Multi-stakeholder consensus on a target product profile for an HIV cure.
Multi-stakeholder consensus on a target product profile for an HIV cure.
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DOI：
10.1016/s2352-3018(20)30234-4
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发表时间：
2021-01
期刊：
影响因子：
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通讯作者：
Sunnylands 2019 Working Group
中科院分区：
文献类型：
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作者：
Lewin SR;Attoye T;Bansbach C;Doehle B;Dubé K;Dybul M;SenGupta D;Jiang A;Johnston R;Lamplough R;McCune JM;Nabel GJ;Ndung'u T;Pottage J;Ripin D;Rooney JF;Sikazwe I;Nsubuga M;Warren M;Deeks SG;Sunnylands 2019 Working Group
开发艾滋病毒治疗方法是全球优先事项。目标产品概况是在整个药物开发过程中常用的工具，用于使相关各方围绕潜在产品的一系列明确目标或要求进行协调。确定了三种不同的治疗方式（联合治疗、体外基因治疗和体内基因治疗），用于HIV治愈的靶向产品特征。使用专家面对面咨询和在线德尔菲咨询的过程中，我们发现一个高度的协议的最佳目标产品配置文件的标准。虽然对治愈的最低属性进行了辩论，但广泛的共识是，可接受的治愈不一定像最佳提供的抗逆转录病毒疗法那样安全有效。成功治愈一部分成年人的干预措施足以进入临床。随着该领域的成熟，这些目标产品简介将需要进一步讨论和不断修订。
Developing a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three distinct therapeutic modalities (combination therapies, ex-vivo gene therapy, and in-vivo gene therapy) for a target product profile for an HIV cure were identified. Using a process of expert face-to-face consultation and an online Delphi consultation, we found a high degree of agreement regarding the criteria for the optimum target product profile. Although the minimum attributes for a cure were debated, the broad consensus was that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. An intervention that successfully cured a reasonable fraction of adults would be sufficient to advance to the clinic. These target product profiles will require further discussion and ongoing revisions as the field matures.