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.
Monday, April 26, 2010
So I started eating, and eating, and eating. I can’t eat much at any one time any more, so I grazed as much as I could all day long. It’s not that the food tasted a whole lot better, though I definitely tried to focus on foods that appealed to me, it was that I realized I had a chance to make up for the past few days when food had been the farthest thing from my mind. Even with all the eating, it wasn’t as if I managed to put away thousands of calories. I had a fruit smoothie for breakfast, some nuts, some cheese, a couple of fruit granola bars, two slices of pizza for dinner and the one attempt to pack on the calories, half of an éclair. Nonetheless I felt stuffed all day long, not unpleasantly so, just unusually so.
What I learned from this is that when you have a day when the old digestive tract feels like it did before you started treatment, take advantage of it. You need to eat to maintain your health and you probably need to eat more than you are actually eating. You are mostly going to feel like eating is a chore after several months of treatment. So when you can eat without the negative side effects raising their ugly heads, you owe it to your health to do so.
As a final note, the various books, articles and advice columns about Hep C all mention the benefits of a varied, balanced and nutritious diet. They are right and trying to eat that way is a good way to deal with the disease and the treatment. However, when food tastes terrible and your body doesn’t want to eat anyway, it doesn’t matter if the food is “good for you,” it only matters that you eat something. So eat what tastes good, eat what appeals to you. When you reach the point where the food tastes like crap and your stomach is jumping, eating at all is more important than eating particular foods. If you like it, eat it. If you can keep it down, eat more of it. That is the reality of Hep C cuisine.
Saturday, April 24, 2010
If none of these simple yet difficult methods appeal to you, there are many dieting options available. The Grapefruit Diet, The Water Diet, The No Carbs Diet, The Take Two of These Pills and Don’t Eat After Eight P.M. Diet, and the many programs that offer you the opportunity to pay them for both food that they prepare and for support during the process of only eating their food. Maybe these diets work and maybe they don’t. I, on the other hand, can offer you a guaranteed method to lose weight over a 6-12 month time period. The interferon and ribavirin diet. You could call it the Hep C Diet, the I & R Diet or even the Treatment Diet but the most accurate title is indeed “The Everything Tastes Like Crap Diet.”
The problem with the 3 most effective ways to lose weight and, for that matter, the popular diets as well, is that you still miss food. You still want to eat. You sit around between meals distracting yourself from the fact that you are hungry and still want more food. Well, the TETLCD solves that problem. After you have been on the plan long enough (which is generally only 6-8 weeks) the last thing you want to do is eat.
How does the TETLCD achieve this miraculous transformation, you ask. Well, there are actually two separate methods the diet uses. The first is that the TETLCD removes all taste from 80% of the foods you used to love. Ice Cream – tastes like cold, sweet Styrofoam; Mexican Food – the beans and tortillas taste like cardboard with the flavor removed; Sandwiches – the taste and texture of the bread actually causes you throat to close; Salad – the lovely tomatoes and avocados and lettuce look enticing but then the smell of the French dressing makes you nauseous. Speaking of nausea, that is the 2nd secret weapon of the diet. You can feel nauseous for hours at a time and boy is there anything less appealing than food when you are desperately trying to keep your gorge from rising, I think not. This two-pronged approach is the secret of the success of the TETLCD. Just ask anyone you know who has been on it.
While I could cite numerous testimonials as to the effectiveness of the diet, most of the folks who have had the opportunity to experience TETLCD are trying so hard to blot the experience from their minds that they, mostly politely, refused to discuss the diet. That leaves it up to me to offer my testimonial. I am only 19 weeks into the full 48-week TETLCD program and I have already lost 16 pounds. Just think, by the end of the program, I could be a shadow of my former self - literally.
So, while I don’t recommend contracting Hep C just to get on the program, for those of you in the midst of it or considering it, the steel-gray lining to undergoing treatment is that you will lose that extra weight. You might also lose weight you can’t afford to lose, but most dieters have no sympathy for those folks anyway.
Tuesday, April 20, 2010
They did all the usual blood draws (only 14 vials this time), and various vitals but no EKG. I didn’t notice that they were not doing it and therefore never asked why it did not happen. When they checked my weight, it turned out I have lost 12 pounds in the last 8 weeks. I had noticed my belt being a bit loose, but I didn’t think I had lost that much weight. I don’t have the energy to exercise heavily so I guess I am eating less than I think.
