- DOR/ISL is a two-drug regimen for HIV-1 treatment.
- Phase 3 trials show non-inferiority to BIC/FTC/TAF at Week 48.
- DOR/ISL maintains virologic suppression at Week 96.
- Adverse events were similar between DOR/ISL and BIC/FTC/TAF.
Introduction
Merck has announced results from three Phase 3 trials evaluating the investigational HIV-1 treatment regimen, doravirine/islatravir (DOR/ISL), at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Denver.
Trial Results
DOR/ISL, a once-daily, oral two-drug regimen, demonstrated non-inferiority to the BIC/FTC/TAF regimen in treatment-naïve adults with HIV-1 at Week 48. The primary efficacy endpoint was the percentage of participants achieving viral suppression, with DOR/ISL achieving 91.8% compared to 90.6% for BIC/FTC/TAF.
Virologic Suppression
In adults with virologically suppressed HIV-1 who switched from other oral antiretroviral therapies, including BIC/FTC/TAF, DOR/ISL maintained virologic suppression at Week 96.
Safety Profile
The safety profile of DOR/ISL was similar to that of BIC/FTC/TAF, with drug-related adverse events occurring in 14% of DOR/ISL participants and 18% of BIC/FTC/TAF participants. Discontinuations due to drug-related adverse events were 1.1% for DOR/ISL and 2.2% for BIC/FTC/TAF.
