A nation-wide medical record database study: Value of hepatitis B surface antigen loss in chronic hepatitis B patients in Japan

IF 3.9 3区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Hepatology Research Pub Date : 2024-05-15 DOI:10.1111/hepr.14056

Kinya Okada, Yoshikazu Nakayama, Jennings Xu, Yang Cheng, Junko Tanaka

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Abstract

Aim

Hepatitis B surface antigen (HBsAg) seroclearance is considered to be one of the best surrogate endpoints of functional cure for hepatitis B virus (HBV) infection. However, evidence regarding the relationship between achieving HBsAg seroclearance or a low baseline HBsAg level, and long-term clinical outcomes in Japanese patients with chronic HBV infection remains to be confirmed in a real-world setting.

Methods

A retrospective observational cohort study was performed with an electronic medical record database, including data from 230 hospitals across Japan. Chronic HBV infection was defined as two consecutive, positive HBsAg laboratory measurements for HBV infection. The date of the second positive was used as a baseline to identify subsequent HBsAg seroclearance and liver disease progression.

Results

In the database, 2523 patients with chronic HBV infection were identified as the chronic hepatitis B (CHB) cohort. Among the CHB cohort with an average observational period of 5.19 ± 3.87 years, 202 patients (8%) achieved HBsAg seroclearance after baseline. They had a lower risk of developing hepatocellular carcinoma (HCC) (adjusted hazard ratio [aHR] 0.206, p < 0.01) and cirrhosis (aHR 0.361, p < 0.01). When the CHB cohort was stratified into two groups based on baseline HBsAg levels (<100 IU/mL and ≥100 IU/mL), patients with a lower baseline level of HBsAg (<100 IU/mL) had a lower risk of developing liver disease (HCC aHR 0.600, p < 0.01; cirrhosis aHR 0.618, p < 0.05).

Conclusions

These results confirm the clinical significance of HBsAg seroclearance and low HBsAg level at baseline with respect to long-term outcomes of patients with CHB in the Japanese population.

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全国病历数据库研究：日本慢性乙型肝炎患者乙肝表面抗原丢失的价值。

目的：乙型肝炎表面抗原（HBsAg）血清清除率被认为是乙型肝炎病毒（HBV）感染功能性治愈的最佳替代终点之一。然而，关于日本慢性 HBV 感染患者达到 HBsAg 血清清除率或较低的 HBsAg 基线水平与长期临床疗效之间关系的证据仍有待在实际环境中证实：我们利用电子病历数据库开展了一项回顾性观察队列研究，其中包括来自日本全国 230 家医院的数据。慢性 HBV 感染的定义是连续两次 HBsAg 阳性。以第二次阳性的日期为基线，确定随后的 HBsAg 血清清除率和肝病进展情况：在数据库中，2523 名慢性 HBV 感染患者被确定为慢性乙型肝炎（CHB）队列。在平均观察期为 5.19 ± 3.87 年的慢性乙型肝炎队列中，有 202 名患者（8%）在基线后实现了 HBsAg 血清清除。这些患者罹患肝细胞癌（HCC）的风险较低（调整后危险比 [aHR] 0.206，p 结论：HBsAg清除后，这些患者罹患肝细胞癌的风险较低：这些结果证实，在日本人群中，HBsAg 血清清除率和基线 HBsAg 水平较低对 CHB 患者的长期预后具有临床意义。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Hepatology Research 医学-胃肠肝病学

CiteScore

8.30

自引率

14.30%

发文量

124

审稿时长

1 months

期刊介绍： Hepatology Research (formerly International Hepatology Communications) is the official journal of the Japan Society of Hepatology, and publishes original articles, reviews and short comunications dealing with hepatology. Reviews or mini-reviews are especially welcomed from those areas within hepatology undergoing rapid changes. Short communications should contain concise definitive information.