Calanca Luzia Nigg, Fehr Thomas, Jochum Wolfram, Fischer-Vetter Julia, Müllhaupt Beat, Wüthrich Rudolf P, Ambühl Patrice M
Department of Nephrology, University Hospital, Rämistrasse 100, CH 8091 Zürich, Switzerland.
J Clin Virol. 2007 May;39(1):54-8. doi: 10.1016/j.jcv.2007.02.006. Epub 2007 Apr 3.
Standard treatment of chronic hepatitis C virus (HCV) infection based on interferon is not an option in renal transplant recipients due to the high risk of acute allograft rejection.
To assess efficacy and tolerability of combined treatment with ribavirin and amantadine regarding viral clearance, normalization of liver enzymes, and improvement of HCV-related hepatopathy and graft nephropathy in HCV-RNA-positive renal transplant patients.
Prospective randomized controlled study comparing ribavirin, 1000 mg daily (n=7), versus ribavirin, 1000 mg, in combination with amantadine, 200 mg daily (n=8), for 12 months, versus no therapy (controls, n=26). Results were evaluated by intention-to-treat analysis.
No relevant differences among treatment groups were found regarding liver enzymes, HCV viremia, liver histology and renal parameters. However, antiviral treatment was limited by anemia, resulting in premature withdrawal from therapy and requiring substitution with recombinant erythropoietin in most patients. The best predictor for tolerability of active treatment was a creatinine clearance rate>50 ml/min.
Addition of amantadine to ribavirin seems not to be superior to ribavirin monotherapy in renal transplant patients with chronic replicating HCV infection. However, this may be explained in part by the poor tolerability of both ribavirin and amantadine in patients with impaired renal function, resulting in drop-outs and subtherapeutic drug dosage.
由于急性移植肾排斥反应风险高，基于干扰素的慢性丙型肝炎病毒（HCV）感染标准治疗方案不适用于肾移植受者。
评估利巴韦林与金刚烷胺联合治疗对HCV-RNA阳性肾移植患者病毒清除、肝酶正常化以及HCV相关肝病和移植肾病改善情况的疗效和耐受性。
前瞻性随机对照研究，比较每日1000mg利巴韦林（n=7）、每日1000mg利巴韦林联合每日200mg金刚烷胺（n=8）治疗12个月与不治疗（对照组，n=26）的效果。结果采用意向性分析进行评估。
治疗组在肝酶、HCV病毒血症、肝脏组织学和肾脏参数方面未发现显著差异。然而，抗病毒治疗受贫血限制，导致大多数患者提前退出治疗并需要用重组促红细胞生成素替代。积极治疗耐受性的最佳预测指标是肌酐清除率>50ml/min。
对于慢性HCV复制的肾移植患者，利巴韦林联合金刚烷胺似乎并不优于利巴韦林单药治疗。然而，这可能部分归因于利巴韦林和金刚烷胺在肾功能受损患者中耐受性差，导致患者退出和药物剂量未达治疗水平。
