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Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication, new strength

October 7, 2021 - The FDA approved Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

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