FDA Will Review Gilead’s HIV BIC/LEN Combination Treatment

The FDA has accepted a priority review of Gilead’s New Drug Application for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). The investigational, once-daily, single-tablet regimen is designed for adults living with HIV who are already virologically suppressed, offering a simplified approach that could reduce treatment burden while maintaining long-term viral control.

The combination pairs bictegravir, an integrase inhibitor known for its high barrier to resistance, with lenacapavir, a first-in-class capsid inhibitor that introduces a novel mechanism of action without cross-resistance to existing antiretrovirals.

“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,” Gilead Sciences Chief Medical Officer Dietmar Berger, MD, PhD, said in a statement.

What the Phase 3 Data Showed

The application is supported by positive Phase 3 results from the ARTISTRY-1 and ARTISTRY-2 trials, which demonstrated that switching to BIC/LEN maintained virologic suppression through 48 weeks with no new safety concerns. ARTISTRY-1 notably included the oldest population ever enrolled in a phase 3 HIV registrational study, underscoring the regimen’s potential relevance for aging populations.

Additional findings showed improvements in certain lipid parameters and patient-reported treatment satisfaction, while ARTISTRY-2 reported no significant impact on weight after switching therapies.

About the Therapies

BIC/LEN in combination remains investigational and is not yet approved anywhere globally. Their safety and efficacy as a fixed-dose combination have not been established.

BIC is an integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiviral agents that target the viral integrase. BIC is used only in combination with other antiretroviral agents in the treatment of HIV.

LEN is approved in multiple countries as preexposure prophylaxis to reduce the risk of HIV, and the agent is also approved for the treatment of multidrug-resistant HIV in adults, in combination with other antiretrovirals.

What Would FDA Approval Mean?

BIC/LEN would expand Gilead’s HIV treatment portfolio alongside Biktarvy, a widely used standard-of-care regimen. The FDA has set a target action date of August 27, 2026.

“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,” Berger said.

Reference
U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus Lenacapavir. Gilead press release. April 29, 2026. Accessed April 29, 2026.
https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir