聚乙二醇化干扰素巩固治疗与核苷（t）ide类似物巩固治疗非

StephenW

Pegylated-interferon consolidation treatment versus nucleos(t)ide analogue consolidation treatment in non-cirrhotic hepatitis B patients with hepatitis B e antigen seroconversion: an open-label pilot trial

    Authors
    Authors and affiliations

    Ying ZhouRong YanGuo Qing RuLi Li YuJiong YaoHong WangEmail author

    Ying Zhou
        1
    Rong Yan
        1
    Guo Qing Ru
        2
    Li Li Yu
        2
    Jiong Yao
        3
    Hong Wang
        1Email author

    1.Department of Infectious Diseases, Zhejiang Provincial People’s HospitalPeople’s Hospital Hang Zhou Medical CollegeZhejiangChina
    2.Department of Pathology, Zhejiang Provincial People’s HospitalPeople’s Hospital Hang Zhou Medical CollegeZhejiangChina
    3.Department of Medical Record Statistic Information, Zhejiang Provincial People’s HospitalPeople’s Hospital Hang Zhou Medical CollegeZhejiangChina

Original Article
First Online: 06 June 2019

    59 Downloads

Abstract
Background

The safety of nucleos(t)ide analogue (NA) treatment cessation remains one of the most controversial topics in the management of chronic hepatitis B (CHB) patients. This study investigated the efficiency of 48-week pegylated-interferon (peg-IFN) alfa-2a consolidation therapy on viral relapse after discontinued NA treatment in CHB patients who achieved hepatitis B e antigen (HBeAg) seroconversion for > 1 year.
Methods

NA-treated HBeAg-positive patients who achieved the standard of discontinued NA treatment (i.e. time of HBeAg seroconversion > 1 year) were randomly assigned to receive peg-IFN consolidation (n = 24) treatment or continue original NA therapy (n = 24) for 48 weeks. The treatments were then discontinued, and the patients were observed up to 144 weeks. The primary endpoint was the proportion of patients with viral relapse at week 144 among those who received at least one dose of study drug or had at least one study visit [modified intention-to-treat population (mITT)].
Results

Of the 24 patients who received peg-IFN treatment, 6 (25%) experienced viral relapse and 8 (36.3%) showed HBsAg loss during 96 weeks of treatment-free follow-up. Of the patients who underwent NA consolidation treatment, only 1 (4.3%) of 23 patients showed HBsAg loss and 14 (58.3%) of 24 patients experienced viral relapse during follow-up. HBsAg level decline < 0.25 log10 IU/mL at week 96 was significantly associated with viral relapse.
Conclusion

A 48-week peg-IFN alfa-2a consolidation therapy increased the rate of HBsAg loss and sustained viral replication suppression in HBeAg-positive patients who achieved HBeAg seroconversion for > 1 year after NA treatment discontinuation.
Keywords
Hepatitis B virus Pegylated-interferon alfa-2a Hepatitis B surface antigen Antivirus

StephenW

聚乙二醇化干扰素巩固治疗与核苷（t）ide类似物巩固治疗非乙肝乙型肝炎e抗原血清转换的非肝硬化乙型肝炎患者：开放标签试验

    作者
    作者和附属机构

    周周荣闫国青茹丽李玉炯姚宏王电子书作者

    周莹
        1
    荣妍
        1
    郭庆茹
        2
    李立宇
        2
    囧瑶
        3
    洪宏
        1Email作者

    1.浙江省人民医院感染科，杭州医学院浙江中医院
    2.浙江省人民医院病理科，浙江省杭州医学院人民医院
    3.浙江省人民医院病历统计信息部杭州医学院浙江省人民医院

来源文章
首次在线：2019年6月6日

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抽象
背景

核苷（酸）类似物（NA）治疗停止的安全性仍然是慢性乙型肝炎（CHB）患者管理中最具争议的话题之一。本研究调查了48周聚乙二醇化干扰素（peg-IFN）α-2a巩固治疗对于乙型肝炎e抗原（HBeAg）血清学转换> 1年的CHB患者停用NA治疗后病毒复发的效率。
方法

NA治疗的HBeAg阳性患者达到停用NA治疗标准（即HBeAg血清学转换时间> 1年），随机分配接受peg-IFN巩固治疗（n = 24）或继续原始NA治疗（n = 24）为期48周。然后停止治疗，观察患者长达144周。主要终点是在接受至少一剂研究药物或至少有一次研究访视[改良的意向治疗人群（mITT）]的患者中，第144周病毒复发患者的比例。
结果

在接受peg-IFN治疗的24名患者中，6名（25％）经历了病毒复发，8名（36.3％）在无治疗随访期间显示出HBsAg丢失。在接受NA巩固治疗的患者中，23例患者中只有1例（4.3％）显示HBsAg消失，24例患者中有14例（58.3％）在随访期间出现病毒复发。第96周时HBsAg水平下降<0.25 log10 IU / mL与病毒复发显着相关。
结论

一项为期48周的peg-IFNα-2a巩固治疗增加了HBsAg消失的速度，并在HBaAg阳性患者中持续病毒复制抑制，这些患者在NA治疗中止后达到HBeAg血清学转换> 1年。
关键词
乙型肝炎病毒聚乙二醇化干扰素α-2a乙型肝炎表面抗原抗病毒