Gilead Reports Positive Phase 3 Results For Bictegravir/ Lenacapavir Single-tablet Regimen For HIV

(RTTNews) - Gilead Sciences, Inc. (GILD) on Thursday announced positive topline results from its Phase 3 ARTISTRY-1 trial evaluating the company's single-tablet regimen of bictegravir and lenacapavir (BIC/LEN) for the treatment of HIV.

Phase 2/3 ARTISTRY-1 study compared the combination of bictegravir and lenacapavir against current multi-tablet therapies in people with HIV who are virologically suppressed on complex regimens.

The trial met its primary endpoint, demonstrating that BIC/LEN was statistically non-inferior in efficacy to multi-tablet regimens. The regimen was generally well tolerated, with no new or significant safety concerns observed.

Gilead said it plans to file the Phase 3 data from the ARTISTRY trials with regulatory authorities.