Department of Hepatology, Key Laboratory of Zoonosis Research, Ministry Education, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
Phase I Clinical Trials Unit, The First Hospital of Jilin University, Changchun 130021, Jilin Province, China.
World J Gastroenterol. 2021 Oct 28;27(40):6927-6938. doi: 10.3748/wjg.v27.i40.6927.
Quantitative hepatitis B core-related antigen (qHBcrAg) has a better correlation with intrahepatic hepatitis B virus (HBV) covalently closed circular DNA (cccDNA) than HBV DNA or hepatitis B e antigen (HBeAg), but data are still lacking for its clinical application.
The aim was to investigate serum qHBcrAg levels in patients with chronic hepatitis B and assess the correlation of serum qHBcrAg with pregenomic RNA (pgRNA), cccDNA, and HBeAg seroconversion.
This study was a secondary analysis of patients who underwent percutaneous liver biopsy between July 2014 and June 2019 in two multicenter randomized controlled clinical trials of peginterferon nucleos(t)ide analog (NUC)-based therapy (NCT03509688 and NCT03546530). Serum qHBcrAg, pgRNA, HBV DNA, hepatitis B core antigen, HBeAg, liver cccDNA, and HBV DNA were measured. The correlations of serum qHBcrAg with other biomarkers were analyzed.
A total of 139 patients were included. The mean qHBcrAg levels were 5.32 ± 1.18 log U/mL at baseline and decreased during treatment (all < 0.0001). Serum qHBcrAg levels were positively correlated with pgRNA ( = 0.597, < 0.0001) and cccDNA ( = 0.527, < 0.0001) levels. The correlation of serum qHBcrAg level and intrahepatic HBV DNA levels at baseline was weak but significant ( = 0.399, < 0.0001). HBcrAg predicted HBeAg seroconversion, with areas under the receiver operating characteristics curve of 0.788 at 24 wk and 0.825 at 48 wk. Log HBcrAg at wk 24 and 48 was independently associated with HBeAg seroconversion [odds ratio (OR) = 2.402, 95% confidence interval (CI): 1.314-4.391, = 0.004; OR = 3.587, 95%CI: 1.315-9.784, = 0.013].
Serum HBcrAg levels were correlated with HBV virological markers and could be used to predict HBeAg seroconversion.
定量乙型肝炎核心相关抗原（qHBcrAg）与肝内乙型肝炎病毒（HBV）共价闭合环状 DNA（cccDNA）的相关性优于 HBV DNA 或乙型肝炎 e 抗原（HBeAg），但其临床应用数据仍缺乏。
旨在研究慢性乙型肝炎患者血清 qHBcrAg 水平，并评估血清 qHBcrAg 与前基因组 RNA（pgRNA）、cccDNA 和 HBeAg 血清学转换的相关性。
这是两项基于聚乙二醇干扰素核苷（酸）类似物（NUC）治疗的多中心随机对照临床试验（NCT03509688 和 NCT03546530）中经皮肝活检患者的二次分析。检测血清 qHBcrAg、pgRNA、HBV DNA、乙型肝炎核心抗原、HBeAg、肝 cccDNA 和 HBV DNA。分析血清 qHBcrAg 与其他生物标志物的相关性。
共纳入 139 例患者。基线时 qHBcrAg 水平的平均值为 5.32 ± 1.18 log U/mL，治疗过程中逐渐下降（均<0.0001）。血清 qHBcrAg 水平与 pgRNA（ = 0.597，<0.0001）和 cccDNA（ = 0.527，<0.0001）水平呈正相关。基线时血清 qHBcrAg 水平与肝内 HBV DNA 水平的相关性较弱，但具有显著意义（ = 0.399，<0.0001）。HBcrAg 预测 HBeAg 血清学转换，在 24 周和 48 周时，受试者工作特征曲线下面积分别为 0.788 和 0.825。第 24 周和第 48 周时的 log HBcrAg 与 HBeAg 血清学转换独立相关[比值比（OR）=2.402，95%置信区间（CI）：1.314-4.391， = 0.004；OR=3.587，95%CI：1.315-9.784， = 0.013]。
血清 HBcrAg 水平与 HBV 病毒学标志物相关，可用于预测 HBeAg 血清学转换。
