Gilead's Bixlenvo wins FDA nod to simplify HIV regimens

FDA approves Gilead’s once-daily Bixlenvo, a single-tablet regimen combining bictegravir and lenacapavir for adults with suppressed HIV who cannot use current one-pill options. It aims to simplify complex regimens and offer switching flexibility without replacing Biktarvy. Priced at about $4,595 for 30 days before discounts, with patient-assistance programs available. The decision is based on two Phase 3 trials showing maintained viral suppression at 48 weeks and generally favorable tolerability, with common side effects being headache, nausea and diarrhea.