HBeAg 阴性慢性乙型肝炎患者 HBsAg 联合治疗消失的真实世界研

StephenW

HBeAg 阴性慢性乙型肝炎患者 HBsAg 联合治疗消失的真实世界研究
朱俊昊 1 , 黄炎 2 , 谢东英 1 3 4 , 邓宏 1 3 4 , 贾伟 5 , 关玉娟 6 , 李国军 7 , 曾宜兰 8 , 杨家宏9、陈新月 10、贾尚 11、李家斌 12、高娜 1、高志良 1 3 4
隶属关系
隶属关系

    1
    中山大学第三附属医院感染科，广东广州 510630
    2
    中南大学湘雅医院感染科,湖南长沙 410008
    3
    中山大学附属第三医院广东省肝病研究重点实验室,广东广州 510630
    4
    教育部热带病防治重点实验室(中山大学), 广州, 广东 510080
    5
    云南省第二人民医院消化内科，云南昆明 650021
    6
    广州市第八人民医院肝内科，广东广州 510440
    7
    深圳市第三人民医院肝内科，广东深圳 518112
    8
    成都公共卫生临床医学中心肝病科，四川 成都 610066
    9
    德阳市人民医院感染科，四川德阳 618099
    10
    首都医科大学北京佑安医院肝内科,北京 100069
    11
    河南省人民医院感染科，河南郑州 450003
    12
    安徽医科大学第一附属医院感染科,安徽合肥 230022

    PMID：35718996 DOI：10.1111/jvh.13722

抽象的

聚乙二醇干扰素 (PEG-IFN) 和核苷（酸）类似物 (NAs) 的联合治疗可增强乙型肝炎表面抗原 (HBsAg) 的清除。然而，具体的治疗策略和受益最多的患者尚不清楚。因此，我们评估了附加 PEG-IFN 的 HBsAg 丢失率，并探讨了与慢性乙型肝炎 (CHB) 患者 HBsAg 丢失相关的因素。这是一项针对慢性乙型肝炎成人的真实世界队列研究。基线 HBsAg ≤ 1,500 IU/mL 和 HBV DNA < 检测下限或 100 IU/mL 的乙型肝炎 e 抗原 (HBeAg) 阴性 NAs 治疗的患者接受了 48 周的附加 PEG-IFN。该研究的主要结果是联合治疗 48 周时 HBsAg 的消失率。使用多变量逻辑回归分析，我们确定了与 HBsAg 消失相关的因素。在 48 周时，2,579 名患者（平均年龄：41.2 岁；80.9% 为男性）的 HBsAg 消失率为 36.7%（947 名患者）。中国中南部和西南地区的患者 HBsAg 消失率最高（40.0%）。与 HBsAg 消失独立相关的因素包括：年龄增加（优势比 = 0.961）；是男性（0.543）；基线 HBsAg 水平 (0.216)； 12 周时 HBsAg 下降（介于 0.5 和 1.0 log10 IU/mL [2.405] 和 > 1.0 log10 IU/mL [7.370]）； 12 周时丙氨酸氨基转移酶 (ALT) 升高 (1.365)； 12 周时血红蛋白 (HGB) 下降 (1.558)。与联合方案相关的主要结果没有差异。总之，中国南方患者通过联合治疗的 HBsAg 消失率高于北方患者。 HBsAg 消失的机会增加与基线特征和临床指标的动态变化有关。

关键词：HBsAg 丢失；乙型肝炎，慢性；联合治疗；核苷（酸）类似物；聚乙二醇干扰素。

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StephenW

Real-world study on HBsAg loss of combination therapy in HBeAg-negative chronic hepatitis B patients
Jun-Hao Chu  1 , Yan Huang  2 , Dong-Ying Xie  1   3   4 , Hong Deng  1   3   4 , Jia Wei  5 , Yu-Juan Guan  6 , Guo-Jun Li  7 , Yi-Lan Zeng  8 , Jia-Hong Yang  9 , Xin-Yue Chen  10 , Jia Shang  11 , Jia-Bin Li  12 , Na Gao  1 , Zhi-Liang Gao  1   3   4
Affiliations
Affiliations

    1
    Department of Infectious Diseases, the Third Affiliated Hospital, Sun Yat-Sen University, Guandong 510630, Guangzhou, China.
    2
    Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, Hunan 410008, China.
    3
    Guandong Key Laboratory of Liver Disease Reaserch , the Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guandong 510630, China.
    4
    Key Laboratory of Tropical Disease Control (Sun Yat-Sen University) , Minsitry of Education, Guangzhou , Guandong 510080, China.
    5
    Department of Gastroenterology, the Second People's Hospital Yunnan Province, Kunming, Yunnan 650021, China.
    6
    Department of Hepatology, Guangzhou Eighth People's Hospital, Guangzhou, Guandong 510440, China.
    7
    Department of Hepatology , Shenzhen Third People's Hospital, Shenzhen, Guandong 518112, China.
    8
    Department of Hepatology, Chengdu Public Health Clinical Medical Center, Chendu, Sichuan 610066, China.
    9
    Department of Infectious Diseases, Deyang people's Hospital, Deyang, Sichuan 618099, China.
    10
    Department of Hepatology , Beijing You'an Hospital, Capital Medical University, Beijing 100069, China.
    11
    Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan 450003, China.
    12
    Department of Infectious Diseases, First Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230022, China.

    PMID: 35718996 DOI: 10.1111/jvh.13722

Abstract

Combination therapy with pegylated interferon (PEG-IFN) and nucleos(t)ide analogs (NAs) can enhance hepatitis B surface antigen (HBsAg) clearance. However, the specific treatment strategy and the patients who would benefit the most are unclear. Therefore, we assessed the HBsAg loss rate of add-on PEG-IFN and explored the factors associated with HBsAg loss in chronic hepatitis B (CHB) patients. This was a real-world cohort study of adults with CHB. Hepatitis B e antigen (HBeAg)-negative NAs-treated patients with baseline HBsAg ≤ 1,500 IU/mL and HBV DNA < the lower limit of detection, or 100 IU/mL, received 48 weeks of add-on PEG-IFN. The primary outcome of the study was the rate of HBsAg loss at 48 weeks of combination treatment. Using multivariable logistic regression analysis, we determined factors associated with HBsAg loss. HBsAg loss in 2,579 patients (mean age: 41.2 years; 80.9% male) was 36.7% (947 patients) at 48 weeks. HBsAg loss was highest in patients from south-central and southwestern China (40.0%). Factors independently associated with HBsAg loss included: increasing age (odds ratio = 0.961); being male (0.543); baseline HBsAg level (0.216); HBsAg decrease at 12 weeks (between 0.5 and 1.0 log10 IU/mL [2.405] and > 1.0 log10 IU/mL [7.370]); alanine aminotransferase (ALT) increase at 12 weeks (1.365); hemoglobin (HGB) decrease at 12 weeks (1.558). There was no difference in the primary outcomes associated with the combination regimen. In conclusion, HBsAg loss by combination therapy was higher in patients from southern China than those from the north. An increased chance of HBsAg loss was associated with baseline characteristics and dynamic changes in clinical indicators.

Keywords: HBsAg loss; Hepatitis B, chronic; combination therapy; nucleos(t)ide analogs; pegylated interferon.

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