索磷布韦和西米普韦在移植后环境中的耐受性和有效性：系统评价和荟萃分析。

Tolerability and effectiveness of sofosbuvir and simeprevir in the post-transplant setting: systematic review and meta-analysis.

作者信息

Nguyen Nghia H, Yee Brittany E, Chang Christine, Jin Minjuan, Lutchman Glen, Lim Joseph K, Nguyen Mindie H

机构信息

School of Medicine, University of California, San Diego , La Jolla, California , USA.

Department of Gastroenterology and Hepatology , Stanford University Medical Center , Palo Alto, California , USA.

出版信息

BMJ Open Gastroenterol. 2016 Jan 4;3(1):e000066. doi: 10.1136/bmjgast-2015-000066. eCollection 2016.

DOI:10.1136/bmjgast-2015-000066

PMID:26966549

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4782279/

Abstract

BACKGROUND

Outcome data on simeprevir and sofosbuvir (SMV+SOF) in patients with liver transplantation (LT) with hepatitis C virus genotype 1 (HCV-1) are limited with individual studies having a small sample size and limited SVR12 (sustained virological response) data. Our goal was to perform a meta-analysis to study the outcome of SMV+SOF±ribavirin (RBV) in recipients with LT.

METHODS

In April 2015, we conducted a literature search for 'simeprevir' in MEDLINE/EMBASE and five major liver meetings. We included studies with SVR12 data in ≥5 post-LT mono-infected HCV-1 patients treated with SMV+SOF±RBV. We used random-effects models to estimate effect sizes, and the Cochrane Q-test (p value <0.10) with I(2) (>50%) to assess study heterogeneity.

RESULTS

We included nine studies with a total of 325 patients with post-LT. Studies included mostly men (59-81%). Pooled SVR12 was 88.0% (95% CI 83.4% to 91.5%). In two studies, HCV-1a patients with mild fibrosis (n=108) had an SVR12 rate of 95.0% (95% CI 82.4% to 98.7%), which was significantly higher than that of HCV-1a patients with advanced fibrosis (n=49) with an SVR12 rate of 81.7% (95% CI 69.8% to 89.5%), OR 4.2 (95% CI 1.1 to 16.1, p=0.03). The most common pooled side effects were: fatigue 21% (n=48/237), headache 9% (n=23/254), dermatological symptoms 15% (n=38/254), and gastrointestinal symptoms 6% (12/193).

CONCLUSIONS

SMV+SOF±RBV is safe and effective in recipients with LT with HCV-1 infection.

摘要

背景

对于丙型肝炎病毒1型（HCV-1）肝移植（LT）患者，simeprevir和索磷布韦（SMV+SOF）的疗效数据有限，个别研究样本量小且持续病毒学应答（SVR12）数据有限。我们的目标是进行一项荟萃分析，以研究SMV+SOF±利巴韦林（RBV）在LT受者中的疗效。

方法

2015年4月，我们在MEDLINE/EMBASE以及五场主要肝脏会议上检索了有关“simeprevir”的文献。我们纳入了在≥5例接受SMV+SOF±RBV治疗的LT后单感染HCV-1患者中具有SVR12数据的研究。我们使用随机效应模型来估计效应量，并使用Cochrane Q检验（p值<0.10）和I²（>50%）来评估研究异质性。

结果

我们纳入了9项研究，共325例LT后患者。研究对象大多为男性（59%-81%）。汇总的SVR12为88.0%（95%CI 83.4%至91.5%）。在两项研究中，轻度纤维化的HCV-1a患者（n=108）的SVR12率为95.0%（95%CI 82.4%至98.7%），显著高于晚期纤维化的HCV-1a患者（n=49），后者的SVR12率为81.7%（95%CI 69.8%至89.5%），比值比为4.2（95%CI 1.1至16.1，p=0.03）。最常见的汇总副作用为：疲劳21%（n=48/237）、头痛9%（n=23/254）、皮肤症状15%（n=38/254）以及胃肠道症状6%（12/193）。