Angelico Mario, Petrolati Alessandra, Lionetti Raffaella, Lenci Ilaria, Burra Patrizia, Donato Maria Francesca, Merli Manuela, Strazzabosco Mario, Tisone Giuseppe
Hepatology Unit, Tor Vergata University, Rome, Italy.
J Hepatol. 2007 Jun;46(6):1009-17. doi: 10.1016/j.jhep.2006.12.017. Epub 2007 Feb 5.
BACKGROUND/AIMS: We performed a randomized trial on pegylated interferon alfa-2a (Peg-IFNalpha) monotherapy vs Peg-IFNalpha and ribavirin in non-cirrhotic liver transplant recipients with recurrent hepatitis C.
Forty-two patients transplanted for HCV-related cirrhosis 12-96 months earlier were randomized to Peg-IFNalpha monotherapy (180 microg weekly) or Peg-IFNalpha and ribavirin, up to the maximum tolerated dose, for 48 weeks.
Early virological response (EVR, i.e., HCV-RNA2 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-INFalpha dose was reduced in 7 and 8 patients, respectively. The average daily dose of ribavirin was 435 mg/day.
Peg-IFNalpha-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.
背景/目的：我们对聚乙二醇化干扰素α-2a（Peg-IFNα）单药治疗与Peg-IFNα联合利巴韦林治疗复发性丙型肝炎的非肝硬化肝移植受者进行了一项随机试验。
42例在12 - 96个月前因丙型肝炎相关肝硬化接受移植的患者被随机分为Peg-IFNα单药治疗组（每周180微克）或Peg-IFNα联合利巴韦林组，直至最大耐受剂量，治疗48周。
分别有76%的单药治疗组和71%的联合治疗组出现早期病毒学应答（EVR，即第12周时HCV-RNA下降2个对数）（意向性治疗分析）。持续病毒学应答（SVR）分别出现在8例（38%）和7例（33%）患者中。EVR对SVR的阳性预测值分别为50%和47%，两组的阴性预测值均为100%。单药治疗组有6例退出（包括3例排斥反应），联合治疗组有7例退出（包括1例排斥反应）。分别有7例和8例患者减少了Peg-INFα剂量。利巴韦林的平均日剂量为435毫克/天。
Peg-IFNα-2a无论是否联合利巴韦林，均可使三分之一的复发性丙型肝炎移植受者获得SVR。无EVR的患者应停止治疗。SVR率低主要是由于无法维持全剂量抗病毒药物以及缺乏利巴韦林的增强作用。
