Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.
Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.
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DOI：
10.1093/cid/cir001
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发表时间：
2011-03-15
期刊：
影响因子：
--
通讯作者：
eIND Peramivir Investigators
中科院分区：
文献类型：
--
作者：
Hernandez JE;Adiga R;Armstrong R;Bazan J;Bonilla H;Bradley J;Dretler R;Ison MG;Mangino JE;Maroushek S;Shetty AK;Wald A;Ziebold C;Elder J;Hollister AS;Sheridan W;eIND Peramivir Investigators
Peramivir是一种试验性静脉注射神经氨酸酶抑制剂，在2009年H1N1流感大流行期间，根据紧急IND条例，对31名患有严重病毒性肺炎的住院患者进行了静脉注射。该药通常耐受性良好，并与大多数患者的康复有关。（参见Jain等人的社论。）背景。Peramivir是一种正在进行住院患者3期临床试验的静脉注射神经氨酸酶抑制剂，在2009年H1N1流感大流行期间根据紧急新药研究条例（eIND）提供。我们描述了在eIND下要求使用帕拉米韦的所有患者的临床特征和结果。方法。在获得美国食品和药物管理局和当地机构审查委员会的eIND批准后，照顾流感住院患者的临床医生静脉注射peramivir，并收集有关人口统计学特征、临床特征和结果的信息。结果。从2009年4月到10月，42名患者申请使用peramivir， 20名成人和11名儿童使用。住院时，所有患者均进展迅速，影像学证实病毒性肺炎合并呼吸衰竭，除1例患者外，其余患者均需要机械通气。在大多数患者中，包括1名记录有奥司他韦耐药感染的患者，尽管接受了奥司他韦治疗，但病情仍有进展。帕拉米韦给药1-14天（中位持续时间10天）。14天、28天、56天存活率分别为76.7%、66.7%、59.0%。帕拉米韦总体耐受良好。结论。静脉注射帕拉米韦耐受性良好，并与大多数因2009年H1N1严重流感病毒性肺炎住院并接受eIND治疗的患者的康复有关。
Peramivir, an investigational intravenous neuraminidase inhibitor, was given to 31 hospitalized patients with severe viral pneumonia during the 2009 H1N1 influenza pandemic under the Emergency IND regulations. The drug was generally well tolerated and associated with recovery in most patientes. (See the editorial commentary by Jain et al, on pages .) Background. Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND. Methods. After obtaining eIND approval from the Food and Drug Administration and local institutional review board approval, clinicians caring for hospitalized patients with influenza administered intravenous peramivir and collected information on demographic characteristics, clinical characteristics, and outcomes. Results. From April through October 2009, peramivir was requested for 42 patients and administered to 20 adults and 11 children. At hospitalization, all patients had rapidly progressing, radiographically confirmed viral pneumonia with respiratory failure, and all but 1 patient required mechanical ventilation. In most patients, including 1 person with documented oseltamivir-resistant infection, the illness had progressed despite oseltamivir treatment. Peramivir was administered for 1–14 days (median duration, 10 days). The 14-day, 28-day, and 56-day survival rates were 76.7%, 66.7%, and 59.0%, respectively. Peramivir was generally well tolerated. Conclusions. Intravenous peramivir was well tolerated and was associated with recovery in most patients hospitalized with severe 2009 H1N1 influenza viral pneumonia and treated under an eIND.
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