Merck's New HIV Treatment Works As Well As Top Drug In Late Trials

Core Insights - The pharmaceutical industry is advancing innovative treatments for chronic disease management, with Merck & Co. Inc. announcing new data from Phase 3 studies on the two-drug regimen of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed HIV-1 infection [1] Group 1: Study Findings - The MK-8591A-052 trial showed that DOR/ISL maintained viral suppression and was non-inferior to the three-drug regimen BIC/FTC/TAF, with no treatment-emergent resistance observed [3] - In the MK-8591A-052 trial, participants switching to DOR/ISL experienced minimal weight changes at Week 48, with a mean weight change of -0.03 kg compared to +0.28 kg for BIC/FTC/TAF [4] - The percentage of participants experiencing significant weight gain (≥5% and ≥10%) was lower in the DOR/ISL group compared to the BIC/FTC/TAF group [4] Group 2: Body Composition and Lipid Changes - Changes in lean body mass, peripheral fat, trunk fat, body mass index, and waist-to-hip ratio were small and comparable between DOR/ISL and BIC/FTC/TAF treatment groups [5] - Minimal changes in fasting lipids were observed across both trials, with no substantial differences between DOR/ISL and comparator groups [6] - Less than 5% of participants with type 2 diabetes modified their medication across treatment groups, indicating stability in diabetic management [6] Group 3: Regulatory and Market Impact - The FDA has accepted the New Drug Application for DOR/ISL, with a target action date set for April 28, 2026 [7] - At the time of publication, Merck & Co shares were down 0.96% at $83.89 [7]