9月1日，在新加坡召开的OPTIONS X 2019会议上，罗氏集团第一时间展示了在研流感药物Xofluza（baloxavir marboxil）两项III期临床试验的积极数据。罗氏引领全球抗击流感的前沿，快随我们一探究竟！

       Xofluza使接触感染者后患上流感的风险降低86%

       · BLOCKSTONE研究达到主要终点，与安慰组相比，使用Xofluza的人群更少被检验出流感，或出现发烧或至少一种呼吸道症状。

       · 无论对减少普通季节性流感，或是限制大规模流感爆发，Xofluza都有望成为便捷、有效的治疗方法。

       III期BLOCKSTONE研究表明，在接触感染流感的家庭成员后，使用Xofluza进行预防治疗，相较于安慰剂，可使患上流感的风险显著降低86%。研究结果表明，使用Xofluza治疗的家庭成员只有1.9%患上流感，而安慰剂治疗组的比例为13.6%（p<0.0001）。而且，在不同亚型的甲型流感中，相比于安慰剂，Xofluza均表现出统计学上的显著获益（H1N1: 1.1% vs 10.6%，p=0.0023；H3: 2.8% vs. 17.5%，p<0.0001）。此外，在流感感染高风险人群（2.2% vs 15.4%，p=0.0435）及更容易患上流感的未满12周岁（4.2% vs 15.5%，p=0.0339）的儿童接触中也观察到这种差异。Xofluza相较于安慰剂表现出可比的安全性，Xofluza的不良事件总体发生率为22.2%，而安慰剂为20.5%。没有严重不良事件报告。

       单剂量Xofluza在儿童流感患者中取得阳性结果

       · III期MINISTONE-2数据显示，Xofluza在儿童中的安全性与已知的安全性特征一致，且疗效与奥司他韦可比。

       · 作为新的单剂口服混悬液给药，Xofluza是一种潜在的对儿童更加方便的治疗选择。

       · 儿童患流感的风险高，每年流感并发症导致全球将近100万5岁以下的儿童住院。

       III期MINISTONE-2研究表明，单剂量Xofluza对未满12周岁既往健康的儿童流感患者，是一种耐受性良好、有效的潜在流感治疗手段。该研究评估了截至研究第29天出现不良事件（AEs）或严重不良事件的患者比例，结果表明与Xofluza的已知安全性一致，达到主要终点。在接受Xofluza治疗的参与者中，有46.1%经历至少一次治疗引发的不良事件，而奥司他韦组为53.4%。研究还表明，Xofluza的疗效与奥司他韦（一种证实有效的儿童流感治疗方案）可比 。此外，与成人和青少年群体的数据一致，与奥司他韦相比，Xofluza使流感病毒从体内排出的时间缩短了两天多 （病毒排毒中位时间分别为24.2小时与75.8小时）。

       注：原文有删减

       参考文献

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