title: Efficacy and safety of sofosbuvir-based therapy for the treatment of chronic hepatitis C in treatment-naïve and treatment-experienced patients.
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.
authors.affiliation: Department of Pathology, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Xi
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Laboratory Medicine, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Yawen
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Pathology, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Guanjun
authors.initials: G
authors.lastname: Zhang
authors.affiliation: Department of Infectious Diseases, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Na
authors.initials: N
authors.lastname: Li
authors.affiliation: Department of Infectious Diseases, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Qianqian
authors.initials: Q
authors.lastname: Zhu
authors.affiliation: Department of Pathology, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Hongyun
authors.initials: H
authors.lastname: Chang
authors.affiliation: Department of Infectious Diseases, First Affiliated Hospital, School of Medicine, Xi' an Jiaotong University, Xi' an 710061, Shaanxi, China.
authors.forename: Qunying
authors.initials: Q
authors.lastname: Han
authors.affiliation: Department 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.
authors.forename: Yi
authors.initials: Y
authors.lastname: Lv
authors.affiliation: Department 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.
authors.forename: Zhengwen
authors.initials: Z
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D000069474:Sofosbuvir; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: Hepatitis C; Meta-analysis; Pegylated interferon-α; Ribavirin; Sofosbuvir