Gilead Prepares Regulatory Filing for Single-Tablet HIV Regimen

Gilead Sciences is preparing to seek regulatory approval for its new single-tablet HIV regimen after the Phase II/III ARTISTRY-1 trial met its primary endpoint. The study evaluated adults with virologically suppressed HIV who switched from multi-tablet therapy to a once-daily pill containing bictegravir and lenacapavir (BIC/LEN). Results showed the single pill was non-inferior to multi-tablet regimens, with no new safety concerns and strong viral suppression at week 48.

Patients in the trial were previously taking between two and 11 pills daily, making the simplified regimen a meaningful advancement for adherence and quality of life. ARTISTRY-2, a double-blind study comparing BIC/LEN with Biktarvy, is also underway with data expected in 2025.

Gilead continues expanding its HIV leadership through long-acting and convenient treatments, including a once-weekly regimen with MSD and the twice-yearly PrEP therapy Yeztugo, which showed 99.9% efficacy and received FDA approval in 2025.

17-11-2025