Gilead Leverages Priority Review to Advance Bic/Len in HIV Care

Gilead Sciences announced that the U.S. Food and Drug Administration has accepted its New Drug Application for an investigational once-daily single-tablet regimen combining bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) for the treatment of HIV in virologically suppressed adults, granting priority review with a PDUFA action date of August 27, 2026.

The fixed-dose combination pairs bictegravir, an integrase strand transfer inhibitor with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that acts at multiple stages of the HIV lifecycle and shows no cross-resistance with existing antiretroviral classes in vitro.

The submission is supported by Phase 3 ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials in virologically suppressed adults, including those switching from multi-tablet regimens or from Biktarvy (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF), demonstrating comparable efficacy in maintaining viral suppression at Week 48 and a favorable safety profile with no new concerns.  

In ARTISTRY-1, switching to BIC/LEN was associated with improvements in certain fasting lipid parameters and patient-reported treatment satisfaction, while ARTISTRY-2 showed no significant effect on weight. The ARTISTRY-1 study also included the oldest population enrolled in a Phase 3 HIV registrational trial to date, with results published in The Lancet in March 2026.

Dietmar Berger M.D., Ph.D., Chief Medical Officer, Gilead Sciences emphasized that the bictegravir/lenacapavir combination leverages a high resistance barrier and a novel capsid inhibition mechanism without cross-resistance, and is being developed as a simplified, single-tablet option to maintain long-term viral suppression in a broad range of virologically suppressed patients, including those with complex treatment histories or comorbidities.

Jared Baeten, M.D., Ph.D., Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences stated that the regimen reflects Gilead’s ongoing focus on evolving patient needs in HIV care and, if approved, would expand treatment options while complementing established therapies such as Biktarvy, which remains a standard of care.

 Reference

Gilead Sciences, Inc. – U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir

Study Details | NCT05502341 | Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen | ClinicalTrials.gov

Study Details | NCT06333808 | Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy | ClinicalTrials.gov