Sitting In Limbo

After not getting in to the Vertex – Telaprevir study in January of 2009 and being thrust into a primary management role in my employer’s reorganization and construction project in early 2009, I ended up in limbo regarding my plans for dealing with Hep C. I was so exhausted from running the project that I did not have the energy and mental focus to make any informed decisions.

One of the good pieces of fallout from not being in the study was getting to meet the team at the California Pacific Medical Center (CPMC) Hepatology Center. The study coordinators are not only intelligent, empathetic people, but they genuinely felt bad about the circumstances of my not qualifying for the study. They knew that the bad test result had been a result of a lab testing glitch and that I was a good candidate for being in a study. So they kept me informed of the various studies that were in the pipeline at their center. I told them that I would not be able to do anything until the summer as I needed time to recover and get the new systems at work up and running. But as soon as May and June arrived, I began to get phone calls about studies. I turned down one that was an early phase 1 trial of another protease inhibitor as it was a short (4 week) trial to determine whether the drug had any efficacy against the Hep C virus. I did not want to do a short course of treatment. When I committed to a program, I wanted to have it be for a full-term course of treatment designed to wipe out the virus. I also did not want to give up my treatment-naïve status unless it was for a serious, later stage study that was trying to determine whether the test drug was good for a cure, not just good for some effect against the drug.

Treatment-naïve means that you have never taken drugs to combat Hepatitis C. This is the state that most researchers look for in test subjects. They want to test their compounds on people whose Hep C virus has never had the chance to react to any attacking drugs. You are only treatment-naïve once. As soon as you have taken drugs to attack your Hep C, whether it be the standard Interferon and Ribavirin therapy or a drug study involving alternate or additional drugs. So, if you are considering entering a medical research trial, you may want to protect your treatment-naïve status until you see a study you like. Of course, if you are in serious later stage liver disease, you take the treatment that sounds best to deal with the situation you have and the hell with preserving treatment-naïve status for the future.

There are also studies for treatment-experienced patients as well. These studies are often somewhat later phase 2 or 3 studies that are trying to determine if the study drug works were other drugs have not. Let’s face it, if you can develop a drug that not only can cure Hep C in treatment-naïve patients, but also can cure the disease in people have tried other treatments and failed, you are looking at a much bigger slice of the treatment money pie. So drug companies all want to know if their drug works where others have failed. There is no need to despair of being able to access experimental therapies just because you have already tried a drug regime and failed. This is a thought that I hold clearly in my head when I think about the possibility of relapsing after the trial ends. I can still go for other options, assuming I want to go through this experience again.

So I was indeed drifting a bit, trying to see if an interesting study came up and indeed thinking about the whole necessity of entering treatment Right Now. As the immortal Jimmy Cliff would have it, I was indeed sitting here in limbo, waiting for the dice to roll.