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Ode to California Pacific Medical Center Hepatology Center

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

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

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

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

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

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

A Good Word For Big Pharma

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

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

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

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

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

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

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)

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.

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…

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.

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.

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…

Research Leverage – Use It or Lose It

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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