Abstract
Hepatitis C virus (HCV)-infected patients with decompensated cirrhosis mostly have no treatment options. In this study, we evaluated Effectiveness and Safety of Sofosbuvir in the Treatment of Hepatitis C. Patients were randomized 1:1 to receive sofosbuvir with or without ribavirin for 12 weeks. Randomization was stratified by CPT class and genotype. Sustained virologic response 12 weeks following completion of treatment (SVR12) was the primary efficacy endpoint.
Of the 102 patients enrolled, 57% were treatment naive, 78% and 20% had genotype 1 and 2 HCV infection, respectively, and 77% and 20% had CPT class B and C cirrhosis, respectively, at baseline. Overall, 61% of patients were female and the mean age was 66 years (range 41-83). SVR12 rates were 92% (47/51) in each group. Among patients who achieved SVR12, 26% had improved CPT class from baseline to post treatment week 12. Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin. Four patients (8%) who received sofosbuvir and seven (14%) who received sofosbuvir plus ribavirin experienced a serious AE. The 3 deaths (bacterial sepsis, gastric varices hemorrhage, hepato-cellular carcinoma) were attributed to liver disease progression.
Sofosbuvir for 12 weeks provides a highly effective and well-tolerated therapy in patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.