I am a 57-year-old white American male infected with Hepatitis C. I am involved in a controlled medical research study by Roche Pharmaceuticals of an experimental Polymerase Inhibitor (RO5024048 also known as RG7128) drug therapy for the virus. This document is the story of my illness and the experience of treatment. My lovely and pretty damn wonderful wife will be contributing her take on the experience as well.
Saturday, January 30, 2010
Because of going in for a retest, I was able to see my Week 6 lab results 7 days before my next official testing appointment.
First of all, my viral load is now less than 15 IU per milliliter. That number means that they can no longer detect the actual count of virus in the blood. They label this state "Undetectable" and it is the goal we are all striving for. It is great news.
This means that I have gone from 12,900,000 IU per ml. to under 15 IU per ml. in 6 WEEKS. This response continues to reinforce AVB’s (and my) belief that I am on the RG 7128 Polymerase Inhibitor as she has never seen a viral response like this on the standard therapy. If this stuff works this well on the other folks in this study and does not have side effects that are any more (and hopefully less) serious than the standard therapy, this is great news for those of us with Hep C. The study may also confirm that this new drug (combined with the Standard of Care) can achieve a Sustained Viral Response (SVR) in 24 weeks instead of the 48 weeks that is the current standard.
Let’s face it, any reduction in the length of time we endure the side effects from all this combined with a potential higher Sustained Viral Response (SVR) percentage, is the best news possible.
Secondly, AVB and I went over the total lab results package in serious detail. This is something I cannot recommend more highly. No matter what therapy you are on, go over the test results thoroughly and ask lots of questions about what the various numbers mean in terms of your general health.
The key item I discovered in this round is that my Hemoglobin is at 10.9 (the normal range is 12.7 – 18.1). Hemoglobin is the blood cell that carries oxygen around the body. My baseline number was 14.8. That means the hemoglobin content in my blood is 27% lower than it was at the beginning of the test only 6 weeks ago and I have become anemic. No wonder I am out of breath after relatively light exercise and movement and tired most of the time. My blood can only carry ¾ of the oxygen it could 6 weeks ago. It’s not that I have become a doughy sack of fat, it’s that I don’t have enough hemoglobin to carry the oxygen.
While that is a bit scary considering I now also running low on the white blood cells that fight infection, at least I know why one of my symptoms is happening and I can see it in hard numbers.
Tuesday, January 26, 2010
She did not attempt to clear the air with me, but instead went to our boss the next day with a complaint that I had been yelling at her and then he had to come to me and admonish me for my unprofessional behavior. It was an unpleasant situation all around.
The reason I bring this all up is that anger management is a major component of successfully negotiating Hep C treatment. One of the known side effects of Interferon (Pegasys) is a measurable increase in irritability in the patient. Given that the standard therapy also can cause low energy, exhaustion and along with those things, depression (which can have a side effect of bouts of rage) and you have the potential for serious issues cropping up both in your personal and your professional life.
There are a number of ways to deal with this. Try to manage your interactions with difficult people to times when you are prepared to deal with them. Try to deal with personal and professional problems during times of the day that you have more energy and mental focus.
A tactic that my wife recommends (she has worked in many different organizations and office environments in her working career) is to memorize a few responses to people who do blindside you with issues or problems when you are unprepared to deal with them. “I am in the middle of something right now, but perhaps we can get together later to discuss this.” “I’m sorry, but that does not fall within my area of responsibility, perhaps we should meet with our boss to work out how this will be handled.” “The issue is a new one that needs to be more broadly discussed, perhaps we should bring it up at our group meeting.”
The final recommendation that came from AVB our study coordinator, is to Walk Away. If you feel that you are becoming upset, Walk Away. If you feel the other person is not respecting your wish to deal with this later or in a different manner, Walk Away. If you feel you are getting angry definitely Walk Away.
As AVB points out, walking away from someone can bring its own set of problems as they might view the behavior as disrespectful but dealing with that is always easier than dealing with the aftermath of having an angry exchange with someone. That someone can be either a professional colleague or a family member, but it is always easier to explain that you walked away to avoid an unpleasant incident, than to explain your way out of the angry, unpleasant incident that happens if you don’t walk away.
Definitely Walk On By.
Sunday, January 24, 2010
I do not know officially that I am getting the RO5024048 experimental drug. My assumption is based entirely on the viral load results and the fact that AVB, the study coordinator has told me that her 14 years of experience in managing trials and watching the results of those trials, she has not seen Viral Response at that level unless there is something acting in addition the standard Interferon and Ribavirin.
But given my results and her gut feeling, I think that I am receiving it and that it is working tremendously well at inhibiting the reproduction of the Hep C virus.
My viral load after 28 days in treatment is now at a level of 195 IU per milliliter of blood.
