A Shout Out to Gregg Allman

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.

Changes In Visualizations During Treatment

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.

The Disability Two-Step

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.

Science Café About Hepatitis C Research

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.

Undetectable

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.

Latest Viral Load Count – So Close…

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.

It Is Chemotherapy; It Is Not “Treatment.”

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...

Standard of Care Pace vs. Research Pace

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.

RO5024048 Side Effects Reconsidered

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.

Why Did I Continue Treatment…

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

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

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.

Bad News Is Not So Bad News 1

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.

Complexity, Thy Name Is Drug Interactions

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…

Week 18 – On A More Personal Note…

Yesterday I passed on the news about the expansion of the RO5024048 combination drug trial. Today I’ll pass on the personal news about my condition.

They did all the usual blood draws (only 14 vials this time), and various vitals but no EKG. I didn’t notice that they were not doing it and therefore never asked why it did not happen. When they checked my weight, it turned out I have lost 12 pounds in the last 8 weeks. I had noticed my belt being a bit loose, but I didn’t think I had lost that much weight. I don’t have the energy to exercise heavily so I guess I am eating less than I think.

I’m still undetectable as of week 14 (which was 4 weeks ago) which is the best news of the day. 8 official weeks of no detectable virus levels is encouraging and definitely helps during the various bouts of side effects. About 3 weeks ago they dropped my Copegus dose to 1000mg from 1200mg per day. My Hemoglobin has popped up very slightly but I am still down 35% over normal. The only new development with the shortness of breath associated with the anemia is that now I occasional get out of breath while talking. Thankfully it only tends to happen when I have to project a bit to be heard in a noisy room or in a large group, the usual day-to-day nattering is unaffected (to the occasional chagrin of those subjected to it). White blood cells are low but just above the cutoff line.

About 3 weeks ago, my neutrophil count increased enough that they restored me to a full dose (180mg) of Pegasys from the 3/4 dose (135 mg) that I had been on for about 6 weeks. This brought back a whole raft of side effects that had moderated during the lower dose of interferon. Headaches, rash with itching (thankfully mild), nausea and more intense insomnia all were once again daily, or at least several times weekly, features of life. I had actually thought that my body had begun to acclimate to the treatment drugs, but with the return of all of these side effects, I believe the lower occurrence was due to the lower dose.

I have been having bouts of insomnia for several weeks and given that they have increased with the increase in my interferon dose, the consulting doctor to the study decided to proscribe trazodone to help me sleep. I have taken it twice and while on the first night it did not seem to help at all, the second night found it working better and I think I got a decent night’s sleep. I will report back on the results in the future.

As for reports, taking acetaminophen instead of ibuprofen, just before my Pegasys (interferon) injection has had no effect on my fatigue in the 24-36 hours after the injection. I feel just as crappy taking Tylenol as I do taking Motrin, so much for the miracles of modern pharmacology.

Time to head out the door to the support group. Best of all, I can listen to the Giants game on the way there and maybe on the way back…if I don’t forget they’re playing before I get to the car.

New Developments in Roche RO5024048 Combination Treatment Drug Trial

I went in last Friday for my week 18 tests. Before we started the usual blood draws, EKG and vital signs routine, there was a new development. There is a change to the study protocols that required signing a new consent form. There had been a previous, minor, change that necessitated my signing a one-sheet addendum to the original consent form, but this change involved major changes and resulted in my having to agree to changes throughout the agreement. The new protocol is very good news for the safety of the drug and offers an additional chance for study under-responders.

What is happening is that Roche is adding another treatment arm to the study. In this arm “The safety and efficacy of open-label HCV polymerase inhibitor Prodrug (RO5024048) in combination with PEG-INF and RBV in the subset of patients who only received currently approved combination of SOC in the main study and who did not demonstrate an early virologic response (Treatment Failures) will be evaluated.” What this means is that the people in the arm of the study that received the SOC (pegylated interferon and ribavirin) and did not receive the experimental drug and who did not have a log 210 reduction in virus after 12 weeks or who had virus still in the blood after 24 weeks and thus had to stop taking all medications will get a shot at receiving the full triple-drug therapy.

The new arm (Group F) will take RO5024048 1000mg twice daily for 24 weeks in combination with the SOC of weekly Pegasys (interferon) and daily Copegus (ribavirin), followed by an additional 24 weeks of the SOC (Pegasys and Copegus). The study will be open-label meaning patients and doctors will know the medications they are receiving.

