When to start paediatric testing of the adult HIV cure research agenda?
When to start paediatric testing of the adult HIV cure research agenda?
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DOI：
10.1136/medethics-2015-103116
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发表时间：
2017-02-01
影响因子：
4.1
通讯作者：
Shah，Seema K.
中科院分区：
文献类型：
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作者：
Shah，Seema K.
伦理指南建议，实验性干预措施应首先在成人身上进行测试，然后再在儿童身上进行测试和批准。然而，一些人对这一范式提出了挑战，并建议在某些情况下在成人进行初步安全测试后启动儿科测试。例如，评论员们主张加快对儿童艾滋病毒疫苗的测试。此外，在一定程度上受到密西西比州婴儿病例的推动，关于在婴儿中使用非常早期治疗(VET)的艾滋病毒治愈研究，是目前正在婴儿身上进行测试的策略的一个例子，之后才在成年人中进行了良好的测试。由于婴儿的免疫系统仍在发育中，婴儿中艾滋病毒的传播时间比成年人更容易识别，而且接受VET治疗的婴儿可能永远不会形成使艾滋病毒如此难以根除的病毒库，因此婴儿可能处于独特的位置，可以实现艾滋病毒治愈或持续病毒缓解。几位评论员现在主张在儿童中更早地启动艾滋病毒治疗干预，而不是(或除了)兽医。因此，艾滋病毒治愈研究是重新审视何时启动儿科研究这一重要问题的一个很好的例子。我认为，尽管艾滋病毒治愈研究有可能造福儿童，而且让儿童参与这项研究具有科学价值，但艾滋病毒治愈议程不应加速儿童的参与，原因如下：艾滋病毒治愈研究具有高度的投机性、风险，旨在结合各种方法，而且不能与现有的替代方案相提并论。最后，我总结了启动儿科测试的一般含义，包括必须与其他干预措施结合使用的干预措施以及慢性病的治疗方法可能不足以证明及早进行儿科测试是合理的。
Ethical guidelines recommend that experimental interventions should be tested in adults first before they are tested and approved in children. Some challenge this paradigm, however, and recommend initiating paediatric testing after preliminary safety testing in adults in certain cases. For instance, commentators have argued for accelerated testing of HIV vaccines in children. Additionally, HIV cure research on the use of very early therapy (VET) in infants, prompted in part by the Mississippi baby case, is one example of a strategy that is currently being tested in infants before it has been well tested in adults. Because infants’ immune systems are still developing, the timing of HIV transmission is easier to identify in infants than in adults, and infants who receive VET might never develop the viral reservoirs that make HIV so difficult to eradicate, infants may be uniquely situated to achieve HIV cure or sustained viral remission. Several commentators have now argued for earlier initiation of HIV cure interventions other than (or in addition to) VET in children. HIV cure research is therefore a good case for re-examining the important question of when to initiate paediatric research. I will argue that, despite the potential for HIV cure research to benefit children and the scientific value of involving children in this research, the HIV cure agenda should not accelerate the involvement of children for the following reasons: HIV cure research is highly speculative, risky, aimed at combination approaches and does not compare favourably with the available alternatives. I conclude by drawing general implications for the initiation of paediatric testing, including that interventions that have to be used in combination with others and cures for chronic diseases may not be valuable enough to justify early paediatric testing.