A longitudinal study to detect hepatitis B surface and core-related antigens in chronic hepatitis B patients with hepatitis B surface antigen seroclearance using highly sensitive assays.


Journal

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
ISSN: 1873-5967
Titre abrégé: J Clin Virol
Pays: Netherlands
ID NLM: 9815671

Informations de publication

Date de publication:
03 2023
Historique:
received: 19 08 2022
revised: 29 11 2022
accepted: 22 12 2022
pubmed: 10 1 2023
medline: 25 2 2023
entrez: 9 1 2023
Statut: ppublish

Résumé

This study aimed to evaluate the usefulness of two novel assays, namely the iTACT-hepatitis B surface antigen (iTACT-HBsAg) and iTACT-hepatitis B core-related antigen (iTACT-HBcrAg) assays, in chronic hepatitis B (CHB) patients with HBsAg seroclearance (SC) documented by standard assays. HBsAg and HBcrAg were measured by the two iTACT-assays in 556 serial sera collected from 96 CHB patients at 7 different time points spanning from 5 years before to 10 years after SC and 120 HBsAg-negative, anti-HBc-positive individuals. As controls, 60 seronegative individuals, who were negative for HBsAg, anti-HBc and anti-HBs, were tested. Using the iTACT-assays, HBsAg was detectable in 154/418 (36.8%) samples collected after SC. HBcrAg was detectable in 78.3% and 65.9% of samples collected before and after SC, respectively. The detectability rates of both HBsAg and HBcrAg progressively decreased over time after SC. At 10 years after SC, 20.4% and 64.5% of the patients still had detectable HBsAg and HBcrAg, respectively. 66 (71%) patients had detectable HBsAg and/or HBcrAg. Among the 120 HBsAg-negative, anti-HBc-positive individuals, 11 (9.2%) and 4 (3.3%) had detectable HBsAg and HBcrAg respectively. Both HBsAg and HBcrAg were undetectable in the controls. The iTACT assays detected a low level of HBsAg and/or HBcrAg in >70% of patients even at 10 years after SC, suggesting that CHB patients with SC still harbour a low level of HBV protein expression. The clinical significance of detectable viral proteins after SC with regard to disease progression and HBV reactivation deserves further investigations.

Sections du résumé

BACKGROUND
This study aimed to evaluate the usefulness of two novel assays, namely the iTACT-hepatitis B surface antigen (iTACT-HBsAg) and iTACT-hepatitis B core-related antigen (iTACT-HBcrAg) assays, in chronic hepatitis B (CHB) patients with HBsAg seroclearance (SC) documented by standard assays.
METHODS
HBsAg and HBcrAg were measured by the two iTACT-assays in 556 serial sera collected from 96 CHB patients at 7 different time points spanning from 5 years before to 10 years after SC and 120 HBsAg-negative, anti-HBc-positive individuals. As controls, 60 seronegative individuals, who were negative for HBsAg, anti-HBc and anti-HBs, were tested.
RESULTS
Using the iTACT-assays, HBsAg was detectable in 154/418 (36.8%) samples collected after SC. HBcrAg was detectable in 78.3% and 65.9% of samples collected before and after SC, respectively. The detectability rates of both HBsAg and HBcrAg progressively decreased over time after SC. At 10 years after SC, 20.4% and 64.5% of the patients still had detectable HBsAg and HBcrAg, respectively. 66 (71%) patients had detectable HBsAg and/or HBcrAg. Among the 120 HBsAg-negative, anti-HBc-positive individuals, 11 (9.2%) and 4 (3.3%) had detectable HBsAg and HBcrAg respectively. Both HBsAg and HBcrAg were undetectable in the controls.
CONCLUSION
The iTACT assays detected a low level of HBsAg and/or HBcrAg in >70% of patients even at 10 years after SC, suggesting that CHB patients with SC still harbour a low level of HBV protein expression. The clinical significance of detectable viral proteins after SC with regard to disease progression and HBV reactivation deserves further investigations.

Identifiants

pubmed: 36623378
pii: S1386-6532(22)00307-9
doi: 10.1016/j.jcv.2022.105375
pii:
doi:

Substances chimiques

Hepatitis B Surface Antigens 0
Hepatitis B Core Antigens 0
Hepatitis B Antibodies 0
DNA, Viral 0
Hepatitis B e Antigens 0
Biomarkers 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105375

Informations de copyright

Copyright © 2022. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The iTACT-assays used in this study was supported by Fujirebio Inc. D Wong received speaker's fee from Abbott Laboratories and meetings and/or travel support from Gilead Sciences. T Inoue received research funding from Fujirebio, Inc. and Sysmex Corporation. J Fung is an advisory board member of Gilead Sciences. WK Seto received speaker's fees from AstraZeneca and Mylan, is an advisory board member of Abbott, is an advisory board member and received speaker's fees from AbbVie, and is an advisory board member, received speaker's fees and researching funding from Gilead Sciences. Y Tanaka received research funding from FUJIFILM Corporation, Janssen Pharmaceutical K.K., Gilead Sciences, Board of Trustees of the Leland Stanford Junior University, GlaxoSmithKline PLC, Fujirebio Incorporation and Sysmex Corporation and received speaker's fees from Fujirebio, Inc., Gilead Sciences and GlaxoSmithKline PLC. MF Yuen received research funding from Assembly Biosciences, Arrowhead Pharmaceuticals, Fujirebio Incorporation, Sysmex Corporation, and is an advisory board member and/or received research funding from AbbVie, Aligos therapeutics, Arbutus Biopharma, Bristol Myer Squibb, Dicerna Pharmaceuticals, Finch Therapeutics, GlaxoSmithKline, Gilead Sciences, Janssen, Merck Sharp and Dohme, Clear B Therapeutics, Springbank Pharmaceuticals, Roche. The rest of the authors have nothing to disclose.

Auteurs

Danny Ka-Ho Wong (DK)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.

Takako Inoue (T)

Department of Clinical Laboratory Medicine, Nagoya City University Hospital, Nagoya, Japan.

Lung-Yi Mak (LY)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.

Rex Wan-Hin Hui (RW)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.

James Fung (J)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.

Ka-Shing Cheung (KS)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong.

Wai-Kay Seto (WK)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong.

Yasuhito Tanaka (Y)

Department of Gastroenterology and Hepatology, Kumamoto University, Kumamoto, Japan.

Man-Fung Yuen (MF)

Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Queen Mary Hospital, Hong Kong; State Key Laboratory of Liver Research, The University of Hong Kong, Hong Kong. Electronic address: mfyuen@hku.hk.

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Classifications MeSH