Merck announces results from Phase III studies of Zepatier in chronic hepatitis C patient populations

Data from these additional Phase III studies were presented at The International Liver Congress 2016.

Results from C-EDGE IBLD demonstrated high rates of sustained virologic response (SVR) 12 weeks after the completion of treatment (SVR12, considered virologic cure) and a safety profile consistent with that observed in prior studies (abstract #SAT-128). Findings from C-EDGE CO-STAR showed a high rate of SVR 24 weeks after completion of treatment (SVR24) for the baseline chronic HCV infection and provided insights into the incidence of reinfection in this high risk population (abstract #SAT-163). The SVR24 data confirm the C-EDGE CO-STAR SVR12 results unveiled at The Liver Meeting in November 2015. Zepatier – Merck’s once-daily, fixed-dose combination tablet indicated with or without ribavirin (RBV) for the treatment of chronic HCV genotype (GT) 1 or GT4 infection in adults – was approved by the FDA in January 2016, based in part on prior studies from the Phase III program. Data from these additional Phase III studies were presented at The International Liver Congress 2016 (ILC).

“To reduce the global burden and potential spread of chronic hepatitis C, it is important that we develop evidence about meaningful options for those patients for whom treatment may be challenging,” said Dr Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “These data from Merck’s broad clinical development program underscore the company’s commitment to evaluating Zepatier in historically underserved and understudied chronic hepatitis C populations, such as patients with inherited blood disorders or those receiving opioid agonist therapy.”