On Wednesday, Merck & Co Inc (NYSE:MRK) announced the presentation of results from two Phase 3 trials of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection that is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei (BIC/FTC/TAF) in trial MK-8591A-052) or 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 company released the topline data from both studies in December 2024.
Merck plans to begin submitting applications for marketing authorization to regulatory agencies by mid-2025.
In the trial MK-8591A-052, results for the primary endpoint (HIV-1 RNA ≥50 copies/mL) showed that 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF.
At Week 48, 91.5% of participants who switched to DOR/ISL maintained viral suppression (HIV-1 RNA <50 copies/mL) compared to 94.2% of participants who continued receiving BIC/FTC/TAF.
In the trial MK-8591A-051, results for the primary endpoint showed that 1.4% of participants who received DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 4.9% on bART.
At Week 48, 95.6% of participants who switched to DOR/ISL maintained viral suppression (HIV-1 RNA <50 copies/mL) compared to 91.9% of participants who continued on bART.
https://finance.yahoo.com/news/merck-plans-regulatory-submission-two-173037785.html
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