August 8, 2016
Merck has announced the publication of results from C-EDGE CO-STAR, which is a Phase 3 trial evaluating the use of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets in patients with chronic hepatitis C (HCV) genotype (GT) 1, GT4 and GT6 infection who receive opioid agonist therapy (OAT) (methadone and buprenorphine) that is normally used for the treatment of opioid addiction. The results were recently published online in the Annals of Internal Medicine, which indicated that treatment with 12 weeks of ZEPATIER resulted in high rates of sustained virologic response 12 weeks after the completion of therapy (SVR12, considered virologic cure based on undetectable HCV RNA levels).
Dr. Alain Litwin, professor of medicine and psychiatry and behavioral sciences at Albert Einstein College of Medicine, New York, said: “C-EDGE CO-STAR is the first phase 3 clinical trial dedicated to evaluating direct-acting antiviral therapy for chronic hepatitis C infection in patients on opioid agonist therapy without excluding patients actively using drugs with high abuse potential. This study demonstrates that people who inject drugs can be effectively treated with direct-acting antiviral therapy.”
“Merck continues to take a leadership role in exploring the potential to treat chronic hepatitis C infection in underserved and undertreated patient populations, including those who continue to use illicit drugs. These findings contribute to the robust body of evidence supporting the efficacy and safety profile of ZEPATIER in a broad range of patients with chronic hepatitis C genotype 1 or genotype 4 infection,” said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories.