Indications of Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients with a body weight of at least 14 kg, including:

1. Patients with no prior antiretroviral treatment history;

2. Patients with a prior antiretroviral treatment history who have not achieved virologic suppression and have no known or suspected substitutions associated with resistance to the integrase strand transfer inhibitor (INSTI) class, emtricitabine, or tenofovir;

3. Patients for replacing the current antiretroviral regimen—specifically, those who have achieved virologic suppression (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen and have no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

FDA，2025.07