Study design
Randomized, double-blind, placebo-controlled study in patients with HCV GT1 infection, with or without cirrhosis, with chronic kidney disease (CKD) stage 4 (eGFR 15–29 mL/min/1.73 m2) or stage 5 (eGFR <15 mL/min/1.73 m2), including patients on hemodialysis, who were TN or who failed prior therapy with IFN or peg-IFN ± RBV. Patients were randomized in a 1:1 ratio to the following treatment groups: ZEPATIER for 12 weeks (immediate-treatment group, n=111) or placebo for 12 weeks followed by open-label treatment with ZEPATIER for 12 weeks (deferred-treatment group, n=113). In addition, 11 patients received open-label ZEPATIER for 12 weeks (intensive pharmacokinetic [PK] group). Among patients in the immediate-treatment and intensive PK groups, 45% were Black or African American, 6% had cirrhosis, 52% had GT1a infection, and 48% had GT1b infection. SVR12 was assessed in the pooled immediate-treatment group and the intensive PK group (n=122).