I’m still undetectable as of week 14 (which was 4 weeks ago) which is the best news of the day. 8 official weeks of no detectable virus levels is encouraging and definitely helps during the various bouts of side effects. About 3 weeks ago they dropped my Copegus dose to 1000mg from 1200mg per day. My Hemoglobin has popped up very slightly but I am still down 35% over normal. The only new development with the shortness of breath associated with the anemia is that now I occasional get out of breath while talking. Thankfully it only tends to happen when I have to project a bit to be heard in a noisy room or in a large group, the usual day-to-day nattering is unaffected (to the occasional chagrin of those subjected to it). White blood cells are low but just above the cutoff line.
About 3 weeks ago, my neutrophil count increased enough that they restored me to a full dose (180mg) of Pegasys from the 3/4 dose (135 mg) that I had been on for about 6 weeks. This brought back a whole raft of side effects that had moderated during the lower dose of interferon. Headaches, rash with itching (thankfully mild), nausea and more intense insomnia all were once again daily, or at least several times weekly, features of life. I had actually thought that my body had begun to acclimate to the treatment drugs, but with the return of all of these side effects, I believe the lower occurrence was due to the lower dose.
I have been having bouts of insomnia for several weeks and given that they have increased with the increase in my interferon dose, the consulting doctor to the study decided to proscribe trazodone to help me sleep. I have taken it twice and while on the first night it did not seem to help at all, the second night found it working better and I think I got a decent night’s sleep. I will report back on the results in the future.
As for reports, taking acetaminophen instead of ibuprofen, just before my Pegasys (interferon) injection has had no effect on my fatigue in the 24-36 hours after the injection. I feel just as crappy taking Tylenol as I do taking Motrin, so much for the miracles of modern pharmacology.
Time to head out the door to the support group. Best of all, I can listen to the Giants game on the way there and maybe on the way back…if I don’t forget they’re playing before I get to the car.
Monday, April 19, 2010
What is happening is that Roche is adding another treatment arm to the study. In this arm “The safety and efficacy of open-label HCV polymerase inhibitor Prodrug (RO5024048) in combination with PEG-INF and RBV in the subset of patients who only received currently approved combination of SOC in the main study and who did not demonstrate an early virologic response (Treatment Failures) will be evaluated.” What this means is that the people in the arm of the study that received the SOC (pegylated interferon and ribavirin) and did not receive the experimental drug and who did not have a log 210 reduction in virus after 12 weeks or who had virus still in the blood after 24 weeks and thus had to stop taking all medications will get a shot at receiving the full triple-drug therapy.
The new arm (Group F) will take RO5024048 1000mg twice daily for 24 weeks in combination with the SOC of weekly Pegasys (interferon) and daily Copegus (ribavirin), followed by an additional 24 weeks of the SOC (Pegasys and Copegus). The study will be open-label meaning patients and doctors will know the medications they are receiving.
The best aspect of this new arm being added to the study is that the folks who were in the placebo arm of the original study and did not respond, now have a shot at getting a drug whose initial results against the HCV virus are very positive. One of the problems with experimental studies, particularly early stage studies, is that there is always an arm of the study that does not receive the experimental drug and thus you are potentially both entering a difficult treatment process and giving up your treatment-naïve status and not getting anything but the treatment you would have received outside of the study. Here, even the folks in the placebo arm who did not respond, will get a chance to attack their Hep C with cutting-edge treatment.
The other positive news is that the safety issues they were testing for regarding possible kidney damage have shown themselves to be of lesser importance. One of the reasons they are adding this arm to the study, I was told by my research coordinator, was that the kidney problems were not showing up in the test subjects so far in the study. That is one of the reasons that the length of treatment in the Group F arm will be extended to 24 weeks from the 12 weeks of treatment the rest of the study arms received. The researchers believe they can give the drug for longer periods without undue fear of kidney damage.
There is another potential development in the study as well. There is a petition in front of the study governors to allow test subjects in the low dose arm (Group A) of the study who had rebounds in their HCV Viral Load amounts to join the Group F arm as well. Group A received 500mg of RO5024048 twice a day, the other arms receiving the experimental drug either received higher doses (1000mg twice daily) or a more concentrated dose (1000mg once daily). There is apparently some thought that the dose in Group A might not have been powerful enough to have the desired effect on the virus and that by including those patients in Group F, they would find out if a higher dose had the desired effect even on people who had been already treated with the RO5024048.
The developments in the trial seem all to the positive to me. People who did not respond to the SOC placebo treatment, get a chance to actually receive the experimental triple-drug therapy, the kidney damage issues seem to be less of a concern than originally thought and finally even those who did not respond to a low dose of the drug might get a chance to see if a high dose can smack down their Hep C.
