索磷布韦-维帕他韦的安全性和疗效：一项荟萃分析。

Safety and efficacy of sofosbuvir-velpatasvir: A meta-analysis.

机构信息

Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Medicine (Baltimore). 2022 Oct 21;101(42):e31183. doi: 10.1097/MD.0000000000031183.

INTRODUCTION

The sofosbuvir-velpatasvir single-tablet regimen (Epclusa) is a newly FDA-approved inhibitor of hepatitis C virus (HCV). This meta-analysis aimed to investigate the safety and efficacy of velpatasvir-sofosbuvir in the treatment of chronic HCV infection.

METHODS

A comprehensive literature search of PubMed, Cochrane CENTRAL, EMBASE and Web of Science was conducted. Data from eligible studies were pooled in a fixed-effect meta-analysis model, using Open-Meta and RevMan software's.

RESULTS

Pooled data showed that velpatasvir-sofosbuvir achieved sustained virological response (SVR12) rates of 94.2% (95% CI 90.7-97.7%, P < .001) in 1277 patients. The addition of ribavirin did not significantly increase the SVR12 (RR = 1.03, 95%CI [0.95, 1.11]) in HCV genotype-1 patients and the SVR12 (RR = 1.09, 95%CI [0.86, 1.38]) in HCV genotype-2 patients. However, adding ribavirin significantly increased SVR12 (RR = 1.13, 95% CI [1.04, 1.23]) in genotype-3 patients.

CONCLUSION

In conclusion, the 12-week regimen of sofosbuvir-velpatasvir was highly effective in HCV patients. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates.

简介

索磷布韦-维帕他韦单片制剂（Epclusa）是一种新的美国食品和药物管理局批准的丙型肝炎病毒（HCV）抑制剂。本荟萃分析旨在研究维帕他韦-索磷布韦治疗慢性丙型肝炎感染的安全性和疗效。

方法

对 PubMed、Cochrane 中央、EMBASE 和 Web of Science 进行了全面的文献检索。使用 Open-Meta 和 RevMan 软件的固定效应荟萃分析模型，对合格研究的数据进行了汇总。

结果

汇总数据显示，在 1277 名患者中，维帕他韦-索磷布韦的持续病毒学应答（SVR12）率为 94.2%（95%CI 90.7-97.7%，P<.001）。利巴韦林的加入并没有显著提高丙型肝炎基因型 1 患者的 SVR12（RR=1.03，95%CI [0.95，1.11]）和丙型肝炎基因型 2 患者的 SVR12（RR=1.09，95%CI [0.86，1.38]）。然而，利巴韦林的加入显著提高了基因型 3 患者的 SVR12（RR=1.13，95%CI [1.04，1.23]）。