Purpose / DescriptionIn this phase 3, active-comparator, open-labeled trial, 314 patients with chronic hepatitis C genotype 1-3 with prior direct-acting antiviral (DAA) therapy without an NS5A inhibitor were randomized to receive either sofosbuvir-velpatasvir-voxilaprevir (SOF-VEL-VOX) or sofosbuvir-velpatasvir (SOF-VEL) for 12 weeks; 19 patients with genotype 4 were assigned to the triple arm. Compensated cirrhosis was present in 46% and prior sofosbuvir exposure in 80% of patients. The overall sustained virologic response rates were 98% and 90% for the SOF-VEL-VOX and SOF-VEL arms respectively. Virologic relapse was confirmed at week 4 for one SOF-VEL-VOX patient and 14 SOF-VEL patients, of whom 8 had genotype 3a. Note: this study was published in tandem with POLARIS-1. Note: this study was published in tandem with POLARIS-1.