Gilead Sciences and Merck announced positive topline results from two Phase 3 trials of islatravir/lenacapavir, an investigational oral regimen taken once weekly as a single tablet. If approved, it would be the first long-acting oral HIV treatment dosed weekly — an alternative to daily pills for the tens of millions of people living with HIV.
In the double-blind ISLEND-1 trial, the once-weekly regimen was statistically non-inferior to Biktarvy, the leading single-tablet daily treatment, at keeping HIV-1 RNA under 50 copies/mL at week 48. In the open-label ISLEND-2 trial, it was non-inferior to standard-of-care daily antiretroviral therapy. The safety profile was generally comparable to the comparators, with no new safety concerns, the companies said. Gilead and Merck plan to file the data with regulatory authorities globally.
The results land as long-acting formulations reshape HIV care: twice-yearly injectable lenacapavir is already approved for prevention, and a weekly pill could extend that flexibility to treatment. "Long-acting oral therapies represent a new wave of transformational innovation," said Jared Baeten, head of clinical development for virology at Gilead. The news also reframes the prevention landscape: Science reported this week that as the weekly pill nears the market, the leading HIV vaccine candidates face a setback — a trial of the antibodies vaccines aim to trigger failed.
