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HCV Combo Therapy Demonstrates Antiviral Activity in Hard-to-Cure Patients

MK-5172/MK-8742 shows promise in mid-stage trial

Positive results have been reported from the ongoing C-WORTHy study, a phase II clinical trial evaluating the efficacy and safety of an all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor (Merck), in patients with chronic HCV genotype 1 (GT1) infection.

The C-WORTHy trial is a randomized, dose-responsive, parallel-group, double-blind study comparing different patient populations exposed to different durations of treatment with MK-5172 (100 mg once daily) in combination with MK-8742 (50 mg once daily) with or without ribavirin (RBV) in subjects with chronic HCV infection. A total of 471 patients with chronic HCV GT1 infection and HCV RNA levels of = 10,000 IU/mL were enrolled into the study.

The participants included the following hard-to-cure subpopulations: treatment-naïve patients with liver cirrhosis (12- and 18-week arms, with and without RBV); prior null responders with and without cirrhosis (12- and 18-week arms, with and without RBV); and patients with human immunodeficiency virus (HIV)/HCV co-infection (12-week arms).

An interim analysis of hard-to-cure patients treated with MK-5172/MK-8742, with and without RBV, for 12 or 18 weeks showed a sustained viral response (SVR) at 4 to 8 weeks after the completion of therapy. SVR was achieved by:

  • 97% (28/29) of HCV GT1-infected, treatment-naïve cirrhotic patients treated with MK-5172/MK-8742 for 12 weeks and 97% (29/30) of patients treated for 18 weeks.
  • 90% (28/31) of HCV GT1-infected, treatment-naïve cirrhotic patients treated with MK-5172/MK-8742 plus RBV for 12 weeks and 97% (30/31) of patients treated for 18 weeks.
  • 91% (30/33) of HCV GT1-infected prior null responders (with or without cirrhosis) treated with MK-5172/MK-8742 for 12 weeks and 97% (29/30) of patients treated for 18 weeks.
  • 94% (30/32) of HCV GT1-infected prior null responders (with or without cirrhosis) treated with MK-5172/MK-8742 plus RBV for 12 weeks and 100% (32/32) of patients treated for 18 weeks.
  • 90% (26/29) of treatment-naïve, non-cirrhotic patients with HIV/HCV co-infection treated with MK-5172/MK-8742 for 12 weeks.
  • 97% (28/29) of treatment-naïve, non-cirrhotic patients with HIV/HCV co-infection treated with MK-5172/MK-8742 plus RBV for 12 weeks.

These data were presented at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL), held April 9–13 in London.

Based on the results of the phase II clinical program, Merck has initiated phase III trials of MK-5172/MK-8742. The phase III program, called C-EDGE, will evaluate the safety and efficacy of MK-5172/MK-8742 with and without RBV in various genotypes and across a broad range of patient populations with chronic HCV.

Study cohorts will include: C-EDGE TN (GT1, GT4–6; treatment-naïve, with or without cirrhosis); C-EDGE CO-INFXN (GT1, GT4–6; treatment-naïve, with or without cirrhosis, with HIV/HCV co-infection); C-EDGE RECOVERY (GT1, GT4–6; treatment-naïve, with or without cirrhosis, with or without HIV/HCV co-infection, on opiate-substitution therapy); and C-EDGE TE (GT1, GT4–6; prior failed treatment with peginterferon/RBV; with or without HIV/HCV co-infection).

Source: Merck; April 11, 2014.

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