Rong Fan, Rui Deng, Qing Xie, Fang Wang, Xieer Liang, Hong Ma, Huiying Rao, Yanhang Gao, Chunxiu Zhong, Qing Guo, Sheng Shen, Ya Xu, Xingyu Lu, Hongbo Gao, Honglian Bai, Xiaoguang Dou, Jian Sun
{"title":"新的HBV生物标志物引导的NAs停药策略促进亚洲CHB患者HBsAg清除：一项随机对照试验。","authors":"Rong Fan, Rui Deng, Qing Xie, Fang Wang, Xieer Liang, Hong Ma, Huiying Rao, Yanhang Gao, Chunxiu Zhong, Qing Guo, Sheng Shen, Ya Xu, Xingyu Lu, Hongbo Gao, Honglian Bai, Xiaoguang Dou, Jian Sun","doi":"10.1016/j.cgh.2025.09.009","DOIUrl":null,"url":null,"abstract":"<p><strong>Background & aims: </strong>Nucleos(t)ide analogue (NA) discontinuation promotes hepatitis B surface antigen (HBsAg) clearance among European patients with chronic hepatitis B virus (HBV) infection. The efficacy and safety of a novel HBV biomarker-guided NA withdrawal strategy among Asian patients was evaluated in this multicenter randomized controlled trial.</p><p><strong>Methods: </strong>NA-experienced patients achieving HBsAg <200 IU/mL and undetectable HBV DNA for ≥12 months with HBV RNA or hepatitis core-related antigen undetectable were randomized 2:1 to stop or continue NA therapy. Ninety patients were included in final modified intention-to-treat analysis (60 in the NA-Stop group and 30 in the NA-Continue group). Cumulative rates of HBsAg loss and relapse were evaluated at week 144.</p><p><strong>Results: </strong>Patients enrolled were 45.9 ± 10.2 years of age, with a median 9.4 years (interquartile range, 6.0-13.0 years) of treatment. Baseline characteristics between the two groups were balanced, with a median HBsAg level of 1.7 and 1.8 log<sub>10</sub> IU/mL in the NA-Stop and NA-Continue groups, respectively (P = .224). Compared with patients in the NA-Continue group, NA-stoppers showed an increased 144-week cumulative incidence of HBsAg clearance (25.9% vs 4.2%; P = .013) and more profound HBsAg decline during follow-up (0.90 log<sub>10</sub> IU/mL vs 0.46 log<sub>10</sub> IU/mL; P = .056). Cumulatively, 38.6% and 20.2% of patients experienced virological and clinical relapse after stopping NAs, with 16 patients retreated and no serious adverse events occurring. Subgroup analysis revealed that hepatitis B e antigen-negative patients with baseline HBsAg level <100 IU/mL had a more favorable response following NA withdrawal, achieving an HBsAg loss rate of 40.0%.</p><p><strong>Conclusions: </strong>Asian patients with long-term HBV suppression benefit from NA discontinuation guided by novel HBV markers, which provides rationale for finite NA treatment. 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Compared with patients in the NA-Continue group, NA-stoppers showed an increased 144-week cumulative incidence of HBsAg clearance (25.9% vs 4.2%; P = .013) and more profound HBsAg decline during follow-up (0.90 log<sub>10</sub> IU/mL vs 0.46 log<sub>10</sub> IU/mL; P = .056). Cumulatively, 38.6% and 20.2% of patients experienced virological and clinical relapse after stopping NAs, with 16 patients retreated and no serious adverse events occurring. Subgroup analysis revealed that hepatitis B e antigen-negative patients with baseline HBsAg level <100 IU/mL had a more favorable response following NA withdrawal, achieving an HBsAg loss rate of 40.0%.</p><p><strong>Conclusions: </strong>Asian patients with long-term HBV suppression benefit from NA discontinuation guided by novel HBV markers, which provides rationale for finite NA treatment. 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引用次数: 0
摘要
背景和目的：在欧洲慢性乙型肝炎病毒（HBV）感染患者中，核苷类似物（NAs）停药可促进乙型肝炎表面抗原（HBsAg）的清除。在这项多中心随机对照试验中，评估了一种新的HBV生物标志物引导的NAs停药策略在亚洲患者中的有效性和安全性。结果：纳入的患者年龄为45.9±10.2岁，中位治疗时间为9.4（6.0,13.0）年。两组的基线特征是平衡的，NAs-Stop组和NAs-Continue组的中位HBsAg水平分别为1.7和1.8 log10 IU/mL （p=0.224）。与NAs-Continue组相比，nas - stoper组144周HBsAg累计清除率增加（25.9% vs. 4.2%, p=0.013），随访期间HBsAg下降更明显（0.90 vs. 0.46 log10 IU/mL, p=0.056）。分别有38.6%和20.2%的患者停药后出现病毒学和临床复发，其中16例患者退药，未发生严重不良事件。结论：在新型HBV标志物的指导下，长期HBV抑制的亚洲患者可从NAs停药中获益，这为有限的NAs治疗提供了理论依据。
Novel HBV Biomarkers-Guided NA Withdrawal Strategy Promotes HBsAg Clearance in Asian CHB Patients: A Randomized Controlled Trial.
Background & aims: Nucleos(t)ide analogue (NA) discontinuation promotes hepatitis B surface antigen (HBsAg) clearance among European patients with chronic hepatitis B virus (HBV) infection. The efficacy and safety of a novel HBV biomarker-guided NA withdrawal strategy among Asian patients was evaluated in this multicenter randomized controlled trial.
Methods: NA-experienced patients achieving HBsAg <200 IU/mL and undetectable HBV DNA for ≥12 months with HBV RNA or hepatitis core-related antigen undetectable were randomized 2:1 to stop or continue NA therapy. Ninety patients were included in final modified intention-to-treat analysis (60 in the NA-Stop group and 30 in the NA-Continue group). Cumulative rates of HBsAg loss and relapse were evaluated at week 144.
Results: Patients enrolled were 45.9 ± 10.2 years of age, with a median 9.4 years (interquartile range, 6.0-13.0 years) of treatment. Baseline characteristics between the two groups were balanced, with a median HBsAg level of 1.7 and 1.8 log10 IU/mL in the NA-Stop and NA-Continue groups, respectively (P = .224). Compared with patients in the NA-Continue group, NA-stoppers showed an increased 144-week cumulative incidence of HBsAg clearance (25.9% vs 4.2%; P = .013) and more profound HBsAg decline during follow-up (0.90 log10 IU/mL vs 0.46 log10 IU/mL; P = .056). Cumulatively, 38.6% and 20.2% of patients experienced virological and clinical relapse after stopping NAs, with 16 patients retreated and no serious adverse events occurring. Subgroup analysis revealed that hepatitis B e antigen-negative patients with baseline HBsAg level <100 IU/mL had a more favorable response following NA withdrawal, achieving an HBsAg loss rate of 40.0%.
Conclusions: Asian patients with long-term HBV suppression benefit from NA discontinuation guided by novel HBV markers, which provides rationale for finite NA treatment. ClincialTrials.gov, Number: NCT04519359.
期刊介绍：
Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion.
As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
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