Efficacy and safety of sofosbuvir-based therapy for the treatment of chronic hepatitis C in treatment-naïve and treatment-experienced patients.

Sofosbuvir, a hepatitis C virus (HCV) NS5B polymerase inhibitor, is a new direct-acting antiviral for chronic HCV infection. This systematic review and proportional meta-analysis examined the efficacy and safety of sofosbuvir-based therapy for chronic HCV infection in treatment-naïve and -experienced patients. Medline, Cochrane Database of Systematic Reviews, EMBASE and Web of Science databases were searched. Clinical trials examining sofosbuvir plus ribavirin (RBV) and pegylated interferon-α (peg-IFN) or sofosbuvir plus RBV among adults with chronic HCV infection were included. Data were extracted on virological responses including sustained virological response at post-treatment Week 12 (SVR12), relapse, treatment discontinuation due to an adverse event (AE), virological breakthrough during treatment, and AEs. One trial and 13 treatment arms/cohorts from seven studies met the criteria for analysis in treatment-naïve patients who were treated with sofosbuvir, RBV and peg-IFN; the SVR12 was 89% (95% CI 85-92%), relapse was 5% and the serious adverse event (SAE) rate was 4%. Six treatment arms/cohorts met the criteria for analysis in treatment-naïve patients who were treated with sofosbuvir and RBV; the SVR12 was 72% (95% CI 60-81%), relapse was 27% and the SAE rate was 3%. Three treatment arms/cohorts met the criteria for analysis in treatment-experienced patients who were treated with sofosbuvir and RBV; the SVR12 was 51% (95% CI 27-75%), relapse was 46% and the SAE rate was 4%. In conclusion, sofosbuvir-based treatment is effective and safe in treating chronic HCV infection, although the SVR12 of its combination with RBV, especially in treatment-experienced patients, requires improvement.