Ultra-high sensitivity HBsAg assay can diagnose HBV reactivation following rituximab-based therapy in patients with lymphoma.

Aged Antineoplastic Agents, Immunological / administration & dosage Comorbidity DNA, Viral / isolation & purification Drug Monitoring / methods Female Hepatitis B Surface Antigens / analysis Hepatitis B virus / drug effects Hepatitis B, Chronic / blood Humans Japan / epidemiology Lymphoma / drug therapy Male Reinfection / etiology Reproducibility of Results Rituximab / administration & dosage Serologic Tests / methods
Anti-CD20 antibody HBV reactivation Preemptive antiviral therapy Resolved HBV infection Rituximab Ultra-high sensitivity HBsAg assay

Journal

Journal of hepatology
ISSN: 1600-0641
Titre abrégé: J Hepatol
Pays: Netherlands
ID NLM: 8503886

Informations de publication

Date de publication:
08 2020
Historique:
received: 28 09 2019
revised: 04 03 2020
accepted: 05 03 2020
pubmed: 21 3 2020
medline: 4 11 2021
entrez: 21 3 2020
Statut: ppublish

Résumé

HBV reactivation is a risk in patients receiving anti-CD20 antibodies for the treatment of lymphoma. The purpose of this post hoc analysis was to evaluate the efficacy of an ultra-high sensitivity HBsAg assay to guide preemptive antiviral treatment in patients with lymphoma and resolved HBV infections using prospectively stored samples from an HBV DNA monitoring study. HBV reactivation (defined as HBV DNA levels of ≥11 IU/ml) was confirmed in 22 of 252 patients. A conventional HBsAg assay (ARCHITECT, cut-off value: 0.05 IU/ml) and an ultra-high sensitivity HBsAg assay employing a semi-automated immune complex transfer chemiluminescence enzyme technique (ICT-CLEIA, cut-off value: 0.0005 IU/ml) were performed at baseline, at confirmed HBV reactivation and monitored after HBV reactivation. Baseline HBsAg was detected using ICT-CLEIA in 4 patients; in all of whom precore mutants with high replication capacity were reactivated. Of the 6 patients with HBV DNA detected below the level of quantification at baseline, 5 showed HBV reactivation and 3 of the 5 had precore mutations. Sensitivity for detection by ARCHITECT and ICT-CLEIA HBsAg assays at HBV reactivation or the next sampling after HBV reactivation was 18.2% (4 of 22) and 77.3% (17 of 22), respectively. Of the 5 patients undetectable by ICT-CLEIA, HBV reactivation resolved spontaneously in 2 patients. All 6 patients reactivated with precore mutations including preS deletion could be diagnosed by ICT-CLEIA HBsAg assay at an early stage of HBV reactivation. Multivariate analysis showed that an anti-HBs titer of less than 10 mIU/ml, HBV DNA detected but below the level of quantification, and HBsAg detected by ICT-CLEIA at baseline were independent risk factors for HBV reactivation (adjusted hazard ratios, 15.4, 31.2 and 8.7, respectively; p <0.05). A novel ICT-CLEIA HBsAg assay is an alternative method to diagnose HBV reactivation. UMIN000001299. Hepatitis B virus can be reactivated in lymphoma patients receiving anti-CD20 antibodies such as rituximab. Currently, reactivation requires the monitoring of HBV DNA, but monitoring of the surface antigen (HBsAg) could provide a relatively inexpensive, quick and easy alternative. We assessed the performance of an ultra-high sensitivity HBsAg assay and showed that it could be effective for the diagnosis and monitoring of HBV reactivation.

Sections du résumé

BACKGROUND & AIMS
HBV reactivation is a risk in patients receiving anti-CD20 antibodies for the treatment of lymphoma. The purpose of this post hoc analysis was to evaluate the efficacy of an ultra-high sensitivity HBsAg assay to guide preemptive antiviral treatment in patients with lymphoma and resolved HBV infections using prospectively stored samples from an HBV DNA monitoring study.
METHODS
HBV reactivation (defined as HBV DNA levels of ≥11 IU/ml) was confirmed in 22 of 252 patients. A conventional HBsAg assay (ARCHITECT, cut-off value: 0.05 IU/ml) and an ultra-high sensitivity HBsAg assay employing a semi-automated immune complex transfer chemiluminescence enzyme technique (ICT-CLEIA, cut-off value: 0.0005 IU/ml) were performed at baseline, at confirmed HBV reactivation and monitored after HBV reactivation.
RESULTS
Baseline HBsAg was detected using ICT-CLEIA in 4 patients; in all of whom precore mutants with high replication capacity were reactivated. Of the 6 patients with HBV DNA detected below the level of quantification at baseline, 5 showed HBV reactivation and 3 of the 5 had precore mutations. Sensitivity for detection by ARCHITECT and ICT-CLEIA HBsAg assays at HBV reactivation or the next sampling after HBV reactivation was 18.2% (4 of 22) and 77.3% (17 of 22), respectively. Of the 5 patients undetectable by ICT-CLEIA, HBV reactivation resolved spontaneously in 2 patients. All 6 patients reactivated with precore mutations including preS deletion could be diagnosed by ICT-CLEIA HBsAg assay at an early stage of HBV reactivation. Multivariate analysis showed that an anti-HBs titer of less than 10 mIU/ml, HBV DNA detected but below the level of quantification, and HBsAg detected by ICT-CLEIA at baseline were independent risk factors for HBV reactivation (adjusted hazard ratios, 15.4, 31.2 and 8.7, respectively; p <0.05).
CONCLUSIONS
A novel ICT-CLEIA HBsAg assay is an alternative method to diagnose HBV reactivation.
CLINICAL TRIAL NUMBER
UMIN000001299.
LAY SUMMARY
Hepatitis B virus can be reactivated in lymphoma patients receiving anti-CD20 antibodies such as rituximab. Currently, reactivation requires the monitoring of HBV DNA, but monitoring of the surface antigen (HBsAg) could provide a relatively inexpensive, quick and easy alternative. We assessed the performance of an ultra-high sensitivity HBsAg assay and showed that it could be effective for the diagnosis and monitoring of HBV reactivation.

