Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a ± Ribavirin for Chronic Hepatitis C.
Durability of Response in Children Treated With Pegylated Interferon alfa [corrected] 2a ± Ribavirin for Chronic Hepatitis C.
复制标题
接受聚乙二醇干扰素α治疗的儿童的反应持久性[校正] 2a ± 利巴韦林治疗慢性丙型肝炎。
DOI：
10.1097/mpg.0000000000000929
复制
发表时间：
2016
影响因子：
2.9
通讯作者：
Thompson,Bruce
中科院分区：
文献类型：
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作者：
Schwarz,KathleenB;Molleston,JeanP;Jonas,MaureenM;Wen,Jessica;Murray,KarenF;Rosenthal,Philip;Gonzalez-Peralta,ReginoP;Lobritto,StevenJ;Mogul,Douglas;Pavlovic,Vedran;Warne,Charles;Wat,Cynthia;Thompson,Bruce
目的：关于聚乙二醇化干扰素(PEG干扰素)治疗儿童慢性丙型肝炎后应答持续时间的长期数据尚未发表。这项前瞻性、多中心、长期随访(LTFU)研究旨在评估PEDS-C试验中接受PEG干扰素α-2a±利巴韦林(RBV)治疗的儿童持续病毒学应答(SVR)的长期持久性、长期安全性和耐受性，以及IL28B基因与治疗应答的相关性。患者参加了2次研究访问：停止治疗后5年(平均5.6年，范围4.1~6.6)和6年(6.6年，5.1~7.7年)。在这些访问中进行了标准化的病史、体检和实验室检测。结果：LTFU队列是原始PEDS-C队列的代表，因为基线和治疗特征都具有可比性。在38名参与者中，21人在PEDS-C试验期间实现了SVR(应答者)，17人没有(无应答者)。与表现出持续性病毒血症的无反应者相比，所有21名应答者在LTFU期间(实现SVR后4.4-7.0年)都保持了无法检测到的丙型肝炎病毒RNA。IL28B CC基因型与SVR相关(非CC组为67%比30%，P=0.028)。结论：慢性丙型肝炎患儿接受PegIFNα-2a治疗后，SVR的远期耐受性良好；IL28B CC组的SVR高于非CC组。
Objectives:No long-term data have been published on the durability of response following pegylated interferon (PegIFN) treatment in children with chronic hepatitis C. This prospective, multicenter, long-term follow-up (LTFU) study aimed to assess long-term durability of sustained virological response (SVR), long-term safety and tolerability, and the association between IL28B genotype and treatment response, in children previously treated with PegIFN alfa-2a±ribavirin (RBV) in the PEDS-C trial.Methods:A total of 93 patients were assessed for enrollment, and 38 enrolled in the study. Patients attended 2 study visits: 5 (mean 5.6, range 4.1–6.6) and 6 (6.6, 5.1–7.7) years after treatment cessation. Standardized medical history, physical examination, and laboratory testing were performed at these visits. Reminder telephone calls were conducted at 4 and 8 months after the initial visit.Results:The LTFU cohort was the representative of the original PEDS-C cohort because both baseline and treatment characteristics were comparable. Of the 38 participants, 21 achieved SVR (responders) during the PEDS-C trial and 17 had not (nonresponders). All 21 responders maintained undetectable hepatitis C virus RNA during the LTFU (4.4–7.0 years after achieving SVR) in contrast to the nonresponders who demonstrated persistent viremia. IL28B CC genotype was associated with SVR (67% vs 30% in non-CC, P= 0.028).Conclusion:Long-term durability of SVR is excellent following PegIFN alfa-2a treatment in children with chronic hepatitis C; SVR is higher in those with IL28B CC versus non-CC.