New Drugs, New Treatments, New Hype

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

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

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

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

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

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

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

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

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

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

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

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

Puzzling Evidence

Viral Load Blips Up and Then Back Down

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

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

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

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

This led to three decisions about the disease.

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

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

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

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

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

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

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

Health Care versus Health Insurance

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

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

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

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

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

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

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

Vacation In The Sierras

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

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

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

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

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

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

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

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

A Nice Soft Belly

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

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

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

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

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

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

Which Side Effects Matter…and to Whom

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

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

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

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

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

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

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

Going Camping With Drugs

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

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

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

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

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

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

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

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.

Treatment Update - 5 weeks along in Standard Therapy

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

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

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

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

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

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

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…

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.

Round and Round the Drug Carousel.

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

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

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

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

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

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

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


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

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

Hepatitis C and Fantasy Baseball: The Auction

I spent the last 5 days in (mostly) sunny Los Angeles. I was there for my fantasy baseball auction. This is an event in which grown men (mostly) pretend they are baseball general managers and buy a team of actual major league players. This becomes “your” team and you use the actual statistics they accumulate during the year to determine who wins your league.

I have been doing this for 25 years and have gathered a certain level of experience at it as well as a number of beliefs about how best to proceed at the actual process of buying players and assembling a team. A great deal of this accumulated wisdom (a tricky term to apply to this sort of experience, but there it is) had to be thrown out for this auction as the facts of Hepatitis C treatment intruded on the natural rhythms of the fantasy world.

The auction started at 9:00 a.m. on Saturday. I generally inject Interferon on Thursday night. I have determined that the side effects of the Interferon, both mental and physical generally start to hit about 14 to18 hours after the injection. They peak in the 36 to 48 hour period and then gradually lessen until the next injection. I delayed my injection until Friday night around 10:00 p.m. This would mean that the side effects would most likely start to hit from noon till 4:00 p.m. Saturday, I would have a solid 3 hours and possibly as many as 6 before I lost my edge, such as it is. I also realized I had to create a strategy that allowed me to buy most of my players before I started to feel physically sick and mentally spaced out.

One of the tenets of auction theory is that people involved in the auction tend to get caught up in the emotional intensity of the moment and pay too much early in the process. As the auction proceeds and people run out of money, bargains can be had if you are patient enough and a canny judge of talent. This requires concentration and attention over a several hour process. Hah! I say. The side effects timing I mentioned above make that kind of long term concentration impossible, at least for this particular patient. The strategy I devised was to choose actual players that I wanted on my team and buy them in the auction no matter what the price. I made educated guesses as to how much all the available players would be expected to cost. Within those general guidelines, I chose players that would fit my budget and help my team. I went to the auction intending to buy mostly those players and thus I would not have to concentrate on every player just the ones I intended to buy.

It worked far better than I expected. I needed to buy 15 players to fill out my team. I managed to buy 12 of the players I had picked before the auction. I only had to fill 3 positions from the general group of players. The down side to this success is that I have no one to blame but myself if my team is awful.

I was a good thing it worked because, like clockwork, the nausea hit at about 1:30 and I really noticed my concentration lagging from about 2:00 p.m. on. By the time 3:00 p.m. rolled around and the auction was over, I was spent.

This is all really just an example for any specific event or activity that you do while you are undergoing treatment. Successfully completing activities, classes, or special events and occasions is all about planning. Determine what your own body and mind are capable of for given days and time frames and plan your involvement with activities around those capabilities. If it means that you change the way you normally or traditionally do things, make those changes. It will mean all the difference in your enjoyment of the activity or event and your success in completing it. You are the only one who knows what your capabilities are and you are the one who needs to both plan for those capabilities and let others know what they are. This way, no one is surprised and/or disappointed by the level of involvement you can bring to an event.