The best aspect of this new arm being added to the study is that the folks who were in the placebo arm of the original study and did not respond, now have a shot at getting a drug whose initial results against the HCV virus are very positive. One of the problems with experimental studies, particularly early stage studies, is that there is always an arm of the study that does not receive the experimental drug and thus you are potentially both entering a difficult treatment process and giving up your treatment-naïve status and not getting anything but the treatment you would have received outside of the study. Here, even the folks in the placebo arm who did not respond, will get a chance to attack their Hep C with cutting-edge treatment.

The other positive news is that the safety issues they were testing for regarding possible kidney damage have shown themselves to be of lesser importance. One of the reasons they are adding this arm to the study, I was told by my research coordinator, was that the kidney problems were not showing up in the test subjects so far in the study. That is one of the reasons that the length of treatment in the Group F arm will be extended to 24 weeks from the 12 weeks of treatment the rest of the study arms received. The researchers believe they can give the drug for longer periods without undue fear of kidney damage.

There is another potential development in the study as well. There is a petition in front of the study governors to allow test subjects in the low dose arm (Group A) of the study who had rebounds in their HCV Viral Load amounts to join the Group F arm as well. Group A received 500mg of RO5024048 twice a day, the other arms receiving the experimental drug either received higher doses (1000mg twice daily) or a more concentrated dose (1000mg once daily). There is apparently some thought that the dose in Group A might not have been powerful enough to have the desired effect on the virus and that by including those patients in Group F, they would find out if a higher dose had the desired effect even on people who had been already treated with the RO5024048.

The developments in the trial seem all to the positive to me. People who did not respond to the SOC placebo treatment, get a chance to actually receive the experimental triple-drug therapy, the kidney damage issues seem to be less of a concern than originally thought and finally even those who did not respond to a low dose of the drug might get a chance to see if a high dose can smack down their Hep C.

Suddenly Being Sleepy

A new version of an old side effect surfaced during my recent stay in Los Angeles. Fatigue is one of the more common side effects of Hep C Treatment and I have been experiencing it in mild and severe forms since beginning the treatment study. It has generally built up during the day and peaked in the afternoon at which time I have to lay down and take a nap or I have a hard time functioning mentally or physically. What I noticed over the weekend was that the fatigue started to come on very suddenly. One moment I was functioning more or less normally with my usual moderate level of energy and attention. Over just a few minutes I would be yawning uncontrollably and have a strong need to sit down or lie down. I just didn’t have the energy to sit up and pay attention much less walk around and function normally. This could happen in the early afternoon, mid afternoon or late afternoon and did not seem to directly relate to the intensity of the activity that had been occurring.

This is not something that has been occurring up to now and presents a new challenge for managing the treatment and the side effects. It is going to be a bit more difficult to plan activities if I do not know when I am going to become tired or how suddenly the fatigue will be coming on. This is not a welcome development, to say the least, and I am not sure what it is related to.

I recently resumed injecting a full dose of interferon. Since that time, I have noticed the return of two symptoms that occurred earlier in the study but had since disappeared. I have a mild rash on various parts of my body, mostly the arms and legs, which itches. The itching is not severe and I can usually ignore it. I also have headaches that I tend to feel mostly behind the eyes. I had both of these symptoms in the first several weeks of the study and I had thought that their gradual disappearance was my body acclimating to the interferon and ribavirin. About 6 weeks into the study my neutrophil count and lymphocyte count had dropped to the point that my dose of interferon was reduced to 135 mcg. from 185 mcg. It occurs to me now, that the disappearance of those symptoms corresponded to the reduction in dosage and perhaps that was the reason for the disappearance as opposed to becoming acclimated to the drugs. If so, now that I am back on a full dose I my have a more complete menu of side effects to look forward to for the duration of the treatment.

It also makes me wonder if the new, more sudden, onset of fatigue is related to the increased interferon dose. Since fatigue is a known side effect of the drug, and the longer you take interferon, the more you feel the side effects, perhaps this is also caused by the return to a full dose of interferon.

I am also going to start taking more acetaminophen (Tylenol) with the interferon. I had been told by a lot of people that taking acetaminophen before injecting helped relieve the pain associated with the injection site and generally in the limb that you injected. I usually take ibuprophen instead as I have never experienced much of a pain relief effect from acetaminophen. In doing further reading, it has been reported that taking acetaminophen at the time of the injection can help relieve the fatigue associated with interferon, especially the fatigue that occurs 24-36 hours after the injection. I will definitely try it with my injection this Thursday and report my results. I hope it works; I am definitely tired of being sleepy, especially on short notice.

