Although 23 antiretroviral drugs are approved for use in adults, only six are approved by regulatory authorities for use in term neonates born to women with HIV, with even fewer options for preterm neonates. A major hurdle for approvals is the delay in the generation of pharmacokinetic and safety data for antiretrovirals in neonates. The median time between the year of approval from the US Food and Drug Administration of an antiretroviral agent for adults and the first publication date for pharmacokinetic data in neonates less than 4 weeks old is 8 years (range 2–23 years). In this Viewpoint, we address pharmacokinetic research gaps and priorities for current and novel antiretroviral use in neonates. We also consider the challenges and provide guidance on neonatal clinical pharmacology research on antiretroviral agents with the goal of stimulating research and expediting the availability of safe medications for the prevention and treatment of HIV in this vulnerable population.

尽管有 23 种抗逆转录病毒药物被批准用于成人，但只有 6 种药物被监管机构批准用于感染 HIV 的妇女所生的足月新生儿，而用于早产新生儿的选择就更少了。批准的一个主要障碍是新生儿抗逆转录病毒药物的药代动力学和安全数据的生成延迟。美国食品和药物管理局批准成人抗逆转录病毒药物的年份与 4 周龄以下新生儿的药代动力学数据首次发布日期之间的中位时间为 8 年（范围 2-23 岁）。在这个观点中，我们解决了新生儿当前和新型抗逆转录病毒药物使用的药代动力学研究差距和优先事项。