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最近FDA警告对免疫抑制和抗癌药乙肝激活:冰山的一角? [复制链接]

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发表于 2014-11-26 14:25 |只看该作者 |倒序浏览 |打印
Recent FDA warnings on hepatitis B reactivation with immune-suppressing and anti-cancer drugs: Just the tip of the iceberg?

    Adrian M. Di Bisceglie MD1,*,
    Anna S. Lok MD2,
    Paul Martin MD3,
    Norah Terrault MD, MPH4,
    Robert P. Perrillo MD5 and
    Jay H. Hoofnagle MD6

DOI: 10.1002/hep.27609

Copyright © 2014 by the American Association for the Study of Liver Diseases

Issue
Cover image for Vol. 60 Issue 6
Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)
Article has an altmetric score of 1


Author Information

    1    Department of Internal Medicine, Saint Louis University School of Medicine, St Louis, MO
    2    Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI
    3    Univerisity of Miami, Miami, Florida
    4    University of California - San Francisco, San Francisco, CA
    5    Baylor University Medical Center, Dallas, TX
    6    Liver Disease Research Branch, Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD

*Corresponding author: Adrian M. Di Bisceglie, Department of Internal Medicine, 1402 South Grand Blvd, St. Louis, MO 63104. Telephone 314-577-8760. Fax: 314-268-5108.

Abstract

Reactivation of hepatitis B in the context of immunosuppressive therapy may be severe and potentially fatal. The FDA 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 HBV reactivation which may occur with a wide variety of immunosuppressive therapies in benign or malignant disease. This manuscript summarizes the data behind this issue. These data support the recommendation that all patients undergoing chemotherapy, immunosuppressive therapy, HSCT or solid organ transplantation be screened for active or prior HBV infection by testing for HBsAg and anti-HBc in serum. Those who are found to be HBsAg 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 HBV 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. This article is protected by copyright. All rights reserved.

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发表于 2014-11-26 14:26 |只看该作者
最近FDA警告对乙肝激活与免疫抑制和抗癌药:冰山的一角?

    阿德里安·M.迪比谢列MD1,*,
    安娜S.乐MD2,
    保罗·马丁MD3,
    诺拉Terrault MD,MPH4,
    罗伯特·P. Perrillo MD5和
    周杰伦H.胡夫纳格尔MD6

DOI:10.1002/ hep.27609

版权所有©2014年由美国协会肝病研究

问题
封面图片的卷。 60第6期
肝病

接受第(接受,未经编辑的文章在网上和引述的公布,最终编辑和记录排版本将出现在未来。)
第二十有altmetric比分1


作者信息

    内科,圣路易斯大学医学院,圣路易斯,密苏里州的1系
    胃肠病学和肝病,密歇根大学,密歇根州安阿伯的2部
    迈阿密,迈阿密,佛罗里达州的3 Univerisity
    旧金山,旧金山,加州 - 美国加州大学4
    5贝勒大学医学中心,达拉斯,德克萨斯
    6肝病研究科,消化疾病和营养,糖尿病研究所,消化和肾脏病科,美国国立卫生研究院,马里兰州贝塞斯达

*通讯作者:阿德里安·M.迪比谢列,内科,1402南方大大道,圣路易斯,密苏里州63104.电话314-577-8760系。传真:314-268-5108。

抽象

在免疫抑制治疗的上下文中乙型肝炎再活化可能是严重的和潜在致命的。美国食品药物管理局最近提请注意的乙肝激活了潜在的致命风险接受抗CD20剂,或的ofatumumab利妥昔单抗的患者。这个动作着重于HBV再激活的更广泛的问题可与各种良性或恶性疾病的免疫抑制治疗的发生注意。这份手稿背后总结这个问题的数据。这些数据支持接受化疗,免疫抑制治疗,造血干细胞移植或实体器官移植的患者在血清测试HBsAg和抗-HBc进行筛选,活性或先前HBV感染的建议。那些被发现谁是乙肝表面抗原阳性者应适当开始抗病毒治疗,以防止重新激活。此外,即使是那些谁从乙肝康复将受益于抗病毒治疗,因为与HBV再激活被称为逆向血清学转换的一种形式相关的风险一定的情况下。但仍然存在值得进一步研究和进一步发展将来自各个医学专科,监管机构和研究人员之间的密切互动中受益很多不确定的地方。

结论:有很好的证据来接受化疗或免疫抑制治疗前支持所有患者对乙肝的常规筛查。及时使用抗病毒治疗的出现减少乙型肝炎这篇文章是受版权保护的严重或致命激活的风险。版权所有。
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