Common TitleASTRAL-2
Official Title Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection
Purpose / DescriptionThe ASTRAL-2 trial was published in tandem with the similar trial involving adults with genotype 3 infection (ASTRAL-3). ASTRAL-2 was a randomized, open-label phase 3 trial that compared the safety and efficacy of the fixed-dose combination of sofosbuvir-velpatasvir for 12 weeks with sofosbuvir plus ribavirin for 12 weeks in adults with chronic HCV genotype 2 infection, including treatment-naïve and treatment-experienced patients. Patients with compensated cirrhosis were permitted and comprised 14% of the total 266 patients enrolled in the study. The SVR12 rate among sofosbuvir-velpatasvir recipients was 99% and was superior to the SVR12 rate of 94% among those who received sofosbuvir plus ribavirin, P-value=0.02. The single patient who did not achieve SVR12 in the sofosbuvir-velpatasvir group had received only one dose of the drug and discontinued after experiencing headache and anxiety. The incidence of serious adverse events was low (1%) and not different between treatment arms. The investigators concluded the sofosbuvir-velpatasvir regimen was superior to the standard regimen of sofosbuvir plus ribavirin in patients with chronic HCV genotype 2 infection.
Phase Phase III
ClinicalTrials.gov NCT02220998
Treatments
Sofosbuvir-Velpatasvir

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