be bored by stupid, mindless crap is a great gift of mental achievement that has been returned to me by modern bio-medical research and I am grateful.

This is yet another reason to keep notes about yourself while you are in treatment. If I had done nothing more than record the number of hours I was watching television, it might have tipped me off that my mental outlook was going downhill. So take notes, date them and look them over from time to time as treatment goes on. You have to review them regularly because the interferon is going to fog your brain and ruin your memory during treatment. If you do these things, you can stay ahead of the side effects and do your doctors a great service by having good information to give them. Both of these things will help you come through you treatment more successfully.

PS: A purely personal note about Celexa because it means a lot, SEX IS BACK!

Back on the Interferon Bandwagon

2010-05-22T20:27:00.000-07:00

After a reduced dose of Pegasys two weeks ago and a skipped dose last week, I am back under the hammer, so to speak. The dose reduction was due to my neutrophils being below 500. The study doctors believed my neutrophils would rebound without the interferon pounding down the white blood cells. They were right. The number popped up to 1250 and they put me back on a half dose of Pegasys.

It is amazing how much you can forget in 20 days. While I had a lot going on the past few weeks what with the acclimatization side effects of the antidepressants and the new drugs I was taking because of it, nonetheless the number of interferon related physical symptoms that disappeared without my noting their passing surprises me.

I injected Thursday evening and that night I had night sweats and had to change my t-shirt twice. By Friday late morning/early afternoon I had the mild headache and general crappy feeling in the head that you feel when you are coming down with something. By 5:00 p.m. my muscles started to ache, especially in the butt area (How can you mindlessly watch TV while feeling crappy and sore if you butt is aching?). That night I had a generally stuffy head and by Saturday morning the middle of my back was stiff and cramping. I had my first wave of nausea around noon and I also had a sore spot in my breast but with my general clumsiness of late, it could easily be the result of my running into a door, or wall, or chair, you get the idea.

All of these symptoms had disappeared over the past 20 days. Their disappearance was accompanied by completely forgetting about them. I didn’t really even register the fact that I hadn’t felt nauseous in almost three weeks. That would seem to be the sort of thing that you might take note of.

I think this points up the importance of keeping notes about your general health, side effects and mental state throughout your treatment. It doesn’t have to be elaborate. Just a small notebook wherein you note how you are feeling generally and any unusual or unique effects you are feeling. It really helps to be able to flip through you notes and realize that a particular symptom or side effect or your general state of health and feeling is something that you have experienced before. The interferon really affects your concentration and memory and it is very easy to completely forget about something earlier in the treatment cycle that seemed it would be unforgettable at the time. So make notes and keep records. A little notebook of the history of your treatment can be a great friend to you when something seems to be coming out of nowhere, but actually happened to you in the past.

Complexity, Thy Name Is Drug Interactions

2010-05-20T22:29:00.000-07:00

I do not envy medical researchers their jobs. While puzzling out the secrets of biochemical reactions and how they can be used to counteract the malign effects of viruses, bacteria, cancerous cells and the effects of defective genes must be fascinating and rewarding work, sorting out the effects and side effects seems dauntingly complex.

To use my case as an example, initially I was taking 3 drugs to attack the Hepatitis C virus. The interferon (Pegasys) and Ribavirin (Copegus) were well known drugs; indeed they are the Standard of Care or SOC, with well-documented effects and side effects. Those effects, however, all vary with the individual receiving treatment. For some, they have little effect on the Hep C virus, for others they are tremendously effective. Some individuals are devastated by the side effects, even to the point of being unable to complete the treatment, others individuals have a relatively straightforward time of it with a few difficult side effects but none that are debilitating. To this well-known set of circumstances they added a new drug, the polymerase inhibitor RO5024048 aka RG7128. Phase 1 testing had already been done using the new drug alone and its side effects noted, but aside from a worrying potential effect on the kidneys, many of the side effects mimicked those of the SOC. So as the study progresses and the effects and side effects are tracked and cataloged, it becomes vastly more complex to attempt to determine which drug might be doing what; what synergistic effects might be occurring between drugs; and what other effects might be the just the degree of effect of each drug on the specific individual undergoing treatment.

