Lancet

CROI 2026: Simpler HIV regimen matches complex therapy in global phase 3 trial

February 26, 2026

In the phase 3 ARTISTRY‑1 trial (NCT05502341), 557 virologically suppressed adults (median age, 60 years; median 28 years on ART) taking 2 to 11 pills daily were randomized 2:1 to switch to once‑daily bictegravir–lenacapavir (BIC/LEN) or continue their complex regimen. At week 48, only 1% in each group had viral load ≥50 copies/mL, meeting non‑inferiority, with no emergent resistance and similar adverse‑event rates; treatment satisfaction improved after switching. These findings will be presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2026. Additional clinical trials are underway to confirm the long-term safety and effectiveness of the BIC/LEN combination tablet.

Source:

Orkin C, et al. (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://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00307-7/fulltext