Emergency Use Authorization for Intravenous Peramivir: Evaluation of Safety in the Treatment of Hospitalized Patients Infected With 2009 H1N1 Influenza A Virus

Sorbello, Alfred; Jones, S. Christopher; Carter, Wendy; Struble, Kimberly; Boucher, R; Truffa, Melissa; Birnkrant, Debra; Gada, Neha; Camilli, Sara; Chan, Irene; Dallas, Scott; Scales, Twanda; Kosko, Robert; Thompson, Elizabeth; Goodman, Jesse L.; Francis, Henry; Pan, Gerald J. Dal

doi:10.1093/cid/cis351

Cited by 36 publications

(40 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…It is difficult to ascertain the precise effect of peramivir. Further studies must assess its clinical effectiveness and safety because peramivir recipients under the EUA were critically ill and were at high risk for influenza-related complications 37,38…”

Section: Resultsmentioning

confidence: 99%

“…Independent risk factors associated with fatal outcomes have not been well established because of smaller sample sizes 38,39,43,44. Critically ill patients with a median age of 40 years (5 months to 81 years) with pH1N1 virus infection in California were also evaluated.…”

Section: Resultsmentioning

confidence: 99%

“…11 Results obtained from some clinical studies show that peramivir is more effective in alleviating influenza symptoms than are other NAIs (Table 3). 39,47 After the pandemic, a few retrospective clinical studies of adults and children were performed only in Japan, where peramivir has been used at the discretion of physicians since its approval on January 2010 38,39,43,47. In a retrospective observational study conducted during the 2010–2011 influenza season, 263 pediatric influenza patients receiving oseltamivir, zanamivir, laninamivir, or peramivir were analyzed.…”

Section: Resultsmentioning

confidence: 99%

“…No general or severe AEs were attributable to peramivir 35. Sorbello et al38 evaluated the safety of intravenously administered peramivir for suspected or confirmed pH1N1 virus infection. Safety surveillance was limited because clinical reports were submitted to the US FDA Adverse Event Reporting System.…”

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Safety and efficacy of peramivir for influenza treatment

Hata¹,

Akashi-Ueda²,

Takamatsu³

et al. 2014

DDDT

View full text Add to dashboard Cite

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.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Safety and efficacy of peramivir for influenza treatment

Hata¹,

Akashi-Ueda²,

Takamatsu³

et al. 2014

DDDT

View full text Add to dashboard Cite

show abstract

“…In 2013, China decided to approve the use of peramivir due to the threat of increasing human transmission viral infections (3), including the novel influenza virus H7N9 (4). Although some investigators have reported that peramivir has significant efficacy in treating serious infections with the influenza virus (5-7), the safety of this drug remains controversial (8)(9)(10). We herein report the case of a patient with severe immune thrombocytopenia (ITP) that was possibly triggered by peramivir.…”

Section: Introductionmentioning

confidence: 93%

Severe Immune Thrombocytopenia Possibly Elicited by the Anti-influenza Viral Agent Peramivir

et al. 2014

View full text Add to dashboard Cite

A 44-year-old man whose platelet count had been at the lower limit of the normal range for years visited the urgent care department of our hospital for treatment of a high fever and severe fatigue. The influenza A virus was detected, and the patient therefore received the intravenous antiviral agent, peramivir. One week later, he developed systemic petechial rashes. A peripheral blood examination showed a markedly decreased platelet count (3.0×10 9 cells/L), and the bone marrow findings were compatible with a diagnosis of immune thrombocytopenia (ITP). Furthermore, a drug-induced lymphocyte-stimulating test was positive for peramivir. The thrombocytopenia slowly responded to treatment with oral prednisolone. This case suggests that neuraminidase inhibitors, including peramivir, can elicit or worsen ITP.

show abstract

Emergency Use Authorization of Remdesivir

Ison

Wolfe

Boucher

2020

JAMA

View full text Add to dashboard Cite

Services (DHHS) determined that there was a public health emergency due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On March 27, 2020, the DHHS secretary declared that circumstances existed to justify the authorization of emergency use of drugs and biologics during the coronavirus disease 2019 (COVID-19) outbreak, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act. 1 To date, 3 medications-chloroquine phosphate, hydroxychloroquine sulfate, and remdesivir-have been granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for COVID-19. Since chloroquine and hydroxychloroquine are FDA-approved drugs, clinicians had options for prescribing them outside the EUA mechanisms, and prescribing appears to have been robust.Because remdesivir is not yet FDA-approved, until now, the only way to access this drug was through clinical studies (ClinicalTrials.gov: NCT04280705, NCT04292899, NCT04292730), expanded access programs (ClinicalTrials.gov: NCT04323761), and compassionate use programs. 2 The issuance of an EUA on May 1, 2020, should expand access to remdesivir, yet details about how this drug will become available are opaque and distribution remains limited. 3 A clear and transparent process for access to remdesivir through the EUA is needed and is in the best interest of patients.The authority of the FDA to issue an EUA was granted by Congress through various statues. 1 An EUA can be issued only after the Secretary of DHHS has declared a public health emergency. The FDA commissioner, in consultation with the DHHS Assistant Secretary for Preparedness and Response, US Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria under the statute are met. An EUA is not approval of a drug for sale and has a term of 1 year, which can be renewed, based on the circumstances of the emergency. 4 Continued clinical studies

show abstract

Emergency Use Authorization for Intravenous Peramivir: Evaluation of Safety in the Treatment of Hospitalized Patients Infected With 2009 H1N1 Influenza A Virus

Cited by 36 publications

References 11 publications

Safety and efficacy of peramivir for influenza treatment

Safety and efficacy of peramivir for influenza treatment

Severe Immune Thrombocytopenia Possibly Elicited by the Anti-influenza Viral Agent Peramivir

Emergency Use Authorization of Remdesivir

Contact Info

Product

Resources

About