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Safety and efficacy of peramivir for influenza treatment.

Hata A, Akashi-Ueda R, Takamatsu K, Matsumura T - Drug Des Devel Ther (2014)

Bottom Line: Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo.It is likely to be as effective as other neuraminidase inhibitors.Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan ; Department of Infectious Diseases, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.

ABSTRACT

Objective: This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic.

Methods: Literature was accessed via PubMed (January 2000-April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers.

Results: We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose-response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors.

Conclusion: Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.

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Mean duration of fever after onset.Notes: The median time required for patients’ body temperatures to return to normal (ITTI) is shown. Analyzed using a Cox proportional hazards model. The ITTI returned to a normal temperature (<37°C), and it remained for more than 12 hours. Copyright ©2013 Shionogi & Co., Ltd. Adapted from Fever lasting for less than 34 hours in patients treated with peramivir [pamphlet]. Osaka: Shionogi & Co., Ltd.; 2013.10 Data are from a multinational, randomized, double-blind Phase III study in Japan, Taiwan, and South Korea.11Abbreviations: ITTI, intent-to-treat infected; n, number; IV, intravenous; PO, per os.
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f1-dddt-8-2017: Mean duration of fever after onset.Notes: The median time required for patients’ body temperatures to return to normal (ITTI) is shown. Analyzed using a Cox proportional hazards model. The ITTI returned to a normal temperature (<37°C), and it remained for more than 12 hours. Copyright ©2013 Shionogi & Co., Ltd. Adapted from Fever lasting for less than 34 hours in patients treated with peramivir [pamphlet]. Osaka: Shionogi & Co., Ltd.; 2013.10 Data are from a multinational, randomized, double-blind Phase III study in Japan, Taiwan, and South Korea.11Abbreviations: ITTI, intent-to-treat infected; n, number; IV, intravenous; PO, per os.

Mentions: The safety and efficacy of peramivir treatment in patients with uncomplicated seasonal influenza virus infection were first evaluated in dose–response studies. A placebo-controlled, double-blind Phase II study23 demonstrated that, compared with placebo, a single intravenous dose of peramivir at either 300 mg (hazard ratio: 0.681; adjusted P=0.0092) or 600 mg (hazard ratio: 0.666; adjusted P=0.0092) significantly reduced the duration of influenza symptoms for adult influenza outpatients, irrespective of the influenza virus subtype or the duration of symptoms before the study (Table 1). A randomized, double-blind Phase III study11 comparing single-dose intravenously administered peramivir with oral oseltamivir in uncomplicated patients with seasonal influenza was conducted in Japan, Taiwan, and South Korea. The median durations of influenza symptoms were 78.0 hours, 81.0 hours, and 81.8 hours, respectively, in groups treated with 300 mg of peramivir, 600 mg of peramivir, and 75 mg oseltamivir, orally twice a day. The fever lasted for <34 hours in patients treated with peramivir, but 37 hours in patients treated with oseltamivir, as shown in Figure 1, demonstrating that peramivir is not inferior to oseltamivir for treating seasonal influenza A and B (Table 1).11 A Phase III study comparing oseltamivir to intravenously administered zanamivir in hospitalized patients is underway.24


Safety and efficacy of peramivir for influenza treatment.

Hata A, Akashi-Ueda R, Takamatsu K, Matsumura T - Drug Des Devel Ther (2014)

Mean duration of fever after onset.Notes: The median time required for patients’ body temperatures to return to normal (ITTI) is shown. Analyzed using a Cox proportional hazards model. The ITTI returned to a normal temperature (<37°C), and it remained for more than 12 hours. Copyright ©2013 Shionogi & Co., Ltd. Adapted from Fever lasting for less than 34 hours in patients treated with peramivir [pamphlet]. Osaka: Shionogi & Co., Ltd.; 2013.10 Data are from a multinational, randomized, double-blind Phase III study in Japan, Taiwan, and South Korea.11Abbreviations: ITTI, intent-to-treat infected; n, number; IV, intravenous; PO, per os.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4216046&req=5

