Glecaprevir/pibrentasvir: Ph III CERTAIN-1 data
Top-line data from 181 patients with chronic HCV genotype 1 infection without cirrhosis not previously treated with DAAs in the first part of the open-label, Japanese Phase III CERTAIN-1 trial showed that once-daily 300/120 mg oral glecaprevir/pibrentasvir for 8 weeks met the primary endpoint of non-inferiority to a 12-week regimen of Viekirax ombitasvir/paritaprevir/ritonavir in SVR12 rate. Specifically, glecaprevir/pibrentasvir led to SVR12 rates of 99% in patients without the Y93H HCV variant (n=106) and 100% in patients with the Y93H HCV variant (n=23) vs. 100% for Viekirax (n=52). The second part of the trial is evaluating glecaprevir/pibrentasvir in patients with chronic HCV genotypes 1-6 infection with specific treatment challenges, including compensated cirrhosis, chronic kidney disease (CKD) and failure of previous DAA treatment...