Money Saved Is Money Earned

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

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

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

Coming Back To Life

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

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

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

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

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

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…

Ribavirin, You Take My Breath Away.

Friday the 19th I went in for my week 14 tests. I have now been off the RG-7128 aka RO5024048 study meds for two weeks. They took the usual 15 vials of blood. AG, the other study coordinator, told me that one reason she likes Roche studies is that they do a lot of testing for safety. She said they are concerned about certain test results and side effects that some other drug companies view as peripheral. That is some comfort although the constant returns to the lab for retesting and redraws of blood is grinding me down.

The good news is that the Viral Load remains undetectable. It has now been 6 weeks since I went undetectable. This is an excellent result and makes continuing the study easier to do. Having an EVR is a positive sign for obtaining a sustained viral response (SVR) and being declared cleared of the virus (the doctor’s term) or cured of the virus (the drug company’s term).

The bad news is that my hemoglobin is down to 9.9 on their scale. Normal hemoglobin is 12.7 – 17.00, my baseline was 14.8; this means I am now short about 33% or one third of my hemoglobin and boy does it show. I was walking along the waterfront in San Francisco on Sunday with my wife. I was a short walk of about 1 mile round trip. I had to sit down at the halfway point. Even though I know the reason for it, this just drives me crazy. I hate not being able to physically do the things I would normally be able to do easily. Imagine for yourself doing all the things you normally do during a day only doing them with one third less oxygen in your blood. It tends to make you take things quite a bit slower.

I did a Saturday shift at my job a few weeks ago. This involved running a book sale and boxing up the books after the sale. I had some volunteers to help and they did a great job, but I had to do a lot of boxing and lifting. When I got home, I soaked in the tub for an hour or so and went to bed early. While the next day wasn’t bad, the following Monday, I was barely able to stay awake at work and my boss sent me home early because I looked so exhausted it was beginning to depress our (mostly much older than me) volunteers.

All this keeps bringing me back to what I read in one of the Hep C books, “be patient with yourself, you will not have the same capacity you did before starting treatment.” The book has it exactly right. The problem is actually being patient with yourself. If you had any level of energy and drive before starting treatment, the state you find yourself in whilst on treatment will depress the hell out of you.

I had a great conversation about this with my kid sister the other day and she told me to put down the date I will be ending treatment on the calendar, and to plan to celebrate it in some way. She emphasized that it will be over eventually and things will return to normal. Her advice was that prominently noting the date of the end of treatment would reinforce the concept that there is a definite end to the process. I wonder if spray-painting the date across the front of the house might be going too far; maybe a neon sign? Whatever will put the idea firmly in my head that this too will pass is what I want to do.

One last thought comes to mind about all this. There was a closing page article in the latest Liver Health Today about a guy in Texas who is doing very well while on treatment. He is a hemophiliac with HIV and Hep C. He got himself into top shape over the past few years and has been riding in 100-mile bike races. When he started Hep C treatment, he noted that it slowed him down for a few weeks, but that after a few months he was back and the bike and recently rode in a 150-mile race. He attributes his success to being in shape and to his Christianity. I can’t dispute any of this and in fact I applaud him for his dedication and his ability to deal with adversity and challenge. At our support group, the overwhelming feeling was that stories like this are in some ways inspirational but in many other ways depressing. One of our folks did a 72-week stint of treatment and there were times she could barely move around her house, she was so exhausted. Others talked about being thrilled that they could ride a bike for a bit or going to the golf driving range. Not one of all the people I have talked to who have gone through treatment came close to this gentleman’s achievement. So, is it inspirational or is it egotistical to report these sorts of stories. Don’t know, but the vast majority of us are more in the middle of the bell curve and might be able to use a bit encouragement and advice that actually seems possible.

Deciding About Treatment - did I avoid a disaster?

I few posts ago I wrote a bit about Questions you need to think about in regards to treatment.

