The relentless pursuit of innovative treatments in the pharmaceutical industry continues to reshape the landscape of chronic disease management. Merck & Co. Inc. (NYSE:MRK) on Wednesday announced additional data from two Phase 3 studies of a two-drug regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection.In the MK-8591A-052 trial, the suppression was on bictegravir/emtricitabine/tenofovir alafenamidei (BIC/FTC/TAF) and baseline antiretroviral therapy (bART) in tri ...

Oct 15, 2025 6:45 AM Eastern Daylight Time Merck Announces New Data from Phase 3 Trials Evaluating the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) in Adults with Virologically Suppressed HIV-1 Infection Share DOR/ISL data presented show minimal changes in weight and body composition and no clinically meaningful effect on fasting lipids and the homeostatic model assessment of insulin resistance (HOMA- IR) across clinical trials In the double-blind trial MK-8591A-052 ...

Core Insights - Merck (MRK) has received FDA acceptance for the new drug application (NDA) for its investigational two-drug regimen doravirine/islatravir (DOR/ISL) aimed at treating virologically suppressed adults with HIV-1 infection, with a decision expected by April 28, 2026 [1][7] Drug Efficacy and Studies - If approved, DOR/ISL would be the first non-integrase inhibitor-based two-drug regimen demonstrating comparable efficacy and safety to the current three-drug standard, BIC/FTC/TAF, in phase III studies [2] - The NDA is supported by data from two pivotal phase III studies (MK-8591A-051 and MK-8591A-052), which showed that DOR/ISL (100 mg/0.25 mg) was non-inferior to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 [3] Ongoing Research and Collaborations - Merck is continuing its HIV research with additional trials, including MK-8591A-053 and MK-8591A-054, which evaluate DOR/ISL in treatment-naïve individuals and those from earlier studies, respectively [9][10] - The company is collaborating with Gilead Sciences (GILD) to evaluate islatravir in combination with GILD's lenacapavir in a phase II study for HIV treatment [10] Stock Performance - Year to date, Merck's shares have decreased by 15.5%, contrasting with a 0.2% rise in the industry [4]