Gilead Sciences presented Phase 3 ARTISTRY-1/2 data at CROI 2026, showing investigational BIC/LEN single-tablet HIV regimen noninferior to complex regimens or BIKTARVY® in maintaining virologic suppression at Week 48, with improved lipids and high tolerability.
Written By: Marka Sheshi, PharmD
Reviewed By: Pharmacally Editorial Team
Gilead Sciences announced late-breaking results from the ARTISTRY-1 and ARTISTRY-2 trials at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado. The data show that switching to the investigational once-daily single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) maintained virologic suppression in people living with HIV, including those on complex multi-tablet regimens.
Jared Baeten, Gilead’s Senior VP of Clinical Development for Virology, highlighted the ARTISTRY trials as exemplars of the company’s ongoing HIV innovation. He emphasized that the once-daily BIC/LEN single-tablet regimen pairs bictegravir’s proven durability with lenacapavir’s novel capsid inhibition to maintain virologic suppression for patients seeking alternatives, with plans to pursue regulatory approval.
ARTISTRY-1 Key Findings
In ARTISTRY-1 (NCT05502341), BIC/LEN proved noninferior to complex multi-tablet regimens at Week 48, with 0.8% of BIC/LEN participants having HIV-1 RNA ≥50 copies/mL versus 1.1% in the control group (FDA snapshot algorithm). CD4 counts stayed stable, no emergent resistance occurred, and lipid parameters improved (median total cholesterol change: -15 mg/dL for BIC/LEN vs. +2 mg/dL for controls). Patient satisfaction rose by a mean of 7 points on the HIVTSQs score.
The regimen was well tolerated, with drug-related adverse events in 14.3% of BIC/LEN participants versus 1.6% in controls; discontinuations due to adverse events were low (1.6% vs. 0.5%). These results were published in The Lancet on February 25, 2026.
ARTISTRY-2 Key Findings
ARTISTRY-2 (NCT06333808) compared BIC/LEN to BIKTARVY®, showing noninferiority at Week 48: 1.3% of BIC/LEN participants had HIV-1 RNA ≥50 copies/mL versus 1.0% on BIKTARVY. CD4 counts remained stable, weight and BMI showed no significant changes, and resistance was minimal (no capsid mutations).
Adverse events were comparable (10.4% for BIC/LEN vs. 12.0% for BIKTARVY), with no serious drug-related events and low discontinuations (1.6% in both).
Chloe Orkin, Clinical Professor at Queen Mary University of London, noted that pre-existing resistance, intolerances, or drug interactions often bar HIV patients from guideline-recommended single-tablet regimens. In ARTISTRY-1, participants on complex regimens took 2-11 pills daily (40% multiple times/day), highlighting adherence burdens; she stressed BIC/LEN’s single-tablet convenience as key to optimizing access to innovations like bictegravir and lenacapavir.
Bictegravir (BIC) is a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high resistance barrier, approved in combinations like BIKTARVY® for HIV treatment. Lenacapavir (LEN), a first-in-class capsid inhibitor, targets multiple HIV lifecycle stages without cross-resistance to other classes; it’s approved for multidrug-resistant HIV treatment and PrEP (injectable form) in multiple countries.
Regulatory Status
BIC/LEN is investigational and not approved globally; safety/efficacy of this combination is unestablished, though Gilead plans regulatory submissions using ARTISTRY data. BIC and LEN have separate approvals: BIC in fixed-dose oral regimens, LEN for resistant HIV and prevention (e.g., FDA/EMA nods for PrEP).
Ongoing Studies
Gilead is evaluating long-acting BIC/LEN options (oral/injectable) in early/late-stage trials for HIV treatment/prevention, aiming for flexible regimens. Additional studies explore BIC/LEN in viremic patients and special populations like older adults.
Reference
Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People with HIV Who Switched Antiretroviral Therapy, 25 February 2026, 25 February 2026, Gilead Sciences, Inc. – Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated with a Complicated Regimen (ARTISTRY-1), ClinicalTrials.gov ID NCT05502341, https://clinicaltrials.gov/study/NCT05502341
Orkin, Chloe Sokhela, Simiso et al., Switch to single-tablet bictegravir–lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial, The Lancet, Volume 0, Issue 0, https://doi.org/10.1016/S0140-6736(26)00307-7
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated with Biktarvy (ARTISTRY-2), ClinicalTrials.gov ID NCT06333808, https://clinicaltrials.gov/study/NCT06333808
About Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.