Let me tell you about the first time I made a decision

It was my second visit to the Gastroenterologist, the fabulous Doctor C. The first visit was relatively brief in that we went over a bit about the disease and he order a full set of labs to determine the genotype of the virus, the viral load and a bunch of liver function tests as well as some general blood work. The primary result of the visit was to realize that I had a great doctor on my side. Doctor C is a warm, supportive personality and also a doctor who Listens. He is not one of those folks who are merely waiting for a chance to talk when he is silent. He listens carefully, gives considered answers and is well versed in the details of the disease. He is not a certified Hepatologist, but he does a great deal of work with coinfected HIV patients and is up on the research and the treatments for Hep C.

The second visit was more detailed as we went over the results of the labs. The bad news was that I had genotype 1 which is the hardest to cure. It is also the one infecting the vast majority of North Americans. My viral load was over 4,000,000 IU per ml. which put me in the category considered to be medium-high viral load. My liver seemed to be in good shape with the various enzyme and function tests not indicating there was much damage. By this time my wife and I had read a great deal about Hep C (interestingly enough for those of you following the progression of side effects, I have forgotten a great deal of that information and have to keep looking stuff up to refresh my memory). We had lots of questions and Doctor C took a great deal of time answering them. Then he asked the fateful question. Do you want to be aggressive in your approach to the disease?

Yes, I replied. He told me that he knew of one of his colleagues currently enrolling a study for a Vertex compound VX-950 (now Telaprevir) and reached for the phone. He caught the doctor in, set up an appointment for two days hence and I was in the process of potentially beginning treatment for the disease. I spent the next 2 days doing research on VX-950. It is a protease inhibitor in phase 3 testing and has a Sustained Viral Response result of 62-64% in trials when it is combined with the Standard of Care (Interferon and Ribavirin). The study in question was an open label phase 3 study wherein every participant got the experimental drug; they were just testing for dosage effects. I admit I had a romantic fantasy about the possibility of being in the study: Man is diagnosed with Hep C on Halloween, goes into treatment in January, finishes treatment in December and is declared clear of the virus under 18 months after being diagnosed. We all have our fantasies, mine are usually not about drugs, but this time they were.

I went to the meeting, learned about the study, was told about the drug and the SOC side effects, signed the papers and went in for the lab tests the next day. It turned out that I showed a thyroid abnormality in my blood tests and there was not enough time to get me retested by the official lab in time to get me into the trial. So close and then the chance for the experimental drug was snatched away. It was particularly painful at the time because there are so few phase 3 tests of promising drugs and so very few tests as well wherein everyone gets the experimental drug and there is no placebo group.

As it turned out, it was probably for the best that I did not make the trial.

The next 3 months were spent in an extremely high-stress situation. My organization was moving an entire portion of its operation into a new space. I had been managing a great deal of the operation for my boss, who was in the middle of number of large projects. In January as the facilities move hit is most vital period, his wife became dangerously ill and they suffered a financial reverse which threatened to wipe out their life savings. I had to step forward and assume control of the entire project and manage it through the actual move and start-up of the new facility. I managed to do it, but the cost to my health was extreme. I was exhausted all the time. I went home from work every day and was capable of merely sitting for a few hours before going to bed. My wife is convinced to this day that the stress load spiked my viral load from the 4,000,000 range to the 6,500,000 number it hit in my next test in June.

If I had been going through treatment, I would never have been able to handle the job that was thrust upon me. I would most likely have collapsed either physically or mentally due to the strain. So, even though I lost the chance to get a late-stage experimental drug which raises SVR rates 40% above the standard of care treatment, my health may be better in the long run for missing the opportunity.

I did not examine all the ramifications of my decision before I made it. That is why it is so important to examine all sides of the issue before you reach a decision. It is hard to go through treatment. Even at its best, it is tiring and depressing and long. So think clearly and try to plan for as many eventualities as you can. It can make the difference between a successful outcome and something potentially very ugly.

Good Days and Bad Days

Before I started treatment for Hep C, I did not give a lot of thought to Good days and Bad days. I certainly had good and bad days and they were straightforward to identify. Fight with my wife, Bad day. Finish a piece of art, Good day. Stuck on the bridge because of an accident, Bay day, the two starting pitchers on my fantasy baseball team that day both win and throw shutouts, Good day, etc. etc. But the majority of days were just days, some good elements, some bad elements, a lot of generic, average elements. That all changed with the onset of treatment.

