Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg?
Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg?
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DOI：
10.1002/hep.27609
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发表时间：
2015-02
期刊：
影响因子：
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通讯作者：
Hoofnagle JH
中科院分区：
文献类型：
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作者：
Di Bisceglie AM;Lok AS;Martin P;Terrault N;Perrillo RP;Hoofnagle JH
在免疫抑制治疗的背景下，乙肝的重新激活可能是严重的，并可能是致命的。美国食品和药物管理局最近提醒人们注意，在接受抗CD20药物阿图玛单抗或利妥昔单抗治疗的患者中，乙肝病毒再次激活的潜在致命风险。这一行动将注意力集中在乙肝病毒重新激活这一更广泛的问题上，良性或恶性疾病的各种免疫抑制疗法可能会发生这种情况。本文总结了这一问题背后的数据。这些数据支持这样的建议，即所有接受化疗、免疫抑制治疗、造血干细胞移植或实体器官移植的患者都应通过检测血清中的乙肝表面抗原和乙肝核心抗原抗体来筛查活动性或既往的乙肝病毒感染。那些被发现是乙肝表面抗原阳性的人应该开始适当的抗病毒治疗，以防止复发。此外，即使是那些从乙肝中恢复过来的人，在某些情况下也会从抗病毒治疗中受益，因为与一种形式的乙肝病毒重新激活有关的风险被称为“反向血清转换”。仍然有许多不确定的领域需要进一步研究，进一步的进展将受益于各种医学专业、监管机构和研究人员之间的密切互动。有很好的证据支持在接受化疗或免疫抑制治疗之前对所有患者进行常规的乙肝筛查；使用及时的抗病毒治疗似乎可以降低严重或致命的乙肝复发的风险。
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. 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.