“Sofosbuvir (SOF)/velpatasvir (VEL) is a new pan-genotypic regimen for hepatitis C virus (HCV) infection that has been associated with high efficacy. The goal of this study was to assess patient-reported outcomes (PROs),” said Zobair Younossi, MD, of the Center for Liver Disease, Department of Medicine, Inova Fairfax Hospital, at a presentation at Digestive Disease Week 2016, a joint meeting of the American Academy for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Patients with HCV infection often experience severe fatigue that impacts their health-related quality of life and work productivity. Previously used interferon-based regimens added to the impairment during and shortly after treatment. Newly developed interferon-free HCV regimens not only successfully clear the HCV virus but may also improve a number of different patient-reported outcomes.
In the ASTRAL-1 clinical trial, a phase 3, multicenter, multinational, blinded, placebo-controlled trial, patients with HCV genotypes 1-2 and 4-6 were randomized to receive either a fixed-dose combination of 400 mg/100 mg of SOF/VEL or matching placebo once daily for 12 weeks. This fixed-dose combination has been shown to be highly efficacious in HCV genotype 1-6 patients in a series of ASTRAL studies. Here, four different instruments, including the Short-Form 35 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Chronic Liver Disease-HCV (CLDQ-HCV), and Work Productivity and Activity Improvement-Specific Health Problem (WPAI:SP), were used to assess patient reported outcomes at baseline, during treatment, and up to 24 weeks of follow-up.