Purpose / DescriptionIn this open-label phase 3 trial, investigators randomized 647 treatment-naive patients with genotype 1 chronic hepatitis C to one of three regimens that included the fixed-dose combination of ledipasvir-sofosbuvir: 8 weeks of ledipasvir-sofosbuvir, 8 weeks of ledipasvir-sofosbuvir plus ribavirin, or 12 weeks of ledipasvir-sofosbuvir. Patients with cirrhosis were not eligible to enroll. Similar SVR12 rates were observed in the three treatment arms: 94% with 8 weeks of ledipasvir-sofosbuvir, 93% with 8 weeks of ledipasvir-sofosbuvir plus ribavirin, and 95% with 12 weeks of ledipasvir-sofosbuvir. A subanalysis showed that a pre-treatment HCV RNA level less than 6 million IU/mL correlated with higher SVR12 rates in the group that received 8 weeks of ledipasvir-sofosbuvir. This study has shown that (1) ledipasvir-sofosbuvir is highly effective in treatment-naive genotype 1 patients without cirrhosis and (2) an 8-week treatment course is a reasonable and more cost-effective option for treatment-naive patients without cirrhosis if they have a baseline HCV RNA less than 6 million IU/mL.