Phase III C-EDGE CO-STAR trial of elbasvir + grazoprevir shows success in hepatitis C patients who receive opioid agonist therapy- Merck

Merck announced the presentation of results from the company’s Phase III C-EDGE CO-STAR clinical trial evaluating the efficacy and safety of the investigational once-daily tablet elbasvir/grazoprevir (50mg/100mg) in patients with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6 infection who inject drugs and are receiving opioid agonist therapy (OAT). Ninety-five percent (189/198) of patients treated with elbasvir/grazoprevir for 12 weeks in the pre-specified primary efficacy analysis population achieved sustained virologic response 12 weeks after the completion of treatment (SVR12, considered virologic cure). Adherence to treatment was high, with 97% of patients taking at least 95% of their study medication over the 12 weeks of therapy. These findings were featured at the American Association for the Study of Liver Diseases and presented in an oral session on 15 November (Abstract #40).

Comment: The trial data from C-EDGE CO-STAR showed that the combination was able to cure the vast majority of hepatitis C patients who also had compensated liver cirrhosis, a traditionally difficult-to-treat population.