As the treatment progresses the Ribavirin wipes out your hemoglobin and gives you anemia and potentially itchy rashes. The interferon wipes out your white blood cells, saps your energy, fogs your brain, tends to give you depression and robs you of the ability to sleep well if at all. So to counteract these effects, additional drugs are prescribed. To continue the example of my case, I am currently taking 4 additional drugs. Firstly, I was given Tramadol (Ultram) to counteract the fact that as part of my interferon cycle, the muscles along the sides of my body can be achy and painful enough to leave me unable to lie down. As you might imagine this makes it difficult to sleep. Next, as the general insomnia caused by the interferon kicked in, I was given Trazadone to use as a sedative. Then, as the interferon gradually eroded my natural good cheer (okay my occasional good cheer) they prescribed an antidepressant, Paxil. In order to bridge the time it took for the Paxil to reach full effect, they added Ativan to the witches’ brew of drugs. The side effects of the Paxil necessitated a switch to another antidepressant, Celexa, but the total result is still the same. I am taking 4 additional drugs to counteract the effects of the drugs I am taking for the Hep C.

A final complication during the trial is changing dosing of drugs. In this trial, we only took the experimental polymerase inhibitor for either 8 or 12 weeks and potentially (depending on which arm of the trial you were in) at three different strengths. So after the first 12 weeks of the trial we were all down to 2 anti-Hep C drugs. There is also dose-adjusting going on for those two drugs as well. I have administered full, half and ¾ doses of interferon and even been told to skip a dose at various times during the study depending on my various white blood cell counts. I have been reduced to a lower level of Ribavirin to attempt to counteract my anemia. These sorts of adjustments are the norm for various patients throughout the course of the study.

To all this you can add the complicating effects of human foolishness, forgetfulness and folly (I should have written sports headlines). Again, we have the convenient example of my own case as an illustration. The context for this particular case of foolish forgetfulness comes from two previous posts. In one, I detailed all the benefits of The Everything Tastes Like Crap Diet, in the other I mentioned that chocolate had some very powerful effects on me after I started treatment. Well, the third day after I started the Paxil, while still in the speed rush phase of the acclimation period, I began to actually fell hungry again. I don’t know if it was the psychological effects of the Paxil or just because my body was using so many calories it was crying for food, but I went to the store with a real desire to buy food. I also noticed that foods I had not though appealing in weeks or months began to seem like they would be really good. The though of eating ice cream occurred to me for the first time in months, particularly chocolate ice cream. So I bought a pint of chocolate ice cream and went home and ate it in one sitting. The next day I did it again, and the next. All this time I was noticing that I was jittery and had a great deal of nervous energy. The jitteriness was moderating as the days went by (as I acclimated to the Paxil I thought), but did it occur to me that the effects of the massive doses of chocolate might be contributing to this? Heck no, never crossed my mind. By the way, despite the massive influx of delicious fat into my body, I still continued to lose weight.

Due to side effects that I believe are completely unrelated to any chocolate consumption (chocolate is supposed to increase libido, I believe), they switched me to Celexa. About 4 days in to the Celexa regimen, I once again noticed that I was a bit jittery and nervous. Finally it occurred to me that I had been eating a lot of chocolate. That same day, as I bought my pint of ice cream on the way home from work, I bought vanilla and have ever since. I haven’t noticed a huge difference, though I continue to be less jittery and nervous every day, but there is one more piece of evidence that I just can’t ignore.

I was at work today and I got a bit hungry around 11:00 a.m. I went down to the lunchroom and among the volunteer snax there was a bowl what I thought was trail mix but turned out to be pure M&Ms. I took a small cup of them went back up to my lair and proceeded to nibble on them as I prepped eBay auctions. About 15 minutes later I noticed I was a lot more wired than I had been before. It was not just a sugar rush, it was the jitters, case closed.

So, not only do the researchers have to deal with the seemingly endless complications of drug to disease interactions, drug to drug interactions and drug to human interactions, they also have the wild card of patients who can’t even keep track of their own food reactions. And these reactions are the ones the researchers are never even aware exist. Good luck to all of them, because we patients aren’t always reliable reporters.

I blame it all on the brain fog…

Round and Round the Drug Carousel.

2010-05-17T22:05:00.000-07:00

It’s been a few more days and the antidepresseant cycle has modified into a steady spaced out condition. It has the sort of charectaristics I mentioned in the past post be without much nervous energy, or any energy at all for that matter. It’s sort of a passive, pleasant, unconcerned state of mind. I have no real idea if that is the intent of using antidressants in the context of a chemotherapy regimen, but that is where we are.

