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Grazoprevir 联合 Elbasvir 治疗丙型肝炎病毒基因 1 型感染的荟萃分析。

Meta-Analysis of Grazoprevir plus Elbasvir for Treatment of Hepatitis C Virus Genotype 1 Infection.

机构信息

Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt.

Medical Research Group of Egypt, Cairo, Egypt.

出版信息

Ann Hepatol. 2018 January-February;17(1):18-32. doi: 10.5604/01.3001.0010.7532.

Abstract

BACKGROUND AND AIM

Grazoprevir is an NS3/4A protease inhibitor (PI), while elbasvir is an NS5A inhibitor. We performed this meta-analysis to directly compare grazoprevir plus elbasvir and ribavirin regimen vs. grazoprevir and elbasvir without ribavirin in the treatment of hepatitis C virus genotype 1 infection and to precisely evaluate the efficacy of the latter regimen in cirrhotic, IL28 CC genotype patients and those coinfected with human immunodeficiency virus.

MATERIAL AND METHODS

A computer literature search of PubMed, Scopus, EBSCO, Embase, and Cochrane central was conducted. Studies were screened for eligibility. Sustained virologic response (SVR) rates were pooled using OpenMeta[Analyst] software for windows. A subgroup analysis was performed to stratify the treatment efficacy according to the different baseline characteristics of HCV patients.

RESULTS

Eight randomized controlled trials (n = 1,297 patients) were pooled in the final analysis. The overall SVR rate was 96.6% with 95% CI [95.5% to 98%]. For cirrhotic patients, the SVR rate was 95.7% with 95% CI [93.9% to 97.5%] and for non-cirrhotic patients, the SVR rate was 97% with 95% CI [95.9% to 98.4%]. Furthermore, the addition of ribavirin (RBV) to the treatment regimen did not significantly improve the SVR (RR 1.003, 95% CI [0.944 to 1.065]). The dual regimen was effective in patient populations with NS3 resistance-associated (RAS). However, this regimen achieved lower SVR rates (< 90%) in patients with NS5A RAS.

CONCLUSIONS

We conclude that the 12-week treatment regimen of the fixed dose combination of grazoprevir plus elbasvir achieved high SVR rates in patients with HCV genotype 1 infection. The addition of ribavirin to this regimen did not add a significant benefit.

摘要

背景和目的

格拉瑞韦是一种 NS3/4A 蛋白酶抑制剂(PI),而埃巴韦尔是一种 NS5A 抑制剂。我们进行了这项荟萃分析,旨在直接比较格拉瑞韦加埃巴韦尔和利巴韦林方案与不加利巴韦林的格拉瑞韦和埃巴韦尔方案治疗丙型肝炎病毒基因型 1 感染的疗效,并精确评估后者方案在肝硬化、IL28 CC 基因型患者和合并感染人类免疫缺陷病毒患者中的疗效。

材料和方法

计算机检索 PubMed、Scopus、EBSCO、Embase 和 Cochrane 中心数据库。筛选合格的研究。使用 OpenMeta[Analyst]软件对持续病毒学应答(SVR)率进行汇总分析。进行亚组分析,根据丙型肝炎病毒患者的不同基线特征分层治疗效果。

结果

最终分析共纳入 8 项随机对照试验(n=1297 例患者)。总体 SVR 率为 96.6%,95%CI[95.5%至 98%]。对于肝硬化患者,SVR 率为 95.7%,95%CI[93.9%至 97.5%],对于非肝硬化患者,SVR 率为 97%,95%CI[95.9%至 98.4%]。此外,利巴韦林(RBV)的加入并没有显著提高 SVR(RR 1.003,95%CI[0.944 至 1.065])。该联合方案在具有 NS3 耐药相关(RAS)的患者人群中有效。然而,该方案在具有 NS5A RAS 的患者中获得的 SVR 率较低(<90%)。

结论

我们得出结论,格拉瑞韦加埃巴韦尔的 12 周固定剂量联合治疗方案在丙型肝炎病毒基因型 1 感染患者中实现了高 SVR 率。利巴韦林的加入并没有显著增加该方案的获益。

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