Gilead Sciences Inc. said on Wednesday the U.S. Food and Drug Administration approved Bixlenvo, a once-daily oral treatment for HIV in virologically suppressed adults.
The single-tablet regimen combines 75 mg of bictegravir, an integrase strand transfer inhibitor, and 50 mg of lenacapavir, a capsid inhibitor. Patients must first take a two-day initiation dose with Gilead’s Sunlenca before transitioning to the daily Bixlenvo regimen.
Approval follows Phase 3 trials ARTISTRY-1 and ARTISTRY-2, which evaluated Bixlenvo in adults with stable viral suppression. In ARTISTRY-1, participants had a median age of 60 years, took between two and 11 pills daily at baseline, and had a median of 28 years on antiretroviral therapy. Approximately 40% were on multiple daily doses, and 67% showed resistance to nucleoside reverse transcriptase inhibitors (NRTIs), while 81% followed complex regimens due to antiretroviral resistance.
At week 48, Bixlenvo demonstrated comparable efficacy in maintaining virological suppression to existing therapies. The most common adverse reactions, reported in at least 2% of participants, were headache, nausea, and diarrhea.
Bixlenvo is contraindicated with dofetilide and strong CYP3A inducers, as these can significantly reduce the concentrations of its active components. The combination has not been approved outside the United States.
Gilead, based in Foster City, California, did not disclose pricing or commercial launch timing for Bixlenvo.
