Gilead’s ARTISTRY-2 Trial Shows Bictegravir Lenacapavir Combo Matches Biktarvy in Virologically Suppressed Adults With HIV

Gilead has shared positive results from its Phase III ARTISTRY-2 (NCT06333808) clinical trial evaluating a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) in adults with HIV switching over from Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).¹

Bictegravir-lenacapavir combo demonstrates non-inferiority

Breaking data showed that BIC/LEN was statistically non-inferior to Biktarvy. Additionally, the novel combination was generally well tolerated, with no new safety signals identified during the trial.

In combination with recent findings from the Phase III ARTISTRY-1 trial (NCT05502341), Gilead will use the new ARTISTRY-2 data as basis for future regulatory submissions.

In a company press release, Eric Meissner, MD, PhD, associate professor, director of HIV and hepatitis patient care and research, Medical University of South Carolina, said: “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. 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 study design

The ARTISTRY-2 study is a multicenter, randomized, double-blind trial in virologically suppressed adults with HIV.

• Participants stable on Biktarvy were randomized 2:1 to switch to once-daily BIC/LEN or continue Biktarvy.
• The study compares the safety and efficacy of the investigational fixed-dose combination versus standard therapy.
• The primary endpoint is the proportion of patients with HIV-1 RNA ≥50 copies/mL at week 48 using the FDA snapshot algorithm.
• Key secondary endpoints include virologic suppression rates, change in CD4 cell count, and incidence of treatment-emergent adverse events at week 48.

In the press release, Jared Baeten, MD, PhD, senior vice president, clinical development, virology therapeutic area head, Gilead Sciences, added: “The HIV treatment landscape is evolving. As a collective HIV community, we must look to the future of tailored treatments to meet the needs and preferences of people affected by HIV. 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 III data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval.”

Earlier findings from ARTISTRY-1 back new data

Gilead announced results from ARTISTRY-1 earlier in November. In the trial, an investigational single-tablet regimen of BIC/LEN met its primary success criterion, demonstrating non-inferiority to baseline multi-tablet antiretroviral therapy regimens.²

ARTISTRY-1 is a randomized, open-label, multicenter, active-controlled Phase II/III study evaluating BIC/LEN in adults with HIV who are virologically suppressed and switched from a multi-tablet regimen.

• In the Phase III portion of ARTISTRY-1, participants were randomized 2:1 to switch to bictegravir 75 mg/lenacapavir 50 mg or continue their existing multi-drug regimen.
• The primary endpoint assessed the proportion of patients with HIV-1 RNA ≥50 copies/mL at 48 weeks.
• Key secondary endpoints at week 48 included rates of virologic suppression (<50 copies/mL), changes in CD4 cell counts, and incidence of treatment-emergent adverse events.

In a company statement from the time, Baeten said: “People living with HIV who are on complex antiretroviral treatment regimens may experience pill burden, adherence challenges and difficulties with the long-term management of HIV. Gilead developed the first single-tablet complete regimen for the treatment of HIV in 2006. Today, innovative single-tablet regimens are still needed to help suit people’s needs, modernizing treatment while helping to sustain viral suppression. By reducing the multi-tablet burden, we hope to improve health outcomes while expanding options.”

References

1. Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-2 Trial. News release. Gilead. December 15, 2025. Accessed December 15, 2025. 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

2. Gilead’s Single-Tablet Bictegravi/Lenacapavir Regimen Shows Positive Phase III ARTISTRY-1 Results in Virologically Suppressed Adults with HIV. Applied Clinical Trials. November 13, 2025. Accessed December 15, 2025. https://www.appliedclinicaltrialsonline.com/view/gilead-single-tablet-bictegravi-lenacapavir-regimen-positive-artistry-results-virologically-suppressed-hiv