乙肝新药研发幻灭：是时候重置了？

StephenW

乙肝新药研发幻灭：是时候重置了？

    Jean-Michel Pawlotsky 教授，医学博士

发表时间：2022 年 11 月 4 日DOI：https://doi.org/10.1016/S2468-1253(22)00341-7
PlumX 指标

    概括
    参考
    文章信息
    相关专业馆藏

将此期刊推荐给您的图书管理员
概括
经过 5 年多的紧张临床前和临床研究，新型乙型肝炎病毒 (HBV) 药物的开发似乎停滞不前。造成这种情况的主要原因是开发路径的主要限制，包括使用不适当的临床开发终点、疗效和批准标准过于严格（短期有限治疗后的功能性治愈）、期望化合物做它们不能做的事情这样做是因为它们已知的目标和作用机制，并希望一种尺寸适合所有人，尽管事实上 HBV 感染是异质的。仅用目前正在开发的化合物类别进行几周或几个月的治疗，无法轻易实现功能性 HBV 治愈。因此，研究人员、药物开发商和监管机构需要就临床相关且可实现的终点建立新的共识，并重新定义新的 HBV 药物开发的目标、时间表和途径。

StephenW

New hepatitis B drug development disillusions: time to reset?

    Prof Jean-Michel Pawlotsky, MD

Published:November 04, 2022DOI:https://doi.org/10.1016/S2468-1253(22)00341-7
PlumX Metrics

    Summary
    References
    Article Info
    Related Specialty Collections

Recommend this journal to your librarian
Summary
After more than 5 years of intense preclinical and clinical research, the development of new hepatitis B virus (HBV) drugs appears to be stalling. The main reasons for this are the major limitations of the developmental path, including the use of inappropriate endpoints for clinical development, the standards for efficacy and approval being too strict (functional cure after short finite treatment duration), expecting compounds to do what they cannot do because of their known targets and mechanisms of action, and hoping that one size will fit all, despite the fact that HBV infection is heterogeneous. A functional HBV cure cannot be easily attained with only a few weeks or months of treatment with the classes of compounds that are currently in development. Therefore, researchers, drug developers, and regulators need to establish a new consensus about endpoints that are both clinically relevant and achievable, and redefine the objectives, timelines, and pathways of new HBV drug development.