I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.

Tuesday, June 29, 2010

World Cup Manifesto

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.

Monday, June 28, 2010

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…

Friday, June 25, 2010

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.

Sunday, June 20, 2010

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.

Thursday, June 17, 2010

The Rest of the Story…

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)


Wednesday, June 16, 2010

Drummed Out of the Study

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.

Monday, June 14, 2010

Bad/Good News 3 – Participating in Future Research Trials

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…

Saturday, June 12, 2010

Bad News is Not So Bad 2

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…

Wednesday, June 9, 2010

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.

Monday, June 7, 2010

Ruminating Before The Retest

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.


Saturday, June 5, 2010

Thoughts From The Nail

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…


Friday, June 4, 2010

The Million Pound Shit-Hammer

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…