Program Schedule

1169
Peramivir Safety in Hospitalized Influenza

Session: Poster Abstract Session: Viral Infections: Treatment and Prevention
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • 1169_IDWPOSTER.pdf (187.9 kB)
  • Background:

    Peramivir is a parenteral neuraminidase inhibitor (NAI) with potent in vitro activity against all influenza sub-types. Although oseltamivir is widely used for the treatment of influenza, a need still exists for an effective and safe parenteral treatment. Peramivir has been studied as a single dose treatment in acute uncomplicated influenza.

    Methods:

    A total of 2217 subjects were enrolled in five randomized, double-blind trials in acute uncomplicated influenza with either placebo or oseltamivir controls. A total of 1411 subjects received peramivir, 485 by intramuscular injection and 926 by intravenous infusion. A bioequivalence study demonstrated equivalent systemic exposure for IM and IV administration. An integrated analysis of adverse events (AE) was performed by treatment group. Since peramivir dose varied (150-600 mg), the results below include only subjects receiving the proposed dose of peramivir 600 mg.

    Results:

    AEs had a similar frequency across arms. Serious AEs (SAEs) and AEs leading to study discontinuation (AELTSD) were rare. AELTSD were mainly infection, GI or rashes. The most common AEs in peramivir treated subjects were diarrhea, decreased neutrophils, hyperglycemia, and positive urine protein. The only AE with ≥2% difference over placebo was decreased neutrophils. Mean decreases in neutrophil counts were similar: peramivir -2.1 x 103/µL, placebo -2.0 x 103/µL, oseltamivir -2.5 x 103/µL. Neutrophils  < 500/mm3 occurred in 0.4% peramivir, 0.2% placebo and 0.6% oseltamivir treated subjects. No AEs in peramivir treated subjects occurred at ≥2% difference over oseltamivir. AEs occurring at ≥2% difference over peramivir in oseltamivir treated subjects were decreased neutrophils, nausea, vomiting, and decreased monocytes.

     

    Acute Uncomplicated Influenza

    Peramivir  600 mg (N=664)

    Placebo        (N=441)

    Oseltamivir    (N=365)

                    AEs (%)

                    SAEs (%)

                    AELTSD (%)

    48.3

    0

    0.9

    51.0

      0.5

    0

    48.8

      0.5

      1.4

     

    Conclusion:

    Peramivir’s safety profile was similar to placebo and AEs were consistent with the underlying influenza. Nausea and vomiting, which may be factors in discontinuation of oral oseltamivir, occurred at a lower incidence in peramivir treated subjects compared to placebo. Parenteral peramivir has excellent tolerability and no unique safety risks.

    Sylvia Dobo, MD1, Jenna Elder, PhD2, Phil Collis, PhD1 and William Sheridan, MB BS1, (1)BioCryst Pharmaceuticals, Durham, NC, (2)Pharpoint Research, Wilmington, NC

    Disclosures:

    S. Dobo, BioCryst: Employee and Shareholder, Salary

    J. Elder, BioCryst: Consultant, Consulting fee

    P. Collis, BioCryst: Employee and Shareholder, Salary

    W. Sheridan, BioCryst: Employee and Shareholder, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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