Gilead announces FDA approved new indication for Biktarvy to treat HIV

Gilead Sciences “announced the U.S. Food and Drug Administration approved a new, expanded indication for Biktarvy, bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF, to treat people with HIV who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range, 22%-63%, of PWH with pre-existing resistance to nucleoside reverse transcriptase nhibitors across various HIV subtypes. This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor -based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services guideline recommended for PWH who are virally suppressed with M184V/I resistance.”