Gilead’s Investigational Single-Tablet Regimen of Bictegravir and Lenacapavir for HIV-1 Treatment Meets Primary Endpoint in Phase 3 ARTISTRY-1 Trial

Gilead Sciences announced positive topline results from the Phase 3 ARTISTRY-1 trial, which evaluated switching virologically suppressed adults with HIV from multi-tablet regimens to an investigational single-tablet regimen combining bictegravir (75 mg) and lenacapavir (50 mg). The new regimen met the primary endpoint of non-inferiority at Week 48, with HIV-1 RNA ≥50 copies/mL assessed by the FDA snapshot algorithm. It was generally well tolerated, with no new safety concerns.
The trial addresses a key unmet need for people on complex regimens who face high pill burden, adherence challenges, and reduced quality of life. At baseline, participants were taking 2–11 pills daily, with ~40% dosing more than once per day. A single-tablet option could simplify treatment and improve outcomes.
ARTISTRY-1 is a Phase 2/3 multicenter study; Phase 3 randomized participants 2:1 to BIC/LEN or their existing regimen. Secondary endpoints included virologic suppression (<50 copies/mL), CD4 count changes, and treatment-emergent adverse events.
Further evaluation is ongoing in ARTISTRY-2, a double-blind Phase 3 trial comparing BIC/LEN to BIKTARVY® in virologically suppressed individuals, with topline data expected later this year. Bictegravir and lenacapavir in combination remain investigational and are not yet approved globally.

Additional information to the following link: Gilead’s Investigational Single Tablet Regimen of Bictegravir and Lenacapavir for HIV 1 Treatment Meets Primary Endpoint in Phase 3 ARTISTRY 1 Trial