Department of Hepatology, The Second People's Hospital of Yunnan Province, Kunming, China.
J Viral Hepat. 2019 Jul;26 Suppl 1:69-76. doi: 10.1111/jvh.13154.
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'.
在慢性乙型肝炎（CHB）儿童中，通过安全有效的抗病毒治疗实现“临床治愈”是未满足的医疗需求。聚乙二醇干扰素（PegIFN）对乙型肝炎表面抗原（HBsAg）的清除率高于核苷类似物（NUC）。目前，中国儿童 CHB 干扰素（IFN）治疗的研究相对较少。本研究旨在进一步探讨 PegIFNα-2a 作为抗病毒治疗在我国儿童中的疗效，并分析停药后的长期随访情况。我们纳入了 2009 年 2 月至 2015 年 2 月作者在昆明市第三人民医院治疗的 118 例 CHB 患儿（2-16 岁，79 例为男性），采用 PegIFNα-2a 治疗。疗程为 52 周，随访期为 104 周。所有患者均至少接受 1 剂治疗，其中 104 例完成至少 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。停药时 HBeAg 清除率和血清学转换率分别为 53.8%和 49%，停药结束时分别为 72.1%和 72.1%，持续应答率分别为 98.2%和 98%。停药时 HBsAg 清除率和血清学转换率分别为 48.1%和 47.1%，停药结束时分别为 53.8%和 52.9%，持续应答率分别为 94%和 95.9%。停药时 HBV DNA 抑制率为 89.4%，停药结束时为 90.4%，持续应答率为 97.8%。2 例患者在随访期间发生病毒学复发（2.3%），但未发生临床复发。多因素回归分析显示，基因型 B、体重<25kg 或 25-45kg 以及治疗 24 周后 HBsAg 减少>1log 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反应与以往 PegIFN 临床研究报道的相似。本研究结果表明，PegIFN 治疗 CHB 儿童安全有效，治疗后可获得持续应答。PegIFN 治疗 CHB 有助于更多患儿实现“临床治愈”。