Much of the advice that you get about how to approach treatment, how to manage it and how to respond to it, involves not letting it take over your life. You have to continue to live your life as much as possible, that is why you are undergoing treatment, to have your life be about your life and not about your disease. But invasive drug therapy for any disease for which it is required, has a way of making that difficult. Some therapies are periodic and regular. You go in for chemo once a week, or radiation for a few times a week for a month, in other words, a regular defined pattern of treatment. With Hep C, it is a defined treatment regimen, but there is both a daily and a weekly portion of the regimen and the total treatment generally is a minimum of 48 weeks. The weekly interferon injections build up over time to eventually give you a high constant serum level of interferon and the daily Ribavirin keeps that drug at a steady serum level as well. This creates a situation that gives you a constant set of side effects that do not fluctuate in the same way as someone who gets a chemo dose once a week. The side effects may vary individually on a daily basis, but the fact that you will be feeling side effects every single day is constant throughout the length of the treatment.

So you get attuned very quickly to Good days and Bay days. Nausea and dyspepsia, Bad day; Walking up stairs without gasping at the top, Good day; Feeling some energy and enthusiasm, good day; realizing that you said a total of 10 words to your co-workers over the course of the day, bad day – these things become signposts of your days and can easily begin to take over how you feel about your life. You can find yourself sitting inside at home instead of getting outside for a walk or talking to a neighbor or calling your sister or any of the vast number of things that can keep you connected to your life.

A Bad day with the treatment does not a Bad day make. You can have nausea and cramps for most of the day and have a wonderful conversation with an old friend in the evening that makes any day a Good day. You can feel exhausted and breathless and then pick up some take-out food and a movie and have a wonderful night with your family and have a Great day. You can also screw up a day when you are feeling physically good and mentally sharp by having a verbal dustup with a coworker.

This is all very uplifting and such, but the reason I am musing about this is that having the flu on top of Hep C treatment, is a Bad day. And the Bad day lasts several days. I have spent whole days inside the house on weekends when I was dealing with interferon doses but at least felt like I could leave the house. I felt that it was somehow my choice that I was a hermit, that I could get out if I had enough juice, a good reason. When you have the Flu, you don’t really go out unless there is not choice. I don’t want to be the typhoid guy who infects everyone so I don’t go out. This drives me crazy in normal flu years, but given the fact that exhaustion from the Hep C treatment has given me more days in the house than normal this winter and it really feels like a run of Bad days.

But hey, I am about to send an email to an old friend about visiting on Easter weekend, and I will be calling my mother after that. I am trying not to have my life defined by my treatment, but it can certainly creep up on you quickly if you let down your guard.

When baseball season starts, that will solve everything (really, everything). How bad can a day be when there are box scores to read and games to listen to on the radio? The baseball diamond can be a strange place to see a pattern to the universe, but it’s as good a place as any.

Up, Down, All Around

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

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

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

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

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

A Brief Note About Caffeine

The side effect that is most acute is the reaction of the meds with caffeine. I don’t know which one it is, whether it is the Interferon, the Ribavirin or the RG7128 aka RO5024048. What I do know is that I have had to cut my caffeine intake to near zero.

I was never a coffee drinker. It always made me jittery and I never liked the taste. I never like tea much either, the taste was not compelling. The caffeine I took in was all in the form of caffeinated sodas. Sometimes several of them a day. Then as I got older, I had to cut down to nothing caffeinated after about 2:30 in the afternoon, as I would be awake at nights if I had any later than that.
Several years ago, I trained myself into the habit of having a glass of green tea in the mornings at breakfast and that became my primary intake method, along with a soda or two during the day.

As soon as I started the study, I had to cut out all caffeinated sodas. If I had so much as a diet Dr. Pepper, I would get jittery and have the attention span of a gnat. Then I started to cut down the size of my Green Tea in the morning. If I had a full glass – about 10 ounces, I could definitely feel the effects and not in a pleasant and stimulating way. So, it was a small cup of tea in the mornings and then nothing the rest of the day. I still noticed some effects though, and realized that I was going to have to cut out chocolate as well.

