Common TitleASTRAL-1
Official Title Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection
Purpose / DescriptionIn this randomized, placebo-controlled phase 3 trial, treatment-naïve and treatment-experienced adults with chronic hepatitis C genotype 1, 2, 4, 5, or 6 infection were randomized in a 5:1 ratio to receive either sofosbuvir-velpatasvir or placebo. In the treatment arm (n=624), 19% had compensated cirrhotic and 28% were treatment-experienced. The overall SVR12 rate was 99% (618 of 624), with a range of 97 to 100% across the genotypes. Only two viral relapses occurred and these involved participants with genotype 1a and 1b. Among the 121 patients with cirrhosis, 99% (120 of 121) achieved an SVR 12. The presence of baseline NS5A resistance-associated variants, present in 42% of evaluated participants, did not appear to influence SVR12. There was no significant difference in the rate of adverse events between the treatment and placebo arms.
Phase Phase III
ClinicalTrials.gov NCT02201940
Treatments
Sofosbuvir-Velpatasvir

Sofosbuvir-Velpatasvir
Tradename:EpclusaOther Names:SOF-VELClass:FDA-ApprovedFunding
IndustryGilead Sciences