NEW ORLEANS – Intravenous zanamivir served as a safe and well-tolerated anti-influenza treatment for hospitalized pediatric patients at high risk for complications and intolerable of enteral therapy, according to data presented at ID Week 2016.
“The safety and tolerability of this has been demonstrated in adults,” Jeffrey L. Blumer, MD, PhD, chair of the department in pediatrics at the University of Toledo, said in the presentation. “This study was really designed to evaluate the safety and tolerability and the pharmacokinetics of this formulation of zanamivir in hospitalized children, because we need a drug that is available for the critically ill; we need a drug available for kids who are unable to take raw therapy, and for treatment of oseltamivir resistance strain.”
Blumer and colleagues enrolled 71 children and adolescents with influenza from five countries in a phase 2 open-label study assessing the safety, efficacy and PK of intravenous zanamivir, a neuraminidase inhibitor. Patient average age was 7 years and doses of zanamivir were administered to one arm. Patients aged 6 and younger who were hospitalized within 7 days of illness onset received 14 mg/kg over 5 to 10 days, and patients aged 6 to 18 years received between 12 mg/kg to 600 mg for 5 to 10 days. The researchers evaluated patients for safety, PK, clinical outcomes and virology at 23-days’ follow-up.
Clinical trial results showed that 72% of patients experienced adverse events and 21% experienced serious adverse events, including five patient deaths. Sixty-five percent of patients needed to be admitted to the ICU, and 56% had chronic underlying medical conditions. However, there appeared to be no association between negative reactions and intravenous zanamivir.
“What we saw in this open-label trial was the dose selection that we utilized gave us the kind of exposure we would expect, and seeing that it was an appropriate way to approach pediatric patients,” Blumer said. “There were not any safety signal attributable to the drug and the overall pattern of serious influenza rather than a drug exposure; the conclusion from the group was that IV zanamivir offered a suitable treatment option for children with severe influenza.” – by Kate Sherrer
Blumer J, et al. Abstract 90b. Presented at: IDWeek; October 25-30, 2016; New Orleans.
Disclosure: Blumer reports research support from and is an investigator for GlaxoSmithKline. Please see the full study for a list of all other authors’ financial disclosures.