On Aug. 27, 2026, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) approved Bixlenvo^™ (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for the treatment of HIV in adults who are virologically suppressed. Bixlenvo is now the first and only STR option for virologically suppressed people with HIV who are on complex regimens and unable to take currently available STRs.

This novel HIV treatment pairs bictegravir, a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that has a novel mechanism of action with no cross-resistance to other antiretrovirals.

The FDA approval is based on results from the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials, with data presented during late-breaker sessions at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026). The trials evaluated Bixlenvo in adults with HIV who are virologically suppressed, including those who switched from complex multi-tablet regimens or from Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). In both trials, Bixlenvo demonstrated comparable efficacy in maintaining virologic suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified. Most common adverse reactions reported in at least 2% of participants across the ARTISTRY program were headache, nausea, and diarrhea. Detailed ARTISTRY-1 results were published in The Lancet, and ARTISTRY-2 results were published in Lancet HIV.

ARTISTRY-1 enrolled the oldest study population in a Phase 3 registrational trial for HIV-1 treatment to date, with a median participant age of 60 years. Participants were taking between two and 11 pills per day at baseline, with approximately 40% taking antiretroviral therapy more than once daily. Additionally, the trial participants had extensive HIV treatment experience, with a median treatment duration of 28 years, a high level of historical antiretroviral resistance (67% with NRTI resistance) and a high proportion of participants on a complex regimen because of antiretroviral resistance (81%). The Phase 3 results demonstrated that switching from complex multi-tablet regimens to Bixlenvo was associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction. ARTISTRY-2 showed that switching to Bixlenvo had no significant impact on weight.

Bixlenvo requires a two-day initiation dose with Sunlenca^® (lenacapavir), thereafter only Bixlenvo is taken orally once a day.

Bictegravir and lenacapavir in combination are not approved by any regulatory authority outside of the United States.

There is currently no cure for HIV or AIDS.