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NEJM：EDP-938，一种呼吸道合胞病毒抑制剂效果如何？

2022-02-17 MedSci原创 MedSci原创

EDP-938呼吸道合胞病毒抑制剂
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所有EDP-938治疗方案在降低病毒载量、总症状评分和粘液重量方面均优于安慰剂，且没有明显的安全性问题。

呼吸道合胞病毒(RSV)感染引起了婴儿、老年人和免疫功能低下成人大量的发病和死亡。EDP-938是RSV的非融合复制抑制剂，通过调节病毒核蛋白起作用。

近日，顶级医学期刊N Engl J Med上发表了一篇研究文章，在这项分为两部分、2a期、随机、双盲、安慰剂对照的挑战试验中，研究人员分配已接种RSV-AMemphis37b的参与者接受EDP-938或安慰剂治疗。此外，研究人员还评估了不同剂量EDP-938的效果。从第2天到第12天获取洗鼻液样本用于评估。参与者评估临床症状，并获得药代动力学特征。该研究的主要终点是RSV病毒载量的曲线下面积(AUC)，并通过逆转录酶定量聚合酶链反应测定法测量。该研究的关键次要终点是总症状评分的AUC。

在该试验的第1部分中，115名参与者被分配接受EDP-938（600mg每天一次[600mg每天一次组]或500mg负荷剂量后每天两次300mg[300mg每天两次组])或安慰剂治疗。在第2部分中，共有63名参与者被分配接受EDP-938（600mg负荷剂量后每天300mg[300mg每天一次组]或400mg负荷剂量后每天两次200mg[200毫克每日两次组]）或安慰剂治疗。

在第1部分中，平均病毒载量（小时×log10拷贝/毫升）的AUC在600mg每天一次组中为204.0，在300mg每天两次组中为217.7，在安慰剂组中为790.2。平均总症状评分（小时×评分，数值越高表示严重程度越高）的AUC在600mg每天一次组中为124.5，在300mg每天两次组中为181.8，在安慰剂组中为478.8。第2部分的结果与第1部分结果相似：300mg每日一次组的平均病毒载量AUC为173.9，200mg每日两次组为196.2，安慰剂组为879.0组，平均总症状评分的AUC分别为99.3、89.6和432.2。在这两个部分中，每个EDP-938剂量组的粘液产量都比安慰剂组低70%以上。四种EDP-938治疗方案的安全性与安慰剂相似。在所有给药方案中，EDP-938达到最大浓度的中位时间范围为4至5小时，平均半衰期范围为13.7至14.5小时。

由此可见，所有EDP-938治疗方案在降低病毒载量、总症状评分和粘液重量方面均优于安慰剂，且没有明显的安全性问题。

原始出处：
 
Alaa Ahmad,et al.EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge.NEJM.2022.https://www.nejm.org/doi/full/10.1056/NEJMoa2108903

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2007029, encodeId=3f2f200e029d6, content=<a href='/topic/show?id=9d62e0946c6' target=_blank style='color:#2F92EE;'>#病毒抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70946, encryptionId=9d62e0946c6, topicName=病毒抑制)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/qqapp/101296147/385F510BDFE0F55A4FFDFDFFD9892943/100, createdBy=a3262500163, createdName=siiner, createdTime=Sat Mar 19 20:38:30 CST 2022, time=2022-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852890, encodeId=1066185289074, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sun Jul 17 18:38:30 CST 2022, time=2022-07-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2093716, encodeId=95b62093e1659, content=<a href='/topic/show?id=d89f1049559b' target=_blank style='color:#2F92EE;'>#EDP-938#</a>与我们国内的<a href='/topic/show?id=e5a510495234' target=_blank style='color:#2F92EE;'>#爱司韦#</a>相比如何？值得关注，这都是小分子, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=104955, encryptionId=d89f1049559b, topicName=EDP-938), TopicDto(id=104952, encryptionId=e5a510495234, topicName=爱司韦)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aa0e14, createdName=lifestar, createdTime=Fri Oct 14 03:30:34 CST 2022, time=2022-10-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1957095, encodeId=2ac1195e095c0, content=<a href='/topic/show?id=a8d5e09475e' target=_blank style='color:#2F92EE;'>#病毒抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=70947, encryptionId=a8d5e09475e, topicName=病毒抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTIOca9icPByKxo3ZRUrvuibf7tWt7EScQ1NEiaKy4NCUctSU2jDjOayLicDIaicwUxaQhJ1SZKdEevgjRg/132, createdBy=4f272500131, createdName=若水123, createdTime=Mon Jun 13 05:38:30 CST 2022, time=2022-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282574, encodeId=98b112825e4b1, content=<a href='/topic/show?id=700239e0772' target=_blank style='color:#2F92EE;'>#呼吸道#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=39707, encryptionId=700239e0772, topicName=呼吸道)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e94174, createdName=zhmscau, createdTime=Fri Feb 18 23:38:30 CST 2022, time=2022-02-18, status=1, ipAttribution=)]
    2022-03-19 siiner

    #病毒抑制#

    0

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    2022-07-17 jklm09

    #抑制剂#

    0

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    2022-10-14 lifestar

    #EDP-938#与我们国内的#爱司韦#相比如何？值得关注，这都是小分子

    0

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    2022-06-13 若水123

    #病毒抑制剂#

    0

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    2022-02-18 zhmscau

    #呼吸道#

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