Program Schedule

827
The efficacy of single dose peramivir in acute uncomplicated influenza: an integrated subject-level meta-analysis

Session: Poster Abstract Session: Clinical - Clinical Trials
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • ID Week peramivir efficacy meta-analysis poster final 2014_10_01.pdf (167.8 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:

    Subjects presenting within 48 hours of symptom onset of acute uncomplicated influenza were enrolled in four randomized, double-blind placebo-controlled trials of single dose peramivir (IV or IM doses ranging from 150-600 mg). Bioequivalence studies demonstrated equivalent systemic exposure for IM and IV administration. Subjects recorded severity of influenza signs and symptoms in a diary. Serial viral titers were measured from nasopharyngeal swabs. An integrated analysis of efficacy was performed.

    Results:

    Of the 1131 subjects enrolled, 1028 subjects with influenza confirmed by laboratory test were included in the integrated efficacy analysis. Key clinical and virologic outcomes are shown:

     

     

     

    Peramivir

    Placebo

    N=408

    150 mg
    N = 104

    300 mg
    N = 262

    600 mg
    N = 258

    Overall
    N = 624

    Time to alleviation of symptoms, median, hrs (95% CI)

    107.4

    (95.8, 115.9)

    114.1

    (95.2, 145.5)

    84.1

    (68.6, 102.0)

    79.4

    (69.3, 92.0)

    87.6

    (79.3, 95.0)

    Time to resolution of fever,

    Median, hrs (95% CI)

    47.2

    (43.3, 55.6)

    51.7

    (43.5, 61.7)

    39.1

    (32.3, 41.0)

    38.4

    (31.5, 43.3)

    40.8

    (39.0,42.7)

    Time to resumption of usual activities, median, days (95%CI)

    10.0        (8.0, 10.0)

    10.0        (9.0, 12.0)

    8.0          (7.0, 9.0)

    6.0          (6.0, 7.0)

    8.0          (7.0, 9.0)

    Viral titer: change from baseline at 48 hrs, mean log10 TCID50/mL (SD)

    -1.43    (1.31)

    -1.84    (1.43)

    -1.94    (1.32)

    -1.97    (1.52)

    -1.91    (1.38)

    Subgroup analyses by region, age, gender, race, smoking status, influenza virus subtype, symptom duration at baseline, and severity of illness showed consistency in demonstrating that peramivir was generally superior to placebo across the subgroups studied.

    Conclusion:

    Consistent, significant, dose ordered improvements were seen in each endpoint. The treatment effect size is similar to that reported for other NAIs.

    Richard Whitley, MD, FIDSA1, Phil Collis, PhD2, Sylvia Dobo, MD2, Jenna Elder, PhD3, Shigeru Kohno, MD, PhD4 and William Sheridan, MB BS2, (1)Pediatrics, Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, (2)BioCryst Pharmaceuticals, Durham, NC, (3)Pharpoint Research, Wilmington, NC, (4)Nagasaki Univ., Nagasaki, Japan

    Disclosures:

    R. Whitley, Gilead Sciences: Board Member, Consulting fee

    P. Collis, BioCryst: Employee and Shareholder, Salary

    S. Dobo, BioCryst: Employee and Shareholder, Salary

    J. Elder, BioCryst: Consultant, Consulting fee

    S. Kohno, None

    W. Sheridan, BioCryst: Employee and Shareholder, Salary

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