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.

Sunday, January 17, 2010

Week 2 Results: Giving It The Lowdown

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

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

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

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

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

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

But now the news that matters: Viral Load.

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

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

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

1 comment:

  1. Way to go dude. I just started the same treatment and so far I have had no serious side effects. I started Jan 22 2010 so I've only had one shot.

    Take care and looking forward to more of your posts on your progress.

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