The federal agency gave the nod for the smallest once-daily single tablet regimen available for virologically suppressed adults with HIV, including those on complex regimens. The approval is based on the results of the 2 phase 3 ARTISTRY trials.
Gilead’s combination pill, bictegravir 75 mg/lenacapavir 50 mg (Bixlenvo), was approved by the federal agency and becomes the smallest once-daily single tablet regimen (STR) for virologically suppressed adults with HIV.1 Additionally, Bixlenvo is now the first and only STR option for people with HIV on complex regimens who are unable to take currently available STRs. The combination pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor with no cross-resistance to other antiretrovirals.
The approval is based on results from the phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, presented as late breakers at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026).1 Bictegravir and lenacapavir in combination are not approved by any regulatory authority outside the United States.
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.2 Participants were taking between two and 11 pills per day at baseline, and approximately 40% received antiretroviral therapy more than once daily. The trial population had extensive treatment experience, with a median treatment duration of 28 years, NRTI resistance reported in 67% of participants, and a complex regimen driven by antiretroviral resistance in 81% of participants.
Both trials evaluated Bixlenvo in adults with HIV who were virologically suppressed, including those switching from complex multi-tablet regimens or from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; Gilead Sciences).2 At week 48, Bixlenvo demonstrated efficacy comparable to prior regimens in maintaining virologic suppression, with no significant or new safety concerns identified. Switching to Bixlenvo in ARTISTRY-1 was associated with improvements in certain fasting lipid parameters and participant-reported treatment satisfaction, and ARTISTRY-2 showed no significant impact on weight.
The most common adverse reactions reported in at least 2% of participants across the ARTISTRY program were headache, nausea, and diarrhea.² Bixlenvo requires a two-day initiation dose with Sunlenca (lenacapavir; Gilead Sciences), after which patients take Bixlenvo alone once daily.
Listen to ARTISTRY investigators discuss the 2 trials.
Chloe Orkin, MD, lead investigator for ARTISTRY-1 study, discusses data findings from it.
Eric Meissner, MD, PhD, lead investigator of the ARTISTRY-2 study, discusses its takeaways.
"Bixlenvo offers a new once-daily STR designed for the evolving needs of people with HIV,"
ARTISTRY-2 is a phase 3, double-blind, multicenter study and enrolled adults who were randomized 2:1 to switch to once-daily oral bictegravir/lenacapavir (75/50 mg) or to continue bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). The primary endpoint assessed the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA Snapshot algorithm, with a noninferiority margin of 4%.5
The study met its primary end point, showing that switching to BIC/LEN was statistically noninferior to continuing B/F/TAF in maintaining viral suppression at week 48.5
