FDA Grants Priority Review to Gilead's Once-Daily Bictegravir/Lenacapavir HIV Regimen
The FDA has accepted Gilead's New Drug Application for the investigational once-daily HIV regimen bictegravir/lenacapavir and granted priority review, with a PDUFA action date of August 27, 2026. The filing is supported by Phase 3 ARTISTRY-1 and ARTISTRY-2 data showing comparable efficacy in maintaining virological suppression. If approved, BIC/LEN would be the smallest single-tablet regimen for HIV treatment.
Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN), an investigational once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed. The FDA granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.
If approved, BIC/LEN would be the smallest single-tablet regimen (STR) for HIV treatment and the first STR studied in adults with virological suppression on complex multi-tablet regimens. The combination pairs bictegravir, a guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor with a novel mechanism of action that has no cross-resistance with other antiretrovirals.
The NDA submission is supported by positive Phase 3 data from the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials, which evaluated BIC/LEN in adults with HIV with virological suppression, 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, BIC/LEN demonstrated comparable efficacy in maintaining virological suppression at Week 48 and was generally well tolerated, with no significant or new safety concerns identified. ARTISTRY-1 enrolled the oldest study population in a Phase 3 HIV treatment registrational trial to date. Week 48 data presented at CROI 2026 showed that switching to BIC/LEN from complex regimens was also associated with improvements in certain fasting lipid parameters and patient-reported treatment satisfaction, while ARTISTRY-2 showed that switching to BIC/LEN had no significant impact on weight. Detailed ARTISTRY-1 results were published in The Lancet on March 28, 2026.
“This once-daily, single-tablet regimen brings together the high barrier to resistance of bictegravir, with lenacapavir, a first-in-class capsid inhibitor with a novel mechanism of action that has no cross-resistance with other antiretrovirals,” said the company's chief medical officer. “If approved, BIC/LEN has the potential to be a single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance for people living with HIV who are virologically suppressed, including those who are aging, with comorbidities, seeking to streamline a complex regimen, with prior ARV resistance, and those seeking novel treatment options.”
The senior vice president of clinical development stated that BIC/LEN, if approved, could help address the evolving needs of people living with HIV and complement Gilead's portfolio together with Biktarvy, which is a standard of care for HIV treatment.
Bictegravir plus lenacapavir in combination are investigational and not approved anywhere globally. Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults and as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. Biktarvy is a complete HIV treatment that combines three medicines into the smallest 3-drug, INSTI-based single-tablet regimen available. There is currently no cure for HIV or AIDS.