2335. Single Dose IV Peramivir is Safe and Effective in the Treatment of Pediatric Influenza
Session: Poster Abstract Session: Pediatric Virology
Saturday, October 7, 2017
Room: Poster Hall CD
Background:

Peramivir (PVR) is a potent neuraminidase inhibitor with in vitro activity against all influenza virus subtypes. Previous studies demonstrated the efficacy and safety of PVR as a single dose intravenous (IV) treatment for acute uncomplicated influenza in adults.

Methods:

A phase 3 study compared age-appropriate doses of single dose IV PVR to 5 days of oral oseltamivir (OSE) (4:1 randomization, stratified by age) in pediatric subjects age 0 -17 years within 48 hours of onset of acute uncomplicated influenza. Plasma concentrations of PVR were measured up to 6 hours post dose. Serial viral titers were measured from nasopharyngeal swabs. Severity of influenza signs and symptoms were recorded in a diary.

Results:

122 subjects were enrolled up to a data cutoff of March 31, 2017 (<2 yrs, n=7; 2-<7yrs, n=37; 7-<13 yrs, n=48; 13-17 yrs, n=30). Interim results are reported for the first 108 subjects randomized, of which 101 (94%) received study drug. Influenza was confirmed by PCR in 75 (74%) subjects who received study drug (Intent-to-treat-Infected [ITTI] population). Key endpoints are summarized:

PVR

OSE

Intent to treat (ITT) population: n (all age groups)

85

23

ITTI population: n (%)

A/H1N1

A/H3N2

A/Ind

B

A + B

59

22 (37%)

12 (20%)

1 ( 2%)

23 (39%)

1 ( 2%)

16

9 (56%)

3 (19%)

0 ( 0%)

4 (25%)

0 ( 0%)

Proportion of ITTI population shedding virus1, n (%)

Baseline

Day 3

Day 7

Day 14

53/59 (90%)

27/59 (46%)

2/59 ( 3%)

0/59 ( 0%)

14/16 (88%)

10/16 (63%)

0/16 ( 0%)

0/16 ( 0%)

Time to alleviation of symptoms, hrs2

75.6 (47.0, 109.2)

99.8 (34.7, 133.6)

Time to resolution of fever, hrs2

 40.5 (22.1, 47.0)

34.7 (13.7, 42.3)

1 Determined by virus culture assay; 2ITTI population: median (95% CI)

No serious adverse events were reported. AEs occurring in more than two subjects overall were:

PVR

OSE

Safety population: n

78

23

Any event

17 (22%)

5 (22%)

Vomiting

2 ( 3%)

2 ( 9%)

Nausea

0 ( 0%)

2 ( 9%)

Pyrexia

2 ( 3%)

0 ( 0%)

Tympanic membrane hyperemia

2 ( 3%)

0 ( 0%)

Conclusion:

Treatment of influenza in pediatric subjects with single dose IV PVR or 5 days of oral OSE was generally safe and well tolerated. Whilst not powered for efficacy differences, trends were observed in more rapid reduction in virus shedding and symptom alleviation for PVR treated subjects compared to OSE. The study continues to enroll subjects < 7 years.

John Vanchiere, MD, PhD1, Stephanie Plunkett, MD2, Rajasekaran Annamalai, MD3, Katie Julien, MD4, James Peterson, MD2, Marcy Goisse, MD5, Shane Christensen, MD6, Priyesh Mehta, DO7, Stephen Coleman, MD8, Flor Munoz, MD9, Amy Flynt, PhD10, Sylvia Dobo, MD11, Eniko Nagy, MD11, Deborah Kargl, BSc11, Amanda Mathis, Ph.D.12, Phil Collis, PhD11 and William Sheridan, MB BS12, (1)Pediatrics, LSUHSC-Shreveport, Shreveport, LA, (2)J Lewis Research, Salt Lake City, UT, (3)East Montgomery County Clinic, Splendora, TX, (4)J Lewis Research, South Jordan, UT, (5)Montgomery Medical, Smithfield, PA, (6)J. Lewis Research, Salt Lake City, UT, (7)DOC Clinical Research, Dayton, OH, (8)J Lewis Research, Draper, UT, (9)Pediatric Infectious Diseases, Baylor College of Medicine, Texas Children's Hospital, Houston, TX, (10)PharPoint Research, Wilmington, NC, (11)BioCryst Pharmaceuticals, Durham, NC, (12)BioCryst Pharmaceuticals Inc., Durham, NC

Disclosures:

J. Vanchiere, BioCryst Pharmaceuticals: Consultant and Investigator , Consulting fee and Research support

S. Plunkett, BioCryst Pharmaceuticals: Investigator , Research support

R. Annamalai, BioCryst Pharmaceuticals: Investigator , Research support

K. Julien, BioCryst Pharmaceuticals: Investigator , Research support

J. Peterson, BioCryst Pharmaceuticals: Investigator , Research support

M. Goisse, BioCryst Pharmaceuticals: Investigator , Research support

S. Christensen, BioCryst Pharmaceuticals: Investigator , Research support

P. Mehta, BioCryst Pharmaceuticals: Investigator , Research support

S. Coleman, BioCryst Pharmaceuticals: Investigator , Research support

F. Munoz, BioCryst Pharmaceuticals: Investigator , Research support

A. Flynt, BioCryst Pharmaceuticals: Consultant , Consulting fee

S. Dobo, BioCryst Pharmaceuticals: Employee , Salary

E. Nagy, BioCryst Pharmaceuticals: Employee , Salary

D. Kargl, BioCryst Pharmaceuticals: Consultant , Consulting fee

A. Mathis, BioCryst Pharmaceuticals: Employee , Salary

P. Collis, BioCryst Pharmaceuticals: Employee , Salary

W. Sheridan, BioCryst Pharmaceuticals: Employee , Salary

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