You Give Me Fever

Five days after the last post and I still have the Flu and I still feel like hammered dogshit, as my boss would say.

I guess having a low lymphocyte and neutrophil count can indeed counteract the helpful effects of Flu vaccines. It’s not a terrible case of the Flu as those things go, but as all of us who have had it over the years know, you sure don’t feel like doing much of anything. Add to that the fact that doing much of anything sure does make you feel like going back to bed and you get a lot of days of not much getting done.

And then there is the fact that my job running an online store means that every day there are orders to fill and inventory to track means that I am probably working at least a few hours every day and then I get too tired to think and go home. So at the end of the day, or really in the middle of the day or even at the beginning of the day, I don’t have a lot of worthwhile thoughts about the nature of my condition or the world, or the world of my condition.

So I don’t have much to say right now other than that I am so glad I have a home to recuperate in and a lovely wife to ask me if there is anything I need her to get at the store on the way home. There are a lot of folks dealing with all this same stuff who don’t have the same level of support and if you know someone like that, take some time out and do what you can.

Up, Down, All Around

There are ups and downs to this research regimen. Yesterday, I went in for my 12-week tests. I am finishing the experimental drug tomorrow. They needed to determine how fast the drug disseminates into the bloodstream, so the time of the testing was controlled so that they could take blood samples at specific times after I had taken my dose of the meds. None of this is a particularly big deal, it just means a bit more time and a few more questions to answer. It is interesting to note that, despite the attempts to make these tests consistent and rigorous, the human error factor rears its head from time to time. In previous visits, they have forgotten to take my weight, in this test they took my weight, but forgot to take my blood pressure and temperature. I’m sure somebody got a ding for that as they have been quite concerned about the state of my blood pressure throughout the project thus far.

I came in to this visit with a sore throat and told AVB that I had the sore throat, some coughing and nasal stuff. We also discussed the side effects, which ones were decreasing (itching, general cough, irritability) and which were either steady or increasing (fatigue, shortness of breath, muscle weakness). I then went off for the blood draws for this round.

They took 17 vials of blood. The blood guy (who has been drawing my blood for several visits now) estimated that it was from 18-20 ounces of blood. This is roughly the amount that they have been taking since the beginning of the test. So they took about a pint at the start of the test, at weeks one, two, four, eight, ten and twelve or roughly 7 pints of blood in 12 weeks. Despite their claims to the contrary this has to be stressing all my systems. This is a lot of blood to be replacing in normal circumstances, but given that my red cell and white cell producing systems are both being suppressed by the Interferon and Ribavirin as well as some additional white cell suppression by the RO5024048 Polymerase Inhibitor, I can’t believe it is without consequences.

I think I am living them now as the sore throat and developed into a full-blown flu-like outbreak last night and today. Mild fever, productive cough, sore throat, all the delights of flu. Sure I could have developed this anyway, but somehow having over a pint of blood withdrawn just while it was coming on seems like it must have contributed to the onset. Who knows? I did get vaccinated for both strains of flu this year and that has to help, but I think that if the timing of all this were different, I might have a milder case of this. In any case, I’m going to delay my Interferon injection for a day to give my immune system a bit of help before dosing it again with an inhibiting agent.

The good news: Still Undetectable. It is now officially 3 taqman tests showing undetectability. This is great news and I will celebrate accordingly when the flu goes away. Really, I promise.

Deciding About Treatment – Lot’s to Think About

I have had several people ask me why I decided to enter treatment. Specifically, they wanted to know why now?
My situation was this: 56 years old, high viral load at 13,000,000 per ml of blood, stage 1 liver disease, my Hep C had been symptomatic for 18-24 months.
Mine was not a desperate situation, no advanced liver disease, symptoms were present and annoying but not yet debilitating, and I was not in poor health generally. It came down to a long and serious consideration of a number of variables from health to work to family considerations. Here are some of the considerations:

What is the stage of your liver disease? Clearly, if you have advanced liver disease, treatment becomes something much more important and possibly mandatory than if your liver is not so deteriorated. If it early stage, you have the gift of time to consider all your options and potentially await additional treatment developments. If it is late stage, you have to decide much more quickly as the consequences of putting off treatment become exponentially more serious.

