Single Dose IV Peramivir is Safe and Effective in the Treatment of Pediatric Influenza

Abstract

BackgroundPeramivir (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.MethodsA 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.Results122 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:PVROSEIntent to treat (ITT) population: n (all age groups)8523ITTI population: n (%)5916A/H1N122 (37%)9 (56%)A/H3N212 (20%)3 (19%)A/Ind1 (2%)0 (0%)B23 (39%)4 (25%)A + B1 (2%)0 (0%)Proportion of ITTI population shedding virus1, n (%)Baseline53/59 (90%)14/16 (88%)Day 327/59 (46%)10/16 (63%)Day 72/59 (3%)0/16 (0%)Day 140/59 (0%)0/16 (0%)Time to alleviation of symptoms, hrs275.6 (47.0, 109.2)99.8 (34.7, 133.6)Time to resolution of fever, hrs240.5 (22.1, 47.0)34.7 (13.7, 42.3) 1Determined by virus culture assay; 2ITTI population: median (95% CI).No serious adverse events were reported. AEs occurring in more than two subjects overall were:PVROSESafety population: n7823Any event17 (22%)5 (22%)Vomiting2 (3%)2 (9%)Nausea0 (0%)2 (9%)Pyrexia2 (3%)0 (0%)Tympanic membrane hyperemia2 (3%)0 (0%)ConclusionTreatment 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 with OSE. The study continues to enroll subjects < 7 years.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: ...

New drug: Peramivir for influenza

“…Preliminary results have been published for 85 patients treated with peramivir and 23 given oseltamivir. The symptoms of influenza were alleviated in a median of 75.6 hours with peramivir and 99.8 hours with oseltamivir 4…”