聚乙二醇干扰素α单药治疗在中国非活动性慢性乙型肝炎病

StephenW

Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers
Fengping Wu  1 , Rui Lu  1 , Yixin Liu  1 , Yikai Wang  1 , Yan Tian  1 , Yaping Li  1 , Mei Li  1 , Wenjun Wang  1 , Xin Zhang  1 , Xiaoli Jia  1 , Shuangsuo Dang  1
Affiliations
Affiliation

    1
    Department of Infectious Diseases, the Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China.

    PMID: 33896094 DOI: 10.1111/liv.14897

Abstract

Background &aims: The effectiveness and safety of peginterferon alpha (peg-IFN-α) monotherapy in inactive hepatitis B virus (HBV) carriers (IHCs) have not been fully evaluated.

Methods: This observational study prospectively enrolled 298 IHCs in China from 2015 to 2019. Participants were given the right to choose to either receive peg-IFN-α monotherapy (treatment group, n=142) or be monitored without treatment (control group, n=156) according to their wishes. The scheduled treatment duration was 48 weeks. All participants were followed up to 72 weeks. The main efficacy endpoint was Hepatitis B surface antigen (HBsAg) clearance at 72 weeks.

Results: Baseline characteristics were similar between both groups. At 72 weeks, intention-to-treat analysis showed that the rates of HBsAg clearance and seroconversion of the treatment group were 47.9% (68/142) and 36.6% (52/142), respectively, which were significantly higher than the HBsAg clearance rate of 1.9% (3/156) and the seroconversion rate of 0.6% (1/156) in the control group (both P < 0.001). Baseline HBV DNA< 20 IU/mL, lower HBsAg levels at baseline, 12 weeks and 24 weeks, alanine aminotransferase elevation at 12 weeks, and greater HBsAg reduction from baseline to 12 weeks and 24 weeks were independent predictors of HBsAg clearance. Generally, the therapy was well tolerated. Only 5 participants discontinued therapy as a result of peg-IFNα-related adverse events.

Conclusion: Peg-IFN-α monotherapy results in high rates of HBsAg clearance and seroconversion and the treatment is safe for IHCs.

Keywords: HBsAg clearance; HBsAg seroconversion; Inactive hepatitis B virus carriers; Peginterferon alpha; safety.

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StephenW

聚乙二醇干扰素α单药治疗在中国非活动性慢性乙型肝炎病毒携带者中的疗效和安全性
吴凤萍1，陆瑞1，刘一欣1，王一凯1，田岩1，李亚平1，李美1，王文俊1，张欣1，小李家1，双锁党1
隶属关系
联系

    1个
    西安交通大学附属第二医院传染病科，陕西西安710004

    PMID：33896094 DOI：10.1111 / liv.14897

抽象的

背景与目的：聚乙二醇干扰素α（peg-IFN-α）单一疗法在非活动性乙型肝炎病毒（HBV）携带者（IHCs）中的有效性和安全性尚未得到充分评估。

方法：这项观察性研究从2015年至2019年在中国前瞻性纳入了298例IHC。参与者有权选择接受peg-IFN-α单药治疗（治疗组，n = 142）或接受不治疗的监测（对照组，n = 156）根据他们的意愿。计划的治疗时间为48周。所有参与者均接受了长达72周的随访。主要功效终点是在72周时清除乙型肝炎表面抗原（HBsAg）。

结果：两组的基线特征相似。在72周时，意向性治疗分析显示，治疗组的HBsAg清除率和血清转化率分别为47.9％（68/142）和36.6％（52/142），显着高于HBsAg清除率对照组的血清转化率为1.9％（3/156），血清转化率为0.6％（1/156）（均P <0.001）。基线HBV DNA <20 IU / mL，基线，12周和24周时HBsAg水平降低，12周时丙氨酸转氨酶升高，基线至12周和24周时HBsAg降低更多是HBsAg清除率的独立预测指标。通常，该疗法具有良好的耐受性。由于peg-IFNα相关的不良事件，只有5名参与者中止了治疗。

结论：Peg-IFN-α单一疗法可导致HBsAg清除和血清转化率高，对IHCs的治疗是安全的。

关键词：HBsAg清除率； HBsAg血清转化；非活动性乙型肝炎病毒携带者；聚乙二醇干扰素α;安全。

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