f1-dddt-8-2017: Mean duration of fever after onset.Notes: The median time required for patients’ body temperatures to return to normal (ITTI) is shown. Analyzed using a Cox proportional hazards model. The ITTI returned to a normal temperature (<37°C), and it remained for more than 12 hours. Copyright ©2013 Shionogi & Co., Ltd. Adapted from Fever lasting for less than 34 hours in patients treated with peramivir [pamphlet]. Osaka: Shionogi & Co., Ltd.; 2013.10 Data are from a multinational, randomized, double-blind Phase III study in Japan, Taiwan, and South Korea.11Abbreviations: ITTI, intent-to-treat infected; n, number; IV, intravenous; PO, per os.
Mentions: The safety and efficacy of peramivir treatment in patients with uncomplicated seasonal influenza virus infection were first evaluated in dose–response studies. A placebo-controlled, double-blind Phase II study23 demonstrated that, compared with placebo, a single intravenous dose of peramivir at either 300 mg (hazard ratio: 0.681; adjusted P=0.0092) or 600 mg (hazard ratio: 0.666; adjusted P=0.0092) significantly reduced the duration of influenza symptoms for adult influenza outpatients, irrespective of the influenza virus subtype or the duration of symptoms before the study (Table 1). A randomized, double-blind Phase III study11 comparing single-dose intravenously administered peramivir with oral oseltamivir in uncomplicated patients with seasonal influenza was conducted in Japan, Taiwan, and South Korea. The median durations of influenza symptoms were 78.0 hours, 81.0 hours, and 81.8 hours, respectively, in groups treated with 300 mg of peramivir, 600 mg of peramivir, and 75 mg oseltamivir, orally twice a day. The fever lasted for <34 hours in patients treated with peramivir, but 37 hours in patients treated with oseltamivir, as shown in Figure 1, demonstrating that peramivir is not inferior to oseltamivir for treating seasonal influenza A and B (Table 1).11 A Phase III study comparing oseltamivir to intravenously administered zanamivir in hospitalized patients is underway.24

Bottom Line: Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo.It is likely to be as effective as other neuraminidase inhibitors.Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatrics, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan ; Department of Infectious Diseases, Division of Respiratory Medicine, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan.

ABSTRACT

Objective: This report presents a review of the efficacy and safety of peramivir, a neuraminidase inhibitor that was granted Emergency Use Authorization by the US Food and Drug Administration (FDA) from October 23, 2009 to June 23, 2010 during the 2009 H1N1 pandemic.

Methods: Literature was accessed via PubMed (January 2000-April 2014) using several search terms: peramivir; BCX-1812; RWJ 270201; H1N1, influenza; antivirals; and neuraminidase inhibitors. The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings. Information was obtained from the Centers for Disease Control and Prevention (CDC) and from US FDA websites. English-language and Japanese-language reports in the literature were reviewed and selected based on relevance, along with information from the CDC, US FDA, and the drug manufacturers.

Results: We obtained eleven clinical trial reports of intravenous peramivir, two of which described comparisons with oseltamivir. Seven of nine other recently reported published studies was a dose-response study. Clinical reports of critically ill patients and pediatric patients infected with pandemic H1N1 described that early treatment significantly decreased mortality. Peramivir administered at 300 mg once daily in adult patients with influenza significantly reduces the time to alleviation of symptoms or fever compared to placebo. It is likely to be as effective as other neuraminidase inhibitors.

Conclusion: Although peramivir shows efficacy for the treatment of seasonal and pH1N1 influenza, it has not received US FDA approval. Peramivir is used safely and efficiently in hospitalized adult and pediatric patients with suspected or laboratory-confirmed influenza. Peramivir might be a beneficial alternative antiviral treatment for many patients, including those unable to receive inhaled or oral neuraminidase inhibitors, or those requiring nonintravenous drug delivery.

Show MeSH
Related in: MedlinePlus