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一个随机的第一阶段研究,评估高度,长效卡博特格拉维尔配方在没有艾滋病病毒的成年人中的药理动力学,安全性和耐受性

Kelong Han¹, Paul Benn², Jörg Sievers²

¹GSK, Collegeville, PA, USA.

Clinical pharmacology in drug development

|April 29, 2025

概括

长效卡博特格拉维尔400毫克/毫升 (CAB400-D) 注射显示吸收速度比CAB200快,限制了较少的剂量. 在没有艾滋病毒的成年人中观察到可接受的安全性和耐受性.

科学领域:

药理学药理学是指药理学的学科.
传染性疾病传染性疾病
药物开发药物开发

背景情况:

长效 (LA) 卡博特格拉维尔 (CAB200) 已被批准用于HIV-1预防和治疗.
开发了一种更高度的配方,CAB400-D,用于可能更少的剂量和自我管理.

研究的目的:

评估肌内 (IM) 脏,皮下 (SC) 腹部和IM大腿CAB400-D注射的药理动力学,安全性和耐受性.
为了比较CAB400-D和CAB200注射在没有艾滋病毒的成年人.
评估与复合人体 hialuronidase (rHuPH20) 联合使用对 CAB400-D 吸收的影响.

主要方法:

第1期,双盲,随机化研究 (NCT04484337) 在138名没有艾滋病毒的成年人中进行.
通过IM关,SC腹部和IM大腿路径给药CAB400-D (200-800毫克),使用CAB200作为活性对照.
评估与rHuPH20,局部NSAID或局部类固醇用于某些SC注射的同时使用.

主要成果:

与CAB200相比,CAB400-D在所有评估路线上的吸收速度更快.
在4周内,CAB400-D在整个注射途径的类似血暴露,超过了CAB200的暴露.
与rHuPH20同时使用增加了CAB400-D的吸收率;没有死亡或严重的副作用报告.
99%的患者经历了注射部位反应 (ISRs);4%的患者因副作用 (3 ISR相关) 而停止治疗.

结论:

在没有艾滋病毒的成年人中,CAB400-D注射表明了可接受的安全性和耐受性.
吸收速度比CAB200更快,表明每月服用一次,时间间隔不少.
用于更长的剂量间隔的替代卡博特格拉维尔配方正在临床研究中.

关键词:

艾滋病病毒艾滋病病毒艾滋病病毒抗逆转录病毒药物治疗卡博特格拉维尔 (Cabotegravir) 是一个肌肉内注射肌肉内注射自主管理的自治.

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