FDA Approves Gilead's Bixlenvo as a Once-Daily Single-Tablet Regimen for Virologically Suppressed Adults Living with HIV

The U.S. Food and Drug Administration (FDA) has approved Bixlenvo (bictegravir 75 mg and lenacapavir 50 mg), a new once-daily single-tablet regimen developed by Gilead Sciences. This treatment is for adults with undetectable HIV-1 who are managing complex, multi-tablet therapies due to past resistance or tolerability challenges. The approval is supported by 48-week safety and efficacy findings from the Phase III ARTISTRY clinical trial program.