Medical Research Group of Egypt, Cairo, Egypt; Faculty of Medicine, Zagazig University, Zagazig, El-Sharkia, Egypt; Student Research Unit, Zagazig University, Zagazig, El-Sharkia, Egypt.
Medical Research Group of Egypt, Cairo, Egypt; Faculty of Medicine, Ain Shams University, Cairo, Egypt; NovaMed Medical Research Association, Cairo, Egypt.
J Infect Public Health. 2018 Mar-Apr;11(2):156-164. doi: 10.1016/j.jiph.2017.09.004. Epub 2017 Sep 29.
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.
维帕他韦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) NS5A 蛋白抑制剂。我们进行了这项系统评价和荟萃分析，以调查维帕他韦联合索磷布韦治疗慢性 HCV 感染的安全性和疗效。使用相关关键字在 PubMed、SCOPUS、EMBASE、EBSCO、Web of science 和 Cochrane CENTRAL 上进行了计算机文献检索。使用 OpenMeta[Analyst]软件，将来自合格研究的数据汇总到固定效应荟萃分析模型中。来自六项随机试验（n=1427 例患者）的汇总数据显示，维帕他韦联合索磷布韦在基因型 1 患者中的持续病毒学应答 (SVR12) 率为 98.2%，基因型 2 为 99.4%，基因型 3 为 94.7%，基因型 4 为 99.6%，基因型 5 为 97.1%，基因型 6 为 98.8%。添加利巴韦林并没有显著提高 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]）在 HCV 基因型 1 患者中。然而，添加利巴韦林可显著提高基因型 3 患者的 SVR12（RR=89.5，95%CI [80.4，99.5]）。总之，12 周的索磷布韦联合维帕他韦方案对 HCV 患者，包括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 率的显著提高无关。进一步的研究应调查在该方案中添加利巴韦林的效果，特别是在 HCV 基因型 3 患者中。
