Purpose / DescriptionIn this open-label phase 3 trial, investigators enrolled 865 treatment-naive patients with genotype 1 chronic hepatitis C and compared a 12- and 24-week treatment course of the fixed-dose combination of ledipasvir-sofosbuvir, given with our without ribavirin. In this study, patients with compensated cirrhosis were eligible to enroll (up to 20% of the total study participants could have cirrhosis). All treatment arms had SVR12 rates greater than 95% and no differences were observed in the 12-week versus the 24-week treatment course.  In addition, use of ribavirin did not improve SVR rates. Further, patients with cirrhosis had similar SVR rates as those without cirrhosis. This study clearly established that a 12-week course of the fixed-dose combination ledipasvir-sofosbuvir, without ribavirin, is highly effective in treatment-naive patients with chronic HCV genotype 1 infection, including those with cirrhosis.