Study Rundown: HCV infection has the potential to become a chronic infection causing cirrhosis and thus decompensated liver failure. Currently one of the main management options is liver transplantation. However recent developments in antivirals have opened the doors to medical management that may lead to complete viral suppression. The NS5B nucleotide inhibitor is currently approved for HCV infection however the new velpatasvir is currently in Phase 3 clinical trials. This open-label randomized controlled trial compared sofosbuvir-velpatasvir with and without ribavirin for 12 weeks or sofosbuvir-velpatasvir for 24 weeks in patients infected with HCV genotypes 1 to 6 and decompensated cirrhosis to assess for efficacy and safety.
All three treatment regimens resulted in sustained virologic responses at 12 weeks across all HCV genotypes; meeting the prespecified primary efficacy end point set by study investigators. There was evidence for improvement in liver function as measured by Child-Pugh-Turcotte (CPT) and Model for End-Stage Liver Disease (MELD) scores. Strengths of the study include being a multicenter and randomized study looking at efficacy of these medications in the sick decompensated cirrhosis patient population. A major limitation of this study is that it was not statistically powered to detect significant differences between efficacy and adverse events across treatment groups. Also it must be cautioned extrapolating these results to very ill patients with severe liver disease as the patient population in this study had moderate hepatic decompensation.