The US FDA has approved Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), a once-daily single-tablet regimen (STR) for HIV-1 treatment in virologically suppressed adults — including, for the first time, those on complex multi-tablet regimens who could not previously use an STR. Gilead Sciences (Nasdaq: GILD) said the combination is the smallest oral STR and the first approved STR option for virologically suppressed patients on complex regimens who are unable to use existing STRs because of factors including historical resistance or tolerability.
Bixlenvo is indicated as a complete regimen for adults with HIV-1 RNA below 50 copies per mL on a stable antiretroviral regimen, with no known or suspected resistance to either component. Initiation requires a two-day loading period with Sunlenca (lenacapavir) co-administered alongside Bixlenvo, after which Bixlenvo is taken alone once daily. Contraindications include co-administration with dofetilide and strong CYP3A inducers.
Approval rested on two Phase III trials — ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) — both evaluating virologic suppression maintenance at Week 48 after switching to Bixlenvo. ARTISTRY-1 enrolled a notably treatment-experienced population: median age 60 years, median 28 years on antiretroviral therapy, 67% with nucleoside reverse transcriptase inhibitor (NRTI) resistance, and 81% on complex regimens due to resistance. Both trials reported comparable efficacy to prior regimens and no new safety signals; the most common adverse reactions were headache (4%), nausea (3%), and diarrhea (2%). ARTISTRY-1 results were published in The Lancet and ARTISTRY-2 in Lancet HIV.