Phase III trials of Zepatier (elbasvir and grazoprevir) in hepatitis C shows efficacy in different patient subgroups- Merck

Merck has announced the presentation of results from two Phase III clinical trials evaluating Zepatier (elbasvir and grazoprevir) 50mg/100mg tablets in chronic hepatitis C (HCV) patients with inherited blood disorders (C-EDGE IBLD) and in patients with a history of intravenous drug use who are receiving opioid agonist therapy (C-EDGE CO-STAR), respectively. Results from C-EDGE IBLD demonstrated high rates of sustained virologic response (SVR) 12 weeks after the completion of treatment and a safety profile consistent with that observed in prior studies. The most common (greater than 10%) adverse events (AEs) among patients receiving Zepatier for 12 weeks in C-EDGE IBLD, compared with those receiving placebo, were headache (21%, 12%) and fatigue (17%, 8%).

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. The SVR24 data confirm the C-EDGE CO-STAR SVR12 results unveiled in November 2015. An analysis of AEs during the initial treatment period and first two weeks of follow-up showed the most common AEs among patients receiving blinded Zepatier or placebo were fatigue (16%, 20%), headache (13%, 14%), nausea (11%, 9%) and diarrhea (10%, 9%), respectively.

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.