Merck announces positive data from Phase 3 trials that show the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir (DOR/ISL) maintained HIV-1 viral suppression at week 48
Merck announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50mg/200mg/25mg)] in trial MK-8591A-052 ) or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051. In both trials, DOR/ISL met the primary efficacy success criterion for non-inferiority to comparator antiretroviral therapies and primary safety objectives at Week 48. The findings were shared in late-breaking oral presentations at the 32nd Conference on Retroviruses and Opportunistic Infections (CROI). Merck plans to begin submitting applications for marketing authorization to regulatory agencies by mid-2025.
Read the full company press release here.
SEE ALSO:
- aidsmap: Studies confirm non-inferiority of doravirine / islatravir to standard HIV treatment
- Life4me+: New oral islatravir/doravirine regimen shows strong results in two Phase 3 studies
- Contagion Live: Doravirine and islatravir combination shown to be noninferior to once-daily ART
Source : Merck
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