Department of Internal Medicine, Hepatitis Research Center, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan.
Clin Infect Dis. 2010 Sep 1;51(5):541-9. doi: 10.1086/655682.
Hemodialysis patients are at risk of hepatitis C virus (HCV) infection. However, little is known about the efficacy and safety of pegylated interferon (IFN) therapy for hemodialysis patients with acute hepatitis C.
From 2005 through 2008, 35 hemodialysis patients with acute hepatitis C who did not have spontaneous clearance of HCV by 16 weeks were treated with pegylated IFN alfa-2a at a dosage of 135 microg weekly for 24 weeks. In contrast, 7 patients with clearance of HCV by 16 weeks were under observation only. Thirty-six hemodialysis patients from 2002-2005 who had acute hepatitis C but did not receive treatment served as historical controls. The primary efficacy and safety end points were sustained virologic response (undetectable HCV RNA levels at 24 weeks after therapy) by intention-to-treat analysis and treatment-related withdrawal.
The rate of sustained virologic response in the treatment group was significantly higher than the rate of spontaneous HCV clearance in the control group (88.6% vs 16.7%; P < .001). Two patients (5.7%) prematurely terminated treatment at 8 and 10 weeks because of constitutional symptoms, and both did not have sustained virologic response. All but one patient had rapid virologic response (undetectable HCV RNA levels at 4 weeks of therapy), and all patients who received >12 weeks of therapy had early and end-of-treatment virologic responses. All patients who had clearance of HCV by 16 weeks had undetectable HCV RNA levels until the end of follow-up.
Pegylated IFN alfa-2a monotherapy is safe and efficacious for hemodialysis patients with acute hepatitis C. It is suggested that patients without spontaneous clearance of HCV by week 16 should receive therapy.
血液透析患者存在感染丙型肝炎病毒（HCV）的风险。然而，对于血液透析患者急性丙型肝炎应用聚乙二醇干扰素（IFN）治疗的疗效和安全性所知甚少。
2005 年至 2008 年，35 例 16 周未能自发清除 HCV 的血液透析急性丙型肝炎患者接受聚乙二醇干扰素 alfa-2a 治疗，剂量为每周 135 μg，疗程 24 周。相反，16 周时清除 HCV 的 7 例患者仅进行观察。2002 年至 2005 年的 36 例未接受治疗的血液透析急性丙型肝炎患者作为历史对照。主要疗效和安全性终点为意向治疗分析和治疗相关停药后的持续病毒学应答（治疗后 24 周时 HCV RNA 水平不可检测）。
治疗组的持续病毒学应答率显著高于对照组的自发 HCV 清除率（88.6%对 16.7%；P<.001）。2 例（5.7%）患者因全身症状在 8 周和 10 周时提前终止治疗，且均未出现持续病毒学应答。除 1 例患者外，所有患者均出现快速病毒学应答（治疗第 4 周时 HCV RNA 水平不可检测），所有接受>12 周治疗的患者均出现早期和治疗结束时的病毒学应答。所有在 16 周时清除 HCV 的患者在随访结束时均未检测到 HCV RNA 水平。
聚乙二醇干扰素 alfa-2a 单药治疗血液透析急性丙型肝炎患者安全有效。建议 16 周时未能自发清除 HCV 的患者应接受治疗。
