FDA Approves Odefsey (a Fixed-Dose Combination Tablet) to Treat HIV Infection

March 11, 2016

On March 1, 2016, the Food and Drug Administration (FDA) approved Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide), a new fixed-dose combination tablet, for the treatment of HIV infection.
Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA levels less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey

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