Suzuki Takanori, Tamori Akihiro, Matsuura Kentaro, Inoue Takako, Kusumoto Shigeru, Hagiwara Shinya, Sagi Haruka, Kaneko Atsushi, Murakami Shuko, Kawamra Hayato, Fujiwara Kei, Aoyagi Katsumi, Enomoto Masaru, Kozuka Ritsuzo, Kataoka Hiromi, Tanaka Yasuhito
Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Department of Hepatology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan; Department of Hepatology, Kashiwara Municipal Hospital, Kashiwara, Japan.
Ann Hepatol. 2025 Jan-Jun;30(1):101764. doi: 10.1016/j.aohep.2024.101764. Epub 2024 Dec 3.
We aimed to compare the usefulness of the ultra-high-sensitivity hepatitis B surface antigen (iTACT-HBsAg), high-sensitivity hepatitis B core-related antigen (iTACT-HBcrAg), and anti-HBs assays in determination of cessation of nucleot(s)ide analogue (NA) treatment to prevent against hepatitis B virus (HBV) reactivation.
Twenty-two patients who developed HBV reactivation under immunosuppressive therapy or chemotherapy and had been administered NA and subsequently discontinued were enrolled. The stored serum samples taken at NA cessation were applied to iTACT-HBsAg (lower limit of detection; 0.0005 IU/mL), iTACT-HBcrAg (lower limit of detection; 2.1 log U/mL), and anti-HBs assays. Detection of serum HBV DNA level ≥1.3 log IU/mL after NA cessation was defined as virological relapse (VR).
Two patients were excluded due to re-introduction of NA despite a negligible level of HBV DNA (<1.3 log IU/mL). Of the remaining 20 patients, 11 (55 %) had HBcrAg <2.1 log U/mL at the cessation of NA, and 7 of the 11 patients (64 %) had no VR thereafter. On the other hand, 15 patients (75 %) had HBsAg <0.0005 IU/mL at the cessation of NA, and 13 of the 15 patients (87 %) subsequently lacked VR. Further, 12 patients (60 %) had anti-HBs ≥10 mIU/mL at the cessation of NA, and 10 of the 12 patients (83 %) had no VR thereafter. The iTACT-HBsAg assay had the highest positive predictive value and the best overall diagnostic performance for predicting non-VR after cessation of NA.
The iTACT-HBsAg assay was useful to determine the cessation of NA treatment to prevent against HBV reactivation.
我们旨在比较超敏乙肝表面抗原（iTACT-HBsAg）、高敏乙肝核心相关抗原（iTACT-HBcrAg）和抗-HBs检测在确定核苷酸类似物（NA）治疗停药以预防乙肝病毒（HBV）再激活方面的效用。
纳入22例在免疫抑制治疗或化疗期间发生HBV再激活、接受过NA治疗并随后停药的患者。将NA停药时采集并储存的血清样本用于iTACT-HBsAg检测（检测下限；0.0005 IU/mL）、iTACT-HBcrAg检测（检测下限；2.1 log U/mL）和抗-HBs检测。NA停药后血清HBV DNA水平≥1.3 log IU/mL被定义为病毒学复发（VR）。
2例患者尽管HBV DNA水平可忽略不计（<1.3 log IU/mL）但因重新使用NA而被排除。在其余20例患者中，11例（55%）在NA停药时HBcrAg<2.1 log U/mL，其中7例（64%）此后未发生VR。另一方面，15例（75%）患者在NA停药时HBsAg<0.0005 IU/mL，其中13例（87%）随后未发生VR。此外，12例（60%）患者在NA停药时抗-HBs≥10 mIU/mL，其中10例（83%）此后未发生VR。iTACT-HBsAg检测在预测NA停药后无VR方面具有最高的阳性预测值和最佳的总体诊断性能。
iTACT-HBsAg检测有助于确定NA治疗的停药以预防HBV再激活。
