Recent US food and drug administration warnings on hepatitis b reactivation with immune-suppressing and anticancer drugs

Just the tip of the iceberg?

Adrian M. Di Bisceglie, Anna S. Lok, Paul Martin, Norah Terrault, Robert P. Perrillo, Jay H. Hoofnagle

Research output: Contribution to journalArticle

101 Citations (Scopus)

Abstract

Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The US Food and Drug Administration has recently drawn attention to the potentially fatal risk of hepatitis B reactivation in patients receiving the anti-CD20 agents ofatumumab or rituximab. This action focuses attention on the broader issue of hepatitis B virus reactivation, which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This article summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, hematopoietic stem cell transplantation, or solid organ transplantation be screened for active or prior hepatitis B viral infection by testing for hepatitis B surface antigen and the antibody to hepatitis B core antigen in serum. Those who are found to be hepatitis B surface antigen-positive should start appropriate antiviral therapy to prevent reactivation. Additionally, even those who have recovered from hepatitis B will benefit from antiviral therapy in certain circumstances because of the risks associated with a form of hepatitis B virus reactivation referred to as "reverse seroconversion." There remain many uncertain areas that warrant further study, and further advances will benefit from close interactions between various medical specialties, regulatory agencies, and researchers. Conclusions: There is good evidence to support routine screening of all patients for hepatitis B prior to undergoing chemotherapy or immunosuppressive treatment; use of prompt antiviral treatment appears to diminish the risk of severe or fatal reactivation of hepatitis B.

Original languageEnglish
Pages (from-to)703-711
Number of pages9
JournalHepatology
Volume61
Issue number2
DOIs
StatePublished - Jan 1 2015

Fingerprint

United States Food and Drug Administration
Hepatitis
Hepatitis B
Immunosuppressive Agents
Pharmaceutical Preparations
Antiviral Agents
Hepatitis B Surface Antigens
Hepatitis B virus
Therapeutics
Hepatitis B Core Antigens
Drug Therapy
Hematopoietic Stem Cell Transplantation
Organ Transplantation
Virus Diseases
Research Personnel
Medicine
Antibodies
Serum

ASJC Scopus subject areas

  • Hepatology

Cite this

Recent US food and drug administration warnings on hepatitis b reactivation with immune-suppressing and anticancer drugs : Just the tip of the iceberg? / Di Bisceglie, Adrian M.; Lok, Anna S.; Martin, Paul; Terrault, Norah; Perrillo, Robert P.; Hoofnagle, Jay H.

In: Hepatology, Vol. 61, No. 2, 01.01.2015, p. 703-711.

Research output: Contribution to journalArticle

Di Bisceglie, Adrian M. ; Lok, Anna S. ; Martin, Paul ; Terrault, Norah ; Perrillo, Robert P. ; Hoofnagle, Jay H. / Recent US food and drug administration warnings on hepatitis b reactivation with immune-suppressing and anticancer drugs : Just the tip of the iceberg?. In: Hepatology. 2015 ; Vol. 61, No. 2. pp. 703-711.
@article{c9994e0ed335433f958228e1d6a7015a,
title = "Recent US food and drug administration warnings on hepatitis b reactivation with immune-suppressing and anticancer drugs: Just the tip of the iceberg?",
abstract = "Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The US Food and Drug Administration has recently drawn attention to the potentially fatal risk of hepatitis B reactivation in patients receiving the anti-CD20 agents ofatumumab or rituximab. This action focuses attention on the broader issue of hepatitis B virus reactivation, which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This article summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, hematopoietic stem cell transplantation, or solid organ transplantation be screened for active or prior hepatitis B viral infection by testing for hepatitis B surface antigen and the antibody to hepatitis B core antigen in serum. Those who are found to be hepatitis B surface antigen-positive should start appropriate antiviral therapy to prevent reactivation. Additionally, even those who have recovered from hepatitis B will benefit from antiviral therapy in certain circumstances because of the risks associated with a form of hepatitis B virus reactivation referred to as {"}reverse seroconversion.{"} There remain many uncertain areas that warrant further study, and further advances will benefit from close interactions between various medical specialties, regulatory agencies, and researchers. Conclusions: There is good evidence to support routine screening of all patients for hepatitis B prior to undergoing chemotherapy or immunosuppressive treatment; use of prompt antiviral treatment appears to diminish the risk of severe or fatal reactivation of hepatitis B.",
author = "{Di Bisceglie}, {Adrian M.} and Lok, {Anna S.} and Paul Martin and Norah Terrault and Perrillo, {Robert P.} and Hoofnagle, {Jay H.}",
year = "2015",
month = "1",
day = "1",
doi = "10.1002/hep.27609",
language = "English",
volume = "61",
pages = "703--711",
journal = "Hepatology",
issn = "0270-9139",
publisher = "John Wiley and Sons Ltd",
number = "2",

