FOSTER CITY, Calif.--(BUSINESS WIRE)-- #CROI2026--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of new Phase 3 ARTISTRY-1 and ARTISTRY-2 trial data at CROI 2026 showing a treatment switch to an investigational, single-tablet combination regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) was effective in people living with HIV with virological suppression, including those switching from complex multi-tablet regimens or a global guideline-recommended single-tablet regimen. The n. ...

Core Insights - Gilead Sciences Inc. announced topline results from the Phase 3 ARTISTRY-1 trial, which evaluated the efficacy of a single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) for HIV patients who are virologically suppressed [1][2] - The trial demonstrated that the BIC/LEN regimen met the primary success criterion for non-inferiority compared to baseline multi-tablet antiretroviral therapy [2] - BIC/LEN was generally well tolerated, with no significant safety concerns identified during the trial [2] Trial Details - ARTISTRY-1 is a multicenter Phase 2/3 clinical trial comparing the once-daily combination of bictegravir and lenacapavir against current therapies for HIV patients on complex regimens [3] - Participants were randomized in a 2:1 ratio to receive either the BIC/LEN combination or continue their stable baseline regimen [4] - Key secondary endpoints included virologic suppression rates, changes in CD4 cell count, and treatment-emergent adverse events (TEAEs) at week 48 [4] Future Evaluations - Further evaluation of the BIC/LEN combination is ongoing in the double-blind Phase 3 ARTISTRY-2 trial, which is assessing the safety and efficacy of switching from BIKTARVY to BIC/LEN in virologically suppressed HIV-1 patients [5] - Topline data for the primary endpoint of ARTISTRY-2 is expected before the end of the year [5] Market Reaction - Following the announcement, Gilead's stock price increased by 2.97%, reaching $127.07 [6]