Zepatier grazoprevir/elbasvir: Phase III data
Top-line data from the open-label, international Phase III C-EDGE Head-to-Head trial in 255 treatment-naive and treatment-experienced patients with chronic HCV genotypes 1 or 4 infection showed that once-daily oral Zepatier 50 mg elbasvir/100 mg grazoprevir for 12 weeks met the primary endpoint of a greater proportion of patients achieving an SVR 12 weeks after the end of treatment vs. Sovaldi sofosbuvir plus PegIntron peginterferon alfa-2b and Rebetol ribavirin for 12 weeks (99% vs. 90%). In patients with chronic HCV genotypes 1a (n=35), 1b (n=209) and 4 infection (n=11), Zepatier led to SVR12 rates of 100%, 99% and 100%, respectively, vs. 100%, 90% and 60% for Sovaldi plus PegIntron and Rebetol. There were no virologic failures in the Zepatier arm vs. 11 in the Sovaldi arm. Additionally, Zepatier led to >=1 Tier 1 adverse event, a secondary endpoint, in 1% of patients vs. 28% of patients in the Sovaldi arm. Tier 1 adverse events included serious treatment-related adverse events, discontinuations due to serious treatment-related adverse events, a neutrophil count of <7.5 x 108/L and a hemoglobin level of <10 g/dL. No patients discontinued Zepatier due to serious treatment-related adverse events vs. 1 patient receiving Sovaldi plus PegIntron and Rebetol. Data were presented at the European Association for the Study of the Liver meeting in Barcelona. ...