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announce success in forming single-pill anti-HIV regimen

announce success in forming single-pill anti-HIV regimen

Single-pill antiretroviral regimen could be submitted to the FDA in the second quarter.

The third time seems to be the charm for drugmakers Bristol-Myers Squibb and Gilead Sciences, who struck out in two previous attempts to craft a single-pill, once-daily antiretroviral regimen. The companies on Monday announced they've successfully combined the drugs Sustiva and Truvada into a single formulation. Truvada is already a combination pill containing Emtriva and Viread. The companies plan to file for Food and Drug Administration approval of the resulting single-pill regimen in the second quarter of 2006. Should the FDA approve the pill, it would be the only one-pill, once-daily full antiretroviral regimen available in the United States. The medication could be available to consumers before the end of the year.

"The advancement of our fixed-dose regimen represents an important step forward in the further simplification of HIV treatment," said John C. Martin, president and chief executive officer of Gilead Sciences in a press statement. "Gilead and Bristol-Myers Squibb share a commitment to the treatment of HIV, a disease for which significant unmet medical need continues to exist, and we look forward to working with regulatory authorities."

Gilead and Bristol-Myers Squibb announced in December 2004 that they planned to collaborate on a venture to combine Gilead's Truvada with Bristol-Myers Squibb's Sustiva into a single pill that would be taken just once daily. The first two attempts to combine the medications were unsuccessful, as the resulting combination pill did not have the same bioequivalence of the drugs dosed separately. The new pill uses bilayering technology to incorporate the drugs into a single fomulation, and studies show it has the same bioequivalence as the individual medications.

Health and Human Services guidelines recommend the combination of Sustiva and Truvada as a preferred nonnucleoside reverse transcriptase inhibitor-based regimen for treatment-naive HIV-positive adults. (

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