Gilead's Bixlenvo Wins FDA Approval for Low-Level HIV Treatment

Gilead Sciences has secured FDA approval for its once-daily oral combination pill, Bixlenvo, designed to treat adults whose HIV infection is already at very low levels. The drug combines Gilead's HIV medicines bictegravir and lenacapavir. A 30-day supply of Bixlenvo will have a wholesale acquisition cost of $4,595.

The approval was based on two late-stage studies where Bixlenvo proved as effective as complex multi-pill regimens or Biktarvy in keeping the virus suppressed after 48 weeks. Dr. Monika Shah, an infectious disease specialist at Memorial Sloan Kettering Cancer Center, noted that Bixlenvo offers a simpler option for patients who might currently be on more complex regimens due to a history of drug-resistant virus.

Bixlenvo enters the competitive HIV-treatment market, which includes Merck's Idvynso, a once-daily two-drug pill approved in April. According to Jared Baeten, Gilead's head of clinical development for virology, about 5% of people living with HIV in the United States take complex regimens involving more than one tablet a day.