US FDA Approves New Biktarvy Indication For People With HIV Who Are Treatment Experienced And Restarting Antiretroviral Treatment
🗓 FDA Approval:
On July 30, 2025, the U.S. Food and Drug Administration approved a supplemental New Drug Application (sNDA) for Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) to expand its indication. The drug may now be used in people with HIV (PWH) who have prior antiretroviral treatment, are not virologically suppressed, and are re‑starting ART, provided they have no known or suspected resistance to integrase strand inhibitors (INSTIs), emtricitabine, or tenofovir.