Identifiants

DOI: 10.1016/j.jhep.2020.03.009 PMID: 32194183
pubmed: 32194183
pii: S0168-8278(20)30167-7
doi: 10.1016/j.jhep.2020.03.009
pii:
doi:

Substances chimiques

Antineoplastic Agents, Immunological 0
DNA, Viral 0
Hepatitis B Surface Antigens 0
Rituximab 4F4X42SYQ6

Banques de données

UMIN-CTR
['UMIN000001299']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

285-293

Informations de copyright

Copyright © 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Conflicts of interest Shigeru Kusumoto: Research funding from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., and honoraria from Chugai Pharmaceutical Co., Ltd., Zennyaku Kogyo Co. Ltd., Bristol-Myers Squibb. Yasuhito Tanaka: Research funding from Fujifilim Corp., Gilead Sciences Inc., Bristol-Meyers Squibb, Chugai Pharmaceutical Co., Ltd., Fujifilim Corp., Janssen Pharmaceutical K.K, Glaxosmithkline pharmaceuticals ltd, Stanford Junior University and and Honoraria from Fujirebio Inc., Gilead Sciences Inc. Bristol-Meyers Squibb, Sysmex Corp. Ritsuro Suzuki: Honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Bristol-Meyers Squib, Meiji Seika, MSD, Takeda, Celgene, Eisai, Ono Pharmaceuticals, Janssen, AbbVie, Novartis, Shionogi, Ohtsuka, Sawai, Sumitomo Dainippon, Alexion Pharma, Sanofi, Gilead Sciences, Jazz Pharma. Takashi Watanabe: Funding resources from TakaraBio and United Immunity, Co., Ltd., to support Department of Immuno-Gene Therapy in Mie University Graduate School of Medicine, to which TW belongs, and honoraria from Bristol-Meyers Squibb, AstraZeneca Pharmaceutical, and Chugai Pharmaceutical Co., Ltd. Rika Sakai: Research funding from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Ono Pharmaceuticals, Yakult, Taiho Pharma, and Eisai and honoraria from Takeda, Bayer, Bristol-Meyer-Squibb, Sumitomo Dainippon, Celgene, Mundipharma, Eisai, and Kyowa Kirin Co., Ltd. Kuniaki Itoh: Consultant or Advisory Role on Zennyaku Kogyo Co. Ltd. Kisato Nosaka: Honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Bristol-Myers Squibb, Celgene K.K. Masashi Sawa: Honoraria from Chugai, Pfizer, Astellas, Nippon-Shinyaku, Ono, MSD, Bristol-Myers Squibb, Kyowa-Hakko Kirin, Asahi-Kasei, Novartis, Eisai, Otsuka, Sumitomo Dainippon, Sanofi, Takeda, Celgene, Mochida, Shire, Mundipharma. Rumiko Okamoto: Honoraria from Kissei, Celgene, Chugai. Toshiki Uchida: Honoraria from Pfizer, Chugai Pharmaceutical, Takeda Pharmaceutical, Janssen Pharmaceutical, Eisai, Celgene, Mundipfarma, Bristol-Myers Squibb, Ono Pharmaceutical, Novartis Pharma, Otsuka Pharmaceutical, Nippon Shinyaku, Kyowa Kirin. Masataka Okamoto: Research funding from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Taiho Pharma, Takeda Pharmaceutical Co. Ltd., Ono Pharmaceutical Co., Ltd. Yasushi Onishi: Research funding from Takeda, Bristol-Myers Squibb, MSD, and honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Bristol-Myers Squibb, Pfizer, Astellas, Novartis, Celgene, Sumitomo Dainippon, Ono, Nippon Shinyaku, Janssen. Otsuka, MSD. Hiroyuki Takahashi: Consultant or Advisory role on Celgene, Takeda, Chugai Pharmaceutical Co., Ltd., honoraria from Kyowa Kirin Co., Ltd., Bristol-Meyers Squibb, Novartis, Ono, Janssen. Akihiro Tomita: Research funding from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Taiho Pharma, and honoraria from Chugai Pharmaceutical Co., Ltd. Yoshiko Atsuta: Honoraria from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Mochida, Meiji Seika, Bristol-Myers Squibb, Yakult Honsha, Janssen. Dai Maruyama: Research funding from Chugai Pharmaceutical Co., Ltd., Zennyaku Kogyo Co. Ltd., Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, Janssen Pharmaceutical, Bristol-Myers Squibb, Merck, Amgen Astellas BioPharma, Astellas Pharma, Sanofi, Novartis Pharma, Otsuka Pharmaceutical and honoraria from Chugai Pharmaceutical Co., Ltd., Zennyaku Kogyo Co. Ltd., Ono Pharmaceutical, Celgene, Takeda Pharmaceutical, Janssen Pharmaceutical, Eisai, Kyowa Hakko Kirin, Bristol-Myers Squibb, SYNMOSA BIOPHARMA, NIPPON SHINYAKU. Eiji Tanaka: Honoraria from Sysmex Corporation. Tomohiro Kinoshita: Research funding from Takeda, Chugai, Ono, MSD, Eisai, Gilead, Zenyaku, Soleisia, and honoraria from Takeda, Chugai, Ono. Michinori Ogura: Consultant or Advisory Role on Celgene, Celltrion, Teva-Takeda, MeijiSeika Pharma, Mundi Pharma, Verastem, SymBio, Denovo Biopharma, Yakult, Eisai, and honoraria from Celgene, Takeda, MeijiSeika Pharma, Chugai. Ryuzo Ueda: Consultant or Advisory Role on Terumo Co., Ltd., and research funding from Chugai Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Ono Pharmaceutical Co., Ltd., Rikaken Co., Ltd., Medical & Biological Laboratories Co., Ltd. Masashi Mizokami: Honoraria from Gilead Sciences, Sysmex Corporation. Please refer to the accompanying ICMJE disclosure forms for further details.

