Gilead Sciences has announced positive topline results from the Phase 3 ARTISTRY-1 trial evaluating an investigational single-tablet regimen of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) in adults living with HIV who were virologically suppressed on complex multi-tablet antiretroviral therapy (ART). The regimen met the primary endpoint, demonstrating statistically non-inferior efficacy compared with participants’ baseline multi-tablet regimens.

In ARTISTRY-1, BIC/LEN maintained viral suppression with HIV-1 RNA levels ≥50 copies/mL at Week 48 consistent with FDA snapshot algorithm standards. The single-tablet regimen was generally well tolerated, and no new or unexpected safety concerns were observed. Participants enrolled were taking between two and eleven pills daily prior to switching, with roughly 40% on multi-daily dosing schedules.

“Developing new effective, convenient regimens for those left behind by advances in medical research is necessary to close the unmet HIV treatment gap,” said Chloe Orkin, MBE, clinical professor of infection and inequities at Queen Mary University of London. “These ARTISTRY-1 trial results demonstrate that a combination regimen of bictegravir and lenacapavir maintains viral suppression in people living with HIV who would otherwise have to take a complex multi-tablet regimen.”

ARTISTRY-1 is a multicenter Phase 2/3 trial comparing the investigational fixed-dose combination to participants’ existing therapy. Key secondary endpoints included the proportion of participants maintaining virologic suppression, changes in CD4 cell counts, and treatment-emergent adverse events. The trial population included adults with long-standing HIV and common age-related comorbidities, highlighting the need for simplified regimens compatible with multiple medications.

“People living with HIV who are on complex antiretroviral treatment regimens may experience pill burden, adherence challenges and difficulties with long-term management,” said Jared Baeten, MD, PhD, senior vice president, clinical development, virology therapeutic area head at Gilead Sciences. “By reducing the multi-tablet burden, we hope to improve health outcomes while expanding options.”

Further evaluation of BIC/LEN is ongoing in the double-blind Phase 3 ARTISTRY-2 trial, which is assessing the safety and efficacy of switching from BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) to the fixed-dose combination in virologically suppressed adults. Topline results for the primary endpoint are expected before the end of 2025.

Bictegravir and lenacapavir in combination remain investigational and are not approved anywhere globally. No cure for HIV or AIDS currently exists, underscoring the continued need for innovative treatment strategies that simplify therapy and support long-term viral suppression.