Pharmaceuticals Division, F. Hoffmann-La Roche Ltd, PBMT Bldg 74/3O Z1.06, CH-4070, Basel, Switzerland.
Adv Ther. 2011 Nov;28(11):927-59. doi: 10.1007/s12325-011-0072-7. Epub 2011 Nov 1.
Oseltamivir (Tamiflu®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) is an orally administered antiviral for the treatment and prevention of influenza A and B infections that is registered in more than 100 countries worldwide. More than 83 million patients have been exposed to the product since its introduction. Oseltamivir is recommended by the World Health Organization (WHO) for use in the clinical management of pandemic and seasonal influenza of varying severity, and as the primary antiviral agent for treatment of avian H5N1 influenza infection in humans. This article is a nonsystematic review of the experience gained from the first 10 years of using oseltamivir for influenza infections since its launch in early 2000, emphasizing recent advances in our understanding of the product and its clinical utility in five main areas. The article reviews the pharmacokinetics of oseltamivir and its active metabolite, oseltamivir carboxylate, including information on special populations such as children and elderly adults, and the co-administration of oseltamivir with other agents. This is followed by a summary of data on the effectiveness of oseltamivir treatment and prophylaxis in patients with all types of influenza, including pandemic (H1N1) 2009 and avian H5N1 influenza. The implications of changes in susceptibility of circulating influenza viruses to oseltamivir and other antiviral agents are also described, as is the emergence of antiviral resistance during and after the 2009 pandemic. The fourth main section deals with the safety profile of oseltamivir in standard and special patient populations, and reviews spontaneously reported adverse event data from the pandemic and pre-pandemic periods and the topical issue of neuropsychiatric adverse events. Finally, the article considers the pharmacoeconomics of oseltamivir in comparison with vaccination and usual care regimens, and as a component of pandemic influenza mitigation strategies.
奥司他韦(达菲®;罗氏制药,巴塞尔,瑞士)是一种用于治疗和预防甲型和乙型流感感染的口服抗病毒药物,已在全球 100 多个国家注册。自推出以来,已有超过 8300 万患者接触过该产品。世界卫生组织(世卫组织)建议在严重程度不同的大流行和季节性流感的临床管理中使用奥司他韦,并将其作为治疗人类 H5N1 禽流感感染的主要抗病毒药物。本文是对 2000 年初奥司他韦推出以来用于流感感染的前 10 年经验的非系统性综述,重点介绍了在五个主要领域对该产品及其临床应用的最新认识进展。本文综述了奥司他韦及其活性代谢物奥司他韦羧酸的药代动力学,包括有关儿童和老年人群等特殊人群以及奥司他韦与其他药物联合使用的信息。接着总结了奥司他韦治疗和预防各种流感患者的有效性数据,包括大流行(H1N1)2009 年和 H5N1 禽流感。还描述了循环流感病毒对奥司他韦和其他抗病毒药物敏感性变化的影响,以及在大流行期间和之后出现的抗病毒耐药性。第四部分主要讨论奥司他韦在标准和特殊患者人群中的安全性概况,并回顾了大流行和大流行前期间自发报告的不良事件数据以及神经精神不良事件这一热点问题。最后,本文还比较了奥司他韦与疫苗和常规护理方案的药物经济学,并将其作为大流行性流感缓解策略的一部分进行了考虑。