High accuracy model for HBsAg loss based on longitudinal trajectories of serum qHBsAg throughout long-term antiviral therapy,Gut

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High accuracy model for HBsAg loss based on longitudinal trajectories of serum qHBsAg throughout long-term antiviral therapy
Gut ( IF 23.0 ) Pub Date : 2024-10-01 , DOI: 10.1136/gutjnl-2024-332182
Rong Fan ₁ , Siru Zhao ₂ , Junqi Niu ₃ , Hong Ma ₄ , Qing Xie ₅ , Song Yang ₆ , Jianping Xie ₇ , Xiaoguang Dou ₈ , Jia Shang ₉ , Huiying Rao ₁₀ , Qi Xia ₁₁ , Yali Liu ₁₂ , Yongfeng Yang ₁₃ , Hongbo Gao ₁₄ , Aimin Sun ₁₅ , Xieer Liang ₂ , Xueru Yin ₂ , Yongfang Jiang ₁₆ , Yanyan Yu ₁₇ , Jian Sun ₂ , Nikolai V Naoumov ₁₈ , Jinlin Hou ₁ ,

Affiliation

Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Guangdong Provincial Clinical Research Center for Viral Hepatitis, Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Department of Infectious Diseases, Southern Medical University Nanfang Hospital, Guangzhou, China
Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Guangdong Provincial Clinical Research Center for Viral Hepatitis, Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Department of Infectious Diseases, Southern Medical University Nanfang Hospital, Guangzhou, China.
Hepatology Unit, No. 1 Hospital affiliated to Jilin University, Changchun, China.
Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Beijing Ditan Hospital, Capital Medical University, Beijing, China.
Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China.
Department of Infectious Diseases, Shengjing Hospital of China Medical University, Shenyang, China.
Henan Provincial People's Hospital, Zhengzhou, China.
Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China.
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.
Beijing Youan Hospital, Capital Medical University, Beijing, China.
The Second Hospital of Nanjing, Nanjing, China.
8th People's Hospital, Guangzhou, China.
Henan Institute of Medical and Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, China.
Liver Disease Research Center, the Second Xiangya Hospital, Central South University, Changsha, China.
Department of Infectious Diseases, First Hospital of Peking University, Beijing, China.
Royal College of Physicians, London, UK.

Objective Hepatitis B surface antigen (HBsAg) loss is the optimal outcome for patients with chronic hepatitis B (CHB) but this rarely occurs with currently approved therapies. We aimed to develop and validate a prognostic model for HBsAg loss on treatment using longitudinal data from a large, prospectively followed, nationwide cohort. Design CHB patients receiving nucleos(t)ide analogues as antiviral treatment were enrolled from 50 centres in China. Quantitative HBsAg (qHBsAg) testing was prospectively performed biannually per protocol. Longitudinal discriminant analysis algorithm was used to estimate the incidence of HBsAg loss, by integrating clinical data of each patient collected during follow-up. Results In total, 6792 CHB patients who had initiated antiviral treatment 41.3 (IQR 7.6–107.6) months before enrolment and had median qHBsAg 2.9 (IQR 2.3–3.3) log10IU/mL at entry were analysed. With a median follow-up of 65.6 (IQR 51.5–84.7) months, the 5-year cumulative incidence of HBsAg loss was 2.4%. A prediction model integrating all qHBsAg values of each patient during follow-up, designated GOLDEN model, was developed and validated. The AUCs of GOLDEN model were 0.981 (95% CI 0.974 to 0.987) and 0.979 (95% CI 0.974 to 0.983) in the training and external validation sets, respectively, and were significantly better than those of a single qHBsAg measurement. GOLDEN model identified 8.5%–10.4% of patients with a high probability of HBsAg loss (5-year cumulative incidence: 17.0%–29.1%) and was able to exclude 89.6%–91.5% of patients whose incidence of HBsAg loss is 0. Moreover, the GOLDEN model consistently showed excellent performance among various subgroups. Conclusion The novel GOLDEN model, based on longitudinal qHBsAg data, accurately predicts HBsAg clearance, provides reliable estimates of functional hepatitis B virus (HBV) cure and may have the potential to stratify different subsets of patients for novel anti-HBV therapies. Data are available on reasonable request. The data that support the findings of this study are available from the corresponding authors on reasonable request.

更新日期：2024-09-09

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