Purpose / DescriptionIn this phase 3, randomized study, investigators enrolled 224 patient with hepatitis C genotype 1 and chronic renal disease, including patients on hemodialysis, to receive immediate treatment with 12 weeks of therapy with elbasvir plus grazoprevir, or deferred therapy. Subjects in the deferred group received placebo during the first 12 weeks and use of placebo was considered important as a comparator for safety purposes, particularly due to safety concerns in this patient population with advanced renal disease. Overall, 80% of the patients enrolled in the trial were treatment-naive and 76% were on hemodialysis. Among the 116 patients who completed therapy, 115 (99%) achieved an SVR12. Six patients were excluded from the modified full analysis set population, but all six had HCV RNA levels less than 15 IU/ml at that time of study discontinuation. The safety profile observed in patients who received grazoprevir plus elbasvir was comparable to that seen in patients receiving placebo.