195 viruses per milliliter is a log 4.82 reduction from the baseline level at the beginning of the test. It is also beginning to get near the non-detectable level that indicates the body is clearing the virus from the blood.
This is great news as it might mean number of things moving forward if these results hold up. It could mean a much higher percentage of patients with a sustained viral response (SVR). It could mean that the treatment time could be reduced in length which would mean a major reduction in the level of suffering endured by patients undergoing treatment. It could mean variations in the levels of drugs administered which might again have an effect on the level of side effects that must be endured.
There is even a study in the proposal stage that would involve treatment using a combination of Polymerase and Protease inhibitors and no Interferon or Ribavirin. If that sort of treatment became a reality, then future patients with Hep C might never have to undergo the joys of Interferon and Ribavirin side effects.
All of this is extremely speculative and primarily the result of me being way too happy and perhaps overreacting to my person viral load results. But considering where Hep C treatment was 10 years ago, and the exciting new avenues of research opening up seemingly on a weekly basis, the future is indeed so bright we gotta wear shades.
Wednesday, January 20, 2010
Today, I was at the tail end of the working day, alone in the warehouse, finishing up some research on some new and interesting books that had just arrived. It is always enjoyable to be rooting through boxes and finding interesting and potentially valuable stuff hidden away amidst the general run-of-the-mill donations.
As an aside, I work for a non-profit Friends of the Library organization. The part of the organization I work in collects donations of used books and then sells them to raise money for the library. I have experience in the used and rare book field and am specifically tasked with finding the more valuable items and then, generally, selling them through online sales venues like Amazon.com, eBay, and Abebooks.com.
I went upstairs to my desk to finish up some last minute email correspondence and order processing when wham, I was suddenly sad, depressed and tired. Not the tired at the end of the day sort of thing, but the can’t-keep-your-eyes-open kind of tired. My wife called to let me know she was leaving her office and heading out to pick me up and I felt like crying just listening to her. Combining the sadness and fatigue got me right into a great little minor depression. Then when I got home I collapsed in front of the TV for a bit and felt like weeping while watching a bit of the movie "Dave." Now as anyone who has seen this movie knows it is not exactly a three hanky movie. None of this had anything to do with what was going on in my actual life. It was entirely caused by the drugs.
Luckily I knew what was going on. I could actually step back a bit, mentally, and realize that even though I felt bad, it had nothing to do with reality. Maintaining that perspective will be a challenge, but at least I am starting off knowing that it can happen.
This is one of those times that having experience with mind-altering drugs, particularly hallucinogens, is clearly going to be a benefit. I know intimately that small amounts of drugs can have overwhelming effects on your mental and emotional condition. LSD, for instance has powerful effects at a dosage of 300 micrograms, which is an astonishingly small amount of substance. It’s not just that you see your grandmother crawling up you leg with a knife in her teeth, as Hunter Thompson put it, but that suddenly you can be ecstatically happy and within moments be consumed with abject horror. Anyone who has taken LSD or any mind-altering drug can relate to these effects.
The key for folks who may not have any experiences like this is to try to maintain a bit of distance from your own feelings. This can be very difficult to do as you absolutely FEEL that you are sad, depressed and unhappy and it is tricky to separate this very real feeling you are experiencing from the actual circumstances of your life at that moment. This can be particularly challenging to do over time especially as the drugs bring on anemia, exhaustion, muscle weakness or other side effects that genuinely start to make you feel crappy. This is where keeping a journal; even one with very brief entries can help. It doesn’t have to be extensive, just a quick note about the actual circumstances perhaps contrasted with what feelings you are experiencing.
The other big helper is a support group. Keeping in touch with a group of folks who are either going through the same thing as you are right now, or have done so before can be of enormous support. Checking the web for support groups in your area is a first step. If you are not convenient to a physical group there are lots of blogs and bulletin boards out there as well with people who are more than willing to chat with you. The links on the side go to a lot of those resources.
The long-term struggle will be to remember that it is the drugs that are causing many of the feelings. That will be considerably difficult during this trial as it goes on for a minimum of 24 weeks. Even really powerful acid is usually gone in 24 hours
Tuesday, January 19, 2010
The first one I found, Living With Hepatitis C For Dummies (Wiley, 2005), is a great overview written by Nina Paul, PhD. It is a good introduction to the whole confusing mass of information circulating out there about Hep C. The author briefly explains everything -- tests, diagnoses, how people get it, types of treatment (including Western, complementary, and alternative medicine), and what Hep C patients can do to manage their condition.
The most important idea I got from this book was to keep a Hep C notebook -- a record of test results, everything related to the disease, and what you, the patient, are experiencing. It is a complicated condition and your memory may not be so good down the line as the disease progresses, or as you take powerful medications with many side effects.
