Safety of Single Dose IV Peramivir Examined in Pediatric Influenza
This article is written live from ID Week 2017 Annual Meeting in San Diego, CA. MPR will be reporting news on the latest findings from leading experts in infectious diseases. Check back for more news from IDWeek 2017.
SAN DIEGO—According to results of a Phase 3 study presented at IDWeek 2017, peramivir (PVR), a neuraminidase inhibitor, and oral oseltamivir (OSE) were both found to be safe and well tolerated in pediatric patients with influenza.
John Vanchiere, MD, PhD, of LSUHSC-Shreveport, in Shreveport, LA, explained that the 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 to 17 years within 48 hours of onset of acute uncomplicated influenza.” PVR plasma concentrations were analyzed up to 6 hours after dose administration and serial viral titers were obtained via nasopharyngeal swabs. Signs and symptoms of influenza severity were documented in a diary.
Although 122 patients were enrolled in the study, the interim results only included 89 patients who received the study drug and had PCR-confirmed influenza (termed the “intention-to-treat-infected (ITTI) population”).
The study authors also reported that the median time to alleviation of symptoms was 75.6 hours (95% CI: 47.0, 105.2) for PVR patients vs. 99.8 hours (95% CI: 34.7, 133.6) for OSE patients. Additionally, the median time to resolution of fever was reported as 40.5 hours (95% CI: 28.2, 47.0) for PVR patients compared to 34.7 hours (95% CI: 13.7, 42.3) for OSE patients.
The study authors reported that no serious adverse events (AEs) were reported for PVR or OSE patients. Of the patients included in the safety population, 9% of PVR patients experienced any AE as well as 17% of OSE patients. Frequently reported AEs included for PVR and OSE patients, respectively, included: vomiting (3% vs. 9%), nausea (0% vs. 9%), pyrexia (2% vs. 0%), and tympanic membrane hyperemia (2% vs. 0%).
Dr. Vanchiere concluded, “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.”
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Vanchiere J, Plunkett S, Annamalai R, et al. Single Dose IV Peramivir is Safe and Effective in the Treatment of Pediatric Influenza. Poster presented at IDWeek; October 4–8, 2017; San Diego, CA. http://www.idweek.org