FDA approves Bixlenvo, Gilead's once-daily bictegravir and lenacapavir HIV pill

The FDA approved Bixlenvo (bictegravir 75 mg and lenacapavir 50 mg), a once-daily single-tablet HIV regimen for adults who are virologically suppressed and can replace their current regimen. Gilead says it is the smallest once-daily single-tablet HIV regimen and the first and only such option for suppressed patients on complex regimens who cannot take currently available single-tablet regimens. The release gives no launch date or price, so the revenue effect is not yet visible.

• Bixlenvo = bictegravir 75 mg plus lenacapavir 50 mg, taken once daily
• Indication: adults with HIV-1 RNA below 50 copies/mL on a stable regimen with no known resistance
• Pivotal data from Phase 3 ARTISTRY-1 and ARTISTRY-2, presented at CROI 2026
• Starts with a two-day lenacapavir (Sunlenca) lead-in, then Bixlenvo alone
• Bictegravir and lenacapavir in combination are not approved outside the U.S.