Efficacy and Safety of Ribavirin with Sofosbuvir Plus Ledipasvir in Patients with Genotype 1 Hepatitis C: A Meta-Analysis

Abstract

BackgroundSofosbuvir 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.AimTo comprehensively compare the efficacy and safety of the SL and SLR regimen for the treatment of chronic HCV genotype 1 infections.MethodsThe 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).ResultsSeven 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).ConclusionsThe 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.

Effect of Antithrombotic Therapy and Long Endoscopic Submucosal Dissection Procedure Time on Early and Delayed Postoperative Bleeding

“…Some studies defined early postoperative bleeding as bleeding that occurs within 24 h after ESD procedure, whereas others considered early postoperative bleeding as that which occurred within 48 h as in our study [12,13]. Matsumura et al [16] defined early postoperative bleeding as that which occurs anytime within the first 5 days after ESD.…”

“…There is no consensus on the definition of early and delayed postoperative bleeding [6,7,8,11,12,13,14,15,16]. Some studies defined early postoperative bleeding as bleeding that occurs within 24 h after ESD procedure, whereas others considered early postoperative bleeding as that which occurred within 48 h as in our study [12,13].…”

“…Takahashi et al [15] have reported that immediate postoperative bleeding within 24 h after ESD procedure was significantly associated with various factors such as tumor location, size of specimens, and age. In contrast, Na et al [12] have reported that the existence of uncontrolled visible vessels (Forrest IIa) had no significant correlation with delayed postoperative bleeding. Therefore, factors associated with early postoperative bleeding may differ from those linked to delayed postoperative bleeding.…”

“…There is no universally accepted definition of early and delayed bleeding [6,7,8,11,12,13,14,15,16]. Nevertheless, taking into consideration the critical fact that meal consumption resumed 48 h after ESD procedure in our study, we divided postoperative bleeding into 2 groups, such that postoperative bleeding that occurred within 48 h of ESD procedure was defined, as early postoperative bleeding and subsequent bleeding was defined as delayed postoperative bleeding.…”

Efficacy and safety outcomes of sofosbuvir-based treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials

“…With the extension of treatment to 12 or 24 weeks, additional benefits were not linked with the inclusion of RBV in the SOF/LDV regimen. Thus, as demonstrated in the previous reviews, the 12- or 24-week SOF/LDV regimen should adequately treat most patients with HCV genotype 1 infection, considering the risk of AEs from RBV use 33,36,37. However, the 8-week SOF/LDV regimen should also be considered carefully in certain patients, because a reduction in the treatment duration may lead to lower treatment costs.…”