Purpose / DescriptionIn this randomized phase 3 trial, the safety and efficacy of the fixed-dose combination of elbasvir-grazoprevir (50/100 mg) once daily was evaluated in treatment-naïve patients with genotype 1, 4, or 6 hepatitis C infection, with or without compensated cirrhosis. Investigators randomized (in a 3:1 ratio) 421 patients to immediate versus delayed treatment arms. In the latter group, patients received a placebo for 12 weeks, followed by a 4-week interval, followed by elbasvir-grazoprevir for 12 weeks. The overall SVR12 rate was 95%, with rates of 92% for genotype 1a, 99% for genotype 1b, 100% for genotype 4, and 80% for genotype 6. Among the 70 cirrhotic patients enrolled in the trial, 97% achieved an SVR12 with no statistically significant difference compared with non-cirrhotic patients.