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 2, 2010

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…

1 comment:

  1. Hello. Thanks for starting this diary about your clinical trial experience. Please do keep us updated and good luck! Treatment is different for everyone - so don't read too much about others experiences (especially the bad ones) as no one knows how they will react to treatment until they try it. The polymerase inhibitor sounds promising. I will look forward to your updates.

    Peace
    Pam

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