Bictegravir-Lenacapavir: Further Study Insights on the Investigative HIV Therapy

During the CROI conference this week, investigators presented data around ARTISTRY-2, a comparator trial that studied bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), [brand name Biktarvy] vs bictegravir/lenacapavir (BIC/LEN) (75/50 mg), which is a late-stage, investigational HIV therapy, in adults with HIV who were virological suppressed.¹

The study met its primary end point, showing that switching to BIC/LEN was statistically noninferior to continuing B/F/TAF in maintaining viral suppression at week 48.¹

“The fact that BIC/LEN in this randomized trial was noninferior to Biktarvy was very promising, and shows the potential of this investigational regimen,” said study investigator Eric Meissner, MD, PhD, associate professor, director of HIV and hepatitis patient care and research, Medical University of South Carolina.

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.²

Trial Specifics

ARTISTRY-2 is a phase 3, double-blind, multicenter study and enrolled adults who were randomized 2:1 to switch to once-daily oral bictegravir/lenacapavir (75/50 mg) or to continue B/F/TAF. The primary endpoint assessed the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA Snapshot algorithm, with a noninferiority margin of 4%.

Meissner said the investigational regimen was generally well tolerated, with no significant or new safety concerns identified during the trial.

“There were no serious, drug-related adverse events reported, and discontinuations due to the adverse events were low in both groups,” Meissner said. “The safety and tolerability profile of BIC/LEN was quite comparable to Biktarvy.”

In addition, he said other important takeaways were that weight and body mass index did not change over time as well as the CD4 count over the course of the 48 weeks.

Gilead, BIC/LEN’s manufacturer, plans to file the phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials with regulatory authorities for approval.³

“If BIC/LEN does get approved, it would be great to have another single-tablet regimen available to persons to help manage their HIV infection,” Meissner said.

References

1.Meissner E et al.Phase 3 Efficacy and Safety of Switch from B/F/TAF to Single-Tablet BIC/LEN in ARTISTRY-2. Oral abstract. Presented at CROI 2026. February 22-25, 2026. Denver CO.

2.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 February 26, 2026.
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

3.Gilead’s investigational single-tablet regimen of bictegravir and lenacapavir for HIV-1 treatment meets primary endpoint in phase 3 ARTISTRY-1 trial. News release. Gilead Sciences. November 13, 2025. Accessed February 26, 2026. 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