Advancing Novel PrEP Products - Alternatives to Non-Inferiority.
Advancing Novel PrEP Products - Alternatives to Non-Inferiority.
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DOI：
10.1515/scid-2019-0011
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发表时间：
2019-01-01
期刊：
影响因子：
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通讯作者：
Glidden, David V
中科院分区：
文献类型：
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作者：
Glidden, David V
随着使用替诺福韦（TDF）联合或不联合恩曲他滨（FTC）的HIV暴露前预防（PrEP）的规模扩大，我们已经进入了一个高效HIV预防的时代，有越来越多的潜在产品可供研究。这些研究可能是口服TDF/FTC对照组的随机试验，这些研究需要比较偶发感染，可能是时间和资源密集型的。活性对照试验的设计和分析的传统方法可能会导致非常大的样本量。我们证明了背景感染的重要性，解释试验结果的假设，并提出了替代标准，证明潜在的PrEP药物的疗效和有效性。
With the scale-up of HIV pre-exposure prophylaxis (PrEP) with tenofovir (TDF) with or without emtricitabine (FTC), we have entered an era of highly effective HIV prevention with a growing pipeline of potential products to be studied. These studies are likely to be randomized trials with an oral TDF/FTC control arm. These studies require comparison of incident infections and can be time and resource intensive. Conventional approaches for design and analysis active controlled trial can lead to very large sample sizes. We demonstrate the important of assumptions about background infections for interpreting trial results and suggest alternative criteria for demonstrating the efficacy and effectiveness of potential PrEP agents.