Positive ARTISTRY-2 Trial Results for BIC LEN HIV Regimen

BIC/LEN HIV Regimen Delivers Non-Inferior Results in ARTISTRY-2

Gilead Sciences announced positive topline results from the Phase 3 ARTISTRY-2 trial, demonstrating that the investigational BIC LEN HIV regimen—a single-tablet combination of bictegravir 75 mg and lenacapavir 50 mg—is statistically non-inferior to the established BIKTARVY regimen for virologically suppressed adults with HIV. The trial met its primary endpoint, showing comparable efficacy in maintaining viral suppression, with the BIC LEN HIV regimen also exhibiting a favorable safety profile and no new concerns. These findings, combined with results from the complementary ARTISTRY-1 trial, will support upcoming regulatory submissions to expand treatment options in HIV management, as detailed in Gilead’s official announcement.

Proven Suppression Without Compromise

The ARTISTRY-2 trial highlights the investigational BIC LEN HIV regimen‘s potential as a robust option for sustaining virologic suppression in HIV patients, with efficacy proven non-inferior to BIKTARVY based on the primary endpoint of HIV-1 RNA levels ≥50 copies/mL at Week 48, assessed via the U.S. Food and Drug Administration (FDA) snapshot algorithm. This outcome underscores the regimen’s ability to maintain viral loads below detectable thresholds in a majority of participants, mirroring the performance of the comparator arm where patients either switched to the BIC LEN HIV regimen or continued BIKTARVY in a 2:1 randomization.

Secondary endpoints further reinforced these results, including high rates of virologic suppression (HIV viral load <50 copies/mL) and stable CD4 cell counts from baseline, alongside a low incidence of treatment-emergent adverse events that were generally mild and aligned with known profiles of the individual components. The combination’s distinct mechanisms—bictegravir as an integrase strand transfer inhibitor (INSTI) with a high resistance barrier and lenacapavir as a novel capsid inhibitor lacking cross-resistance to other classes—provide a compelling example of how synergistic drug pairing can enhance treatment durability without overlapping resistance risks, potentially addressing adherence challenges in long-term HIV care.

Switch Study Design Mirrors Real-World Needs

ARTISTRY-2 was structured as a multicenter, double-blind, randomized Phase 3 study specifically targeting virologically suppressed adults with HIV who were stable on BIKTARVY, the fixed-dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF). Participants were randomized 2:1 to switch to the once-daily BIC LEN HIV regimen tablet or remain on BIKTARVY, with evaluations conducted over 48 weeks to assess both efficacy and safety endpoints, including changes in CD4 cell counts and adverse event monitoring. This design builds on the established role of bictegravir within global HIV guidelines as a preferred INSTI component, while integrating lenacapavir’s multi-stage inhibition of HIV replication, which differentiates it from conventional antiretrovirals by targeting the viral capsid without known cross-resistance. The trial’s focus on switch patients reflects real-world scenarios in Health Economics and Outcomes Research (HEOR), where regimen simplification can influence patient retention and cost-effectiveness, and its results complement those from ARTISTRY-1, which evaluated the BIC LEN HIV regimen against multi-tablet regimens in treatment-naïve individuals, collectively strengthening the evidence base for regulatory review.

Streamlining Care for Economic Gains

The ARTISTRY-2 findings introduce a simplified, single-tablet option that could improve adherence and long-term outcomes in virologically suppressed HIV populations, thereby reducing healthcare resource utilization associated with viral rebound or resistance development. In reimbursement contexts, the BIC LEN HIV regimen‘s non-inferiority to guideline-recommended therapies like BIKTARVY positions it as a viable contender for formulary inclusion, particularly if pricing strategies leverage lenacapavir’s established approvals in pre-exposure prophylaxis and multidrug-resistant HIV settings to demonstrate value.

As the HIV treatment options evolve toward long-acting and patient-centered regimens, this regimen could enhance equity in treatment access, especially in low- and middle-income countries where Gilead’s global initiatives aim to address barriers. Reflecting on industry trends, such innovations align with efforts to transition HIV from a chronic burden to a preventable condition, potentially lowering lifetime costs through sustained suppression and fewer interventions, while regulatory approvals could spur competitive pricing models to broaden reimbursement coverage.