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.

Thursday, January 7, 2010

One Week Later – The First Lost Weekend

The 1-week follow-up appointment was the first chance to get a benchmark on what I was experiencing. They allowed me to change my interferon injection to Thursday evening. This gives me an extra 12 hours or so for the side effects to quiet down before returning to work on Monday. They wanted me to take the pills in their presence again, so bringing food was still a must.

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.

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