Next, I discovered The Hepatitis C Help Book, Revised Edition: A Groundbreaking Treatment Program Combining Western and Eastern Medicine for Maximum Wellness and Healing (St. Martin's Griffin, 2007) by Misha Ruth Cohen , OMD, L.Ac and Robert Gish, MD, with Kalia Doner. This book bridges alternative medicine and Western medicine disciplines and introduced me to a bunch of Hep C resources right in my own backyard -- support groups, the Quan Yin Healing Arts Center, meditations for healthy livers, and the like.
Cohen is a doctor of Oriental medicine and a licensed acupuncturist, while Gish is a hepatologist and medical director of the Liver Disease Management and Transplant Program at California Pacific Medical Center in San Francisco (SF). Some heavy hitters here -- this book made me realize how fortunate HR and I are to live in one of the preeminent areas of the world for HepC research.
The penultimate volume I found is Living With Hepatitis C: A Survivor's Guide (Hatherleigh Press, 2006). The new fifth edition just came out (2009) and I immediately bought it, too. Written by Gregory Everson, MD, this book definitely details the Western medicine approach, but it is essential for anyone considering participation in clinical trials. The author summarizes all the clinical trials research and has up-to-date information about the latest experimental treatments. There are lots of graphs and diagrams -- you'll need them to keep up. For the patient who wants to be an informed participant in his or her own treatment decisions, this is the book for you.
I didn't go to the Internet until after I had reviewed these books. I didn't want to be overwhelmed by information. Generally, I love the Internet and search it right away for opinions, data, etc., but I guess I had to ease into this fact-finding mission with some good books because the stakes were (and are) so high.
Monday, January 18, 2010
Today, unfortunately, I am waylaid by the personal and just have no energy at all to try to put together anything thoughtful. It is only 7:30 p.m. and I can barely keep my eyes open. I am noticing that I am much more sensitive to cold and getting chilled; that merely going and doing a bit of shopping with my wife was an experience of wandering around stores in a fog and coming home thoroughly tired. And, thoroughly humiliating to the Midwestern-raised guy I am, I couldn’t even carry the damn basket around the store, I had to follow my wife around while she carried everything heavy. Not a big deal to many, but to the sixth-decade American male, most unmanly.
Luckily at home I have a bathtub and after a hot bath to get some warmth into my bones, and a bit of soup, I was warm, exhausted, not unduly discontent and ready to hit the hay for a few moments of reading before sleep.
I promise I will post some more widely applicable content soon, really, I mean it, as soon as I wake up…
Sunday, January 17, 2010
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.
Saturday, January 16, 2010
That first day, I could only think of our dear friend E., who died from HepC-caused liver damage some years ago. E. and HR have/had very different clinical backgrounds, so their responses to the disease might not be all that similar. Still, it was an agonizing decline to witness and I couldn't stop thinking about the only other experience I'd had with a HepC patient. I do not want that to be the outcome this time, especially with my beloved HepRat!
As with all medical issues brought to my attention, I resolved not to spiral downward into anxiety, negative thoughts, worst-case scenario-building, etc. Instead, I planned to read about HepC and educate myself and HepRat about recent developments in treating and managing humanity's latest scourge.
I found a few books at Borders that seemed pretty good and bought them all. Insights I gleaned from them and Internet research will come to light in subsequent blog entries.
Tuesday, January 12, 2010
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.
Sunday, January 10, 2010
In only 7 Days of being on the treatment program my viral load went from 12,900,000 IUs per ml to 4,260! Now THAT is an effective Viral Response.
AVB said that – though the test is blind and we won’t know for sure for over a year – in her educated opinion those kind of results mean that I must be getting the RG7128 Polymerase inhibitor. She said that less than 5% of people getting the standard treatment have that kind of viral response and even those don’t usually show it so quickly.
She also stated that being able to share the results like this is unusual for a research study. Most of the studies have the results blinded as well as who is taking which meds, so that no individual in the test finds out specifically what their personal viral response is. In this one, the viral load data are not blinded so we can all find out how the virus in our bodies is responding to the drugs. My viruses are going down like foot soldiers in the face of the Mongol Horde.
I know that everyone has different responses to good news, some are overwhelmed, some are stoic, some respond quickly, others have a delayed reaction, in my case I could feel a sort of vibration running up and down my arms and legs and a stupid grin breaking out on my face. You spend a great deal of time and mental and emotional energy gearing up for any kind of serious treatment. In a case like this, you combine the normal buildup with a sort of brainwashing behavior to convince yourself that YOU are one of the 80% who are going to be getting the good stuff, the new stuff, the stuff that really works. Then you screen and are accepted and wait for the study to begin and then wait after it starts for the results to come in. The whole time you are keeping up this suspension of reality in your mind. Yes, I am getting the new drug and it will work as well in me as it did in the original phase 1 test subjects and it will be worth the risk of the side effects because, damn it, it is going to work.