Auteurs

Shigeru Kusumoto (S)

Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Yasuhito Tanaka (Y)

Department of Virology and Liver unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Ritsuro Suzuki (R)

Department of Oncology/Hematology, Shimane University Hospital, Izumo, Japan.

Takashi Watanabe (T)

Department of Immuno-Gene Therapy, Mie University Graduate School of Medicine, Mie, Japan.

Masanobu Nakata (M)

Department of Internal Medicine, Sapporo Hokuyu Hospital, Sapporo, Japan.

Rika Sakai (R)

Department of Hematology and Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan.

Noriyasu Fukushima (N)

Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.

Takuya Fukushima (T)

Department of Hematology, Atomic Bomb Disease and Hibakusha Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.

Yukiyoshi Moriuchi (Y)

Department of Hematology, Sasebo City General Hospital, Sasebo, Japan.

Kuniaki Itoh (K)

Divisions of Oncology and Hematology, National Cancer Center Hospital East, Kashiwa, Japan.

Kisato Nosaka (K)

Department of Hematology and Infectious Diseases, Kumamoto University School of Medicine, Kumamoto, Japan.

Ilseung Choi (I)

Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.

Masashi Sawa (M)

Department of Hematology and Oncology, Anjo Kosei Hospital, Anjo, Japan.

Rumiko Okamoto (R)

Department of Oncology, Chibanishi general Hospital, Chiba, Japan.

Hideki Tsujimura (H)

Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.

Toshiki Uchida (T)

Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.

Sachiko Suzuki (S)

Department of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.

Masataka Okamoto (M)

Department of Hematology, Fujita Health University School of Medicine, Toyoake, Japan.

Tsutomu Takahashi (T)

Department of Oncology/Hematology, Shimane University Hospital, Izumo, Japan.

Isamu Sugiura (I)

Division of Hematology and Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan.

Yasushi Onishi (Y)

Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.

Mika Kohri (M)

Department of Hematology, International Medical Center, Saitama Medical University, Hidaka, Japan.

Shinichiro Yoshida (S)

Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.

Minoru Kojima (M)

Department of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.

Hiroyuki Takahashi (H)

Department of Hematology and Clinical Immunology, Yokohama City University School of Medicine, Yokohama, Japan.

Akihiro Tomita (A)

Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Yoshiko Atsuta (Y)

Department of Hematopoietic Stem Cell Transplantation Data Management and Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.

Dai Maruyama (D)

Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.

Eiji Tanaka (E)

Department for the Promotion of Regional Medicine, Shinshu University School of Medicine, Matsumoto, Japan.

Takayo Suzuki (T)

Department of Hematology, Kusatsu General Hospital, Kusatsu, Japan.

Tomohiro Kinoshita (T)

Japanese Red Cross Aichi Blood Center, Aichi, Japan.

Michinori Ogura (M)

Department of Hematology and Oncology, Kasugai Municipal Hospital, Kasugai, Japan.

Ryuzo Ueda (R)

Department of Tumor Immunology, Aichi Medical University School of Medicine, Aichi, Japan.

Masashi Mizokami (M)

Genome Medical Science Project, National Center for Global Health and Medicine, Ichikawa, Japan. Electronic address: mmizokami@hospk.ncgm.go.jp.

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