A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C
A randomized study on Peg-interferon alfa-2a with or without ribavirin in liver transplant recipients with recurrent hepatitis C
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DOI：
10.1016/j.jhep.2006.12.017
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发表时间：
2007-06-01
影响因子：
25.7
通讯作者：
Tisone, Giuseppe
中科院分区：
文献类型：
--
作者：
Angelico, Mario;Petrolati, Alessandra;Tisone, Giuseppe
背景/目的：我们进行了一项关于聚乙二醇化干扰素α-2a(Peg-干扰素α)单一治疗与聚乙二醇化干扰素α联合利巴韦林治疗复发性丙型肝炎的非肝硬变肝移植受者的随机试验。方法：42名在12-96个月前接受丙型肝炎病毒相关性肝硬变的患者随机接受聚乙二醇化干扰素α治疗(每周180微克)或聚乙二醇化干扰素+利巴韦林治疗，直至最大耐受量。=12周时的对数下降)，76%的单一治疗组和71%的联合治疗组(意向治疗)。持续病毒学应答(SVR)分别为8例(38%)和7例(33%)。EVR对两组SVR的阳性预测值分别为50%和47%，阴性预测值均为100%。单药组有6例(包括3例排斥)，联合组有7例(包括1例排斥)。7例和8例患者的聚乙二醇干扰素α剂量分别减少。利巴韦林的平均日剂量为435 mg/d。结论：聚乙二醇化干扰素α-2a联合或不联合利巴韦林可诱导三分之一复发丙型肝炎的移植受者发生SVR，未合并EVR的患者应停止治疗。SVR率低的主要原因是无法维持全剂量的抗病毒药物，以及缺乏利巴韦林的增强作用。(C)2007年欧洲肝脏研究协会。爱思唯尔出版，版权所有。
Background/Aims: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFN alpha) monotherapy vs Peg-IFN alpha and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C.Methods: Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFN alpha monotherapy (180 mu g weekly) or Peg-IFNa and ribavirin, up to the maximum tolerated dose, for 48 weeks.Results: Early virological response (EVR, i.e., HCV-RNA >= 2 log drop at week 12) occurred in 76% of the monotherapy and 71% of the combination groups, respectively (intention-to treat). Sustained virological response (SVR) occurred in 8 (38%) and 7 (33%) patients, respectively. EVR had a positive predictive value for SVR of 50% and 47%, respectively, and a 100% negative predictive value in both groups. Six drop-outs occurred in the monotherapy (including 3 rejections) and 7 in the combination groups (including one rejection). Peg-INF alpha dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day.Conclusions: Peg-IFN alpha-2a, with or without ribavirin, induces SVR in one-third of transplant recipients with recurrent hepatitis C. Treatment cessation is indicated in patients without EVR. The low SVR rate is mainly due to inability to sustain full doses of antivirals and lack of the booster effect of ribavirin. (C) 2007 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.