FDA

Biktarvy now approved for treatment-experienced patients who are restarting ART

August 8, 2025

FDA approved a new indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), which expands the drug's label to include the treatment of adults and pediatric patients weighing ≥14 kg with HIV with an antiretroviral treatment history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine, or tenofovir.

According to a manufacturer press release, FDA granted the new indication based on strength of evidence for Biktarvy from treatment naïve studies 1489 and 1490 that demonstrated rapid and durable viral suppression, an established long-term safety and tolerability profile, and zero cases of treatment-emergent resistance to Biktarvy through five years.

Sources:

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210251s023lbl.pdf Revised July 2025. Accessed August 7, 2025.

US FDA Approves New Biktarvy Indication For People With HIV Who Are Treatment Experienced And Restarting Antiretroviral Treatment. [News release]. 2025. https://www.gilead.com/company/company-statements/2025/us-fda-approves-new-biktarvy-indication-for-people-with-hiv-who-are-treatment-experienced-and-restarting-antiretroviral-treatment