Gilead's Bixlenvo Wins FDA Approval as HIV Treatment
Gilead Sciences' Bixlenvo HIV treatment has won USFDA approval for adults whose HIV infection is already at very low levels. The once-daily oral combination pill combines Gilead's HIV medicines bictegravir and lenacapavir, the latter of which targets the virus's protective shell to disrupt its multiplication.
The wholesale acquisition cost for a 30-day supply of Bixlenvo is $4,595, according to a Gilead spokesperson. Monika Shah, an infectious disease specialist at Memorial Sloan Kettering Cancer Center, noted that this combination may offer a simpler option for patients currently on complex regimens due to a history of drug-resistant virus.
Gilead expects Bixlenvo to become available within days of approval and is part of the company's multi-year strategy to expand its HIV portfolio grounded in lenacapavir. The approval was based on two late-stage studies where Bixlenvo was as effective as complex multi-pill regimens or Biktarvy in keeping the virus suppressed after 48 weeks.
About 5% of people living with HIV in the United States take complex regimens involving more than one tablet a day, according to Jared Baeten, Gilead's head of clinical development for virology. Bixlenvo enters a competitive HIV-treatment market that includes Merck's Idvynso.