The RESCUE study was a phase IIIb randomized, multicenter, open-label study in the USA and Canada (NCT02600351). Participants were enrolled based on cirrhosis status. Non-cirrhotic participants were randomized to receive either LDV/SOF or LDV/SOF+RBV for 12 weeks. Participants with compensated cirrhosis were randomized to receive either LDV/SOF+RBV for 12 weeks or LDV/SOF for 24 weeks. Participants received LDV/SOF as a fixed-dose, once-daily tablet (Harvoni®, Gilead Sciences Inc., Foster City, CA, USA) containing LDV(90 mg)/SOF(400 mg). Weight-based RBV (1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg) was administered in a divided dose, twice-daily. An interactive web response system was used to manage participant randomization and treatment assignment. Randomization was stratified by prior regimen and genotype.
A5348 was a phase II randomized, open-label study conducted in the USA (NCT02605304), which randomized participants 1:1 to receive LDV/SOF+RBV for 12 weeks or LDV/SOF only for 24 weeks. Randomization was stratified by cirrhosis status. The study was randomized due to clinical equipoise and not with the intent to compare treatment arms.
In both studies, dose reductions for RBV could be performed according to product label or investigator discretion. RBV could be permanently discontinued due to adverse events (AEs) without stopping LDV/SOF.
A5348 was a phase II randomized, open-label study conducted in the USA (NCT02605304), which randomized participants 1:1 to receive LDV/SOF+RBV for 12 weeks or LDV/SOF only for 24 weeks. Randomization was stratified by cirrhosis status. The study was randomized due to clinical equipoise and not with the intent to compare treatment arms.
In both studies, dose reductions for RBV could be performed according to product label or investigator discretion. RBV could be permanently discontinued due to adverse events (AEs) without stopping LDV/SOF.