Gilead, Merck Report Weekly HIV Trial Results

Gilead Sciences and Merck reported positive Phase 3 results for a once-weekly, two-drug HIV regimen of islatravir and lenacapavir, showing non-inferiority to both Gilead’s daily Biktarvy and standard daily regimens through Week 48. The ISLEND-1 and ISLEND-2 trials demonstrated that the weekly combination maintained viral suppression in participants previously virologically controlled, with viral-load thresholds at or below the 50 copies/mL mark. The tested formulation used a 2 mg dose of islatravir with a 300 mg dose of lenacapavir in a single tablet, and the safety profiles were generally comparable to existing options, with no new safety concerns identified. Analysts noted the regimen could address adherence challenges by replacing daily dosing with a weekly option, potentially broadening treatment options for diverse patient needs. Data from the trials will support regulatory submissions and are slated for presentation at AIDS 2026, signaling a potential shift in standard HIV therapy if approved. Overall, the results position ISL/LEN as a leading candidate for the world’s first complete weekly oral HIV treatment.