The feeling that the results brought – Yes It Is Working! – is a combination of elation and relief. A log 3 drop in viral load in 7 days, when a log 2 drop by week 12 is the requirement to continue treatment, is overwhelming. I couldn’t wait to get home and call my wife - Which I did as soon as I got in the door. I didn’t trust myself to try to tell her the news while I was driving.
It’s a good thing I waited because as soon as I called her and told her and she got all excited, I started crying. She was so excited, so happy for me, so relieved to hear that it was working and that we were vastly probably on the test meds, it just thrilled me to be able to tell her something that would make her that happy.
It was such a relief to think that it seems to be working and that I am getting the test drug, which is the reason we all signed up for the study in the first place. We all wanted a better shot at clearing the virus than was offered by the standard therapy and now I know I have that chance. In the midst of the fatigue and heartburn and nausea and itching and all the rest, I know it’s because I have a great shot clearing.
That’s another thing that AVB said, “keep this result with you so that when you hit your walls in treatment, you can take it out and look at it and see why you are going through this.” I feel like framing it, but I know there are lots more results to follow and anything can happen. The one fly in the ointment so far is that my blood pressure remains naggingly high: 155 over 102 this time around. They want me to see my primary care physician about the blood pressure, because if it stays high it might affect drug dosage and other treatment parameters. So it’s off to Doctor K for another round of arguments about which drugs he may want to give me for blood pressure. Oh well, it’s all for a good cause.
But nothing can dampen these feelings. I’ve got a real shot at clearing. It’s never a guarantee for the long term, but it’s great start and I will clutch these results to my bosom as tight as I can until the next news comes. It is definitely time for dancing.
Thursday, January 7, 2010
This time they only took 11 vials of blood, the 2 EKGs, blood pressure twice and a warm urine sample in addition to the chilled one I brought along from home (in the flashy Roche fanny pack, of course).
I gave a full report on the side effects I have been experiencing up to this point in the study. Low, but persistent, levels of nausea, fatigue, some irritability (I reported this, but others who know me are not so sure that the irritability is any worse than normal…), headaches, muscle aches, low energy, bouts of sadness and crying, some minor chills and most importantly to me - insomnia. AVB, the truly wonderful coordinator of the study, was quite thorough in questioning me about the side effects. She was also emphatic in letting me know that they would do whatever fit within the protocols to manage the side effects. One of the things she told me was that once the study started, the researchers at Roche would do a great deal to keep me in the study. They want the data and having people drop out of the study definitely reduces the statistical validity of the results. So a bit of the power shifts from the drug company to the study subject once the study is underway and this can be exploited to the benefit of the study subjects.
It was good to hear this and to realize as well that the people at California Pacific Medical Center (CPMC) who run these studies, are trying very hard to make the experience of treatment as non-debilitating as possible. They want to know if you are having problems and want to help you solve these problems as much as they can.
The high point of the visit was going over the test results from the previous visit. The tests in the first week were all done with blood that had been taken just prior to treatment beginning. So they served as a baseline for the various blood cell and enzyme levels moving forward through the treatment. The most important one to me was the viral load.
When I was first diagnosed with Hep C, I had a viral load of just over 4,000,000 International Units (IU) per milliliter (ml) of blood. This, I was told was considered a moderately high viral load. When I screened for this study 2 months ago, I reported a viral load of 6,270,000 IU per ml of blood, clearly an even higher viral load. The results from the week one test were 12,900,000 IU per ml of blood. This put me just below the high viral load segment of the Hep C population. Now AVB spent some time telling me that the viral load fluctuates all the time and can jump up and down by millions of IU from one day to the next. I realize that, and my own research both in books and on the internet, confirms what she told me. Nonetheless, I can’t say I was happy to see the progression from 4 million to 6 million to 12 million. I am very anxious to see the results at the next appointment as they will show the results from the first week of treatment and I really need to see a drop in the viral load to believe in this study.
The rest of the tests were fine. I have a decent amount of red and white blood cells which I will need to withstand the white blood cell suppression of the Interferon and the red blood cell suppression of the Ribavirin. The enzymes were fine and my heart is working okay as well. Perhaps too well as my blood pressure has been a bit high over the two appointments and they are a bit concerned about that.
All in all an okay visit. The next one is only a few days away (trust the Swiss to start a portion of a major drug study during the holidays – the worst time to try to you’re your subjects to have consistently timed dosing and for the researchers to get consistently spaced testing) and I will be getting the first week of treatment test results. I am both excited and terrified to get them.
Wednesday, January 6, 2010
For RO5024048 and Interferon (Pegasys) and Ribavirin (Copegus) the side effects can be:
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)
Interferon injection site redness
Alopecia (Hair Loss)
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;
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:
Increased liver enzymes
Loss of concentration
Infrequently reported side effect include:
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
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.
Monday, January 4, 2010
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.
Saturday, January 2, 2010
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…