External validation of the GOLDEN model for predicting HBsAg loss in non-cirrhotic chronic hepatitis B patients with interferon-alpha based therapy.

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Xingmei Liao, Qing Xie, Xiaoguang Dou, Junqi Niu, Hong Ma, Yali Liu, Shumei Lin, Huiying Rao, Song Yang, Jianping Xie, Mingxiang Zhang, Qiang Li, Yanyan Yu, Qin Ning, Wu Li, Chengzhong Li, Liaoyun Zhang, Zhengang Zhang, Tao Han, Jian Sun, Jinlin Hou, Rong Fan
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引用次数: 0

Abstract

Background and aims: The GOLDEN model is designed to predict hepatitis B surface antigen (HBsAg) loss based on chronic hepatitis B (CHB) patients receiving nucleos(t)ide analogues therapy. We aimed to validate GOLDEN model's effectiveness in predicting HBsAg loss or decline in interferon-alpha (IFN-α) treated CHB patients.

Methods: IFN-α-treated patients were enrolled from EXCEL study, a randomized controlled trial included HBeAg-positive, non-cirrhotic, treatment-naïve CHB patients, as well as Search-B cohort, a prospective real-world observational cohort of CHB. Utilizing multiple quantitative HBsAg (qHBsAg) measurements, GOLDEN model was employed to calculate patient's probability of achieving HBsAg loss or decline.

Results: Among 200 patients in EXCEL study and 1041 patients from Search-B cohort, the corresponding cumulative incidence of qHBsAg<100 IU/mL or HBsAg loss was 20.0% and 6.7%, after the median follow-up of 18.0 (IQR,18.0-30.0) and 66.7 (IQR,48.8-84.7) months, respectively. The GOLDEN model achieved an area under the curve of 0.820 (95% CI:0.737-0.902) for predicting qHBsAg<100 IU/mL in EXCEL study and 0.964 (95% CI:0.953-0.974) for predicting HBsAg loss in Search-B cohort, maintaining robust performance across subgroups. The favorable group showed higher cumulative incidences of qHBsAg<100 IU/mL (42.5% vs. 4.6%, p<0.001) or HBsAg loss (37.2% vs. 0%, p<0.001) than the unfavorable group, along with significantly lower qHBsAg levels and faster qHBsAg decline rates. Moreover, the favorable group defined by GOLDEN model and qHBsAg levels at enrolment were confirmed as independent predictors for HBsAg loss or decline.

Conclusion: GOLDEN model is a robust tool for predicting HBsAg loss or decline in IFN-α-treated CHB patients, offering valuable support for clinicians in developing personalized, effective management strategies for CHB patients.

GOLDEN模型用于预测非肝硬化慢性乙型肝炎患者以干扰素为基础治疗的HBsAg损失的外部验证。
背景和目的:GOLDEN模型旨在预测慢性乙型肝炎(CHB)患者接受核苷类似物治疗后乙型肝炎表面抗原(HBsAg)的损失。我们的目的是验证GOLDEN模型在预测干扰素-α (IFN-α)治疗的CHB患者HBsAg损失或下降方面的有效性。方法:IFN-α治疗的患者来自EXCEL研究,这是一项随机对照试验,包括hbeag阳性,非肝硬化,treatment-naïve CHB患者,以及Search-B队列,这是一个前瞻性的CHB现实观察队列。利用多次定量HBsAg (qHBsAg)测量,采用GOLDEN模型计算患者实现HBsAg丢失或下降的概率。结果:在EXCEL研究的200例患者和Search-B队列的1041例患者中,相应的qhbsag累积发生率。结论:GOLDEN模型是预测IFN-α治疗的CHB患者HBsAg损失或下降的有力工具,为临床医生制定个性化、有效的CHB患者管理策略提供了有价值的支持。
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来源期刊
CiteScore
16.90
自引率
4.80%
发文量
903
审稿时长
22 days
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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