State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China.
Centre for Pharmaceutical Regulatory Sciences, University of Macau, Macao SAR, China.
BMC Gastroenterol. 2024 Sep 30;24(1):331. doi: 10.1186/s12876-024-03414-5.
Direct-acting antivirals (DAAs) show high cure rates in treating chronic hepatitis C virus (HCV). However, the effect of DAAs on patients infected with genotype 2 (GT2) is difficult to determine despite the availability of several DAA regimens.
A systematic search of six databases (PubMed, Embase, Cochrane Library, Web of Science, CNKI, and Clinicaltrial.gov) was conducted through April 20, 2022. We considered the sustained virological response 12 weeks after treatment (SVR12) as the efficacy outcome, and adverse events (AEs) as the safety outcome. By calculating the mean SVR12 and the proportion of AEs among patients, we considered the intervention effect for each DAA regimen. The random effect model was then used in all meta-analyses. This systematic review and meta-analysis aimed to summarize the evidence on efficacy and safety of DAAs in patients infected with HCV GT2. The Bayesian Markov Chain Monte Carlo (MCMC) network metanalysis was used to indirectly compare regimen in GT2 patients.
Among 31 articles included (2,968 participants), consisting of 1,387 treatment-naive patients and 354 patients with cirrhosis. The overall pooled SVR12 rate was 94.62% (95% CI: 92.43-96.52%) among the participants who received all doses of treatment. Meta-analysis results of AEs revealed that fatigue was the most common AE (14.0%, 95% CI: 6.4-21.6%), followed by headache (13.1%, 95% CI: 9.2-17.1%), whereas death and serious adverse events were uncommon.
We compared DAA-based treatments indirectly using meta-analysis and found the combination of Sofosbuvir plus Velpatasvir and Glecaprevir plus Pibrentasvir, each administered over a 12-week period, were identified as the most effective and relatively safe in managing chronic hepatitis C virus genotype 2 (HCV GT2) infection. Both treatments achieved a SVR12 of 100% (95% CI 99-100%).
直接作用抗病毒药物（DAAs）在治疗慢性丙型肝炎病毒（HCV）方面显示出高治愈率。然而，尽管有几种 DAA 方案可用，基因型 2（GT2）感染患者的效果仍难以确定。
系统检索了六个数据库（PubMed、Embase、Cochrane Library、Web of Science、CNKI 和 Clinicaltrial.gov），检索时间截至 2022 年 4 月 20 日。我们将治疗后 12 周的持续病毒学应答（SVR12）作为疗效结局，将不良反应（AE）作为安全性结局。通过计算患者的 SVR12 平均值和 AE 比例，我们考虑了每种 DAA 方案的干预效果。然后，所有荟萃分析均采用随机效应模型。本系统评价和荟萃分析旨在总结 DAA 治疗 HCV GT2 感染患者的疗效和安全性证据。贝叶斯马尔可夫链蒙特卡罗（MCMC）网络荟萃分析用于间接比较 GT2 患者的方案。
纳入 31 篇文章（2968 名参与者），包括 1387 名初治患者和 354 名肝硬化患者。接受所有剂量治疗的参与者的总体 SVR12 率为 94.62%（95%CI：92.43-96.52%）。AE 的荟萃分析结果显示，疲劳是最常见的 AE（14.0%，95%CI：6.4-21.6%），其次是头痛（13.1%，95%CI：9.2-17.1%），而死亡和严重不良事件并不常见。
我们通过荟萃分析间接比较了基于 DAA 的治疗方法，发现 Sofosbuvir 加 Velpatasvir 和 Glecaprevir 加 Pibrentasvir 联合治疗，每种药物均治疗 12 周，是治疗慢性丙型肝炎病毒基因型 2（HCV GT2）感染最有效且相对安全的方法。这两种治疗方法的 SVR12 均达到 100%（95%CI 99-100%）。
