Baloxavir Marboxil简单流感在成人和青少年。

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海登FG, Sugaya N, Hirotsu N, N,李德容博士伤害AC,石田T, Sekino H,山田K,朴茨茅斯,川口K, Shishido T, Arai M, K,土屋Uehara T,渡边一个

Baloxavir Marboxil简单流感在成人和青少年。

郑传经地中海J。2018年9月6日,379 (10):913 - 923。doi: 10.1056 / NEJMoa1716197。

PubMed ID
30184455 (在PubMed
]
文摘

背景:Baloxavir marboxil是流感帽依赖核酸内切酶的选择性抑制剂。它显示在临床治疗活动模型甲型和乙型流感病毒的感染,包括病毒抵抗目前的抗病毒药物。方法:我们进行了两次随机、双盲、对照试验涉及健康门诊急性无并发症流感。dose-ranging后(10至40毫克)安慰剂对照试验中,我们进行了一个安慰剂oseltamivir-controlled试验单,体重依赖型剂量的剂量baloxavir(40或80毫克)12到64岁的患者在2016 - 2017赛季。奥司他韦的剂量75毫克连续5天每天两次。主要疗效终点是时间减轻流感症状的意向处理被感染的人群。结果:在第二阶段试验中,减轻流感症状的平均时间是23.4到28.2小时短baloxavir组比安慰剂组(P < 0.05)。3期临床试验,意向处理感染人口包括1064例;84.8在每组有88.1%的病人感染甲型流感(H3N2)。时间来减轻症状的中位数是53.7小时(95%可信区间(CI), 49.5 - 58.5) baloxavir,比80.2小时(95% CI, 72.6 - 87.1)与安慰剂组(P < 0.001)。 The time to alleviation of symptoms was similar with baloxavir and oseltamivir. Baloxavir was associated with greater reductions in viral load 1 day after initiation of the regimen than placebo or oseltamivir. Adverse events were reported in 20.7% of baloxavir recipients, 24.6% of placebo recipients, and 24.8% of oseltamivir recipients. The emergence of polymerase acidic protein variants with I38T/M/F substitutions conferring reduced susceptibility to baloxavir occurred in 2.2% and 9.7% of baloxavir recipients in the phase 2 trial and phase 3 trial, respectively. CONCLUSIONS: Single-dose baloxavir was without evident safety concerns, was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load 1 day after initiation of the trial regimen in patients with uncomplicated influenza. Evidence for the development of decreased susceptibility to baloxavir after treatment was also observed. (Funded by Shionogi; JapicCTI number, 153090, and CAPSTONE-1 ClinicalTrials.gov number, NCT02954354 .).

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药物
药物靶点
药物 目标 类 生物 药理作用 行动
Baloxavir marboxil 聚合酶酸性蛋白质 蛋白质 甲型流感病毒(应变/波多黎各/ 8/1934 H1N1)
是的
抑制剂
 细节