Determinants of significant histological response and nomogram construction for entecavir-Biejia Ruangan combination therapy in chronic hepatitis B

XU Ran; HE Quanwei; CHANG Xiujuan; CHEN Yan; YANG Yongping

doi:10.3969/j.issn.1007-8134.2025.02.001

Abstract：Objective This study aimed to investigate the factors influencing significant histological response in chronic hepatitis B(CHB)patients following treatment with entecavir combined with Biejia-Ruangan compound(BRC),and to develop a nomogram model for noninvasive evaluation of treatment efficacy.Methods A total of 500 CHB patients from 14 hospitals between October 2013 and October 2014 were included in the study,with 369 patients ultimately enrolled after screening.Patients received 72 weeks of treatment with entecavir plus BRC and were categorized into responder and non-responder groups based on the achievement of significant histological response post-treatment.Clinical and pathological data were collected at baseline and after treatment,including liver histological examination and liver stiffness measurement(LSM).Multivariate logistic regression analysis was conducted to identify influencing factors,and a nomogram model was established to assess the model's performance.Results The responder group comprised 83 patients,while the non-responder group included 286 patients.Age,LSM at baseline,and LSM along with alanine aminotransferase(ALT)levels after 72 weeks of treatment were identified as independent factors influencing significant histological response.The nomogram model exhibited good predictive accuracy,with the calibration curve closely aligning with the ideal curve.Decision curve analysis(DCA)revealed superior performance compared to APRI,FIB-4,and LSM alone,with an area under the receiver operating characteristic curve(ROC)of 0.83(95％CI:0.78～0.89).Conclusion The nomogram model developed in this study offers an accurate and noninvasive approach for assessing significant histological response in CHB patients treated with entecavir combined with BRC,demonstrating clinical applicability and innovation.