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Gilead's Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial
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- Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults -
- Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions -
Dec 15, 2025
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN efficacy was found to be statistically non-inferior to BIKTARVY. Gilead plans to file the Phase 3 results from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.
In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to BIKTARVY. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, defined by the FDA snapshot algorithm. The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified during the trial.
The investigational regimen combines bictegravir, a global guidelines-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance to other existing drug classes. A single-tablet regimen combining bictegravir and lenacapavir would potentially further transform the treatment landscape, expanding options to enable people with HIV to sustain virologic suppression while taking one of the latest advances in HIV drug development.
"Recent breakthroughs in medical research have led to the approval of new treatments that can help people with HIV sustain viral suppression, facilitating improved health outcomes while also helping to reduce spread of the virus," said Eric Meissner, MD, PhD, Associate Professor, Director of HIV and Hepatitis Patient Care and Research, Medical University of South Carolina. "The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir-a standard-of-care integrase strand transfer inhibitor-and lenacapavir-a novel capsid inhibitor-has a comparable efficacy profile to a global guideline-recommended treatment regimen, demonstrating potential to expand current HIV treatment options."
ARTISTRY-2 (NCT06333808) is a multicenter, double-blind, randomized Phase 3 clinical trial comparing the safety and efficacy of an investigational once-daily combination of bictegravir and lenacapavir versus BIKTARVY in people with HIV who are virologically suppressed. Participants on BIKTARVY were randomized 2:1 to switch onto bictegravir 75 mg/lenacapavir 50 mg or continue their BIKTARVY regimen. The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints at Week 48 included the proportion of participants with virologic suppression (HIV viral load <50 copies/mL per US FDA Snapshot), change from baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events (TEAEs).
We look forward to sharing the full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval."
The results of ARTISTRY-2 will be combined with the findings from the Phase 3 ARTISTRY-1 (NCT05502341) trial to form the basis of regulatory submissions. Top-line results from the ARTISTRY-1 trial announced in November 2025 showed that the investigational combination of BIC/LEN was well tolerated and statistically non-inferior to multi-tablet antiretroviral regimens.
Full text press release:
https://www.gilead.com/news/news-details/2025/gileads-investigational-single-tablet-regimen-of-bictegravir-and-lenacapavir-for-hiv-treatment-meets-primary-endpoint-in-phase-3-artistry-2-trial
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