Influenza Therapeutics in Clinical Practice-Challenges and Recent Advances
Influenza Therapeutics in Clinical Practice-Challenges and Recent Advances
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DOI：
10.1101/cshperspect.a038463
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发表时间：
2021-04-01
影响因子：
5.4
通讯作者：
Hayden, Frederick G.
中科院分区：
文献类型：
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作者：
Beigel, John H.;Hayden, Frederick G.
在过去的几年中，几种新的直接作用的抗流感病毒药物已经获得许可，其他药物也在临床开发中取得了进展。随着抗病毒药物种类的日益多样化，如果对一种药物或种类具有耐药性的病毒广泛传播，就可以采取适当的公共卫生应对措施。一种新的抗病毒药物baloxavir marboxil已在美国被批准用于治疗流感相关并发症高危人群的流感。除欧盟国家的静脉注射扎那米韦外，没有抗病毒药物被批准专门用于重症流感或住院流感的适应症。本文综述了最近的临床进展，涉及选定的聚合酶抑制剂，神经氨酸酶抑制剂，抗体为基础的治疗，和主机定向治疗。由于一些数据尚未发表，且目前正在进行多项关键性研究，因此大多数此类药物存在许多知识空白。该综述还考虑了重要的临床研究问题，包括监管途径，研究设计，终点和新疗法临床开发过程中遇到的目标人群。
In the last few years, several new direct-acting influenza antivirals have been licensed, and others have advanced in clinical development. The increasing diversity of antiviral classes should allow an adequate public health response should a resistant virus to one agent or class widely circulate. One new antiviral, baloxavir marboxil, has been approved in the United States for treatment of influenza in those at high risk of developing influenza-related complications. Except for intravenous zanamivir in European Union countries, no antivirals have been licensed specifically for the indication of severe influenza or hospitalized influenza. This review addresses recent clinical developments involving selected polymerase inhibitors, neuraminidase inhibitors, antibody-based therapeutics, and host-directed therapies. There are many knowledge gaps for most of these agents because some data are not published and multiple pivotal studies are in progress at present. This review also considers important clinical research issues, including regulatory pathways, study designs, endpoints, and target populations encountered during the clinical development of novel therapeutics.