The Journal of infectious diseases · 2025
A Model to Identify Gray Zone Patients With Chronic Hepatitis B Requiring Antiviral Therapy: A Multicenter Retrospective Study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Yang Xue-Yan, Li Xi-Dong, Wu Bai-Yun, Yang Qiao, Zheng Yu-Bao, Zheng Ming-Hua, Wu Yin-Ping, Ma Hang-Yu, Zuo Jing, Jia Ruo-Xi, Yu Yue, Xu Ling-Yun, Tian Yu-Xin, An Qi, Zhang Tao, He Ying-Li, Shi Yu, Fan Yu-Chen
Аннотация
BACKGROUND: Individuals who do not match any specific immune stage of chronic hepatitis B are classified into the gray zone, and appropriate management for these patients remains unclear. This study aimed to develop and validate a noninvasive model to identify gray zone patients requiring antiviral therapy (AVT).
METHODS: We retrospectively collected data on 200 gray zone patients not requiring AVT, according to assessment by noninvasive parameters from 2010 to 2023 in 6 hospitals, and randomized them into development (n = 140) and validation (n = 60) cohorts. Univariable and multivariable regression analyses were performed to identify independent variables for establishing a nomogram to predict the probability of requiring AVT by liver biopsy.
RESULTS: Seventy-eight patients (n = 39%) were identified as requiring AVT. The following were identified as independent variables for constructing the nomogram: age (odds ratio [OR], 1.06; 95% CI, 1.01-1.11), alanine aminotransferase (OR, 2.43; 95% CI, 1.08-5.59), lymphocyte percentage (OR, 6.43; 95% CI, 1.23-33.64), platelet count (OR, 0.99; 95% CI, .98-1.00), and international normalized ratio (per 0.01) (OR, 0.99; 95% CI, .98-.1.00). These variables showed good discriminability based on the development data set (area under the curve, 0.755) and validation data set (area under the curve, 0.707), calibration, and clinical applicability.
CONCLUSIONS: Gray zone patients requiring AVT should be identified, and the model developed here is a promising tool.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT06041022.
METHODS: We retrospectively collected data on 200 gray zone patients not requiring AVT, according to assessment by noninvasive parameters from 2010 to 2023 in 6 hospitals, and randomized them into development (n = 140) and validation (n = 60) cohorts. Univariable and multivariable regression analyses were performed to identify independent variables for establishing a nomogram to predict the probability of requiring AVT by liver biopsy.
RESULTS: Seventy-eight patients (n = 39%) were identified as requiring AVT. The following were identified as independent variables for constructing the nomogram: age (odds ratio [OR], 1.06; 95% CI, 1.01-1.11), alanine aminotransferase (OR, 2.43; 95% CI, 1.08-5.59), lymphocyte percentage (OR, 6.43; 95% CI, 1.23-33.64), platelet count (OR, 0.99; 95% CI, .98-1.00), and international normalized ratio (per 0.01) (OR, 0.99; 95% CI, .98-.1.00). These variables showed good discriminability based on the development data set (area under the curve, 0.755) and validation data set (area under the curve, 0.707), calibration, and clinical applicability.
CONCLUSIONS: Gray zone patients requiring AVT should be identified, and the model developed here is a promising tool.
CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT06041022.