Common TitlePOLARIS-2
Official Title Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials
Purpose / DescriptionIn this phase 3, open-labeled trial, patients with chronic hepatitis C genotype 1-4 infection who were naïve to direct-acting antiviral therapy (prior peginterferon and ribavirin allowed) were randomized to either 8 weeks of sofosbuvir-velpatasvir-voxilaprevir or 12 weeks of sofosbuvir-velpatasvir. Patients with genotype 5-6 were assigned to the sofosbuvir-velpatasvir-voxilaprevir arm. Compensated cirrhosis was present in 18% and genotype 1 infection in 49% of the 941 patients. Sustained virologic response (SVR) occurred in 95% and 98% in sofosbuvir-velpatasvir-voxilaprevir and sofosbuvir-velpatasvir arms respectively. Only 93% of genotype 1 patients achieved SVR in the 8-week arm; 92% among genotype 1a versus 97% among genotype 1B patients. Notably, SVR occurred in 90% of patients with cirrhosis in the 8-week arm compared with 99% in the 12-week arm. Note: this study was published in tandem with POLARIS-3.
Phase Phase III
ClinicalTrials.gov NCT02607800
Treatments
Sofosbuvir-Velpatasvir
, 
Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedSofosbuvir-Velpatasvir-Voxilaprevir

Sofosbuvir-Velpatasvir-Voxilaprevir
Tradename:VoseviOther Names:SOF-VEL-VOXClass:FDA-ApprovedFunding
IndustryGilead Sciences