当前及新的终点指标在实验性乙型肝炎治疗药物评估中的应用
Use of Current and New Endpoints in the Evaluation of Experimental Hepatitis B Therapeutics.
作者信息
Block Timothy M, Locarnini Stephen, McMahon Brian J, Rehermann Barbara, Peters Marion G
机构信息
Hepatitis B Foundation and Baruch S. Blumberg Institute, Doylestown, Pennsylvania, USA.
Victorian Infectious Diseases Reference Laboratory, Doherty Institute, Melbourne, Australia.
出版信息
Clin Infect Dis. 2017 May 1;64(9):1283-1288. doi: 10.1093/cid/cix129.
Abstract
New hepatitis B virus (HBV) therapies are expected to have breakthrough benefit for patients. HBV functional cure is sustained hepatitis B surface antigen loss and anti-HBs gain, with normalization of serum aminotransferases off therapy. Virologic or complete cure additionally includes loss of HBV covalently closed circular DNA. Currently available endpoints of therapy are inadequate to evaluate the efficacy of many of the new therapeutics. Therefore, either new ways of using the existing virologic endpoints and laboratory values or entirely new biomarkers are needed. In this review, we discuss the currently used endpoints, potential new endpoints, as well as what new markers are needed to assess the ability of HBV therapeutics to achieve functional and virologic cure in various phases of HBV infection. In addition, we discuss how patient selection from differing phases of HBV impacts the choice of HBV drug(s) needed to achieve cure.
摘要
新型乙型肝炎病毒（HBV）疗法有望给患者带来突破性益处。HBV功能性治愈是指乙肝表面抗原持续消失且出现抗-HBs，同时在停止治疗后血清转氨酶恢复正常。病毒学治愈或完全治愈还包括HBV共价闭合环状DNA的消失。目前可用的治疗终点不足以评估许多新型疗法的疗效。因此，要么需要采用现有病毒学终点和实验室值的新方法，要么需要全新的生物标志物。在本综述中，我们讨论了目前使用的终点、潜在的新终点，以及评估HBV疗法在HBV感染各阶段实现功能性和病毒学治愈能力所需的新标志物。此外，我们还讨论了从HBV不同阶段选择患者如何影响实现治愈所需的HBV药物选择。
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本文引用的文献
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Serum hepatitis B virus RNA is encapsidated pregenome RNA that may be associated with persistence of viral infection and rebound.血清乙型肝炎病毒 RNA 是包裹前基因组 RNA 的，它可能与病毒感染的持续存在和反弹有关。
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