My weight has stabilized, but the sexual dysfunction persists. I don’t really have the interest to even attempt it anymore. That fact that it doesn’t bother me creeps me out.

I went in today for yet another redraw to check neutrophil and lymphocyte counts. They were low enough last week that I was told to skip my interferon dose. They hope that the interruption of the interferon dose with allow a bounce back of my white cell counts and allow me to resume the interferon with the next dose.

After the blood work, AVB quizzed me at length again about my reactions to the Paxil, whether the Ativan had helped with the symptoms and how I generally felt about being on the Paxil. I told her about the powerful initial side effects and the time it took for them to call down. I mentioned that I was now in a state of steady unconcern with a side order of being spaced out and out of focus. I also told her that I thought that Doctor NB could do a great favor for future patients by spending some time to go over the more likely side effects and the periods of time that they might expect them to last. AVB asked whether the pharmacist went over the side effects and I informed her that at my inner city pharmacy, their was never much in the way of consultation.

I also went over the sexual side effects. She was quite concerned and put in a call to Doctor NB for a consult. As she said, the treatment is hard enough to deal with without removing your enjoyment of a basic component of living. She also mentioned that sex is one of the ways for couples to feel close to each other and offer support and during treatment, you need that more than ever.

It took about 25 minutes for Doctor B to arrive and the fact that I sat calmly and stared out the window without a care in the world for most of that time speaks to the spaceyness I was feeling.

When she arrived, Doctor B apologized to me for not spending the necessary time on side effects the last time we talked. She stated that they often left that to the pharmacists but that was not really acceptable. It was gracious and heartfelt of her and I appreciated it. After hearing about the sexual issues, she decided to switch me to another antidepressant. This one is also an SSRI, but is a different drug. It has a much smaller incidence of negative impact on sexual functioning. She went over the expected side effects (hooray!) and sent me out the door with a prescription for Celexa. She told me to hold on to the Paxil because you never know.

After Doctor B left, AVG talked about the many and varied forms of antidepressants. She said that someone like myself who is a virgin to those types of drugs is much harder to prescribe. Many people come into treatment with a history of antidrepressant use due to the side effects of Hep C and thus already know that Welbutrin works, but Zoloft, Prozac and Celexa do not for example. It may take even another drug before we settle on the best fit for me.

So once again, I am armed and dangerous with celexa in my holster and heading for a showdown with my other drugs, or something.

Doing The Serotonin Space-Out

2010-05-14T17:12:00.000-07:00

The speed rush has finally mellowed. I am no longer jittery with loads of nervous energy. I am now in a mostly calm and definitely spaced-out frame of mind. There is still a bit of jumpy legs and feet that comes on in the evening, but half of an Ativan generally calms that down.

It is difficult to describe the state I find myself in. It feels as though both of my eyes are not focusing together. While I can see clearly when I concentrate on something, those things at the edge of my visual field seemed to be focused at different distances. When I turn my head and move my visual field it has to come to a resting point before everything seems focused. It is as if there is a piece of slightly distorted glass between my eyes and what I am looking at.

This feeling is not disconcerting because my mental state is definitely toward the unconcerned side of the spectrum. I find both the visual and mental effects to be interesting, but ultimately of little matter. I am concerned enough to limit my driving to the minimal I need to do to handle my treatment and occasionally my job. I don’t intend to return to driving as much as I did a few months ago until this all settles down.

There is an additional side effect which is of concern. The fact that it is important to me and yet still does not make me upset or anxious certainly speaks to the power and effect of the antidepressants. Antidepressants in general and Paxil in particular can cause side effects in your sexual functioning. I have noticed a definite and extreme drop in my libido. I don’t much care about sex and indeed have not had an erection in about 5 days. The few times I have achieved an erection and engaged in sexual activity, I have found that it is impossible to have an orgasm. This is most frustrating and that frustration can cause a real impediment to the intimacy that sex brings about between two people. You are much less inclined to want to do it if there is no payoff at the end of the process. The wife of an old friend of mine had the same problem when she was on Prozac. She still liked sex but the complete inability to have an orgasm eventually drove her to swear off all antidepressants.

I am not going to go that far, but I am going to talk to my doctors. I am going in for yet another blood redraw (the 10th time) and will sit down with them and go over the side effects I am experiencing. There are a wide range of antidepressants with a number of mechanisms for achieving their effects, so it is certainly possible to switch from one to another until you find one that works best for you.

