在COVID-19 (EPIC-IC) 免疫功能低下患者中延长尼马特里尔维尔-里托纳维尔治疗持续时间:一个安慰剂控制,随机,双盲,第二阶段试验
Edward Weinstein1, Roger Paredes2, Annie Gardner3
1Antivirals, Global Product Development, Pfizer, New York, NY, USA.
The Lancet. Infectious diseases
|July 17, 2025
概括
延长尼尔马特里尔维尔 - 里托纳维尔 (帕克斯洛维德) 治疗COVID-19免疫功能低下患者超过5天,显示病毒反弹的名义下降. 较长的持续时间通常被很好地容忍,在主要终点上没有显著差异.
科学领域:
- 传染性疾病 传染性疾病
- 病毒学 病毒学
- 临床药理学 临床药理学
背景情况:
- 尼尔马特雷尔维尔-里托纳维尔已被批准用于COVID-19的成年人,有严重疾病的风险.
- 有限的临床数据存在于免疫功能低下患者的最佳涅马特雷尔维尔-里托纳维尔治疗持续时间.
- 这项研究研究了免疫功能低下个体的延长尼马特里尔维尔 - 里托纳维尔疗法.
研究的目的:
- 为了比较5天,10天和15天的涅马特雷尔维尔 - 里托纳维尔疗程的疗效和安全性.
- 为了评估持续的病毒清除和病毒反弹在免疫功能低下的COVID-19患者.
- 评估延长尼马特里尔维尔 - 里托纳维尔治疗持续时间的安全性.
主要方法:
- 一个随机,双盲,安慰剂控制的第二阶段试验.
- 156名12岁以上的免疫功能低下的参与者接受了5,10或15天的涅马特雷尔维尔-里托纳维尔.
- 主要终点:从15-44天持续的SARS-CoV-2RNA阴性;次要:病毒反弹和安全性.
主要成果:
- 主要终点在61.5% (5天),70.8% (10天) 和66.0% (15天) 组中实现.
- 病毒反弹发生在17.3% (5天) 与2.1% (10天) 和2.0% (15天) 的群体中.
- 52.8% (5天),66.7% (10天) 和60.8% (15天) 的小组报告了不良事件;在5天小组有两次住院治疗.
结论:
- 在三次治疗期间之间,没有观察到持续病毒清除的显著差异.
- 延长的尼马特里尔维尔-里托纳维尔治疗 (10或15天) 在减少病毒反弹方面表现出名义上的改善.
- 在这种免疫受损人群中,较长的治疗持续时间通常被很好地容忍和安全.
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