Merck Plans Regulatory Submission For Two-Drug Regime For HIV Infection By Mid-2025

On Wednesday, Merck & Co Inc 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.

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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.

Price Action: MRK stock is down 0.65% at $94.11 at the last check Wednesday.

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Photo Courtesy of Merck