干扰素与联合用药方案在功能性治愈后96周时中国乙型肝炎患

StephenW

Outcome of Chinese Patients with Hepatitis B at 96 Weeks after Functional Cure With IFN versus Combination Regimens
Calvin Q Pan  1   2 , Ming-Hui Li  3   4 , Wei Yi  5 , Lu Zhang  3 , Yao Lu  3 , Hong-Xiao Hao  3 , Gang Wan  6 , Wei-Hua Cao  3 , Xing-Yue Wang  3 , Chong-Ping Ran  3 , Ge Shen  3 , Shu-Ling Wu  3 , Min Chang  3 , Yuan-Jiao Gao  3 , Yao Xie  3   4
Affiliations
Affiliations

    1
    Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
    2
    Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Health, New York University School of Medicine, New York, NY, USA.
    3
    Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
    4
    Department of Hepatology Division 2, Peking University Ditan Teaching Hospital, Beijing, China.
    5
    Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
    6
    Department of Medical and Biological Statistics, Beijing Ditan Hospital, Capital Medical University, Beijing, China.

    PMID: 33486874 DOI: 10.1111/liv.14801

Abstract

Background & aims: Nucleotides with add-on interferon treatment (NUC-IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.

Methods: Patients with CHB who achieved HBsAg loss and HBV DNA levels <20 IU/mL after IFN or NUC-IFN therapy were enrolled and followed up for 96 weeks. The primary outcome was HBsAg negativity without viremia at week 96. Secondary outcomes included virological or clinical relapse and predictors of relapse.

Results: 420 patients were included in intention-to-treat analysis with 290 and 130 in the IFN and NUC-IFN groups, respectively. At week 96, the intention-to-treat analyss revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, p=0.70), viremia (16.90% vs. 13.08%, p=0.32) and clinical relapse (11.38% vs. 10.00%, p=0.68); the per-protocol analyses also showed HBsAg seroreversion, viremia and clinical relapse in IFN group (15.50%, 6.59% and 0.39&) did not differ from those in NUC-IFN group (15.25%, 4.24% and 0.85%, p>0.05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC-IFN-treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero-reversion and recurrence of viremia in IFN treated group.

Conclusion: NUC-IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399).

Keywords: HBsAg seroreversion; clinical relapse; hepatitis B flare; virological relapse.

This article is protected by copyright. All rights reserved.
Associated data

    ClinicalTrials.gov/NCT02336399

StephenW

干扰素与联合用药方案在功能性治愈后96周时中国乙型肝炎患者的结果
潘文Q 1 2，李明慧3 4，魏毅5，陆章3，姚璐3，郝洪晓3，港湾6，曹卫华3，王兴岳3，崇平冉3，葛申3，吴淑玲3，闵昌3，高元娇3，姚Yao 3 4
隶属关系
隶属关系

    1个
    首都医科大学附属北京地坛医院肝病研究中心，北京100015
    2
    美国纽约大学医学院纽约大学朗格健康分校消化内科和肝病科。
    3
    首都医科大学附属北京地坛医院肝病科2
    4
    北京大学地坛教学医院第二医院肝科
    5
    首都医科大学附属北京地坛医院妇产科，北京
    6
    首都医科大学附属北京地坛医院医学与生物统计学教研室，北京

    PMID：33486874 DOI：10.1111 / liv.14801

抽象

背景与目的：联合干扰素治疗的核苷酸（NUC-IFN）在慢性乙型肝炎（CHB）患者中提供更高的乙型肝炎表面抗原（HBsAg）丢失率。这项研究旨在调查HBsAg丢失的可持续性和预防临床复发。

方法：招募了接受IFN或NUC-IFN治疗后达到HBsAg丧失且HBV DNA水平<20 IU / mL的CHB患者，并随访96周。主要结果是在第96周时无病毒血症的HBsAg阴性。次要结果包括病毒学或临床复发以及复发的预测因子。

结果：420名患者被纳入意向性治疗分析，其中IFN和NUC-IFN组分别为290和130。在第96周时，意向性治疗分析显示各组之间的结局相似，包括HBsAg血清逆转（24.83％vs. 23.08％，p = 0.70），病毒血症（16.90％vs. 13.08％，p = 0.32）和临床复发（ 11.38％和10.00％，p = 0.68）；按方案分析还显示，IFN组（15.50％，6.59％和0.39＆）的HBsAg血清逆转，病毒血症和临床复发与NUC-IFN组（15.25％，4.24％和0.85％）无差异，p> 0.05 ）。在联合治疗之前，接受恩替卡韦治疗的患者与接受替比夫定/拉米夫定/阿德福韦治疗的患者的这些结果相似。在用NUC-IFN治疗的患者中，在第96周观察到纤维化消退。在IFN治疗组中，基线HBsAb阴性是HBsAg血清逆转和病毒血症复发的独立预测因子。

结论：NUC-IFN和IFN治疗在实现持续的功能治愈和纤维化消退方面同样有效。 （ClinicalTrials.gov，编号NCT02336399）。

关键字：HBsAg血清逆转；临床复发；乙肝爆发；病毒学复发。

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关联数据

    ClinicalTrials.gov/NCT02336399

newchinabok

干挠素不良反应让人很痛苦，真的需要毅志和精神，65岁以上不建议打干挠素。基础疾病和老年疾病多，打死了个球