Author information
1Department of Pathology, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
2Department of Laboratory Medicine, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
3Department of Infectious Diseases, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
4Department of Hepatobiliary Surgery, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi an 710061, Shaanxi, China; Institute of Advanced Surgical Technology and Engineering, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
5Department of Infectious Diseases, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China; Institute of Advanced Surgical Technology and Engineering, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China. Electronic address: liuzhengwen@medmail.com.cn.
Abstract
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.