Biopharmaceutical company Merck (NYSE: MRK), known as MSD outside the US and Canada, on Wednesday announced positive results from two Phase 3 trials evaluating its investigational HIV treatment, doravirine/islatravir (DOR/ISL).

The once-daily, oral, two-drug regimen demonstrated non-inferiority to existing antiretroviral therapies in maintaining viral suppression at Week 48.

Data from trials MK-8591A-052 and MK-8591A-051 showed that DOR/ISL maintained HIV-1 viral suppression in adults previously treated with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or other baseline antiretroviral therapy (bART). The regimen also exhibited a safety profile comparable to the standard treatments, with no cases of treatment-emergent resistance to DOR or ISL observed.

Merck plans to submit applications for regulatory approval by mid-2025. The findings were presented at the 32nd Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco.