Lancet
CROI 2026: Investigational once-daily bictegravir/lenacapavir maintains HIV suppression in phase 3 trial
Presented at the 2026 Conference on Retroviruses and Opportunistic Infections, phase 2/3 data from ARTISTRY‑1 (NCT05502341) and ARTISTRY‑2 (NCT06333808) show that the investigational single‑tablet regimen bictegravir + lenacapavir (BIC/LEN) yielded efficacy comparable to both bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and complex multi‑tablet regimens. At Week 48 in ARTISTRY‑1, HIV‑1 RNA ≥50 copies/mL occurred in 0.8% on BIC/LEN vs. 1.1% on complex regimens, with stable CD4 counts, no emergent resistance, improved fasting lipids (median total cholesterol –15 mg/dL vs. +2 mg/dL), and higher treatment satisfaction (+7 HIVTSQs points). ARTISTRY‑2 results similarly showed BIC/LEN was noninferior to B/F/TAF, with stable CD4 counts and comparable resistance profiles.
Sources:
Orkin C, et al; ARTISTRY-1 Study Group. (2026, February 25), Lancet. Switch to single-tablet bictegravir-lenacapavir from a complex HIV regimen (ARTISTRY-1): a randomised, open-label, phase 3 clinical trial. https://pubmed.ncbi.nlm.nih.gov/41763229/
(2026, February 25). Gilead. Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy [News release]. https://www.gilead.com/news/news-details/2026/gileads-single-tablet-regimen-of-bictegravir-and-lenacapavir-maintained-virological-suppression-in-people-with-hiv-who-switched-antiretroviral-therapy