Glecaprevir/pibrentasvir: Additional Ph III ENDURANCE-3 data

Data from 233 treatment-naïve, non-cirrhotic patients with chronic HCV genotype 3 infection in the open-label, international Phase III ENDURANCE-3 trial showed that once-daily 300/120 mg oral glecaprevir/pibrentasvir for 12 weeks led to an SVR 12 weeks after the end of treatment in 95% of patients. The trial enrolled 505 patients with chronic HCV genotype 3 infection to receive glecaprevir/pibrentasvir for 8 (n=157) or 12 (n=233) weeks or Sovaldi sofosbuvir plus Daklinza daclatasvir for 12 weeks (n=115). The 12-week regimen of glecaprevir/pibrentasvir was also non-inferior to Sovaldi plus Daklinza in SVR12 rate (95% vs. 97%). Glecaprevir/pibrentasvir for 8 and 12 weeks led to virologic failure rates of 3.8% and 1.7%, respectively, vs. 0.8% for Sovaldi plus Daklinza. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. The partners previously reported that the 8-week regimen of glecaprevir/pibrentasvir led to an SVR12 rate of 95% (see BioCentury Nov. 28, 2016)...