Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Am J Kidney Dis. 2013 Oct;62(4):789-95. doi: 10.1053/j.ajkd.2013.03.037. Epub 2013 Jun 5.
Pegylated interferon (peginterferon; interferon with an attached polyethylene glycol molecule) monotherapy is the recommended treatment for chronic hepatitis C virus (HCV) infection in hemodialysis patients. Limited data concerning peginterferon alfa-2b and ribavirin treatment in this population are available.
2 prospective observational cohort studies.
SETTING & PARTICIPANTS: From 2007-2009, a total of 26 patients received peginterferon alfa-2b monotherapy. From 2009-2012, an additional 26 patients were treated with peginterferon alfa-2b and ribavirin.
Peginterferon alfa-2b monotherapy, 1.0 μg/kg/wk, versus peginterferon alfa-2b, 1.0 μg/kg/wk, and ribavirin, 200 mg, 3 times per week. Treatment durations were 24 and 48 weeks for HCV genotypes non-1 and 1, respectively.
OUTCOMES & MEASUREMENTS: End-of-treatment virologic response and sustained virologic response (SVR) were undetectable HCV RNA at the end of treatment and 24 weeks after treatment ended, respectively. SVR and treatment-related withdrawal rate were evaluated by intention-to-treat (ITT) and per-protocol (PP) analyses. Severe anemia was defined as nadir hemoglobin level <8 g/dL.
Patients who received combination therapy had a higher end-of-treatment virologic response than patients who received monotherapy (85% vs 62% in ITT [P = 0.03] and 100% vs 80% in PP [P = 0.03]). The SVR rate was higher in the combination-treatment cohort than in the monotherapy cohort (62% vs 27% in ITT [P = 0.01] and 73% vs 35% in PP [P = 0.01]). Patients who received combination therapy had a significantly higher rate of severe anemia than those who received monotherapy (58% vs 27%; P = 0.03). However, treatment withdrawal rates were similar between the combination (15%) and monotherapy (23%) groups.
Comparison of 2 sequential cohorts rather than a randomized control study.
Peginterferon alfa-2b and ribavirin combination therapy provided a higher SVR rate than peginterferon alfa-2b monotherapy for treatment-naive dialysis patients with chronic HCV infection through careful monitoring of hematologic parameters and ribavirin dose modification. Severe anemia was significantly higher in patients receiving combination therapy than patients treated with monotherapy.
聚乙二醇干扰素（聚乙二醇化干扰素；与附着的聚乙二醇分子的干扰素）单药治疗是血液透析患者慢性丙型肝炎病毒（HCV）感染的推荐治疗方法。在该人群中，关于聚乙二醇干扰素 alfa-2b 和利巴韦林治疗的数据有限。
2 项前瞻性观察队列研究。
2007 年至 2009 年，共有 26 名患者接受了聚乙二醇干扰素 alfa-2b 单药治疗。2009 年至 2012 年，又有 26 名患者接受了聚乙二醇干扰素 alfa-2b 和利巴韦林治疗。
聚乙二醇干扰素 alfa-2b 单药治疗，1.0 μg/kg/周，与聚乙二醇干扰素 alfa-2b，1.0 μg/kg/周和利巴韦林，200 mg，每周 3 次。HCV 基因型非 1 和 1 的治疗持续时间分别为 24 周和 48 周。
接受联合治疗的患者的治疗结束时病毒学应答（在治疗结束时检测不到 HCV RNA）和持续病毒学应答（SVR）（分别在治疗结束后 24 周和治疗结束后 24 周检测不到 HCV RNA）高于接受单药治疗的患者（意向治疗 [ITT] 分析中分别为 85%和 62%[P=0.03]和 100%和 80%在按方案 [PP] 分析中[P=0.03]）。联合治疗组的 SVR 率高于单药治疗组（ITT 分析中分别为 62%和 27%[P=0.01]和 PP 分析中分别为 73%和 35%[P=0.01]）。接受联合治疗的患者严重贫血的发生率明显高于接受单药治疗的患者（58%和 27%；P=0.03）。然而，联合治疗（15%）和单药治疗（23%）组的治疗停药率相似。
比较了 2 个连续队列，而不是随机对照研究。
聚乙二醇干扰素 alfa-2b 和利巴韦林联合治疗为未经治疗的透析患者慢性 HCV 感染提供了更高的 SVR 率，优于聚乙二醇干扰素 alfa-2b 单药治疗，通过仔细监测血液学参数和利巴韦林剂量调整。接受联合治疗的患者严重贫血的发生率明显高于接受单药治疗的患者。
