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Predicting Hepatitis B Virus (HBV) Surface Antigen Seroclearance in HBV e Antigen–Negative Patients With Chronic Hepatitis B: External Validation of a Scoring System
Jessica Liu1,a, Tai-Chung Tseng2,9,a, Hwai-I Yang1,10,11, Mei-Hsuan Lee3, Richard Batrla-Utermann13, Chin-Lan Jen1, Sheng-Nan Lu12, Li-Yu Wang4, San-Lin You1, Pei-Jer Chen5,7, Chien-Jen Chen1,8 and Jia-Horng Kao5,6,7
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Author Affiliations
1Genomics Research Center, Academia Sinica
2Division of Gastroenterology, Department of Internal Medicine, Taipei Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
3Institute of Clinical Medicine, National Yang Ming University
4MacKay College of Medicine
5Division of Gastroenterology and Hepatology, Department of Internal Medicine
6Hepatitis Research Center
7Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine
8Graduate Institute of Epidemiology and Preventative Medicine, College of Public Health, National Taiwan University, Taipei
9School of Medicine, Tzu Chi University, Hualien
10Molecular and Genomic Epidemiology Center, China Medical University Hospital Taichung
11Graduate Institute of Clinical Medical Science, China Medical University, Taichung
12Department of Gastroenterology, Chang-Gung Memorial Hospital, Kaohsiung, Taiwan
13Roche Diagnostics, Basel, Switzerland
Correspondence: Chien-Jen Chen, ScD, Genomics Research Center, Academia Sinica, 128 Academia Rd, Section 2, Taipei 115, Taiwan ([email protected]).
↵a J. L. and T.-C. T. contributed equally to this report.
Abstract
Background. Hepatitis B virus (HBV) surface antigen (HBsAg) seroclearance is the ultimate serological end point in chronic hepatitis B. This study aimed to develop and validate a prediction score for spontaneous HBsAg seroclearance in HBV e antigen (HBeAg)-negative patients with chronic hepatitis B due to HBV genotype B or C.
Methods. The development cohort included 2491 untreated participants from the community-based REVEAL-HBV study, who were HBeAg negative, anti–hepatitis C virus negative, and cirrhosis free. The independent validation cohort consisted of 1934 hospital-based individuals from the National Taiwan University Hospital. Clinical markers included in the model were age and serum HBV DNA and HBsAg levels. Cox proportional hazards regression models were used to create the prediction model.
Results. A prediction score ranging from 0 to 27 was developed. Predicted probabilities of 5- and 10-year HBsAg seroclearance ranged from 0.95% to 30.49% and from 2.58% to 62.52%, respectively. When applied to the independent validation cohort, the areas under the receiver operating characteristic curves for the 5- and 10-year prediction of HBsAg seroclearance in the validation cohort were 0.82 (95% confidence interval [CI], .76–.88) and 0.74 (95% CI, .70–.78). Model fit was still adequate, according to Hosmer–Lemeshow goodness of fit tests.
Conclusions. A clinically applicable prediction score for HBsAg seroclearance was developed and externally validated. This model can assist clinicians in further stratifying risk groups.
Key words
epidemiology viral hepatitis prediction model
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发表于 2015-4-24 18:28