Monday, April 12, 2010
1. Recognize when those waves of nausea you occasionally feel become more insistent.
2. Make sure the rest room is available and not in use.
3. Move quickly to the rest room when needed.
4. Make sure the rest room has a solid, thick door and is not one of those hollow pocket doors or, even worse, a jalousie style door.
5. Attempt to void your digestive tract in as quiet a manner as possible.
6. Clean all affected areas thoroughly.
7. Attempt to return to your work area discreetly.
I think I managed to follow rules 2, 3 and 6 pretty well; the others not so much. It was last Friday afternoon and I suspect that it all happened the way it did because it had not happened before. I have been remarkably free of the truly vicious nausea that afflicts many people on Hep C treatment. I get waves of it from time to time, but usually by drinking some water, getting up and walking around and doing some controlled breathing, I have been able to manage it. On Friday, things were different.
In mid-afternoon I began to have some waves of nausea. I used my usual tactics to try to manage them, but they didn’t really go away. I felt them get stronger and realized that this might require a trip to the toilet. Then I began to cough (as you sometimes do during these delightful events) and realized it was game on. I ran to the bathroom. As an aside, I work on a mezzanine with a small bathroom close by. Unfortunately because of the design, the bathroom has a hollow pocket door that slides closed. As I ran into the room, I slid the door closed (or as it turned out, almost closed). I then began to noisily lose my stomach contents. It was over quickly enough and after pulling myself together and cleaning up a bit, I walked out of the bathroom. To see my boss standing there with a concerned look on his face as he asked me if I were going to live.
It turns out that because of the flimsy nature of the door and the fact that it did not close completely as I rushed in, it was quite clear throughout the building that someone was having digestive problems. Luckily it was late enough in the afternoon that there were only my boss, one coworker and one volunteer left in the building. If it had all happened about a half-hour earlier, I might have had a crowd of concerned volunteers waiting for me outside the bathroom wondering if my internal organs were still internal.
It’s not exactly that it is embarrassing to have this happen, it’s more that I like to be somewhat discreet and not subject everyone in the building to my health issues. I don’t hide the fact that I have Hep C, but I don’t advertise either the fact that I have it or the fact that I am undergoing treatment. It is just something that doesn’t need to be rubbed in everyone’s face. No doubt an artifact of my Minnesota upbringing.
But it did lead me to formulate the 7 simple rules for avoiding becoming a center of attention at work. So take it for what it’s worth. To be a star or not to be a star, aye, there’s the rub.
Wednesday, April 7, 2010
This is not something that has been occurring up to now and presents a new challenge for managing the treatment and the side effects. It is going to be a bit more difficult to plan activities if I do not know when I am going to become tired or how suddenly the fatigue will be coming on. This is not a welcome development, to say the least, and I am not sure what it is related to.
I recently resumed injecting a full dose of interferon. Since that time, I have noticed the return of two symptoms that occurred earlier in the study but had since disappeared. I have a mild rash on various parts of my body, mostly the arms and legs, which itches. The itching is not severe and I can usually ignore it. I also have headaches that I tend to feel mostly behind the eyes. I had both of these symptoms in the first several weeks of the study and I had thought that their gradual disappearance was my body acclimating to the interferon and ribavirin. About 6 weeks into the study my neutrophil count and lymphocyte count had dropped to the point that my dose of interferon was reduced to 135 mcg. from 185 mcg. It occurs to me now, that the disappearance of those symptoms corresponded to the reduction in dosage and perhaps that was the reason for the disappearance as opposed to becoming acclimated to the drugs. If so, now that I am back on a full dose I my have a more complete menu of side effects to look forward to for the duration of the treatment.
It also makes me wonder if the new, more sudden, onset of fatigue is related to the increased interferon dose. Since fatigue is a known side effect of the drug, and the longer you take interferon, the more you feel the side effects, perhaps this is also caused by the return to a full dose of interferon.
I am also going to start taking more acetaminophen (Tylenol) with the interferon. I had been told by a lot of people that taking acetaminophen before injecting helped relieve the pain associated with the injection site and generally in the limb that you injected. I usually take ibuprophen instead as I have never experienced much of a pain relief effect from acetaminophen. In doing further reading, it has been reported that taking acetaminophen at the time of the injection can help relieve the fatigue associated with interferon, especially the fatigue that occurs 24-36 hours after the injection. I will definitely try it with my injection this Thursday and report my results. I hope it works; I am definitely tired of being sleepy, especially on short notice.
Tuesday, April 6, 2010
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