美国FDA首次批准儿童全基因型抗丙肝药物:艾伯维的Mayyret

2019-05-05 不详 MedSci原创

美国食品和药物管理局(FDA)首次批准将AbbVie的Mavyret(glecaprevir和pibrentasvir组合),用于治疗12-17岁全基因型丙型肝炎病毒HCV(共6种)感染的儿童患者。

美国食品和药物管理局(FDA)首次批准将AbbVie的Mavyret(glecaprevir和pibrentasvir组合),用于治疗12-17岁儿童患者的全基因型(共6种)丙型肝炎病毒HCV感染药物

Mayvret是一种直接作用的抗病毒药物,"通过阻止病毒复制来减少体内HCV的数量,并且在大多数情况下,可治愈HCV感染," FDA抗病毒产品部副主任Jeffrey Murray说。

该决定基于临床试验,该试验评估了47例1,2,3或4基因型无肝硬化或轻度肝硬化的HCV患者,接受治疗8或16周的所有100%的儿童在12周后的血液样本中没有检测到病毒。在5或6基因型 HCV感染的儿科患者中,Mavyret的安全性和有效性也得到支持。

HCV是一种导致肝脏炎症的病毒性疾病,可导致肝功能减退或肝功能衰竭,影响美国估计有270-390万人,其中大约有23000-46000名HCV儿童感染患者。

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    2020-02-24 ysjykql
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    2019-06-06 bioon3
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