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Oct 9, 2003

Hi Dr. Young,

Not too long ago, i read fosamprenavir had gone through clinical trials, successfully. It appears to have great efficacy, little side effects (especially for a PI) and the once daily protocol is favorable. Why hasn't it hit the market yet?


Response from Dr. Young

Fosamprenavir (or 908) is a new HIV protease inhibitor (the follow up to the potent, but unwieldly amprenavir (Agenerase). The maker of fosamprenavir, GlaxoSmithKline has submitted paperwork to the US FDA for review; I expect that we will hear from the FDA any week now about the approval status.

Three large clinical trials have looked at 908 in both therapy naive and therapy-experienced patients; the drug shows a very good profile as a unboosted- or boosted-protease inhibitor. It will certainly increase our treatment options and can be dosed either once- or twice-daily (depending on the situation and whether boosted). In any case, the pill burden will be attractive, with a total (including the boosting Norvir) pill count of 4 per day.

Stay tuned-- BY

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