The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection

We aim to investigate the impact of different clinical phases’ definitions of chronic hepatitis B (CHB) infection on the profiles of grey zone, based on HBV guidelines set by the Chinese Society of Hepatology and Chinese Society of Infectious Diseases (CSH/CSID, 2022 version) and guidelines set by t...

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Main Authors: Xiaoqian Xu, Hao Wang, Shan Shan, Yameng Sun, Xiaoyuan Xu, Hong You, Jidong Jia, Hui Zhuang, Yuanyuan Kong, on behalf of the China Registry of Hepatitis B (CR-HepB) Group
Format: Article
Language:English
Published: MDPI AG 2023-05-01
Series:Viruses
Subjects:
Online Access:https://www.mdpi.com/1999-4915/15/5/1212
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author Xiaoqian Xu
Hao Wang
Shan Shan
Yameng Sun
Xiaoyuan Xu
Hong You
Jidong Jia
Hui Zhuang
Yuanyuan Kong
on behalf of the China Registry of Hepatitis B (CR-HepB) Group
author_facet Xiaoqian Xu
Hao Wang
Shan Shan
Yameng Sun
Xiaoyuan Xu
Hong You
Jidong Jia
Hui Zhuang
Yuanyuan Kong
on behalf of the China Registry of Hepatitis B (CR-HepB) Group
author_sort Xiaoqian Xu
collection DOAJ
description We aim to investigate the impact of different clinical phases’ definitions of chronic hepatitis B (CHB) infection on the profiles of grey zone, based on HBV guidelines set by the Chinese Society of Hepatology and Chinese Society of Infectious Diseases (CSH/CSID, 2022 version) and guidelines set by the American Association for the Study of Liver Diseases (AASLD, 2018 version). We retrospectively examined untreated CHB patients enrolled in the China Registry of Hepatitis B database. Patients’ clinical phases were determined as per CSH/CSID and AASLD. Liver fibrosis was estimated by FIB-4 and/or APRI. Among 3462 CHB patients, 56.9% and 41.7% fell into the grey zone based on AASLD and CSH/CSID. Compared with grey zone patients as per AASLD, those under CSH/CSID guidelines showed lower levels of median ALT (26.0 vs. 37.0 U/L, <i>p</i> < 0.001), AST (25.0 vs. 29.4 U/L, <i>p <</i> 0.001) and APRI (0.3 vs. 0.4, <i>p</i> < 0.001), and lower rates of advanced fibrosis estimated by APRI (7.9% vs. 11.4% <i>p =</i> 0.001), but comparable rates by FIB-4 (13.0% vs. 14.1%, <i>p</i> = 0.389). With the stepwise lowering of ALT upper limits of normal (ULN) values from 50/40 U/L for males/females to 40/40 U/L, 35/25 U/L and 30/19 U/L, the proportions of grey zone patients as per CSH/CSID declined from 46.7% to 41.7%, 34.3% and 28.8%, respectively, whereas they remained stable (55.7%, 56.2%, 56.9% and 57.0%) as per AASLD. Compared with the AASLD guidelines, CSH/CSID guidelines leave fewer and less severe patients in the grey zone. Lowering ALT ULN values reduces the number of grey zone patients as per CSH/CSID, but not under AASLD guidelines.
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spelling doaj.art-e898a18c02af4d40a4dcfbb1e57764042023-11-18T03:40:34ZengMDPI AGViruses1999-49152023-05-01155121210.3390/v15051212The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus InfectionXiaoqian Xu0Hao Wang1Shan Shan2Yameng Sun3Xiaoyuan Xu4Hong You5Jidong Jia6Hui Zhuang7Yuanyuan Kong8on behalf of the China Registry of Hepatitis B (CR-HepB) GroupClinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing Clinical Research Institute, Beijing 100050, ChinaClinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing Clinical Research Institute, Beijing 100050, ChinaLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, ChinaLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, ChinaDepartment of Infectious Diseases, Peking University First Hospital, Beijing 100034, ChinaLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, ChinaLiver Research Center, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, Beijing 100050, ChinaDepartment of Microbiology and Infectious Disease Center, Peking University Health Science Center, Beijing 100191, ChinaClinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing Clinical Research Institute, Beijing 100050, ChinaWe aim to investigate the impact of different clinical phases’ definitions of chronic hepatitis B (CHB) infection on the profiles of grey zone, based on HBV guidelines set by the Chinese Society of Hepatology and Chinese Society of Infectious Diseases (CSH/CSID, 2022 version) and guidelines set by the American Association for the Study of Liver Diseases (AASLD, 2018 version). We retrospectively examined untreated CHB patients enrolled in the China Registry of Hepatitis B database. Patients’ clinical phases were determined as per CSH/CSID and AASLD. Liver fibrosis was estimated by FIB-4 and/or APRI. Among 3462 CHB patients, 56.9% and 41.7% fell into the grey zone based on AASLD and CSH/CSID. Compared with grey zone patients as per AASLD, those under CSH/CSID guidelines showed lower levels of median ALT (26.0 vs. 37.0 U/L, <i>p</i> < 0.001), AST (25.0 vs. 29.4 U/L, <i>p <</i> 0.001) and APRI (0.3 vs. 0.4, <i>p</i> < 0.001), and lower rates of advanced fibrosis estimated by APRI (7.9% vs. 11.4% <i>p =</i> 0.001), but comparable rates by FIB-4 (13.0% vs. 14.1%, <i>p</i> = 0.389). With the stepwise lowering of ALT upper limits of normal (ULN) values from 50/40 U/L for males/females to 40/40 U/L, 35/25 U/L and 30/19 U/L, the proportions of grey zone patients as per CSH/CSID declined from 46.7% to 41.7%, 34.3% and 28.8%, respectively, whereas they remained stable (55.7%, 56.2%, 56.9% and 57.0%) as per AASLD. Compared with the AASLD guidelines, CSH/CSID guidelines leave fewer and less severe patients in the grey zone. Lowering ALT ULN values reduces the number of grey zone patients as per CSH/CSID, but not under AASLD guidelines.https://www.mdpi.com/1999-4915/15/5/1212chronic hepatitis Bantiviral therapygrey zoneindeterminate phase
spellingShingle Xiaoqian Xu
Hao Wang
Shan Shan
Yameng Sun
Xiaoyuan Xu
Hong You
Jidong Jia
Hui Zhuang
Yuanyuan Kong
on behalf of the China Registry of Hepatitis B (CR-HepB) Group
The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
Viruses
chronic hepatitis B
antiviral therapy
grey zone
indeterminate phase
title The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
title_full The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
title_fullStr The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
title_full_unstemmed The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
title_short The Impact of the Definitions of Clinical Phases on the Profiles of Grey-Zone Patients with Chronic Hepatitis B Virus Infection
title_sort impact of the definitions of clinical phases on the profiles of grey zone patients with chronic hepatitis b virus infection
topic chronic hepatitis B
antiviral therapy
grey zone
indeterminate phase
url https://www.mdpi.com/1999-4915/15/5/1212
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