美国批准长效药物Apreude(cabotegravir)用于HIV暴露前预防

2021-12-22 Allan MedSci原创

与每天口服 Truvada PrEP 的女性相比,服用 Apreude 的女性感染 HIV 的风险降低了 89%。

HIV暴露前预防(Pre-exposure Prophylaxis,简称PrEP)是指尚未感染艾滋病病毒的人在发生易感染艾滋病病毒行为之前服用特定的抗病毒药物,以预防HIV感染的方法。预防效果好有一个必要前提,即严格按方案服药,不漏服药物。服药依从性越高,预防效果越好。

美国食品和药物管理局(FDA)本周一批准 ViiV Healthcare 的长效注射药物 Apreude(cabotegravir)用作高危成人和青少年的 HIV 暴露前预防(PrEP)。FDA 药物评价与研究中心抗病毒药物部主任Debra Birnkrant表示,“对于某些群体来说,坚持每日用药是不现实的,长效药物 Apreude 的批准为这些群体增加了一个预防艾滋病毒的重要工具”。

该决定是基于两项 IIb/III 期试验的数据。HPTN 083 研究包括未感染 HIV 的男性和与男性发生性关系并有高危行为的跨性别女性,结果表明,Apreude 比吉利德科学公司的每日口服 Truvada(恩曲他滨/富马酸替诺福韦二吡呋酯)有效 69%。与此同时,另一项名为 HPTN 084 的研究招募了撒哈拉以南非洲地区有感染风险的 HIV 阴性、性活跃的女性,结果表明,与每天口服 Truvada PrEP 的女性相比,服用 Apreude 的女性感染 HIV 的风险降低了 89%。然而,在这两项试验中,Apreude 的副作用比 Truvada 更常见,包括头痛、发烧、疲劳、背痛、肌痛和皮疹。

Apreude 首先作为间隔一个月进行两次初始注射给药,然后每两个月给药一次。

FDA还指出,Apreude 带有黑框警告,除非确认 HIV 检测呈阴性,否则不要使用该药物。

今年早些时候,FDA 批准了 Cabenuva,这是一种治疗成人 HIV-1 感染的长效方案。

 

原始出处:

https://firstwordpharma.com/story/5466213

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    2021-12-24 闆锋旦
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    2021-12-22 1436749007

    学到了很多东西,谢谢各位老师的指导

    0

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