Background: Sofosbuvir and ledipasvir with or without ribavirin (RBV) regimens (SLR vs. SL) have exhibited promising results for the treatment of patients with hepatitis C virus (HCV) genotype 1 infection.
Aim: To comprehensively compare the efficacy and safety of the SL and SLR regimen for the treatment of chronic HCV genotype 1 infections.
Methods: The Cochrane Library, PubMed, 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 chronic HCV genotype 1 infection were included. The primary outcome measures were the sustained virological response weeks 12 (SVR12) post-treatment and adverse events (AEs).
Results: Seven studies comprising 2601 patients were included. Compared with the SL regimen, SLR 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 rate. However, the SLR regimen for 12 or 24 weeks did not show a superior SVR12 rate regardless of treatment history and 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-week or 24-week 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 HCV genotype 1 infection.
Keywords: Efficacy; Genotype 1 hepatitis C; Ledipasvir; Ribavirin; Safety; Sofosbuvir.