在新生儿中使用单剂儿科多卢特格拉维尔可分散片的单剂量支持多剂量:PETITE-Dolutegravir研究
Tim R Cressey1, Nicolas Salvadori1, Helena Rabie2
1AMS-PHPT, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.
Journal of acquired immune deficiency syndromes (1999)
|February 20, 2025
概括
多卢特格拉维尔可分散片 (DTG-DTs) 对新生儿是安全的. 在最初的两周内,每48小时服用5毫克DTG-DT的剂量策略,然后每24小时,确保新生儿的药物水平最佳.
科学领域:
- 儿科药理学 儿科药理学
- 新生儿药理动力学 新生儿药理动力学
- 抗逆转录病毒疗法 抗逆转录病毒疗法
背景情况:
- 多卢特格拉维尔可分散片 (DTG-DTs) 已批准用于4周及以上,体重至少3公斤的婴儿.
- 对于新生儿的DTG-DTs的适合性和最佳剂量仍未确定.
研究的目的:
- 评估杜洛特格拉维尔 (DTG) 的药理动力学 (PK) 和安全性.
- 为了建立一个适当的剂量方案DTG在新生儿出生于基于DTG治疗的母亲.
主要方法:
- 在PETITE-DTG试验中,评估了南非新生儿的DTG PK和安全性.
- 第1阶段涉及14天或14-28天以下新生儿一次性DTG-DT剂量.
- 一个群体PK模型为多剂量治疗方案的模拟提供了信息.
主要成果:
- 在16名新生儿中没有观察到3级或更高的不良事件.
- DTG 清除受体重和产后年龄的影响.
- 模拟表明,在前两周每天服用Cmax时,可能会达到超治疗性Cmax;每48小时服用一次,然后每天服用一次,达到目标水平.
结论:
- 缓慢的产后DTG清除需要对新生儿进行修改的剂量策略.
- 在前两周每48小时服用5毫克DTG-DT的多剂量疗法,然后每24小时服用一次,持续28天,被选为进一步研究.
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