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 10, 2010

Week 1 Test Results: Get On The Good Foot

Well, I went in for the week two tests. The tests involved taking 12 vials of blood, 2 EKGs, 2 Blood pressure tests, I chilled urine from home, I warm sample while I was there. But this is just details, the real meat came when I got the viral load numbers from the first week of treatment: 4,260 IUs per milliliter. YES!!!

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.

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