非肝硬化慢性乙型肝炎患者停用核苷酸类似物后的长期乙型肝炎表面抗原动力学研究

Q2 Medicine

Liver Research Pub Date : 2024-09-01 DOI:10.1016/j.livres.2024.07.001

Lina Wu , Jiadi Lai , Qiumin Luo , Yeqiong Zhang , Chaoshuang Lin , Dongying Xie , Youming Chen , Hong Deng , Zhiliang Gao , Liang Peng , Wenxiong Xu

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引用次数: 0

摘要

背景和目的很少有研究报道非肝硬化慢性乙型肝炎（CHB）患者停用核苷类似物（NA）后的乙肝表面抗原（HBsAg）动力学。该研究特别调查了停用 NA 后的长期 HBsAg 动力学。方法在 2014 年 1 月至 2024 年 1 月期间，该研究前瞻性地招募了 106 名门诊非肝硬化慢性乙型肝炎患者，这些患者在接受 NA 巩固治疗后符合停药标准。结果纳入了96名完成5年随访的患者。在治疗结束（EOT）HBsAg阴性的29名患者中，HBsAg仍然检测不到。在 67 名 EOT HBsAg 阳性患者中，有 12 人（17.9%）的 HBsAg 血清清除，估计每年 HBsAg 血清清除的发生率为 3.6%。EOT HBsAg 水平≤1000 IU/mL 的患者的 HBsAg 血清清除率高于 EOT HBsAg 水平>1000 IU/mL 的患者（33.3% 对 5.4%）。随访期间，HBsAg≤1000 IU/mL的患者比例有所增加。逻辑回归分析表明，EOT HBsAg水平是HBsAg血清清除和HBsAg水平下降超过1 log10 IU/mL的独立因素。结论EOT HBsAg阴性患者在NA停药后的5年随访期间没有复发，并保持HBsAg血清清除。在停用 NA 后的 5 年随访期间，EOT HBsAg 水平≤1000 IU/mL 的患者可获得更高的 HBsAg 血清清除率。临床试验编号Clinicaltrials.gov number NCT02883647。

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Long-term hepatitis B surface antigen kinetics after nucleos(t)ide analog discontinuation in patients with noncirrhotic chronic hepatitis B

Background and aim

Few studies have reported hepatitis B surface antigen (HBsAg) kinetics after nucleos(t)ide analog (NA) discontinuation in patients with noncirrhotic chronic hepatitis B (CHB). The study specifically investigated long-term HBsAg kinetics after NA discontinuation.

Methods

Between January 2014 to January 2024, this study prospectively enrolled 106 outpatients with noncirrhotic CHB who met the discontinuation criteria after NA consolidation treatment. Demographic, clinical, and laboratory data were collected and analyzed after NA discontinuation.

Results

Ninety-six patients who finished 5 years of follow-up were included. HBsAg remained undetectable in 29 patients with end of treatment (EOT) HBsAg negativity. Among 67 patients with EOT HBsAg positivity, HBsAg seroclearance occurred in 12 (17.9%) patients with an estimated annual incidence of HBsAg seroclearance of 3.6%. Patients with EOT HBsAg levels of ≤1000 IU/mL had a higher HBsAg seroclearance rate than those with EOT HBsAg levels of >1000 IU/mL (33.3% vs. 5.4%). The proportion of patients with HBsAg ≤1000 IU/mL increased during follow-up. Logistic regression analysis indicated that the EOT HBsAg level was an independent factor for HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL. The optimal EOT HBsAg cutoff for both HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL was 359 IU/mL.

Conclusions

Patients with EOT HBsAg negativity experienced no relapse and maintained HBsAg seroclearance during 5 years of follow-up after NA discontinuation. A higher HBsAg seroclearance rate can be obtained in patients with EOT HBsAg levels of ≤1000 IU/mL during 5 years of follow-up after NA discontinuation. Close monitoring and proper NA retreatment are recommended to guarantee the safety of NA discontinuation.