Efficacy And Safety Of Sofosbuvir Plus Ledipasvir In Patients With Genotype 1 Hepatitis C Virus Infection: A Meta-analysis

Background: Sofosbuvir(SOF)and ledipasvir(LDV)with or without ribavirin(RBV)regimens(SLR vs SL)have exhibited promising results for the treatment of patients with chronic genotype 1 hepatitis C virus(HCV)infection.Aim: To comprehensively compare the efficacy and safety of the SL and SLR regimen for the treatment of patients with chronic genotype 1 HCV infection.Methods: The Cochrane Library,Pub Med,Web of Science,and EMBASE databases were searched.Only RCTs that compared the efficacy and safety of SL or SLR regimen for the treatment of patients with chronic genotype 1 HCV infection were included.Meta-analysis was performed by using Stata12.0 software.The primary outcomes include the rate of sustained virological response weeks 12(SVR12)post-treatment and adverse events(AEs).Results: Seven studies comprising 2,601 patients were included.The results of Meta-analysis showed that compared with the SLR regimen,SL yielded a similar probability of having an SVR12(RR 1.002,95% CI 0.998,1.017,P = 0.780).Based on subgroup analyses,the addition of RBV to the 8-week SL regimen improved the SVR12 for treatment-naive patients with chronic genotype 1 HCV infection.However,the SLR regimen for 12 or 24 weeks did not show a superior SVR12 regardless of treatment history,the presence or absence of cirrhosis.The pooled incidence of AEs was higher in patients that received the SLR treatment regimen(RR 1.140,95% CI 1.095,1.187,P =0.000).Conclusions: The 12 or 24 weeks SL regimen with a low incidence of AEs is as effective and well-tolerated as the SLR regimen for the treatment of patients with chronic genotype 1 HCV infection.