用聚乙二醇化干扰素α治疗的具有非活性HBsAg载体的受试者中

StephenW

A Potent HBsAg Response in Subjects with Inactive HBsAg Carrier Treated with Pegylated-interferon Alpha
Authors
Zhenhuan Cao1†, MD, Yali Liu1†, MD, Lina Ma1, BS, Junfeng Lu1, MD, Yi Jin1, MS, Shan Ren1,MD, Zhimin He1, BS, Chengli Shen2*, MD Ph.D., Xinyue Chen1*, MS
†Those authors contributed equally to this work
1International Medical Department, Beijing Youan Hospital, Capital Medical University, Beijing,
100069 China
2Section  on  Biomarkers  and  Prediction  Modeling,  Department  of  Medicine,  University  of
Pittsburgh, Pittsburgh, PA, 15261 USA

    Accepted manuscript online: 13 April 2017Full publication history
    DOI: 10.1002/hep.29213  View/save citation
    Cited by (CrossRef): 0 articles Check for updates

Abstract

Background: HBsAg clearance represents a clinical cure although the clearance rate is extremely low. The aim of this study was to evaluate the feasibility and safety profiles of pegylated-interferon α-2a (PEG-IFNα-2a) as a therapeutic option for inactive HBsAg carriers (IHCs). Methods: 144 IHCs were enrolled and divided into a therapeutic group (102 subjects) and control group (42 subjects). PEG-IFNα-2a and PEG-IFNα-2a combined with Adefovir Dipivoxil (ADV) were used for treatment group subjects with hepatitis B virus (HBV) DNA <20 IU/mL and 20 IU/mL≤HBV DNA<2000 IU/mL, respectively. Total therapy duration was no more than 96 weeks. HBsAg clearance and seroconversion rates at the therapeutic week 48 and 96 were used to evaluate the therapeutic efficacy. Results: Per-protocol (PP) analysis showed that HBsAg clearance rate and seroconversion rate in the treatment group were 29.8% and 20.2% at week 48, increased to 44.7% and 38.3% at week 96. However, the HBsAg clearance rate in control group was 2.4% at weeks 48 and 96, and no subject achieved seroconversion. The quantitative HBsAg levels and the changes during the early period of treatment (at week 12 and week 24), alanine transaminase (ALT) elevation at week 12 were strong predictors of HBsAg clearance. The adverse events were similar to the treatment for chronic hepatitis B patients.

Conclusion: High rates of HBsAg clearance and seroconversion could achieve by PEG-IFN α-2a based treatments and the treatments were relatively safe for IHCs. This article is protected by copyright. All rights reserved.

StephenW

用聚乙二醇化干扰素α治疗的具有非活性HBsAg载体的受试者中的有效HBsAg反应
作者
陈振华1，李亚莉1，刘丽娜1，李俊峰1，马毅1，靳金1，山仁1，何志敏1，沉志2 ， 女士
†这些作者对这项工作做出了同样的贡献
1国际医学部，首都医科大学北京友安医院，北京，
100069中国
大学医学系生物标志物与预测建模2
匹兹堡匹兹堡，PA，15261 USA

    在线接受手稿：2017年4月13日全文出版历史
    DOI：10.1002 / hep.29213查看/保存引用
    引用（CrossRef）：0篇文章检查更新

抽象

背景：HBsAg清除率是临床治愈，尽管清除率极低。本研究的目的是评估聚乙二醇化干扰素α-2a（PEG-IFNα-2a）作为无活性HBsAg携带者（IHC）的治疗选择的可行性和安全性。方法：纳入144例IHC，分为治疗组（102例）和对照组（42例）。 PEG-IFNα-2a和PEG-IFNα-2a联合阿德福韦酯（ADV）用于乙型肝炎病毒（HBV）DNA <20 IU / mL和20 IU /mL≤HBVDNA <2000 IU / mL的治疗组受试者， 分别。总治疗时间不超过96周。治疗第48周和第96周的HBsAg清除率和血清学转换率用于评估治疗效果。结果：方案（PP）分析显示，治疗组HBsAg清除率和血清转换率在第48周时分别为29.8％和20.2％，第96周时升高至44.7％和38.3％。但是，对照组HBsAg清除率在第48和96周时，组为2.4％，没有受试者达到血清学转换。定量HBsAg水平和治疗早期（第12周和第24周），第12周时丙氨酸转氨酶（ALT）升高的变化是HBsAg清除率的强烈预测因素。不良事件与慢性乙型肝炎患者的治疗相似。

结论：通过PEG-IFNα-2a治疗可以实现高水平的HBsAg清除率和血清学转换，治疗对于IHC相对安全。本文受版权保护。版权所有。