Posted by Michael Wonder on 01 Aug 2025
US FDA approves new Biktarvy indication for people with HIV who are treatment experienced and restarting antiretroviral treatment
30 July 2025 - Gilead Sciences today announced that the US FDA has granted a new approval for a novel indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets.
This new indication expands Biktarvy’s label to include the treatment of people with HIV with an antiretroviral treatment history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor class, emtricitabine or tenofovir.
