07:37 AM EST, 11/19/2025 (MT Newswires) -- Merck ( MRK ) said Wednesday the pivotal phase 3 trial of its investigational regimen of doravirine/islatravir in treatment-naive adults with HIV-1 infection met its success criterion of primary efficacy.

Trial topline results showed the non-inferiority of the drug and a comparable safety profile to once-daily oral bictegravir/emtricitabine/tenofovir alafenamide, Merck ( MRK ) said.

The US Food and Drug Administration accepted the New Drug Application of doravirine/islatravir for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen and has set a target action date of April 28, 2026, for the application, the company said.

The company added that it is planning to present detailed findings from the trial at a future scientific congress.