}

TY - JOUR

T1 - Recent US food and drug administration warnings on hepatitis b reactivation with immune-suppressing and anticancer drugs

T2 - Just the tip of the iceberg?

AU - Di Bisceglie, Adrian M.

AU - Lok, Anna S.

AU - Martin, Paul

AU - Terrault, Norah

AU - Perrillo, Robert P.

AU - Hoofnagle, Jay H.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The US Food and Drug Administration has recently drawn attention to the potentially fatal risk of hepatitis B reactivation in patients receiving the anti-CD20 agents ofatumumab or rituximab. This action focuses attention on the broader issue of hepatitis B virus reactivation, which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This article summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, hematopoietic stem cell transplantation, or solid organ transplantation be screened for active or prior hepatitis B viral infection by testing for hepatitis B surface antigen and the antibody to hepatitis B core antigen in serum. Those who are found to be hepatitis B surface antigen-positive should start appropriate antiviral therapy to prevent reactivation. Additionally, even those who have recovered from hepatitis B will benefit from antiviral therapy in certain circumstances because of the risks associated with a form of hepatitis B virus reactivation referred to as "reverse seroconversion." There remain many uncertain areas that warrant further study, and further advances will benefit from close interactions between various medical specialties, regulatory agencies, and researchers. Conclusions: There is good evidence to support routine screening of all patients for hepatitis B prior to undergoing chemotherapy or immunosuppressive treatment; use of prompt antiviral treatment appears to diminish the risk of severe or fatal reactivation of hepatitis B.

AB - Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The US Food and Drug Administration has recently drawn attention to the potentially fatal risk of hepatitis B reactivation in patients receiving the anti-CD20 agents ofatumumab or rituximab. This action focuses attention on the broader issue of hepatitis B virus reactivation, which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This article summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, hematopoietic stem cell transplantation, or solid organ transplantation be screened for active or prior hepatitis B viral infection by testing for hepatitis B surface antigen and the antibody to hepatitis B core antigen in serum. Those who are found to be hepatitis B surface antigen-positive should start appropriate antiviral therapy to prevent reactivation. Additionally, even those who have recovered from hepatitis B will benefit from antiviral therapy in certain circumstances because of the risks associated with a form of hepatitis B virus reactivation referred to as "reverse seroconversion." There remain many uncertain areas that warrant further study, and further advances will benefit from close interactions between various medical specialties, regulatory agencies, and researchers. Conclusions: There is good evidence to support routine screening of all patients for hepatitis B prior to undergoing chemotherapy or immunosuppressive treatment; use of prompt antiviral treatment appears to diminish the risk of severe or fatal reactivation of hepatitis B.

UR - http://www.scopus.com/inward/record.url?scp=84921475521&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84921475521&partnerID=8YFLogxK

U2 - 10.1002/hep.27609

DO - 10.1002/hep.27609

M3 - Article

VL - 61

SP - 703

EP - 711

JO - Hepatology

JF - Hepatology

SN - 0270-9139

IS - 2

ER -