The Fifth Medical Center (formerly Beijing 302 Hospital), Chinese PLA General Hospital, Beijing 100039, China.
Medical Statistics Section, Academy of Military Medical Sciences, Beijing 100850, China.
J Hepatol. 2019 Nov;71(5):871-875. doi: 10.1016/j.jhep.2019.06.009. Epub 2019 Jun 20.
BACKGROUND & AIM: There is a paucity of data regarding antiviral therapy in hepatitis B virus (HBV)-infected infants aged <1 year who have elevated alanine aminotransferase. This study aims to assess the efficacy and safety of antiviral therapy initiated in infancy.
A real-world cohort study was conducted from January 2010 to December 2017. HBV-infected infants under 1 year of age, with persistent elevation of alanine aminotransferase and high viral load, were recruited and divided into 2 groups. Group I included 18 infants whose parents chose to initiate antiviral therapy with lamivudine before 1 year of age. Group II included 11 infants whose parents chose to initiate antiviral therapy with interferon-α after 1 year of age and not to receive any antiviral therapies before 1 year of age. The main outcome measure was rate of serum HBV surface antigen (HBsAg) loss at month 12 of treatment.
There were no statistical differences between Groups I and II regarding baseline characteristics. No infants in Group II developed spontaneous HBsAg loss before 1 year of age. In Group I, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were 39%, 67%, 78% and 83%, respectively. In Group II, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were 18%, 27%, 27% and 36%, respectively. Statistical differences existed in the cumulative rates of HBsAg loss between the 2 groups (log-rank test, p = 0.0023). No serious adverse events occurred in the study.
Early initiation of antiviral therapy for infantile-onset hepatitis B contributes to a rapid and significant loss of HBsAg. Further trials with larger cohorts are needed to verify our results.
Chronicity is a serious threat to infants infected with hepatitis B. However, no treatment measure has been recommended for infantile-onset hepatitis B in current guidelines. In order to evaluate the benefit and safety of antiviral therapy in infantile-onset hepatitis B, a real-world cohort study was conducted. Long-term follow-up results showed that early initiation of antiviral therapy with lamivudine safely led to a rapid and significant loss of serum hepatitis B surface antigen in the present subset of infants with alanine aminotransferase ≥2× upper limit of normal. Further trials with larger cohorts are needed.
对于 <1 岁且丙氨酸氨基转移酶（ALT）持续升高的乙型肝炎病毒（HBV）感染婴儿，抗病毒治疗的数据有限。本研究旨在评估婴儿期开始的抗病毒治疗的疗效和安全性。
本研究为 2010 年 1 月至 2017 年 12 月的真实世界队列研究。招募了年龄 <1 岁，ALT 持续升高且病毒载量较高的 HBV 感染婴儿，并将其分为两组。I 组包括 18 名在 1 岁前选择使用拉米夫定进行抗病毒治疗的婴儿。II 组包括 11 名在 1 岁后选择使用干扰素-α进行抗病毒治疗且在 1 岁前未接受任何抗病毒治疗的婴儿。主要观察指标为治疗第 12 个月时血清 HBV 表面抗原（HBsAg）丢失率。
两组患儿基线特征无统计学差异。II 组无婴儿在 1 岁前自发 HBsAg 丢失。I 组治疗第 3、6、9 和 12 个月时 HBsAg 丢失的累积率分别为 39%、67%、78%和 83%。II 组治疗第 3、6、9 和 12 个月时 HBsAg 丢失的累积率分别为 18%、27%、27%和 36%。两组 HBsAg 丢失的累积率存在统计学差异（对数秩检验，p=0.0023）。研究中未发生严重不良事件。
婴儿期开始抗病毒治疗有助于 HBsAg 快速显著丢失。需要更大队列的进一步试验来验证我们的结果。
本研究旨在评估婴儿期开始的抗病毒治疗的疗效和安全性。结果显示，婴儿期开始抗病毒治疗可以显著提高 HBsAg 丢失率，且安全性良好。但本研究为单中心、回顾性研究，存在一定局限性，需要更大规模的前瞻性研究来进一步验证。