Fine, the fatigue, itching, weakness, shortness of breath, irritability and insomnia were all things you can fight your way through, but NO CHOCOLATE, that’s just mean.
And I’m weak, so I am not going to get rid of it entirely, but I have cut way back. It all seems to be helping and I’m more calm and less irritable, but it is not something I read about in the discussions of either the Standard of Care treatment or the experimental drugs.

So be aware, it might help you a great deal to cut way down on your caffeine and anything that helps get through this is something to consider.

Side Effects: Whose Idea Was This Exactly?

I am fascinated with the side effects of medications. I read the data sheets that come with any prescription med I get – provided I can unfold them successfully without destroying them. I listen to all the side effects they are now required to recite in the TV and Radio ads for the meds they claim you should be begging your doctor for. The intensity and extent of some of the side effects that drugs treating relatively benign conditions can induce is quite astonishing. So, in that spirit I offer you the official list of side effects for the drugs in this study:

For RO5024048 and Interferon (Pegasys) and Ribavirin (Copegus) the side effects can be:

Nausea
Vomiting*
Diarrhea
Abdominal pain
Anorexia
Dysgeusia (change in the sense of taste) *
Dry mouth and dyspepsia (feeling of fullness or abdominal pain when eating)
Anemia (low red blood cell count)
Neutropenia (low white blood cell count)
Fatigue*
Chills*
Fever
Muscle pain
Joint pain*
Headache*
Rash
Dizziness
Anxiety
Depression
Insomnia
Irritability
Throat pain
Interferon injection site redness
Sinus congestion
Alopecia (Hair Loss)
Blurred vision*
Eye pain*

The side effects with the star (*) after them occurred more often in people who received higher doses of RO5024048.


For just the Interferon (Pegasys) and Ribavirin (Copegus) the side effects can be:

Flu-like symptoms such as fever, chills, muscle aches, body weakness, joint pain and headaches;
Extreme Fatigue
Skin reactions such as a rash, dry skin or itchy skin
Upset stomach (including related events such as nausea, vomiting, taste changes and diarrhea);
Blood sugar problems which may lead to diabetes,
Redness and swelling at the site of the injection;

Other possible side effects of the Pegasys and Copegus are:
Pain,
Back pain
Laryngitis,
Sore throat,
Increased liver enzymes
Loss of concentration
Confusion

Infrequently reported side effect include:
Fainting,
Palpitations (rapid or irregular heart beat)
Heart or kidney disorders

Additional Serious side effects possible (apparently all the side effects described up till now how been the normal, commonplace sort of side effects) of the Pegasys and Copegus treatment can be:

Risks to pregnancies and unborn children
Mental health problems including irritability, depression, anxiety, aggressive
behavior, suicidal behavior (including thoughts about suicide and suicide
attempts), homicidal thoughts and trouble with drug addiction or overdose,
Blood problems including a drop in various blood cells (white, red and platelets)
that can lead to an increased risk for infections, bleeding and/or heart or
circulatory problems that can result in Death. (Rapid decreases in red blood
cell counts may infrequently be associated with shortness of breath and heart
symptoms).
Autoimmune problems, where the body’s own immune system attacks itself including
psoriasis and thyroid problems,
Heart problems including chest pain and rarely, a heart attack
Macular degeneration (a disorder that affects the macula –the center of the retina –
and causes decreased visual detail and possible loss of central vision
Infections that have sometimes caused death
Lung problems including trouble breathing and pneumonia
Eye problems including blurred vision or loss of vision
Development of an unusual rash (also known as Stevens-Johnson syndrome) which could become severe or life threatening

There are a few more general side effects that were described in yet another pamphlet about the study but only one stood out: Listed under “Rare, but Serious” was the statement, “Patient may collapse and die for no apparent reason.”

Most side effects (with the possible exception of altered thyroid function which may require life long medical treatment and the Definite Exception of Macular Degeneration) will generally reverse upon stopping treatment with the study medication.

I don’t imagine you come back to life if you have died either. If I die, however, I am trusting that the folks who will receive the envelope of unmarked bills will do the right thing by me.