It is most important to keep in close touch with you doctors about the effects whatever antidepressant you are taking is having upon you. If they are debilitating or just very difficult to endure, talk about changing drugs. There are a wide range of them. All individuals react differently to the individual drugs. So moving from one to another to find the one that works best for you is standard procedure for these drugs. Do not let your doctors tell you that you have to endure difficult or debilitating or scary side effects. You do not and in fact have the right to get the best treatment for your situation.

So use the calm resolution that you are striving for to stand up to the man if you have to. Insist on your right to the correct drugs. Make sure that you keep communications open so that you and your doctors can finally settle on the treatment modality that is best for you.

Believe me, it’s better than being spacey, impotent, anxiety-ridden or suicidal, really.

Riding Out The Rush

2010-05-12T18:35:00.000-07:00

Wow, I have not had this powerful an effect from a chemical compound since my experiments in reality hacking over 25 years ago.

I took my first dose of Paxil before going to sleep on Saturday. I woke up by 6:30 a.m. on Sunday (very early for me to awaken on weekend) and could not get back to sleep. I felt a bit restless so I did some yard work in the morning. In the afternoon my wife and I went for a walk and I noticed that I was becoming increasingly spacey and tired. Back at home, I napped for about an hour and woke up to a splitting headache. Ibuprofen handled that and being a bit tired, I went to bed just past 9:00 p.m.

I woke up at about 6:00 a.m. Monday and I was wired. I felt jittery and full of nervous energy. I would sit down for a bit, then get up and pace around the house. I could sit and read the paper, but as soon as I was done with a story, I would get up and pace. I realized my inability to concentrate for any period of time would make going to work useless, so I called in sick for the day. I called my various health professionals to ask if this was a normal reaction or extreme. Their reply was that it was at the upper edge of normal and if it continued for very long to let them know. The rest of the day was about the same and I took some of the Ativan at night to try to calm down the jitters.

Over the next few days the jittery nervous energy gradually moderated. I was able to go to work for a few hours a day until I got so physically restless and mentally scattered that I had to go home. I found myself compulsively doing little things around the house because I could only read for so long before I had to get up and move around and do something. I took small doses of Ativan during the day to steady myself out and returned to taking trazadone to sleep, which helped a great deal.

On the bright side, since starting on the Paxil, I have not felt nauseous at all. In fact all the muscular tension and nervous energy have actually made me hungry for the first time in weeks. Despite this, I have lost 5 pounds in 4 days since starting the drug.

This is definitely Mr. Toad’s Wild Ride going on in my body. Once again, I feel lucky I did a fair amount of reality hacking in my youth because I have clearly recognized that all the side effects I am going through are definitely drug-induced. I’m not going crazy or having anxiety attacks, I am just experiencing a drug reaction. But for the folks out there who haven’t had much experience with drugs that have a direct effect on their mind, this could be a scary experience.

Which leads me to a last comment. Doctor NB did not spend any time going over the commonly occurring side effects of Paxil or explain how much time they continue on average. This would have been a great help and, again, anyone without drug experience who was not prepped about the side effects could have real problems dealing with them.

So now we get to see how the rest of the ride goes. Stay jittery, steady out, maybe even achieve some chemical balance and generally calm down, stay tuned folks, it may stay bumpy…

Coming In Off The Ledge

2010-05-10T18:52:00.000-07:00

We finally had the conversation about antidepressants this week, 21 weeks into the trial.

It came about because I had been noticing that I was feeling an increase in impatience and tension during conversations with people. They were the sorts of conversations you have all the time with co-workers, your partner and your friends. It seems that when I would talk to my wife in the evening about how her day had gone, I could feel myself get tense if she talked for very long at all. The same thing happened with co-workers. I found myself thinking, “all right, I get it, you don’t have to keep going on about it, just leave me alone.” This did not happen all the time, but it was increasing in frequency. Just a note, I was not saying any of this stuff aloud, but I was thinking it, sometimes forcefully.

