FDA Approves Gilead Bixlenvo (Bictegravir 75 mg / Lenacapavir 50 mg), First Single-Tablet Regimen Built Around a Capsid Inhibitor for Virologically Suppressed HIV Adults
The FDA approved Gilead Sciences (NASDAQ: GILD) Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg, a once-daily single-tablet HIV regimen) on Wednesday August 27, 2026 for adults with HIV-1 who are virologically suppressed on a stable antiretroviral regimen for at least 6 months and have no history of treatment failure or known resistance to bictegravir or lenacapavir. Approval was based on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials presented at CROI 2026, both of which met non-inferiority for virologic suppression at Week 48 with a tolerable safety profile. Lenacapavir is Gilead's first-in-class HIV-1 capsid inhibitor (already approved as long-acting subcutaneous Sunlenca), and Bixlenvo is the first oral single-tablet regimen anchored on capsid inhibition. Dosing requires a two-day initiation period with Sunlenca before switching to Bixlenvo alone. The approval extends the single-tablet regimen category to an estimated 5%+ of U.S. HIV-suppressed adults on complex multi-pill regimens who could not previously use one-tablet options.