Treatment: Lord Knows the Shape I’m In.

Started treatment this weekend.

There was a two hour appointment where they took the standard 14 vials of blood, 2 EKGs, Height, Weight, Temp, Blood Pressure and we got the skinny on what the procedures are for the trial. We are doing the Standard of Care (SOC) which is pegylated interferon and Ribivarin as well as the experimental drug or placebo. Of course we are all telling ourselves we are getting the new drug.

We were shown how to fill a syringe with the interferon and how to inject it, given 4 weeks worth of the various drugs and a set of syringes, alcohol wipes and band-aids – all in an attractive mini insulated fanny pack with a prominent Roche logo. Now if we could only get T-shirts and hoodies we could really be stylin’.

The interferon injection is pretty much the same as injecting insulin. It uses the same syringes and needles and the same technique of pinching up a bump of skin, sticking the needle and injecting the drug. It’s only 1 ml, so it’s not a lot and is quite painless at the time of the injection. We will be doing it once a week for the next 24 weeks at the minimum.

The Ribavirin and the RO5024048 are pills. 2 RO5024048 and 3 Ribavirin each morning and evening. With food or they say the nausea will be pretty intense.
We have to keep a diary noting the exact time each dose of the oral meds is taken and the day we inject the interferon. We have to keep all the bottles, vials, labels and syringes and show them to the researchers at every appointment. They count all the pills to make sure we have taken them and check the vial labels to see that we have injected. If we do not keep an accurate diary, we get one chance to make a mistake and at the second mistake or missing data or missed dose of the meds, we are bounced from the trial. (Now I’m not one to encourage the wrong sort of behavior, but if you knew that you were in a trial for a promising drug that ups the cure rate for your disease and you missed a dose, would you report missing a second dose? Or would you just throw the pills out, write something in the diary and never say a word? Human nature is a strange and wonderful thing…).

We were also given information on the common side effects and some techniques to mitigate them. The interferon can be pretty nasty to many people with flu-like symptoms, muscle aches, fever and nausea. It also suppresses the white blood cell production in your bone marrow making you more susceptible to infection during treatment. The Ribavirin will make you anemic over time and also has fatigue and (delightful combination this) insomnia as common side effects – and let’s not forget hair loss, also common. The RO5024048 has some similar side effects but the ones they are really worried about are kidney damage and problems with the eyes.

Did the first injection at the appointment and took the first 5 pills. We were told on a two separate occasions to make sure to bring 2 Tylenol to take before the injection, some food to eat (some sort of snack) to settle the stomach and a urine sample. The other guy who was in the training session with me forgot both Tylenol and food – I hope he remembered the urine but…

Went home and hung around waiting for the side effects shoe to drop. And waited and waited. Eventually I noticed that my neck and shoulders hurt and I was a bit chilled but only a touch of nausea as long as I was stretched out. As soon as I went to bed and slept in my usual side-sleeping fetal position, the nausea hit and I had to straighten out my body. It was a strange feeling to start to go into my normal position, feel really crappy, straighten my legs out and feel it subside. If you were really perverse, you could give yourself waves of nausea at will.

Over the next two days, I had some mild nausea, heartburn whenever I ate anything with any heft to it, and mild muscle aches. Not bad at all compared to the horror stories I had been hearing from people who had done the treatment and from what I read on treatment websites and bulletin boards.

On Sunday night (the third day) the insomnia set in. I was up till 2:00 a.m. before I could sleep. It wasn’t the sort of insomnia I have had before, thoughts racing through my head, anxiety, or nervous energy from late-in-the-day caffeine; it was just lying there with my eyes closed, comfortable and tired without be able to sleep at all.

Needless to say, Monday was a long slow slog through my first day back at work.

Treatment Starts Tomorrow or I’m Dreaming of a Flu-like Christmas

I’ve been accepted for an experimental drug therapy experiment run by Roche Pharmaceuticals. It is to determine the treatment efficacy of a polymerase inhibitor named RO5024048, it’s also called R7128. The early tests have shown a Rapid Viral Response (RVR) in 75% of patients which compares to an RVR of 25-30% in the standard therapy. The standard therapy is Pegylated interferon (brand name Pegasys or Peg-intron) and Ribavirin (brand name Copegus). You inject interferon once a week for 48 weeks and take Ribavirin twice daily for the same amount of time.

