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Development and Validation of a Predictive Model for HBsAg Seroclearance After Peg-IFN-Based Therapy: A Multicentre
Hui-Hui Liu1, Xue-Mei Jiang2, Chao Cui3
1Department of Hepatology, Qilu Hospital of Shandong University, Jinan, Shandong, People's Republic of China.
Drug Design, Development and Therapy
|November 13, 2025
Summary
A new model predicts HBsAg seroclearance in chronic hepatitis B (CHB) patients receiving Peg-IFN therapy. Baseline factors like age, HBsAg levels, and ALT help identify patients likely to achieve HBsAg seroclearance.
Area of Science:
- Hepatology
- Virology
- Clinical Prediction Modeling
Background:
- Hepatitis B virus (HBV) infection remains a global health concern.
- Predicting HBsAg seroclearance is crucial for optimizing treatment strategies in chronic hepatitis B (CHB).
- Pegylated interferon (Peg-IFN)-based therapy offers a potential treatment option for CHB patients.
Purpose of the Study:
- To develop and validate a predictive model for HBsAg seroclearance.
- To identify baseline parameters associated with HBsAg seroclearance after Peg-IFN therapy.
- To aid in clinical decision-making for Peg-IFN-based treatment in virally suppressed HBeAg-negative CHB patients.
Main Methods:
- Retrospective enrollment of 377 nucleos(t)ide analogue-suppressed, HBeAg-negative CHB patients receiving 48-week Peg-IFN therapy.
- Development of a multivariate Cox regression model in a cohort of 229 patients.
- Validation of the model in an independent cohort of 148 patients.
Main Results:
- HBsAg seroclearance rates were 17.9% in the development cohort and 20.27% in the validation cohort.
- The predictive model incorporated age, baseline HBsAg, and alanine aminotransferase (ALT).
- The model demonstrated strong predictive performance (AUC 0.842 in development, 0.852 in validation) and identified patient subgroups with varying seroclearance incidence.
Conclusions:
- A robust predictive model for HBsAg seroclearance was successfully constructed.
- The model utilizes readily available baseline parameters for clinical application.
- This tool can guide the effective use of Peg-IFN-based therapy in CHB management.

