处于慢性乙型肝炎病毒（HBV）感染免疫耐受（IT）期的患者是否应该接受抗病毒治疗并确定最佳治疗方案的问题仍不清楚。对 PubMed、Embase、MEDLINE、Cochrane 图书馆和万方数据从建立到 2023 年 12 月 5 日期间进行了全面检索。报告包括慢性 HBV 感染 IT 阶段患者的 HBV DNA 不可检测、HBeAg 消失或血清转换、HBsAg 消失或血清转换以及肝细胞癌 (HCC) 发病率等关键结果的研究。总共纳入了 23 项研究。在 48 周的随访中，大约 4% 的 IT 阶段患者 HBeAg 自发消失。抗病毒治疗对 HBV DNA 转阴（儿童：风险比 [RR] = 6.83，95% CI：2.90-16.05；成人：RR = 25.84，95% CI：6.47-103.31）和 HBsAg 消失率（儿童）具有有利影响：对于 IT 期患者，RR = 9.49，95% CI：1.74-51.76；成人：RR = 7.35，95% CI：1.41-38.27。亚组分析显示，在 IT 阶段的成年患者中，干扰素加核苷（酸）类似物 (NA) 治疗的患者比 NA 单药治疗的患者表现出更高的 HBsAg 消失或血清转化率（9% 与 0%） 。此外，IT 阶段患者的 HCC 年发病率为每 1000 人年 3.03 例（95% CI：0.99-5.88）。 IT期成年患者的HCC发病风险显着低于HBeAg阳性不确定期患者（RR = 0.46，95% CI：0.32-0.66），IT期和免疫活跃期之间没有观察到显着差异。目前，没有足够的证据仅基于降低 HCC 发病风险来推荐对慢性 HBV 感染 IT 阶段的患者进行治疗。然而，IT 阶段的成人和儿童患者对抗病毒治疗反应良好，显示出 HBsAg 消失或血清转化率良好。© 2024 John Wiley

The question of whether patients in the immune-tolerant (IT) phase of chronic hepatitis B virus (HBV) infection should undergo antiviral therapy and determine the optimal regimen remains unclear. A comprehensive search of PubMed, Embase, MEDLINE, Cochrane Library, and Wanfang Data from inception to 5 December 2023, was conducted. Studies reporting on key outcomes such as HBV DNA undetectability, HBeAg loss or seroconversion, HBsAg loss or seroconversion, and hepatocellular carcinoma (HCC) incidence in patients in the IT phase of chronic HBV infection were included. In total, 23 studies were incorporated. Approximately 4% of patients in the IT phase achieved spontaneous HBeAg loss over 48 weeks of follow-up. Antiviral therapy demonstrated a favourable impact on HBV DNA negative conversion (Children: risk ratios [RR] = 6.83, 95% CI: 2.90-16.05; Adults: RR = 25.84, 95% CI: 6.47-103.31) and HBsAg loss rates (Children: RR = 9.49, 95% CI: 1.74-51.76; Adults: RR = 7.35, 95% CI: 1.41-38.27) for patients in the IT phase. Subgroup analysis revealed that in adult patients in the IT phase, interferon plus nucleos(t)ide analogues (NA)-treated patients exhibited a higher pooled rate of HBsAg loss or seroconversion than those treated with NA monotherapy (9% vs. 0%). Additionally, the pooled annual HCC incidence for patients in the IT phase was 3.03 cases per 1000 person-years (95% CI: 0.99-5.88). Adult patients in the IT phase had a significantly lower HCC incidence risk than HBeAg-positive indeterminate phase patients (RR = 0.46, 95% CI: 0.32-0.66), with no significant differences observed between IT and immune-active phases. Presently, there is insufficient evidence solely based on reducing the risk of HCC incidence, to recommend treating patients in the IT phase of chronic HBV infection. However, both adult and paediatric patients in the IT phase responded well to antiviral therapy, showing favourable rates of HBsAg loss or seroconversion.© 2024 John Wiley & Sons Ltd.