当前位置: X-MOL 学术J. Hepatol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characters: a pilot open-lable randomized study
Journal of Hepatology ( IF 25.7 ) Pub Date : 2018-06-01 , DOI: 10.1016/j.jhep.2018.01.037
Shishu Zhu , Hongfei Zhang , Yi Dong , Limin Wang , Zhiqiang Xu , Weiwei Liu , Yu Gan , Hongmei Tang , Dawei Chen , Fuchuan Wang , Pan Zhao

BACKGROUND & AIM Chronic infection with hepatitis B virus (HBV) in children is a serious health problem worldwide. How to treat children with immune-tolerant chronic hepatitis B infection, commonly characterized by hepatitis B e antigen (HBeAg) positivity, high viral load, normal or mildly elevated alanine aminotransferase and no or minimal inflammation in liver histology, remains unresolved. This trial aims to study the benefits of antiviral therapy in children with these characteristics. METHODS This is a pilot open-label randomized controlled study. From May 2014 to April 2015, 69 treatment-naive chronically HBV-infected children, aged 1 to 16 years, who had immune-tolerant characteristics were recruited to this trial and randomly assigned, in a 2:1 ratio, to treatment group and control group. Patients in the treatment group received either interferon-α (IFN) monotherapy or consecutively received IFN monotherapy, combination therapy of IFN and lamivudine (LAM), and LAM therapy alone. All patients were observed until week 96. RESULTS At baseline, epidemiological, biochemical, serological, virological and histological indices were consistent across the treatment and control groups. Of the 46 patients in the treatment group, 73.91% had undetectable serum HBV DNA, 32.61% achieved HBeAg seroconversion and 21.74% lost hepatitis B surface antigen (HBsAg) at the endpoint. No LAM resistance emerged at week 96. In the control group, only one (4.35%) patient underwent spontaneous HBeAg seroconversion and had undetectable serum HBV DNA during observation, and moreover, none developed HBsAg clearance. For all patients, no serious adverse events were observed. CONCLUSION Antiviral treatment with a sequential combination of IFN and LAM resulted in a significant improvement in the rates of undetectable serum HBV DNA, HBeAg seroconversion and HBsAg loss in children with chronic HBV infection and immune-tolerant characteristics. LAY SUMMARY There is a lack of data regarding treatment of immune-tolerant chronic hepatitis B (CHB). It remains unresolved how children with immune-tolerant CHB should be treated. This paper reports the outcomes from a pilot open-label randomized controlled trial on antiviral therapy in children with immune-tolerant characteristics. It shows that a sequential combination of interferon-α and lamivudine was beneficial.

中文翻译:

具有免疫耐受特征的乙型肝炎病毒感染儿童的抗病毒治疗:一项试验性开放标签随机研究

背景与目的 儿童慢性乙型肝炎病毒 (HBV) 感染是世界范围内严重的健康问题。如何治疗具有免疫耐受性慢性乙型肝炎感染的儿童,通常以乙型肝炎e抗原(HBeAg)阳性、病毒载量高、丙氨酸转氨酶正常或轻度升高以及肝脏组织学无炎症或炎症轻微为特征,仍未解决。该试验旨在研究抗病毒治疗对具有这些特征的儿童的益处。方法 这是一项试点开放标签随机对照研究。从 2014 年 5 月至 2015 年 4 月,69 名 1 至 16 岁、具有免疫耐受特征的未治疗过的慢性 HBV 感染儿童被纳入该试验,并以 2:1 的比例随机分配到治疗组和对照组团体。治疗组患者接受干扰素-α(IFN)单药治疗或连续接受干扰素单药治疗、干扰素和拉米夫定(LAM)联合治疗和单独LAM治疗。所有患者都被观察到第 96 周。 结果 在基线时,流行病学、生化、血清学、病毒学和组织学指标在治疗组和对照组中是一致的。治疗组 46 名患者中,73.91% 的患者血清 HBV DNA 检测不到,32.61% 的患者达到 HBeAg 血清学转换,21.74% 的患者在终点时失去乙型肝炎表面抗原(HBsAg)。第96周未出现LAM耐药。对照组仅有1例(4.35%)患者出现自发性HBeAg血清学转换,观察期间血清HBV DNA检测不到,且均未出现HBsAg清除。对于所有患者,没有观察到严重的不良事件。结论 IFN 和 LAM 序贯联合抗病毒治疗显着改善了慢性 HBV 感染和免疫耐受特征儿童的血清 HBV DNA 检测不到率、HBeAg 血清学转换率和 HBsAg 消失率。概述 缺乏关于免疫耐受慢性乙型肝炎 (CHB) 治疗的数据。免疫耐受型 CHB 儿童应如何治疗仍未解决。本文报告了一项针对具有免疫耐受特征的儿童进行抗病毒治疗的试点开放标签随机对照试验的结果。这表明干扰素-α 和拉米夫定的顺序组合是有益的。结论 IFN 和 LAM 序贯联合抗病毒治疗显着改善了慢性 HBV 感染和免疫耐受特征儿童的血清 HBV DNA 检测不到率、HBeAg 血清学转换率和 HBsAg 消失率。概述 缺乏关于免疫耐受慢性乙型肝炎 (CHB) 治疗的数据。免疫耐受型 CHB 儿童应如何治疗仍未解决。本文报告了一项针对具有免疫耐受特征的儿童进行抗病毒治疗的试点开放标签随机对照试验的结果。这表明干扰素-α 和拉米夫定的顺序组合是有益的。结论 IFN 和 LAM 序贯联合抗病毒治疗显着改善了慢性 HBV 感染和免疫耐受特征儿童的血清 HBV DNA 检测不到率、HBeAg 血清学转换率和 HBsAg 消失率。概述 缺乏关于免疫耐受慢性乙型肝炎 (CHB) 治疗的数据。免疫耐受型 CHB 儿童应如何治疗仍未解决。本文报告了一项针对具有免疫耐受特征的儿童进行抗病毒治疗的试点开放标签随机对照试验的结果。这表明干扰素-α 和拉米夫定的顺序组合是有益的。概述 缺乏关于免疫耐受慢性乙型肝炎 (CHB) 治疗的数据。免疫耐受型 CHB 儿童应如何治疗仍未解决。本文报告了一项针对具有免疫耐受特征的儿童进行抗病毒治疗的试点开放标签随机对照试验的结果。这表明干扰素-α 和拉米夫定的顺序组合是有益的。概述 缺乏关于免疫耐受慢性乙型肝炎 (CHB) 治疗的数据。免疫耐受型 CHB 儿童应如何治疗仍未解决。本文报告了一项针对具有免疫耐受特征的儿童进行抗病毒治疗的试点开放标签随机对照试验的结果。这表明干扰素-α 和拉米夫定的顺序组合是有益的。
更新日期:2018-06-01
down
wechat
bug