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. 作者: StephenW 时间: 2017-4-14 11:53
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。