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一年一次的莱纳卡巴维尔的药理动力学和安全性:一期的开放性研究
Vamshi Jogiraju1, Pallavi Pawar1, Jenna Yager1
1Gilead Sciences, Foster City, CA, USA.
Lancet (London, England)
|March 14, 2025
概括
在HIV暴露前预防 (PrEP) 中,每年一次的肌肉注射显示出良好的药理动力学和安全性. 这种长效的配方为生物医学预防HIV提供了一个有前途的新选择,
科学领域:
- 药理学和制药学
- 传染性疾病
- 临床试验
背景情况:
- 长效抗逆转录病毒药物可以解决与日常艾滋病毒暴露前预防 (PrEP) 相关的坚持和耻辱挑战.
- 在第三阶段试验中,每年两次皮下注射莱纳卡巴维尔的疗效和安全性高.
- 这项研究研究了新的,较少使用的莱纳卡巴维尔剂量策略.
研究的目的:
- 评估两种每年一次的肌肉注射lenacapavir配方的药理动力学和安全性.
- 为了比较每年一次肌肉注射莱纳卡巴维尔的药理学特征与每年两次皮下注射的配方.
- 评估肌肉内注射莱纳卡巴维尔在预防艾滋病毒中的耐受性和安全性.
主要方法:
- 第1阶段的开放性研究,涉及40名没有艾滋病毒的参与者 (18至55岁).
- 两种每年一次的肌肉注射莱纳卡巴维尔配方 (5000毫克单剂量).
- 药物动力学采样至56周;安全性和耐受性评估,包括注射部位疼痛.
主要成果:
- 两种配方的中位时间达到峰值度约为70-84天.
- 血中位数和最低度超过每年两次皮下注射莱纳卡巴维尔的水平.
- 这些不良事件主要是轻微的 (1- 2级),注射部位疼痛是最常见的,在一周内消失.
结论:
- 每年一次的肌肉注射达到了与PrEP疗效相关的持续血度.
- 两种研究的配方均被发现是安全的,耐受性良好.
- 这些发现支持每年一次肌肉内注射莱纳卡巴维尔治疗方案对生物医学预防的潜力.
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