Merck Reports Positive Phase 3 Results for Two-Drug HIV Regimen Doravirine/Islatravir
Reuters
Nov 19
Merck Reports Positive Phase 3 Results for Two-Drug HIV Regimen Doravirine/Islatravir
Merck & Co. Inc. has announced positive topline results from a pivotal Phase 3 clinical trial evaluating its investigational, once-daily, oral two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in treatment-naïve adults with HIV-1 infection. The study demonstrated that DOR/ISL met the primary efficacy endpoint, showing non-inferiority to the three-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in achieving HIV-1 RNA levels below 50 copies/mL at Week 48. The safety profile of DOR/ISL was reported as comparable to BIC/FTC/TAF. Merck stated that detailed findings from the trial will be presented at a future scientific congress. The U.S. Food and Drug Administration has accepted the New Drug Application for DOR/ISL, with a target action date of April 28, 2026.
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