Safety and efficacy of peramivir for influenza treatment

Abstract

ObjectiveThis 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.MethodsLiterature 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 The peramivir manufacturers, Shionogi and Co Ltd and BioCryst Pharmaceuticals, were contacted to obtain unpublished data and information presented at recent scientific meetings.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.ResultsWe 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.ConclusionAlthough 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.

Comparison of Efficacy of Intravenous Peramivir and Oral Oseltamivir for the Treatment of Influenza: Systematic Review and Meta-Analysis

“…Therefore, when considering which drug to choose, resistance should be considered. The H274Y mutation is associated with resistance to oseltamivir and peramivir and mutations at I222 and R292 can reduce peramivir sensitivity 19. The incidence of resistance to oseltamivir and/or peramivir in Japan and USA during the 2013–2014 influenza season was 4.2% and 1.2% for influenza A (H1N1) pdm09, respectively.…”

Peramivir for Influenza A and B Viral Infections: A Pharmacokinetic Case Series

“…Currently, PRV has an FDA approved indication for the treatment of acute uncomplicated influenza in patients 2 years of age and older who have been symptomatic for no more than 2 days . The current FDA recommended dose of PRV in pediatric patients 2–12 years of age with acute uncomplicated influenza is a single 12 mg/kg dose (up to a maximum dose of 600 mg), administered via intravenous infusion over 15–30 minutes . Additionally, during the 2009 influenza, PRV was part of an emergency use authorization in the United States for patients with pandemic A (H1N1) 2009 virus to be given every 24 hours for a period of 5 to 10 days .…”

Combating mutations in genetic disease and drug resistance: understanding molecular mechanisms to guide drug design

“…Influenza neuraminidase inhibitors (NAIs) are the major specific anti-influenza drugs used clinically, despite the emergence of resistance 51 . Currently, the NAIs oseltamivir, zanamivir, peramivir and laninamivir (currently approved only in Japan) have been approved to prevent and treat influenza A and B [51][52][53][54] . Many governments have stockpiled resources of these drugs in the event of an Influenza outbreak.…”