Department of Liver Diseases, National Clinical Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Department of Infectious Diseases, National Clinical Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, 100 Western 4th Ring Middle Road, Beijing, 100039, China.
Hepatol Int. 2024 Apr;18(2):435-448. doi: 10.1007/s12072-023-10631-9. Epub 2024 Feb 20.
Functional cure is difficult to achieve using current antiviral therapies; moreover, limited data are available regarding treatment outcomes in children. This retrospective study aimed to assess the frequency of functional cure among children undergoing antiviral treatment for active chronic hepatitis B (CHB).
A total of 372 children aged 1-16 years, with active CHB were enrolled and underwent either nucleos(t)ide analog monotherapy or combination therapy with interferon-α (IFN-α) for 24-36 months. All children attended follow-up visits every 3 months. Functional cure was defined as evidence of hepatitis B virus (HBV) DNA loss, circulating hepatitis B e antigen (HBeAg) loss/seroconversion, and hepatitis B surface antigen (HBsAg) loss.
After 36 months of antiviral treatment and/or follow-up visits, children with CHB aged 1- < 7 years exhibited higher rates of HBV DNA clearance, HBeAg seroconversion, and HBsAg loss than CHB children ≥ 7-16 years of age (93.75% versus [vs.] 86.21% [p < 0.0001]; 79.30% vs. 51.72% [p < 0.0001]; and 50.78% vs. 12.93% [p < 0.0001], respectively). Longitudinal investigation revealed more rapid dynamic reduction in HBV DNA, HBeAg, and HBsAg levels in children aged 1-7 years than in those aged ≥ 7-16 years with CHB. According to further age-stratified analysis, HBsAg loss rates were successively decreased in children with CHB who were 1- < 3, 3- < 7, 7- < 12, and 12-16 years of age (62.61% vs. 41.13% vs. 25.45% vs. 1.64%, respectively; p < 0.0001) at 36 months. In addition, baseline HBsAg level < 1,500 IU/mL was found to favor disease cure among these pediatric patients. No serious adverse events were observed throughout the study period.
Results of the present study demonstrated that children aged 1- < 7 years, with active CHB can achieve a high functional cure rate by undergoing antiviral therapy compared to those aged ≥ 7 years, who undergo antiviral therapy. These data support the use of antiviral treatment at an early age in children with CHB. However, future prospectively randomized controlled trials are necessary to validate the findings of this study.
目前的抗病毒治疗难以实现功能性治愈；此外，关于儿童治疗结果的数据有限。本回顾性研究旨在评估接受抗病毒治疗的慢性乙型肝炎（CHB）儿童实现功能性治愈的频率。
共纳入 372 名 1-16 岁的慢性乙型肝炎活动期儿童，接受核苷（酸）类似物单药或干扰素-α（IFN-α）联合治疗 24-36 个月。所有儿童均每 3 个月进行一次随访。功能性治愈定义为乙型肝炎病毒（HBV）DNA 丢失、乙型肝炎 e 抗原（HBeAg）丢失/血清转换和乙型肝炎表面抗原（HBsAg）丢失的证据。
经过 36 个月的抗病毒治疗和/或随访，1-<7 岁的慢性乙型肝炎儿童比≥7-16 岁的慢性乙型肝炎儿童表现出更高的 HBV DNA 清除率、HBeAg 血清转换率和 HBsAg 丢失率（93.75%比 86.21%[p<0.0001]；79.30%比 51.72%[p<0.0001]；50.78%比 12.93%[p<0.0001]）。纵向研究显示，1-7 岁儿童的 HBV DNA、HBeAg 和 HBsAg 水平动态下降速度快于≥7-16 岁儿童。根据进一步的年龄分层分析，1-<3 岁、3-<7 岁、7-<12 岁和 12-16 岁的慢性乙型肝炎儿童 HBsAg 丢失率分别为 62.61%、41.13%、25.45%和 1.64%（p<0.0001）。此外，在第 36 个月时，发现基线 HBsAg 水平<1500 IU/mL 有利于这些儿科患者的疾病治愈。整个研究期间未观察到严重不良事件。
本研究结果表明，与接受抗病毒治疗的≥7 岁儿童相比，1-<7 岁、患有慢性乙型肝炎的儿童通过抗病毒治疗可以实现较高的功能性治愈率。这些数据支持在儿童慢性乙型肝炎的早期使用抗病毒治疗。然而，未来有必要进行前瞻性随机对照试验来验证本研究的结果。
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