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FDA expected to
soon approve one-pill antiretroviral regimen

FDA expected to
soon approve one-pill antiretroviral regimen

The Food and Drug Administration is expected to soon approve--possibly as early as this week--a single pill to be taken just once a day that contains a full three-drug antiretroviral regimen, The New York Times reports. Although the federal agency has until October to approve the marketing application for the still unnamed pill, industry experts say the decision is likely imminent.

The single-pill regimen contains Bristol-Myers Squibb's nonnucleoside reverse transcriptase inhibitor Sustiva as well as Gilead Sciences' Truvada--which itself is a two-drug combination of the nucleoside reverse transcriptase inhibitors Emtriva and Viread.

The drugmakers began work on combining the medications into a single pill in December 2004, but the first two attempts did not maintain the same bioequivalence of the drugs dosed individually. Scientists reported in January having successfully combined the drugs by using a new layering technique. The resulting combination pill was submitted for FDA review in April.

If approved by the FDA as expected, the combination pill will be the simplest antiretroviral regimen available in the United States and other Western countries. Currently, generic three-drug combinations of older antiretroviral medications are available for use in developing nations.

Although the price of the new combination pill has not yet been announced, industry experts say it likely will cost the same as Sustiva and Truvada separately, about $1,200 per month. The pill also is expected to be available through not-for-profit agreements with developing nations for about $600 per person per year. (The Advocate)

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