慢性乙型肝炎患者停止核苷（酸）类似物治疗后 96 周的临床

StephenW

慢性乙型肝炎患者停止核苷（酸）类似物治疗后 96 周的临床结果
徐文雄 1 2 , 李杨梅 3 , 李建国 1 2 , 梅永玉 1 2 , 陈友明 1 2 , 李雪军 1 2 , 林超双 1 2 , 邓洪1 2 , 赵志新 1 2 , 谢东英 1 2 , 高志良 1 2 , 梁鹏 1 2
隶属关系
隶属关系

    1
    广东省广州市中山大学附属第三医院感染科。
    2
    广东省广州市中山大学附属第三医院肝病研究广东省重点实验室。
    3
    广东省广州市中山大学附属第三医院预防保健科。

    PMID：34567563 PMCID：PMC8460097 DOI：10.1093/gastro/goab013

抽象的

背景：慢性乙型肝炎（CHB）患者在停止核苷（酸）类似物（NA）治疗后病毒学复发率很高，但临床结果仍不清楚。本研究旨在调查停用 NAs 后 CHB 复发的 96 周临床结果和危险因素。

方法：本研究是一项前瞻性试验；招募了 74 名符合条件的患者。根据 2012 年亚太肝脏研究协会指南，患者接受了 NA 停用和随访。症状、生化（天冬氨酸转氨酶 [AST]、丙氨酸转氨酶 [ALT]、总胆红素、尿素氮、肌酐）、病毒学数据（乙肝表面抗原 [HBsAg]、乙肝 e 抗原 [HBeAg]、乙肝 e 抗体 [HBeAb] ]、乙型肝炎病毒 [HBV] DNA 水平）和彩色多普勒超声检查结果被记录和分析。

结果：停用NA后，19例HBsAg阴性，随访96周无复发。在 55 例停用后 HBsAg 阳性的病例中，观察到四种类型的临床结果。 96 周随访期间 12 名患者未复发（A 型，21.8%），7 名患者发生病毒学复发但自发地出现非病毒学复发（B 型，12.7%），10 名患者保持病毒学复发（C 型） , 18.2%)，26 例患者转为临床复发，接受 NA 再治疗，并在 12 个月内达到 ALT 正常化和 HBV DNA 转阴（D 型，47.3%）。病毒学和临床复发的 2 年总体累积率分别为 58.1% 和 24.3%。与病毒学复发相关的独立因素是 HBV DNA 阴性持续时间、EOT（治疗结束）HBsAg 和 HBeAg 的原始状态。 EOT HBsAg 也是临床复发的独立因素。

结论：慢乙肝患者停止 NA 治疗后有四种临床结局。需要进一步的研究来探索不同临床结果的机制。 EOT HBsAg 水平是与病毒学和临床复发相关的独立因素。

关键词：停止；慢性乙型肝炎;乙型肝炎病毒;核苷（酸）类似物；复发。

© The Author(s) 2021. 牛津大学出版社和中山大学附属第六医院出版。

StephenW

The 96-week clinical outcomes after cessation of nucleos(t)ide analog treatment in chronic hepatitis B patients
Wen-Xiong Xu  1   2 , Yang-Mei Li  3 , Jian-Guo Li  1   2 , Yong-Yu Mei  1   2 , You-Ming Chen  1   2 , Xue-Jun Li  1   2 , Chao-Shuang Lin  1   2 , Hong Deng  1   2 , Zhi-Xin Zhao  1   2 , Dong-Ying Xie  1   2 , Zhi-Liang Gao  1   2 , Liang Peng  1   2
Affiliations
Affiliations

    1
    Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
    2
    Guangdong Key Laboratory of Liver Disease Research, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.
    3
    Department of Prevention and Health Care, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China.

    PMID: 34567563 PMCID: PMC8460097 DOI: 10.1093/gastro/goab013

Abstract

Background: Chronic hepatitis B (CHB) patients have a high virological relapse rate after cessation of nucleos(t)ide analog (NA) treatment, but the clinical outcome remains unclear. This study aimed to investigate the 96-week clinical outcomes and the risk factors for relapse in CHB after cessation of NAs.

Methods: This study was a prospective trial; 74 eligible patients were enrolled. The patients underwent NA cessation and follow-up according to the 2012 Asian Pacific Association for the Study of the Liver Guideline. Symptoms, biochemical (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, urea nitrogen, creatinine), virological data (hepatitis B surface antigen [HBsAg], hepatitis B e antigen [HBeAg], hepatitis B e antibody [HBeAb], hepatitis B virus [HBV] DNA levels), and color Doppler ultrasound examination results were recorded and analysed.

Results: After NA cessation, 19 cases were HBsAg-negative without relapse during the 96-week follow-up. Of the 55 cases of HBsAg-positive after cessation, four types of clinical outcomes were observed. Twelve patients had no relapse during the 96-week follow-up (type A, 21.8%), 7 patients underwent virological relapses but spontaneously had a non-virological relapse (type B, 12.7%), 10 patients maintained virological relapse (type C, 18.2%), and 26 patients turned to clinical relapse, received NA retreatment, and achieved ALT normalization and negative conversion of HBV DNA within 12 months (type D, 47.3%). The 2-year overall cumulative rates of virological and clinical relapses were 58.1% and 24.3%, respectively. Independent factors associated with virological relapse were duration of negative HBV DNA, EOT (end of treatment) HBsAg, and original status of HBeAg. The EOT HBsAg was also an independent factor for clinical relapse.

Conclusions: There are four types of clinical outcomes in patients with CHB after cessation of NA treatment. Further research is needed to explore the mechanism of different clinical outcomes. The EOT HBsAg level is an independent factor associated with both virological and clinical relapse.

Keywords: cessation; chronic hepatitis B; hepatitis B virus; nucleos(t)ide analogs; relapse.

© The Author(s) 2021. Published by Oxford University Press and Sixth Affiliated Hospital of Sun Yat-sen University.

StephenW

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