Jul 30, 2011
I have just completed my third week of this phase III trial using BI 201335 with SOC tx. I was diagnosed in 2000 and since I experimented with IVD use in the late '70's I am guessing I have been infected for well over 30 years. My symptoms led me to see a GI specialist who suggested I try a clinical trial. Here I am at age 52 in the battle for my life.
At this point I'm pretty sure I'm not in the placebo arm as the two capsules I take every morning give dramatic and scary sx that start within minutes. First I get stomach pain, then comes the diarrhea and then sudden violent onset of nausea. These effects can be handled with good food intake before, during and after taking the capsules. Then I try to lie down within half an hour with a good pain killer. Since tx kills the appetite at the best of times it can be challenging to find food appetizing enough to eat an appropriate amount to help with the sx.
The question is am I on the 120 mg or 240 mg daily dose? I hope it's the latter so that I can complete tx in 24 wks if I get a RVR. At this point I have to say the SOC seems like a piece of cake compared to the PI but it is early days. I do notice extreme sun sensitivity, itch, shortness of breath and dry skin. I also find myself feeling weepy, irritable and tired but I keep telling myself that it will pass after tx.
I do not believe I will be able to continue working part-time as a pharmacy technician at my local hospital with the way I feel on these drugs. Luckily I will be able to take a sick leave if things do not improve and the tx drugs are supplied by the drug company ($40,000 worth). If not for this I would be really stuck as I have a family to support and even though I went into this thinking I was strong and healthy (I am) it has knocked me for a loop.
Today was injection #4 and I am going to work in the morning - yikes! At the end of week 4 I see my trial doc and they will check my viral load for RVR. Fingers and toes crossed for good results.