What is the state of your general health? Is the Hep C directly attacking your health through its symptoms and side effects and/or is the state of your liver creating additional health issues that are threatening or debilitating? To a certain extent the poorer your health, the more difficult the side effects of the treatment may be, but the more important it may well be to begin treatment in order to battle the effects of the disease. Again, the better your general health, the less immediate the decision becomes.

How are the general Hep C symptoms affecting you? Are you able to use available therapies to mitigate the effects of the symptoms of Hep C? Fatigue, Depression and Brain Fog are 3 of the more widely reported symptoms of Hep C. There are also joint pain, Ascites or fluid build-up in the abdomen, weight loss and the really serious symptoms of late-stage liver disease. There are a number of therapies for the general symptoms and if you are using them successfully and your life seems to be stable and at an acceptable level of health, this affects your decision. If the symptoms are beginning to overwhelm you, or become more than is tolerable for you, this also will have a large influence on your choice.

What is your health insurance situation? Hugely important of course. In countries with government financed health care systems this is a bit less of a concern, though the time before you can get authorization and enter treatment has to be considered carefully. If you have private health insurance, does it cover Hep C at all and if so, which of the therapies does it cover and for how long? If you eventually have to change insurers, will your Hep C be considered a per-existing condition and therefore the treatment would not be covered by insurance? Does this mean you should go for it while it is still covered? These are really tough questions and can definitely make the difference in treatment decisions. Something as basic as timing your treatment to begin the year right after your insurance renews can make all the difference in being covered through the entire length of treatment.

What is your employment or general work situation? This is a multifaceted question. If you are self-employed or run your own business, can you keep it going while not being able to put in the 40-60 hours per week that self-employment and business ownership generally require. Do you have people who can pick up the slack and help you during the 48 or more weeks that you will be, most likely, not at your best? Can your company survive if you have to take some time off without being able to work much at all?

If you are employed, what is your employer’s attitude going to be? Can you let anyone know you have Hep C? Is it clear to you that the attitudes at work would not be in your favor if they knew you had the disease? While it is illegal to discriminate against someone with a chronic disease like Hep C, remember that the burden of proof is on you. Should it come down to contesting a lay-off or firing, you have to bring the case and prove the action was because of Hep C.

If you believe that there is support from your employer what form will it take? Can you work a shortened workday or 4 day week? Can you take time off during the day to rest if necessary? Will they be supportive of the time you need to visit doctors and have tests? Do you have a sick leave policy or accumulated sick time that can be used to make up the time that you cannot be at the job? All these questions are vitally important and must be considered carefully before you make choices about treatment.


Which Genotype of the Virus am I and what are the chances for success? The common genotypes in North America are genotypes 1, 2 and 3. Genotype 1 is the most common and conversely, the most difficult to treat successfully. Genotypes 2 &3 are much less common in North America (and much more common in the rest of the world) and have a much higher success rate with treatment. The Standard of Care (SOC) is pegylated interferon (Pegasys, Peg-Intron) and Ribavirin (Copagus) taken for 48 weeks. The percentage of patients with a Sustained Virologic Response (SVR) is about 46% for genotype 1 and 80+% for genotypes 2 &3. So you have a bit less than a 50-50 shot to be cleared of the virus after treatment if you have the most common genotype present in the USA. The question boils down to: do you want to endure the effects of treatment for a year (and then some recovery time as well) for a 50-50 shot at a cure?

This is where the question of experimental drug studies comes into consideration. The study I am in uses a polymerase inhibitor (RO5024048) in addition to the SOC. The early studies indicated that it could result in a SVR rate of upwards of 70% in genotype 1 patients. There are very advanced compounds in the protease inhibitor family (Telaprevir is one example) that have shown in phase 3 studies that they have SVR rates of about 64%. When you see these sorts of results, the question changes quite a bit. Can I deal with treatment for a year if it means I have a 2-1 shot at clearing the virus or even a 3-1 shot?

What is your family situation? How stable is your relationship? How do you think your partner and/or children will react to the situation? Will they support you through the difficult parts of treatment? Does your family have the necessary financial means to deal with the potential loss of income and increased costs brought on by undergoing treatment? These are all highly personal questions whose answers are different for every individual considering treatment. They can also be questions whose answers change over time. Sometimes folks can start out very supportive and be worn down over time. Other times people step up to offer support and assistance in ways that can be astonishing in their generosity.

These are just some of the questions that arise when considering treatment. More to come…