Gilead Sciences Presents Positive Phase 3 ARTISTRY Trial Data for Investigational Bictegravir/Lenacapavir HIV Regimen at CROI 2026
Gilead Sciences, Inc. today shared compelling new data from its Phase 3 ARTISTRY-1 and ARTISTRY-2 clinical trials at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado, highlighting the potential of an investigational single-tablet combination regimen of bictegravir 75 mg and lenacapavir 50 mg (BIC/LEN) for adults living with HIV who are virologically suppressed. The data demonstrate that a switch to this novel combination from either complex multi-tablet regimens or current guideline-recommended single-tablet regimens was effective in maintaining viral suppression, well-tolerated, and associated with no new or unexpected safety concerns.
Jared Baeten, M.D., Ph.D., Senior Vice President of Clinical Development and Virology Therapeutic Area Head at Gilead Sciences, emphasized the significance of these results, stating, “The ARTISTRY trials represent the latest example of Gilead’s commitment to advancing HIV treatment through continuous scientific innovation. This once-daily single-tablet regimen combines the durability of bictegravir with lenacapavir, a first-in-class capsid inhibitor. The novel treatment combination is designed to sustain virologic suppression for those seeking new options. We look forward to working with regulatory authorities to potentially bring this combination forward to people with HIV.”
The findings underscore the potential of BIC/LEN to expand HIV treatment options for adults, providing efficacy comparable to BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg, B/F/TAF) as well as to complex multi-tablet regimens, while potentially simplifying treatment and improving patient convenience.
ARTISTRY-1: Single-Tablet Regimen Demonstrates Noninferiority to Complex Multi-Tablet Therapy
The ARTISTRY-1 trial (NCT05502341) evaluated the safety and efficacy of the once-daily BIC/LEN tablet in participants with HIV who were already virologically suppressed on complex multi-tablet regimens. In Phase 3, participants were randomized in a 2:1 ratio to either switch to the BIC/LEN combination or continue their existing multi-tablet regimen. The primary endpoint was the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48, as determined by the US FDA-defined snapshot algorithm. Secondary endpoints included changes in CD4 cell counts, virologic suppression rates, and treatment-emergent adverse events (TEAEs).
Results presented at CROI 2026 indicate that switching to BIC/LEN was noninferior to remaining on complex multi-tablet therapy. At Week 48, only 0.8% of participants receiving BIC/LEN had HIV-1 RNA ≥50 copies/mL, compared with 1.1% of participants who remained on their original multi-tablet regimen. CD4 cell counts remained stable in both groups, and no participants developed treatment-emergent resistance during the study period.
Importantly, switching to the single-tablet BIC/LEN regimen was associated with improvements in fasting lipid profiles. Participants experienced a median reduction in total cholesterol of -15 mg/dL compared with a slight increase of +2 mg/dL among those on multi-tablet regimens. Patient-reported treatment satisfaction, measured using the HIV Treatment Satisfaction Questionnaire (HIVTSQs), increased by a mean of seven points in the BIC/LEN group, while scores remained unchanged for participants on complex regimens.
Chloe Orkin, MBE, Clinical Professor of Infection and Inequities at Queen Mary University of London, highlighted the clinical significance of these findings: “Pre-existing viral resistance, intolerance, contraindications, or drug-drug interactions may prevent many people living with HIV from benefiting from guideline-recommended single-tablet regimens. Complex treatment regimens can pose a significant burden on daily life, as observed in the ARTISTRY-1 trial where participants were taking between 2 and 11 pills per day at baseline, with nearly 40% dosing multiple times per day. Identifying effective single-tablet regimens is essential to improving adherence and quality of life for people living with HIV.”
BIC/LEN was generally well tolerated in ARTISTRY-1. Drug-related adverse events occurred in 14.3% of participants switching to BIC/LEN compared to 1.6% in the multi-tablet group. Serious drug-related adverse events were rare and similar between groups (0.3% BIC/LEN vs 0% multi-tablet), and discontinuations due to adverse events were low (1.6% and 0.5%, respectively). The primary outcomes of ARTISTRY-1 were published in The Lancet on February 25, 2026, under the title: Switch to single-tablet bictegravir/lenacapavir from a complex HIV regimen: results from ARTISTRY-1, a randomised, open-label phase 3 clinical trial.
ARTISTRY-2: BIC/LEN Matches Guideline-Recommended Single-Tablet Therapy
ARTISTRY-2 (NCT06333808), a multicenter, double-blind, Phase 3 trial, further assessed the investigational BIC/LEN combination against BIKTARVY, a guideline-recommended single-tablet regimen. Participants on BIKTARVY were randomized 2:1 to switch to BIC/LEN or continue BIKTARVY. Primary and secondary endpoints were identical to ARTISTRY-1, with virologic suppression, CD4 cell counts, and TEAEs closely monitored through Week 48.
The results demonstrated that BIC/LEN was noninferior to BIKTARVY, with 1.3% of participants on BIC/LEN and 1.0% on BIKTARVY having HIV-1 RNA ≥50 copies/mL at Week 48. CD4 counts remained stable across both treatment arms, and resistance analyses showed no treatment-emergent resistance in three of four participants assessed. An isolated integrase substitution without phenotypic resistance was observed in one participant in the BIC/LEN group, and no capsid mutations were detected. Additionally, switching to BIC/LEN had no significant impact on body weight, with BMI remaining stable throughout the study.
BIC/LEN was generally well tolerated in ARTISTRY-2, with 10.4% of participants experiencing drug-related adverse events compared with 12.0% in the BIKTARVY arm. No serious drug-related adverse events were reported, and discontinuations due to adverse events were similarly low at 1.6% in both groups.
Eric Meissner, MD, PhD, Associate Professor and Director of HIV and Hepatitis Patient Care and Research at the Medical University of South Carolina, commented on the trial’s significance: “The findings from ARTISTRY-2 support the potential of the bictegravir/lenacapavir regimen to expand the range of single-tablet antiretroviral treatments available to people living with HIV. With efficacy comparable to a guideline-recommended therapy, this combination may offer another meaningful treatment option for adults with virologic suppression.”
About Bictegravir and Lenacapavir
Bictegravir, a widely used integrase strand transfer inhibitor (INSTI), has become a cornerstone of modern antiretroviral therapy due to its potent antiviral activity and favorable resistance profile. Lenacapavir, a first-in-class capsid inhibitor, represents a novel mechanism of action in HIV therapy. The combination of these two agents in a single-tablet formulation is investigational and not currently approved for use anywhere globally. The safety and efficacy of BIC/LEN have not been formally established, and there is presently no cure for HIV or AIDS.
About the ARTISTRY Trials
ARTISTRY-1 is a multicenter, Phase 2/3 trial comparing BIC/LEN with existing complex regimens in adults with suppressed viral loads. Participants were randomized 2:1 to receive BIC/LEN or continue their baseline regimen. The trial assessed virologic suppression, changes in CD4 counts, and adverse events over 48 weeks.
ARTISTRY-2 is a double-blind, randomized Phase 3 study comparing BIC/LEN with BIKTARVY in virologically suppressed adults. Participants were randomized to switch to BIC/LEN or continue BIKTARVY, with the primary endpoint being the proportion with HIV-1 RNA ≥50 copies/mL at Week 48. Secondary endpoints included CD4 cell changes, TEAEs, and resistance analysis.