This experiment adds the polymerase inhibitor to the standard therapy (also know as standard of care or SOC). The preliminary results of some early experiments indicate that this new drug combination can result in Sustained Viral Response (SVR) or, basically clearing the virus from you system, at rates slightly over 70%. The standard therapy has an SVR of 43%. It seems like a worthwhile experiment to get in on.
There is a 20% chance I will be getting a placebo which means I will be getting the SOC and some sugar pills. That means I have a 4-1 shot at getting the drug, which is a risk I think is acceptable. I start treatment tomorrow and the following are some notes about how I feel.

Friday the 18th and I’ll be starting treatment.

They will be teaching me how to inject myself with the interferon and what the timing and sequence of the oral drugs will be. There is also a diary I have to keep detailing dosage times and any and all side effect events. I have no idea what to expect. They told me to bring 2 Tylenol, a chilled urine sample and something to eat, as the pills have to be taken with food. One of the nurses called today to remind me what to bring and when I mentioned that I had forgotten about the Tylenol, he said the Tylenol are very important as I will find out; not the best sign.

Despite the fact that they have told me that this is going to make me feel like crap much of the time; that one of the guys who posted to the biker Hep C site Hep C Straight Up said that doing the treatment was harder for him than doing time in prison and that my wife’s friend who is now in his SECOND go at treatment calls the interferon “flu in bottle,” I still am not sure what I am in for.

I don’t think I am afraid, exactly. I am nervous, anxious, have sort of a feeling of dread, but also a feeling of anticipation to get on with it. Flu-like symptoms are not something I deal with well, especially nausea so in that sense I am genuinely dreading getting underway. I know the initial symptoms can be harsh and I am also afraid I won’t be tough enough to deal with it. On the other hand, you have to be treated eventually at some level and I am only going to get older and perhaps more sick the longer I wait.

I am not sure if I should eat before I go in or not as the call came in today while I was dealing with one of my volunteers at work and I was distracted enough not to ask and I can’t remember anything anymore and so forgot to call back and ask.
Is the injection like insulin given in the fat or in the muscle? How much is injected, how much pain is associated with the shot. I am assuming some sort of pain or why the “important” Tylenol. Do the pills immediately make you sick? I am not sure of any of this and even if they tried to tell me, the symptoms and intensity vary a lot from person to person, so I might be wish-you-were-dead miserable or merely feeling like crap.

The oracles indicate that this is something that will be to the good in the long run, but the short term could be a bitch.

I feel blank. Not terrified, not foolishly optimistic, not blithely going in to it without any sense of its seriousness, just sort of wait and see. I’m sure I don’t understand how tough it is going to be. I have endured pain before and long-term discomfort involving back and foot and shoulder pain but not necessarily long term queasiness and long-term lack of energy and long-term achiness and soreness and exhaustion and that sort of thing. I know I have to do it, I know others have done it, but I am not “looking forward to it” in any anticipatory way.

What is it going to mean for my sculpture? Will I have enough energy to work at my studio at all? Will I lose my studio because I can’t afford it anymore? Will I lose the desire to do sculpture at all? Will I just feel too sick to care?

I’m scared, but I think the inevitability of the process means that the fear moves a bit into the background. I have to do it, therefore I will and it doesn’t matter how scared I am, I just have to go ahead. At least once I’m in to it, I’ll know how bad it will be and how difficult the next 6 or 12 months are going to be. I do feel that I’m getting the right drug and that it is going to ramp up my resistance and beat the virus. I feel that it is the right thing to be doing and that this is the right time to do it. I hope that helps. Maybe I can keep rereading that after I puke and convince myself that this is all a good idea.

I also feel it can’t hurt. Even if it doesn’t cure it, it has to knock it back some and buy more time for further developments. But that’s a fallback. The belief is that it will work and the result will be worth the cost.
Hope I can sleep tonight…