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Gilead, Bristol-Myers Squibb Submit Once-a-Day Combination Antiretroviral Pill for FDA Approval

April 28, 2006

Gilead and Bristol-Myers Squibb on Thursday announced they have submitted for FDA approval an application to sell and market a "one pill", once daily antiretroviral treatment regimen that combines BMS' Sustiva and Gilead's Truvada, Reuters reports (Reuters, 4/27). The two companies in December 2004 announced that they would collaborate with the aim of developing the single daily combination antiretroviral drug. Currently, antiretroviral treatment requires patients to take several pills a day, sometimes at specific times and under certain conditions (Kaiser Daily HIV/AIDS Report, 12/21/04). If approved, the once daily combination pill would be the first highly active antiretroviral treatment regimen available in a single, daily pill (King, Dow Jones, 4/27). The pill submitted for approval includes 200 milligrams of emticitabine and 300 milligrams of tenofovir -- the two generic antiretrovirals included in Truvada -- as well as 600 milligrams of Sustiva, known generically as efavirenz (BMS release, 4/27). The application asks that the combination be approved to treat HIV-1 infection in adults, according to the companies (Trenton Times, 4/28).

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