Sikole Aleksandar, Dzekova Pavlina, Selja Nexhmi, Gaseva Magdalena, Nikolov Igor G, Zabzun Mustafa, Muharemi Sheriat, Asani Arben, Amitov Vili, Mena Sami, Grunevska Violeta, Ivanovski Ljubomir, Polenakovic Momir
Department of Nephrology, University Clinical Centre, Skopje, R. Macedonia.
Ren Fail. 2007;29(8):961-6. doi: 10.1080/08860220701641579.
The high prevalence of hepatitis C virus (HCV) infection in hemodialysis patients is of great concern because they have a higher rate of mortality than HCV-negative hemodialysis patients. The aim of the study was to evaluate the efficacy and safety of pegylated interferon alpha-2a monotherapy in hemodialysis patients with chronic HCV infection.
Fourteen dialysis patients with chronic HCV infection were scheduled to receive 135 mug pegylated interferon alpha-2a subcutaneously, once a week, after dialysis session for a period of 48 weeks. Efficacy and safety were assessed by end of treatment viral response, sustained viral response, biochemical response, and adverse events. Serum HCV RNA levels were assessed using reverse transcriptase polymerase chain reaction (RT-PCR), while HCV genotype was analyzed by RT-PCR followed by hybridization of amplified products.
Of the 14 patients enrolled in the study, 9 completed treatment. Eight patients (57%) had undetectable levels of HCV RNA at the end of treatment, while one patient remained positive. Two (14.3%) patients were discontinued because of insufficient therapeutic response. Three patients (21.34%) did not finish treatment because serious adverse events occurred: one patient with bronchopneumonia and one with pericarditis were discontinued from treatment, while one patient died due to cerebral hemorrhage. Sustained viral response was present in 36% of the patients (5/8 patients) at the end of the follow up period. Biochemical response with normalization of serum ALT levels during treatment was observed in all treated patients (83 +/- 20.1 U/L at baseline vs. 23.4 +/- 4.6 U/L at week 48). The most common adverse events were flu-like syndrome, myalgia, arthralgia, and pancytopenia. Most of the adverse events were manageable. The serious adverse events were believed to be unrelated to the therapy, but rather to the co-morbidities of the hemodialysis patients.
Pegylated interferon alpha-2a treatment was effective in a considerable proportion of the treated hemodialysis patients with hepatitis C, and it was reasonably safe to use.
丙型肝炎病毒（HCV）感染在血液透析患者中高发，这令人十分担忧，因为他们的死亡率高于HCV阴性的血液透析患者。本研究的目的是评估聚乙二醇化干扰素α-2a单药治疗慢性HCV感染血液透析患者的疗效和安全性。
14例慢性HCV感染的透析患者计划在每次透析结束后皮下注射135μg聚乙二醇化干扰素α-2a，每周1次，共48周。通过治疗结束时的病毒反应、持续病毒反应、生化反应和不良事件来评估疗效和安全性。使用逆转录聚合酶链反应（RT-PCR）评估血清HCV RNA水平，通过RT-PCR分析HCV基因型，然后对扩增产物进行杂交。
本研究纳入的14例患者中，9例完成治疗。8例患者（57%）在治疗结束时HCV RNA水平检测不到，1例患者仍为阳性。2例患者（14.3%）因治疗反应不足而停药。3例患者（21.34%）因发生严重不良事件未完成治疗：1例支气管肺炎患者和1例心包炎患者停止治疗，1例患者因脑出血死亡。随访期结束时，36%的患者（5/8例患者）出现持续病毒反应。所有接受治疗的患者在治疗期间血清ALT水平均恢复正常，出现生化反应（基线时为83±20.1 U/L，第48周时为23.4±4.6 U/L）。最常见的不良事件是流感样综合征、肌痛、关节痛和全血细胞减少。大多数不良事件是可控的。严重不良事件被认为与治疗无关，而是与血液透析患者的合并症有关。
聚乙二醇化干扰素α-2a治疗对相当一部分接受治疗的丙型肝炎血液透析患者有效，且使用相对安全。
