Gilead and Merck report positive Phase 3 ISLEND-1 and ISLEND-2 results for once-weekly HIV pill

Gilead and Merck said both Phase 3 ISLEND trials of once-weekly oral islatravir plus lenacapavir met their Week 48 primary endpoint. In ISLEND-1 the combination was non-inferior to Biktarvy in patients switching from it, and in ISLEND-2 it was non-inferior to standard daily regimens. The companies plan global filings, and the regimen remains investigational.

• ISLEND-1 (double-blind): non-inferior to Biktarvy in virologically suppressed patients
• ISLEND-2 (open-label): non-inferior to daily standard-of-care regimens
• Primary endpoint: HIV-1 RNA at or above 50 copies/mL at Week 48 (FDA snapshot)
• Global regulatory filings planned; no new safety concerns reported