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Phase III Study of TMC114 TMC125
Mar 15, 2006

Dr.Sherer,

I have been HIV+ since 1992 & have been on almost every medication since that time. I am now resistant to all the current drugs & have also failed on the Tipranivir study. My question is whether I should try the new Duet trials which are starting soon. I am worried that if I only get the TMC114 & not the TMC125 in the trial that I will become resistant to the 114. I know that there is a small group already getting the 2 together and they have had promising results so far. My CD4 are 290 & viral load at 84000 so I am wondering if it might be better to wait until the 2 are available together for compassionate use. Would appreciate any input you might have.

Thank you.

HH

Response from Dr. Sherer

These are the hardest types of questions to answer, because the information I would need from you in order to give you the best possible answer is difficult to convey in a single email. I would urge you to take this question and this response to your doctor, and discuss it with him or her.

In general, I would agree with your concern that you may not receive both drugs simply by enrolling in the trial. You already can access TMC-114 by compassionate access, so the question is, how long can you afford to wait for TMC125 or another second line NNRTI - or, for that matter, a next generation NRTI or entry inhibitor?

The answer to this question is highly variable and dependent on your individual treatment history, the specific mutational patterns that you harbor, and your recent treatment history and recent viral loads and CD4 cell counts, in particular for the past 2 years. I would like to know the recent trends in your CD4 cell count (stable, drifting downwards, or falling rapidly), and in the most recent resistant tests (i.e. are there multiple new mutations? or a stable group?) This is why the answers are so variable.


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