FDA OKs Gilead HIV Combo Pill

FDA has approved a Gilead Sciences NDA Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) for treating HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are made by Gilead Sciences, and rilpivirine made by Janssen Sciences Ireland UC.

Odefsey is indicated as a complete regimen for treating HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. It is also indicated as a replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.

The drug carries a boxed warning on the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute hepatitis B exacerbations.