真实世界中索磷维伏作为HCV挽救治疗方案的有效性和安全性系统评价  

Systematic evaluation of effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir as a HCV salvage therapy in the real-world

作　　者：谢婧[1] 徐斌[2] 魏琳琳[2] 黄春阳 刘炜 XIE Jing;XU Bin;WEI Lin-lin;HUANG Chun-yang;LIU Wei(Department of Pharmacy,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Second Department of Liver Disease Center,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京佑安医院药学部,北京100069 [2]首都医科大学附属北京佑安医院肝病中心二科,北京100069

出　　处：《中国药物应用与监测》2023年第2期75-80,共6页Chinese Journal of Drug Application and Monitoring

基　　金：首都医科大学附属北京佑安医院2021年度院内中青年人才孵育项目(YNKTLC2021001)。

摘　　要：目的:系统评价索磷维伏在真实世界中作为丙型肝炎病毒(HCV)挽救治疗的有效性和安全性。方法:计算机检索PubMed、Embase、Cochrane Library、Web of Science、ClinicalTrials.gov、中国知网、万方、维普和中国生物医学文献等数据库,纳入以索磷维伏为挽救治疗方案的真实世界研究。根据ROBINS-I工具对纳入研究的质量进行评价。采用Stata 15.0和RevMan 5.4软件进行Meta分析。结果:共纳入11项研究,包括1460例HCV感染者,持续治疗12周的人群总体持续病毒应答(SVR12)率为93%(95%CI:0.91~0.95),基因3型人群的SVR12率明显低于非基因3型(OR=0.35,95%CI:0.15~0.81,P=0.01),肝硬化人群的SVR12率低于非肝硬化人群(OR=0.46,95%CI:0.22~0.92,P=0.03)。不良事件(AE)发生率为39.47%。最常见的AE为头痛(11.05%)、乏力(7.37%)、恶心(6.14%)、疲劳(5.96%)和腹泻(5.26%)。因AE而终止治疗的仅有5人。结论:与临床试验结果一致,索磷维伏适用于既往治疗失败的HCV患者,是一种高效且耐受性良好的挽救性治疗方案。Objective:To systematically review the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir(SOF/VEL/VOX)as a hepatitis C virus(HCV)salvage therapy in the real-world.Methods:Real-world studies about SOF/VEL/VOX as a HCV salvage therapy were retrieved in databases including PubMed,Embase,Cochrane Library,Web of Science and ClinicalTrials.gov,CNKI,Wanfang,VIP and CBM,and the quality of the included studies were evaluated by ROBINS-I tool.Meta-analysis was conducted by Stata 15.0 and RevMan 5.4 software.Results:Eleven studies with a total of 1460 HCV patients were included.The total rates of sustained virological response 12(SVR12)were 93%(95%CI:0.91-0.95).SVR12 rate in patients with genotype-3(G3)HCV was significantly lower than that in patients without G3 HCV(OR=0.35,95%CI:0.15-0.81,P=0.01).SVR12 rate in patients with cirrhosis was significantly lower than that in patients without cirrhosis(OR=0.46,95%CI:0.22-0.92,P=0.03).The incidence of adverse events(AEs)was 39.47%.The most frequently reported AEs were headache(11.05%),asthenia(7.37%),nausea(6.14%),fatigue(5.96%)and diarrhea(5.26%).AE-related treatment discontinuation was reported in 5 patients.Conclusion:SOF/VEL/VOX was a highly effective and well-tolerated salvage therapy for HCV patients with previous treatment failure,which was consistent with results of clinical trials.

关 键 词：索磷维伏 丙型肝炎病毒 挽救性治疗 系统评价 

分 类 号：R969.4[医药卫生—药理学] R978.7[医药卫生—药学]