辉瑞新冠口服药Paxlovid用于暴露后预防的II/III期临床失败

2022-05-01 网络 网络

当地时间4月29日,辉瑞对外公布了一项研究其口服新冠药Paxlovid用于暴露后预防的II/III期临床(EPIC-PEP)研究情况,

当地时间4月29日,辉瑞对外公布了一项研究其口服新冠药Paxlovid用于暴露后预防的II/III期临床(EPIC-PEP)研究情况,结果显示该药用于成人暴露后预防效果不佳。

该研究共纳入了2957名成人,这些人新冠抗原检测为阴性,在96小时内接触过一个有症状且抗原检测为阳性的个体。

据显示,与安慰剂相比,在接受PAXLOVID 5天和10天的成年人中,预防感染的风险分别降低了32%和37%,但这些结果在统计上并不显著。因此,辉瑞方面表示,该药用于通过家庭接触暴露于病毒的成人中,在降低有症状的感染上,未达到主要研究终点。

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辉瑞首席执行官阿尔伯特·布尔拉(Albert Bourla)对试验结果感到“失望”,不过他也表示,奈玛特韦在对有重症风险的新冠病人的治疗中依然十分有效。

此前有报道称,该口服药能够让新冠感染者住院或死亡的风险下降九成。

另外,据彭博社报道,一些病人在奈玛特韦疗程结束后,病情又出现了反弹。目前美国政府的研究人员正着手研究这种现象出现的常见程度以及原因。

据报道,在辉瑞公布试验结果后,辉瑞(PFE)美股盘后一度下跌超3.7%。

Paxlovid是3CL蛋白酶抑制剂与低剂量利托那韦的复方制剂,属于小分子口服新冠药。从2021年12月,该药获得FDA的紧急使用授权,用于治疗非住院、具有发展成重症疾病高风险轻中度新冠患者,包括了12岁以上儿童以及成人。今年2月11日,Paxlovid获中国药监局附条件进口批准,用于治疗成人伴有进展为重症高风险因素的至中度新冠患者。

在治疗上,该药体现出较好的效果。以中国为例,Paxlovid已开始用于成人新冠患者治疗中。如近日,深圳市第三人民医院院长、首届深圳市疫情防控公共卫生专家组组长卢洪洲在分享防疫经验时介绍,目前深圳市第三人民医院将首批进入国内的PAXLOVID用于患者的治疗,有33名患者接受了该药物治疗。通过对比研究发现,应用抗病毒药物治疗的感染者,转阴周期明显缩短,也显示了用药安全,无明显副作用。

当前,在奥密克戎疫情下,有不少感染者呈现的是无症状或者轻症,主要原因在于这些人前期已有接种新冠疫苗基础。如何将小分子口服新冠药用于暴露后预防,是药企们正在试图突破的方向。

小分子口服新冠药物多数的作用机制是通过干扰病毒自身的复制来达到消灭病毒的效果,主要作用于细胞内,由于胞内过程相对保守,不易发生突变,因此效果不易受变异株影响。

另外,服用方便、生产储运容易也是这类药物的一大优势。在开发小分子口服药中,3CL蛋白酶抑制剂基于能够抑制3CL蛋白酶的作用,从而阻止病毒后续的一系列复制活动,成为药企们正在开发的热门方向之一。目前在研的一些3CL蛋白酶抑制剂,在一些细胞试验中,有显示出比辉瑞受PAXLOVID更强的抗病毒活性的,但这些药用于暴露后的预防是否还有机会?

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    2022-12-03 gdsun
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    2023-03-05 juliusluan78
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