Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations
Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations
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DOI：
10.1093/cid/cix194
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发表时间：
2017-06-01
影响因子：
11.8
通讯作者：
Abrams, Elaine J.
中科院分区：
文献类型：
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作者：
Penazzato, Martina;Gnanashanmugam, Devasena;Abrams, Elaine J.
全球有180万儿童携带人类免疫缺陷病毒(HIV)，但符合条件的人中只有51%实际开始治疗。儿科抗逆转录病毒药物(ARV)的研发是一个漫长的过程，远远落后于成人的药物开发。为儿童提供安全、有效和耐受性良好的药物仍然是确保全球扩大规模的关键。我们回顾了目前儿科抗逆转录病毒药物研发的方法，并提出了创新建议，以简化、快速和更全面的策略来开发最佳配方。可以采取几种办法，包括侧重于数量有限的优先配方和加强现有的伙伴关系，以确保在药物开发进程的早期制定儿科调查计划。需要建立简化和更有效的研发机制，并使融资机制更具可持续性。应分享从艾滋病毒中吸取的经验教训，以支持在为包括结核病和病毒性肝炎在内的其他疾病制定儿科配方方面取得进展。
Globally 1.8 million children are living with human immunodeficiency virus (HIV), yet only 51% of those eligible actually start treatment. Research and development (R&D) for pediatric antiretrovirals (ARVs) is a lengthy process and lags considerably behind drug development in adults. Providing safe, effective, and well-tolerated drugs for children remains critical to ensuring scale-up globally. We review current approaches to R&D for pediatric ARVs and suggest innovations to enable simplified, faster, and more comprehensive strategies to develop optimal formulations. Several approaches could be adopted, including focusing on a limited number of prioritized formulations and strengthening existing partnerships to ensure that pediatric investigation plans are developed early in the drug development process. Simplified and more efficient mechanisms to undertake R&D need to be put in place, and financing mechanisms must be made more sustainable. Lessons learned from HIV should be shared to support progress in developing pediatric formulations for other diseases, including tuberculosis and viral hepatitis.