聚乙二醇干扰素治疗HBeAg阳性慢性乙型肝炎患儿的远期疗效和

StephenW

J Viral Hepat. 2019 Jul;26 Suppl 1:69-76. doi: 10.1111/jvh.13154.
Long-term efficacy and safety of peginterferon in the treatment of children with HBeAg-positive chronic hepatitis B.
Liu Y1, Li H1, Yan X1, Wei J1.
Author information

1
    Department of Hepatology, The Second People's Hospital of Yunnan Province, Kunming, China.

Abstract

Achieving 'clinical cure' in children with chronic hepatitis B (CHB) with safe and effective antiviral treatment is an unmet medical need. Peginterferon (PegIFN) has higher hepatitis B s antigen (HBsAg) clearance than nucleoside analogs (NUC). Currently, studies on interferon (IFN) in the treatment of Chinese children with CHB are relatively rare. This study aimed to further explore the efficacy of PegIFNα-2a as an antiviral treatment in Chinese children and analyse the long-term follow-up after drug discontinuation. We enrolled 118 patients with CHB (2-16 years old, 79 cases are males) treated with PegIFNα-2a by the author in the Third People's Hospital of Kunming City from February 2009 to February 2015. The course of treatment was 52 weeks, with a follow-up period of 104 weeks. All the patients completed at least 1 dose, of which 104 completed at least 36 weeks of treatment and 104 weeks of follow-up. During treatment and follow-up, indicators such as alanine aminotransferase (ALT), hepatitis B virus (HBV) DNA and HBV serological markers were monitored, and the efficacy and safety of PegIFNα-2a in the treatment of CHB patients were observed. Hepatitis B e antigen (HBeAg) clearance and seroconversion rates were 53.8% and 49%, respectively, when the drug was discontinued; 72.1% and 72.1%, respectively, at the end of the follow-up; and 98.2% and 98%, respectively, for sustained response. HBsAg clearance and seroconversion rates were 48.1% and 47.1%, respectively, when the drug was discontinued; 53.8% and 52.9%, respectively, at the end of the follow-up; and 94% and 95.9%, respectively, for sustained response. The HBV DNA suppression rate was 89.4% when the drug was discontinued, 90.4% at the end of the follow-up and 97.8% for sustained response. Two patients had virological relapse (2.3%) during follow-up; however, no clinical relapse occurred. Multivariate regression analysis showed that genotype B, weight < 25 kg or between 25 and 45 kg, and reduction of HBsAg by more than 1 log following 24 weeks of treatment were independent predictors of HBsAg clearance at the end of follow-up. Adverse events that occurred during treatment were similar to those reported in previous clinical studies on PegIFN. The results of this study showed that PegIFN was safe and effective in the treatment of children with CHB, and sustained response could be achieved after treatment. PegIFN treatment of children with CHB helps more achieve 'clinical cure'.

© 2019 John Wiley & Sons Ltd.
KEYWORDS:

children; chronic hepatitis B; efficacy and safety; peginterferon α-2a

PMID:
    31380585
DOI:
    10.1111/jvh.13154

StephenW

J病毒肝病。 2019年7月; 26增刊1：69-76。 doi：10.1111 / jvh.13154。
聚乙二醇干扰素治疗HBeAg阳性慢性乙型肝炎患儿的远期疗效和安全性
Liu Y1，Li H1，Yan X1，Wei J1。
作者信息

1
云南省第二人民医院肝病科，昆明。

抽象

通过安全有效的抗病毒治疗实现慢性乙型肝炎（CHB）患儿的“临床治愈”是一项尚未得到满足的医疗需求。聚乙二醇干扰素（PegIFN）具有比核苷类似物（NUC）更高的乙型肝炎抗原（HBsAg）清除率。目前，干扰素（IFN）治疗中国儿童CHB的研究相对较少。本研究旨在进一步探讨PegIFNα-2a作为中国儿童抗病毒治疗的疗效，并分析药物停药后的长期随访情况。 2009年2月至2015年2月，作者在昆明市第三人民医院接受了用PegIFNα-2a治疗的118例CHB患者（2-16岁，79例为男性）。治疗过程为52周，随访期为104周。所有患者至少完成1次剂量，其中104次完成至少36周的治疗和104周的随访。在治疗和随访期间，监测丙氨酸氨基转移酶（ALT），乙型肝炎病毒（HBV）DNA和HBV血清学标志物等指标，观察PegIFNα-2a治疗CHB患者的疗效和安全性。药物停药后，乙型肝炎e抗原（HBeAg）清除率和血清转换率分别为53.8％和49％;随访结束时分别为72.1％和72.1％;持续反应分别为98.2％和98％。药物停药后，HBsAg清除率和血清转换率分别为48.1％和47.1％;随访结束时分别为53.8％和52.9％;持续反应分别为94％和95.9％。药物停药时HBV DNA抑制率为89.4％，随访结束时为90.4％，持续应答为97.8％。两名患者在随访期间病毒学复发（2.3％）;然而，没有发生临床复发。多变量回归分析显示，基因型B，体重<25 kg或25至45 kg，以及治疗24周后HBsAg降低超过1 log是随访结束时HBsAg清除的独立预测因子。治疗期间发生的不良事件与先前PegIFN临床研究中报道的相似。本研究结果表明，PegIFN治疗CHB患儿安全有效，治疗后可持续缓解。对患有CHB的儿童进行PegIFN治疗有助于更多地实现“临床治愈”。

©2019 John Wiley＆Sons Ltd.
关键词：

慢性乙型肝炎;功效和安全;聚乙二醇干扰素α-2a

结论：
31380585
DOI：
10.1111 / jvh.13154