Merck Reports Positive Phase 3 Trial Results for HIV-1 Treatment DOR/ISL
- DOR/ISL met primary efficacy and safety objectives in a Phase 3 trial for HIV-1 treatment-naïve adults.
- The FDA set a target action date of April 28, 2026, for the DOR/ISL New Drug Application.
- Participants in the trial were randomized 1:1 to DOR/ISL or BIC/FTC/TAF regimens.
- Islatravir is under evaluation in multiple clinical trials for potential daily and weekly HIV-1 treatments.
Trial Results
Merck announced positive topline results from a Phase 3 trial of the investigational DOR/ISL regimen in treatment-naïve adults with HIV-1. The trial demonstrated that DOR/ISL is non-inferior to the BIC/FTC/TAF regimen in terms of efficacy and safety, meeting the primary objectives.
FDA Application
The U.S. FDA has accepted the New Drug Application for DOR/ISL, targeting a decision by April 28, 2026. This application aims to replace current antiretroviral regimens for virologically-suppressed adults.
Trial Design
The Phase 3 trial, MK-8591A-053, involved 537 participants randomized 1:1 to receive either DOR/ISL or BIC/FTC/TAF. The study will continue through Week 144, with a readout planned at Week 96. Eligible participants may continue in an open-label extension until Week 240 or until DOR/ISL becomes commercially available.
Islatravir Research
Islatravir, a nucleoside reverse transcriptase translocation inhibitor, is under evaluation in various clinical trials for potential daily and weekly HIV-1 treatments. It serves as the anchor medicine in these regimens due to its potency and resistance profile.
Source: Merck