Department of Gastroenterology, Shanghai Changzheng Hospital, Second Military Medical University, China.
Int J Infect Dis. 2012 Oct;16(10):e748-52. doi: 10.1016/j.ijid.2012.06.002. Epub 2012 Jul 25.
The current standard therapy for hepatitis C virus genotype 1 (HCV-1) infection is still suboptimal. Whether adding amantadine (AMA) to pegylated interferon (PEG-IFN) plus ribavirin (RBV) improves the virological response in treatment-naive HCV-1 patients remains unclear.
Searches of the electronic databases including Embase, Medline, Cochrane Controlled Trials Register, and PubMed (updated to September 2011) and manual searches of the bibliographies were carried out. A meta-analysis of randomized clinical trials (RCT) comparing triple therapy (PEG-IFN+RBV+AMA) and double therapy (PEG-IFN+RBV) was performed.
Five RCTs including 1425 patients were assessed. The meta-analysis based on the intention-to-treat analysis indicated that the sustained virological response (SVR) rate was significantly lower in the triple therapy group than in the double therapy group (44.2% vs. 49.2%, risk ratio (RR) 0.90, 95% confidence interval (CI) 0.80-1.00, p=0.05). The frequency of discontinuing therapy because of adverse events was similar in the two groups (RR 1.26, 95% CI 0.90-1.78, p=0.18). The sensitivity analysis including the four studies involving Caucasian populations revealed significantly lower SVR rates in the triple therapy group. The other sensitivity analyses also showed similar trends, but did not reach statistical significance.
This meta-analysis suggests no beneficial effect of adding AMA to PEG-IFN+RBV in treatment-naive HCV-1 patients and even a trend towards a lower virological response rate in the triple therapy group. This study shows that the administration of AMA should be avoided in the management of treatment-naive HCV-1 patients.
目前治疗丙型肝炎病毒基因型 1（HCV-1）感染的标准疗法仍不理想。在初治 HCV-1 患者中，加用金刚烷胺（AMA）是否能提高聚乙二醇干扰素（PEG-IFN）加利巴韦林（RBV）的抗病毒反应尚不清楚。
检索电子数据库包括 Embase、Medline、Cochrane 对照试验注册库和 PubMed（更新至 2011 年 9 月），并手工检索参考文献。对比较三联治疗（PEG-IFN+RBV+AMA）和二联治疗（PEG-IFN+RBV）的随机临床试验（RCT）进行荟萃分析。
共评估了 5 项 RCT，包括 1425 例患者。基于意向治疗分析的荟萃分析表明，三联治疗组的持续病毒学应答（SVR）率显著低于二联治疗组（44.2%比 49.2%，风险比（RR）0.90，95%可信区间（CI）0.80-1.00，p=0.05）。两组因不良反应而停药的频率相似（RR 1.26，95% CI 0.90-1.78，p=0.18）。包括四项涉及白种人群研究的敏感性分析显示，三联治疗组 SVR 率显著降低。其他敏感性分析也显示出相似的趋势，但未达到统计学意义。
这项荟萃分析表明，在初治 HCV-1 患者中加用 AMA 对 PEG-IFN+RBV 没有有益作用，甚至在三联治疗组中出现病毒学应答率降低的趋势。本研究表明，在管理初治 HCV-1 患者时应避免使用 AMA。
