Gilead and Merck report positive Phase 3 results for once-weekly islatravir/lenacapavir HIV treatment

Gilead and Merck reported positive topline results from two Phase 3 studies of once-weekly oral islatravir/lenacapavir for HIV-1. In ISLEND-1, a double-blind study, the regimen was statistically non-inferior to continuing Biktarvy, and in the open-label ISLEND-2 it was non-inferior to standard daily regimens, both measured by HIV-1 RNA at week 48. The companies plan to file the data with regulators globally and present full results at a future scientific congress.

• ISLEND-1: switch from Biktarvy, double-blind, non-inferior
• ISLEND-2: open-label versus standard daily regimens, non-inferior
• Primary endpoint: HIV-1 RNA of 50 copies/mL or more at week 48
• Global regulatory filings planned; full data to come