Sofosbuvir (Sovaldi)

Purpose / DescriptionThis open-label, phase 2 trial, multicenter trial enrolled 63 patients with chronic hepatitis C and compensated cirrhosis awaiting liver transplantation for hepatocellular cancer.  Patients receive sofosbuvir plus ribavirin for up to 48 weeks while awaiting transplant (all patients received at least 12 weeks of therapy). Among the 61 treated patients, 46 underwent liver transplantation; the study analysis was performed on the 43 (93%) of 46 patients who underwent transplant and had an HCV RNA level less than 25 IU/ml at the time of transplant. The sofosbuvir plus ribavirin was discontinued approximately 24 hours prior to transplantation.  At 12 weeks post-transplantation, 30 (70%) of 43 patients had undetectable HCV RNA levels. Overall, the treatment was well-tolerated and the most frequently reported adverse effects were faigure, headache, and anemia.