The study coordinator AVB called me to tell me that they needed to redraw blood because my neutrophil count was so low. They wanted to determine whether to adjust my next interferon dose to a smaller amount. I mentioned that I had been noticing a subtle change in my mental state the past few weeks and told her the nature of it. I told her that when I came in two days to do the blood draw, I would like to talk to someone about whether something needed to be done. She said that I should come in immediately. It took awhile, but I managed to convince her that it wasn’t so serious that I was going to start running people down in my truck or screaming at my wife and coworkers. She finally agreed that it could wait till Friday and we left it at that. Her main concern from years of experience was that these sorts of small changes could quickly escalate. Her example was a patient who suddenly started ramming people with her shopping cart at Costco because they weren’t moving fast enough. I promised I wouldn’t do any shopping before Friday.

When I came in for my appointment, they did the quick blood draws and then AVB quizzed me at length about my mental state. I repeated what I told her on Wednesday and then answered her questions about all my various side effects. She told me that even though I had been telling her that I was getting along okay over the past several weeks, she had been noticing some deterioration in my mood. She said that even though I was a tough guy who was intent on soldiering through the treatment, she had “seen it in my eyes” that I was having an increasingly difficult time. I had to tell her that she was about the only person I could remember who ever used the words tough guy to refer to me. Sure I have a generous helping of Slavic fatalism, midwestern quiet desperation, and general stubbornness, but actual toughness, not so much. Nonetheless, she paged the study doctor NB to come in and go over the situation.

When Doctor NB arrived, we went over the same material and discussion of mental state and symptoms. She concurred with AVB that I might be approaching a tipping point in my mental state. Her solution to the problem was to prescribe the antidepressant Paxil. She also prescribed Ativan as something to take when needed if I felt anxious. She said that Paxil can take 2 weeks or more to take effect and that the Ativan would be something to use as a bridge until the Paxil kicked in.

So now I will be starting antidepressants as soon as I fill the various prescriptions. I am not sure what to think about that or what to expect mentally when I start taking them. I have no real feelings about antidepressants, though they do defeat the concept of Slavic fatalism. My wife took Paxil about 15 years ago and it helped her a great deal. I have also found, through talking with other individuals who have gone through treatment, that I am one of the few people who started treatment without being given antidepressants right at the start of treatment.

When I told my wife that I was going to start taking Paxil, she reminded me that for the first few days she had taken it she felt “rubbery.” While we have no idea what my reaction will be to starting the drug, I am definitely expecting some sort of side effects at the beginning. I guess it’s time to hit the internet and start my research…

Restless Sleep

2010-05-05T21:04:00.000-07:00

I wrote a couple of postings ago about being prescribed trazadone for insomnia. It is an anti-depressant that is also prescribed as a sedative. You can take 50 up to 100 mg per dose if you use it as a sedative and I definitely have to take the higher dose. It does work. There is one side effect that can be a bit aggravating especially as it intensifies a characteristic I’ve had all my life.

I have restless feet, and legs and hands. I have had this all my life. I am sure that if I were growing up today, I would be diagnosed as hyperactive or ADD or whatever the current fashionable term is. When I was about 14 my younger brother was diagnosed with ADD by the family doctor. When he asked my mother if she hadn’t noticed that he was a bit over-energetic and hard to control, she said, “Oh no, I have another one just like him at home.” Whenever I sit down, my feet are tapping, or my knees are jiggling and it goes on 24 hours a day.

I did not know that I did it at night until I was 18. Three high school buddies and I drove to Mexico City from Minneapolis to visit one of the guy’s uncles. That is an innocuous sounding statement until you realize that it is about 2500 miles, 4 guys in one car, driving straight through until we got there. We were young…

The first night we were in Mexico City, we were all bunked in one large room. The next morning, my three friends looked bleary-eyed and haggard. They had been awakened all night long by the sound of my feet rubbing together under the sheets. They thought it might be mice or bugs and it was not for several hours that they traced the noise to my feet. They could not believe that I could sleep through the noise I was making. I was exiled to a small room next door for the duration of our visit.

Trazadone makes my legs jumpy. It doesn’t happen till about 30 minutes after I take it, then it sets in. There is a strange feeling of tension build up in my leg and then it twitches sharply. This goes on until I fall asleep. When I took 50 mg, the jumpy leg defeated the sedative, but when I went to 100 mg. the sedative effect put me to sleep despite the twitching. Luckily for me, and more notably my wife, the twitching subsides shortly after I fall asleep and reverts back to my normal foot rubbing. I can usually get a reasonable night’s sleep after taking it without feeling logy in the morning.

One small, twitchy, step against side effects, one great leap for enduring treatment…