This morning, Gilead Sciences announced positive topline results from its phase 3 ARTISTRY-2 trial evaluating an investigational fixed-dose combination of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) in adults with HIV who were virologically suppressed on bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF, (Biktarvy). The multicenter, double-blind study met its primary endpoint, showing that switching to BIC/LEN was statistically noninferior to continuing Biktarvy in maintaining viral suppression at Week 48.1
“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,” Eric Meissner, MD, PhD, Associate Professor, Director of HIV and Hepatitis Patient Care and Research, Medical University of South Carolina, said in a statement. 1
About the Study
The ARTISTRY-2 enrolled participants who were stable on Biktarvy and randomized them in a 2:1 ratio to switch to BIC/LEN or remain on their existing regimen. The primary efficacy endpoint was the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48, while key secondary endpoints included rates of virologic suppression below 50 copies/mL, changes in CD4 cell count, and treatment-emergent adverse events. The investigational regimen was generally well tolerated, with no significant or new safety concerns identified.1
The BIC/LEN regimen combines bictegravir, a guideline-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance to existing antiretroviral drug classes.1
Gilead noted that a single-tablet regimen pairing these two agents could further expand treatment options for people living with HIV, supporting long-term viral suppression while incorporating one of the newest mechanisms of action in HIV therapy. 1
What You Need to Know
Switching virologically suppressed adults from Biktarvy to the investigational BIC/LEN regimen maintained viral suppression at Week 48, meeting the ARTISTRY-2 primary endpoint and supporting its potential as an effective switch option.
The combination pairs bictegravir with lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance, and was generally well tolerated with no new or significant safety signals.
If approved, a single-tablet BIC/LEN regimen could broaden long-term HIV treatment options by incorporating a new mechanism of action into a simplified, guideline-relevant regimen.
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.2
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.2
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.2
Regulatory Submissions
The company plans to file the phase 3 data from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress.2
“These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed. 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,” Jared Baeten, MD, PhD, senior vice president of clinical development and virology at Gilead, said in a statement. 1
References
1.Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial. Gilead Sciences Press release. December 15, 2025. Accessed December 15, 2025.
https://www.businesswire.com/news/home/20251215879862/en/Gileads-Investigational-Single-Tablet-Regimen-of-Bictegravir-and-Lenacapavir-for-HIV-Treatment-Meets-Primary-Endpoint-in-Phase-3-ARTISTRY-2-Trial
2.Gilead’s investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment meets primary endpoint in phase 3 ARTISTRY-1 trial. Gilead Sciences Press release. November 13, 2025. Accessed November 13, 2025. https://www.gilead.com/news/news-details/2025/gileads-investigational-single-tablet-regimen-of-bictegravir-and-lenacapavir-for-hiv-1-treatment-meets-primary-endpoint-in-phase-3-artistry-1-trial
