Berman Institute of Bioethics, Department of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA.
J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2(0 2):S135-9. doi: 10.1097/QAI.0b013e3182987787.
There is increasing evidence that the use of antiretroviral agents (ARVs) can be a safe and effective means of preventing HIV infection. In fact, a combination of ARVs, tenofovir-emtricitabine, was recently approved by the US Food and Drug Administration (FDA) for use as "pre-exposure prophylaxis"(PrEP), and the US Centers for Disease Control and other regulatory authorities have issued guidance concerning PrEP use. Clinicians and policy makers are now faced with questions about the appropriateness of prescribing ARVs to healthy persons who are at risk of becoming infected with HIV, and those at risk of being infected must decide whether to use PrEP. In addition, researcher stakeholders must grapple with determining whether and how PrEP should be included in future HIV prevention research. In addressing such issues, it is important that their ethical dimensions are identified. When using PrEP, 2 broad ethical domains are of special relevance: well-being and justice. Ethical issues related to well-being include safety, parameters of use, risk behaviors, resistance, stigma, and diversion. Those related to justice include access and competing priorities. In research involving PrEP, ethical issues include determining the appropriate control arm and whether PrEP should be included as a part of the prevention package provided to all at risk participants. Although PrEP could play an important role in HIV prevention, understanding and addressing the related ethical issues is critical to its safe, effective, and appropriate use in practice and future research.
越来越多的证据表明，使用抗逆转录病毒药物（ARV）可以安全有效地预防 HIV 感染。事实上，最近美国食品和药物管理局（FDA）批准了将 ARV、替诺福韦-恩曲他滨的组合用于“暴露前预防”（PrEP），美国疾病控制中心和其他监管机构也发布了关于 PrEP 使用的指南。临床医生和政策制定者现在面临着为有感染 HIV 风险的健康人开处方使用 ARV 的适当性问题，而有感染风险的人必须决定是否使用 PrEP。此外，研究人员必须努力确定是否以及如何将 PrEP 纳入未来的 HIV 预防研究中。在解决这些问题时，确定其伦理维度非常重要。在使用 PrEP 时，有两个广泛的伦理领域特别相关：福祉和公正。与福祉相关的伦理问题包括安全性、使用参数、风险行为、耐药性、污名和滥用。与公正相关的问题包括获取途径和优先事项的竞争。在涉及 PrEP 的研究中，伦理问题包括确定适当的对照组，以及 PrEP 是否应作为提供给所有有风险参与者的预防方案的一部分。虽然 PrEP 可以在 HIV 预防中发挥重要作用，但理解和解决相关的伦理问题对于其在实践和未来研究中的安全、有效和适当使用至关重要。
