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Safety and efficacy of sofosbuvir plus velpatasvir with or without ribavirin for chronic hepatitis C virus infection: A systematic review and meta-analysis

机译:索非布韦联合维帕他韦联合利巴韦林或不联合利巴韦林治疗慢性丙型肝炎病毒的安全性和有效性:系统评价和荟萃分析

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Velpatasvir is a newly FDA-approved inhibitor of hepatitis C virus (HCV) NS5A protein. We performed this systematic review and meta-analysis to investigate the safety and efficacy of velpatasvir plus sofosbuvir in the treatment of chronic HCV infection. A computerized literature search of PubMed, SCOPUS, EMBASE, EBSCO, Web of science, and Cochrane CENTRAL was conducted using relevant keywords. Data from eligible studies were pooled in a fixed effect meta-analysis model, using OpenMeta[Analyst] software. Pooled data from six randomized trials (n = 1427 patients) showed that velpatasvir plus sofosbuvir achieved sustained virological response (SVR12) rates of 98.2% in genotype-1, 99.4% in genotype-2, 94.7% in genotype-3, 99.6% in genotype-4, 97.1% in genotype-5, and 98.8% in genotype-6 patients. The addition of ribavirin did not significantly increase the SVR12 (RR = 0.95, 95%CI [0.88, 1.02]) or decrease relapse rates (RR = 2.52, 95% CI [0.49, 12.87]) in HCV genotype-1 patients. However, adding ribavirin significantly increased SVR12 (RR = 89.5, 95% CI [80.4, 99.5]) in genotype-3 patients. In conclusion, the 12-week regimen of sofosbuvir plus velpatasvir was highly effective in HCV patients, including those with cirrhosis and former treatment experience. Except for genotype-3, adding ribavirin was not associated with significant improvements in SVR12 rates. Further studies should investigate the effect of adding ribavirin to this regimen, especially in HCV genotype-3 patients.
机译:Velpatasvir是一种新的FDA批准的丙型肝炎病毒(HCV)NS5A蛋白抑制剂。我们进行了系统的综述和荟萃分析,以研究维帕他韦+索非布韦在治疗慢性HCV感染中的安全性和有效性。使用相关关键字对PubMed,SCOPUS,EMBASE,EBSCO,Web of Science和Cochrane CENTRAL进行了计算机文献检索。使用OpenMeta [Analyst]软件,将符合条件的研究的数据汇总到固定效应的荟萃分析模型中。来自六项随机试验(n = 1427例患者)的汇总数据显示,velpatasvir和sofosbuvir在基因型1中的持续病毒学应答(SVR12)率为98.2%,基因型2中的99.4%,基因型3中的94.7%,基因型3中的99.6%。基因型4的患者中,基因型5的患者占97.1%,基因型6的患者占98.8%。 HCV基因型1患者的病毒唑添加量未显着增加SVR12(RR = 0.95,95%CI [0.88,1.02])或降低复发率(RR = 2.52,95%CI [0.49,12.87])。然而,在3型基因型患者中,加入利巴韦林可显着增加SVR12(RR = 89.5,95%CI [80.4,99.5])。总之,索非布韦+ velpatasvir的12周方案对HCV患者(包括有肝硬化和既往治疗经验的患者)非常有效。除基因型3外,添加利巴韦林与SVR12率的显着改善无关。进一步的研究应研究在该方案中添加利巴韦林的效果,尤其是在HCV基因型3型患者中。

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