By the way, the 2010 Black Shadows team is:

John Baker C Florida
Miguel Olivo C Colorado
Adam LaRoche 1B Arizona
Brandon Phillips 2B Cincinnati
Ryan Theriot SS Chicago
Freddy Sanchez 2B San Francisco
Mark DeRosa 3B San Francisco
Jeff Baker 3B Chicago
Jay Bruce OF Cincinnati
Shane Victorino OF Philadelphia
Conor Jackson OF Arizona
Marlon Byrd OF Chicago
Garret Jones OF Pittsburgh
Scott Hairston OF San Diego

Wandy Rodriguez SP Houston
Barry Zito SP San Francisco
Aaron Harang SP Cincinnati
Brett Myers SP Houston
Tedd Lilly SP Chicago
Paul Maholm SP Pittsburgh
Chris Volstad SP Florida
David Bush SP Milwaukee
Jeremy Affeldt RP San Francisco
Sean Gallagher RP San Diego
Sam Gervacio RP Houston

Week 2 Results: Giving It The Lowdown

I went in for the week 4 testing and got the week two results. Not that it was all beer and skittles for the testing. This particular blood draw and assorted other tests was to occur before my daily med dosing. To explain this, they gave me a sheet indicating what would occur during this type of test. What was not emphasized was that the sheet they gave me was an example of what could take place during a typical pre-dose test, not what would occur at the actual pre-dose test that I was to undergo.

So there I was at 8:00 a.m. instead of the usual 9:00 a.m., dazed and confused, with all my drugs, needles, vials, sharps container and studly fanny pack. Why, because I remembered seeing the 8:00 a.m. start time on the sheet, that’s why. The fact that I had misplaced the sheet – okay, I lost it – didn’t help matters. About 35 minutes later AVB came in to work and saw me sitting in the waiting room and asked why I was there so early. When I explained about the time on the sheet and the fact that it was pre-dose, she had the wonderful good grace to look embarrassed. She went on to explain that the sheet was a sample and that I was scheduled for my normal 9:00 a.m. appointment.

At any rate, after the sorting out and the trek back to the appointment room, they did the test sequence: 16 vials of blood (a new record), the 2 EKGs, the 2 blood pressure readings and the usual pulse and weight.

Two things stood out. My blood pressure was down to 133/85 from 155/102. AVB was very happy about this as she told me that after the last few blood pressure readings, the research scientists were going to require weekly appointments for the duration of my participation in the study unless my BP went down immediately. Well it did. I personally think that my BP started to go down the moment I got the viral load data from the first week of treatment. My BP had been going up steadily at every testing appointment and I think the data I got for the first week of treatment that showed the treatment was working reduced my stress level immediately.

The other is that my weight is not going down much at all. It has only dropped a few pounds since the start of the study. As one of the side effects of the meds is often some serious weight loss, this is somewhat of a good thing – to the researchers. After the usual holiday larding-on of poundage, I was thinking that with all the other unpleasant side effects, at least I was going to get some weight loss out of it, but nothing significant so far.

I also wonder about the amount of blood they take. I know they need the data on a wide ranged of blood contents but 16 vials of blood at even ½ oz. per vial adds up to 8 ounces of blood every two weeks – perhaps more if I am underestimating the size of the vials. Given that the Pegasys suppresses white blood cell production and the Ribavirin suppresses red blood cell production, does taking that much blood contribute to the potential anemia and low white blood cell counts? Does the test protocol itself contribute to the reported side effects of the drugs?

But now the news that matters: Viral Load.

My viral load was down to 1110 IU per ml. That is a log 4.06 reduction in viral load from the start of the study. Since the week-two blood draw was done early, that means that in 11 days the viral load went from 12,900,000 IU per ml. to 1110 IU per ml. The Mongol Horde is continuing to slaughter the viral peasants. Or perhaps Patton has blown through the defensive line and is wreaking havoc in the enemy rear areas. It doesn’t matter what the metaphor you use to visualize the effects, that fact is the treatment is working and I’m getting a serious viral response. AVB said again, that she would bet money I am on the Polymerase Inhibitor; that you just don’t see that kind of response on standard therapy.

I hope it holds up and I hope it transforms into a sustained viral response. I was a bad candidate for treatment with the viral load I started out with. If this stuff adds that much viral response to the standard therapy, it means a lot of folks with high viral loads and genotype 1 Hep C, have a lot better shot at clearing than they did before.
It is all far too early to talk like this, but I am excited as hell that this is happening and that, so far, I have been able to tolerate the therapy.

Let us hope that in the immediate future, that RG7128 or RO5024048 or the Polymerase Inhibitor or whatever you want to call it, keeps kicking viral ass.