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一种基于模型的方法支持在艾滋病毒-1感染儿童中批准阿巴卡维尔/多卢特格拉维尔/拉米武丁固剂组合

Hardik Chandasana¹, Ann M Buchanan², Michael McKenna³

¹GSK, Collegeville, PA, USA.

Journal of clinical pharmacology

|September 5, 2024

概括

基于模型的药物开发 (MIDD) 加快了对阿巴卡维尔,多卢特格拉维尔和拉米武丁的固定剂量组合 (FDC) 的批准,用于治疗儿科HIV-1患者. 这种方法确保了儿童的药物暴露,安全性和疗效与成人观察到的相似.

科学领域:

药理学药理学是指药理学的学科.
儿科医学儿科医学
药物开发药物开发

背景情况:

含有阿巴卡维尔 (ABC),多卢特格拉维尔 (DTG) 和拉米武丁 (3TC) 的固定剂量组合 (FDC) TRIUMEQ已被批准用于艾滋病毒-1感染的成人和青少年.
在2022年3月之前,它的适用性仅限于体重至少40公斤的患者,尽管单个成分已被批准用于年幼儿童.
开发了一种新的可分散片剂配方 (ABC 60 mg/DTG 5 mg/3TC 30 mg) 用于体重6公斤或以上的儿科患者.

研究的目的:

证明一种基于模型的药物开发 (MIDD) 方法在儿科患者中快速批准ABC/DTG/3TC FDC的实用性.
从单个药物成分和配方中弥合现有的数据,以支持FDC在10公斤至40公斤以下的儿童中使用.

主要方法:

针对ABC/DTG/3TC FDC的三个组成部分的儿科参与者,开发了人口药理动力学 (PK) 模型.
这些PK模型用于暴露预测,并包含相对生物利用率数据.
这些模型有助于将单个实体研究中的安全性和有效性数据推断到FDC.

主要成果:

儿童中FDC剂量的预测血暴露与儿科和成人研究中单个实体观察到的暴露一致.
该MIDD方法证实,与单个组件相比,FDC导致类似的药物暴露.
在单组件研究中观察到的安全性和有效性被充分推断为FDC.

结论:

基于模型的药物开发 (MIDD) 显著促进了ABC/DTG/3TC FDC对儿科HIV-1治疗的快速批准.
这种方法使得使用儿童友好的配方成为可能,改善了年轻人群获得有效的HIV-1治疗的机会.
在加速HIV-1治疗中儿科配方的可用性方面,MIDD发挥着至关重要的作用.

关键词:

艾滋病毒-1病毒.在中期,中期.亚巴卡维尔 (abacavir) 是一种药物.杜洛特格拉维尔 (Dolutegravir) 是一种严重的病毒.拉米丁是一种儿科儿科儿科儿科

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