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Tipanivir Now or TMC 114 Later?
Apr 9, 2005

hello-

i am currently resistant to most all HIV anti-viral drugs and am currently taking agenerase, kaletra and truvada. my latest t-cells were 60 (after years in the 100-150 range) and a viral load >100,000. my dr wants to add Fuzeon, take me off agenerase/kaletra and offered me the choice of adding tipanivir now or holding tight with the current regimen until June or so when TMC 114 could be added with the Fuzeon for a bigger bang for the buck. i am worried about waiting due to low counts and the possible resistance to tipanivir which might reduce the effectiveness of TMC 114 (same class as tipanivir, correct?) in the future. moreover, if i am accepted int he TMC 114 trial, i might get the placebo and was wondering how long i might have to wait to actually get the TMC especially if i get into trouble healthwise. what would u advise? i have been in excellent health since 1988 with no OIs or problems.

Response from Dr. Sherer

Cases like yours, with complex treatment and resistance histories, do not lend themselves well to this kind of exchange. There are simply too many peices of information that a physician needs to answer your question well, or even adequately. I will offer suggestions on the question you have asked, with the caution that it is no substitute for your doctor's advise on the issue with all of the relevant clinical information available to him or her.

I agree with your doctor that the next regimen should be a combination of a next generation PI like tipranavir/RTV, fuzeon, and whatever combination of partly active other drugs, most likely NRTIs, can be assembled.

In the tipranavir (TPV) registrational trials, the patients with the best results at 48 weeks were those who had never had fuzeon and who received fuzeon (or T-20) with tipravanavir and the best possible combination of NRTIs, most of which contained 3TC or FTC.

There is no way to answer your specific question, as there have been no comparative trials between TMC 114 and TPV. Both require boosting with ritonavir. BOth have excellent activity against strains of HIV that are resistant to all current agents, including APV and LPV/r. You may want to review the meager available data on their side effects with your doctor to add to the information on which to make this decision as well, some of which is related to ritonavir, which is co-administered with both drugs.

And, as you suggest, entering a trial might mean that you would receive a placebo, though you should be aware that most trial designs of this kind only require a placebo for a short period of time, e.g. 8 weeks, after which the placebo arm is allowed to switch over to the study drug.

As for timing, I agree with your concern that even a short delay could have serious consequences in your case, and that prompt action is warranted.

Again, please take these comments and discuss them with your doctor, who has a much better understanding of your history and of the exact virus with which you and he or she are dealing.


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