Merck announced additional data from the ongoing Phase 2 C-WORTHy study evaluating the efficacy and safety of MK-5172, a hepatitis C virus (HCV) NS3/4A protease inhibitor and MK-8742, a HCV NS5A replication complex inhibitor in patients with chronic HCV genotype 1 (GT1) infection.
C-WORTHy is a two-part, parallel-group, randomized, clinical trial evaluating a range of subpopulations of patients with HCV GT1 infection. The study evaluated different treatment durations of MK-5172 (100mg once daily) plus MK-8742 (50mg once daily), with or without ribavirin. A total of 471 patients with HCV GT1 RNA levels of ≥10,000 IU/mL were enrolled in C-WORTHy across 16 arms.
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In an interim analysis of treatment-naïve, non-cirrhotic patients administered a 12-week regimen of MK-5172/MK-8742, with and without ribavirin (RBV), a sustained viral response (SVR) was observed in 98% (42/43) of patients administered MK-5172/MK-8742 alone, 94% (75/80) in those administered MK-5172/MK-8742 plus RBV for 12 weeks and 83% in those administered MK-5172/MK-8742 plus RBV for 8 weeks.
Merck is also evaluating SVR24 in a Phase 2 study of MK-5172 once daily with peginterferon alfa-2b and ribavirin (PR, weekly) in treatment-naïve, non-cirrhotic patients with GT1 infection.
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