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Ledipasvir/sofosbuvir with or without ribavirin for the treatment of chronic hepatitis C genotype 1: A pairwise meta‐analysis
Author(s) -
Ferreira Vinicius L,
Assis Jarek Nayara A,
Tonin Fernanda S,
Borba Helena H L,
Wiens Astrid,
Muzzillo Dominique A,
Pontarolo Roberto
Publication year - 2017
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.13620
Subject(s) - medicine , ledipasvir , ribavirin , sofosbuvir , rash , adverse effect , discontinuation , randomized controlled trial , gastroenterology , anemia , relative risk , subgroup analysis , hepatitis c , hepatitis c virus , cirrhosis , confidence interval , immunology , virus
Background and Aim Ledipasvir with sofosbuvir (LED/SOF) for the treatment of patients infected with genotype 1 hepatitis C virus can be used with or without ribavirin (RBV). RBV is well known to promote significant adverse events (AE). The aim of this study was to compare the efficacy and safety of treatment with LED/SOF, with or without RBV, in patients infected with hepatitis C virus genotype 1. Methods We performed a systematic review followed by a pairwise meta‐analysis including randomized controlled trials that reported efficacy (rapid virological response, sustained virological response at 4 and 12 weeks post‐treatment (SVR4 and 12), and viral relapse) and safety outcomes (any AE, serious AE, discontinuation owing to AE, anemia, and rash). It was performed a subgroup analysis evaluating the SVR12 including only cirrhotic patients. Results were reported as risk ratios (RR) and with 95% confidence intervals (95% CI). Results Seven randomized controlled trials were analyzed. LED/SOF with RBV showed a worse safety profile when compared with LED/SOF without RBV for the following outcomes: any AE (RR 0.56 [95% CI 0.46–0.69]), anemia (RR 0.08 [95% CI 0.04–0.17]), and rash (RR 0.35 [95% CI 0.19–0.65]). No significant differences were observed regarding serious AE, rapid virological response, SVR4, SVR12, or viral relapse. The subgroup analysis did not show significant differences between either treatment groups. Conclusion Administration of LED/SOF + RBV to treatment‐naïve patients with or without cirrhosis, and non‐cirrhotic treatment‐experienced patients, did not promote significant additional benefits. Furthermore, it is still unclear whether cirrhotic treatment‐experienced patients could benefit from combined therapy.