Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg) - (ARTISTRY-2)

August 17, 2026: Gilead Sciences (NASDAQ: GILD) said the FDA approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen for adults with HIV-1 who are virologically suppressed, to replace a stable antiretroviral regimen in patients with no known or suspected resistance to its individual components.

The approval was based on Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808), with data presented in late-breaker sessions at CROI 2026. In both trials, Bixlenvo showed comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns. The most common adverse reactions reported in at least 2% of participants were headache (4%), nausea (3%), and diarrhea (2%).

ARTISTRY-1 included heavily treatment-experienced adults switching from complex multi-tablet regimens; the study reported improvements in certain fasting lipid parameters and participant-reported treatment satisfaction. ARTISTRY-2 found no significant impact on weight after switching to Bixlenvo. The regimen requires a two-day initiation with Sunlenca (lenacapavir) before daily Bixlenvo maintenance. Outside the U.S., the bictegravir/lenacapavir combination is not approved.