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Intravenous Zanamivir in Hospitalized Patients With Influenza
John S Bradley1, Jeffrey L Blumer2, José R Romero3
1Division of Infectious Diseases, Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, California; jbradley@rchsd.org.
Insights
Intravenous zanamivir (IV zanamivir) showed a favorable safety profile in hospitalized children with severe influenza. Most children experienced clinical improvement and reduced viral load, with no serious adverse events linked to the drug.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology and Therapeutics
- Virology
Background:
- Severe influenza in children may necessitate parenteral antiviral therapy when oral or inhaled routes are not feasible.
- Intravenous (IV) zanamivir is an investigational treatment option for hospitalized pediatric patients with influenza.
Purpose of the Study:
- To assess the safety and tolerability of investigational IV zanamivir in hospitalized children with influenza.
- To evaluate clinical outcomes, pharmacokinetics, and virologic efficacy as secondary endpoints.
Main Methods:
- Phase II, open-label, multicenter, single-arm study involving 71 hospitalized children with influenza.
- Safety outcomes included treatment-emergent adverse events (TEAEs), serious TEAEs (STEAEs), laboratory measurements, and vital signs.
- Pharmacokinetic and virologic data were collected to assess drug exposure and viral load reduction.
Main Results:
- 71 children received IV zanamivir; TEAEs and STEAEs occurred in 72% and 21% of patients, respectively.
- No STEAEs or deaths were attributed to IV zanamivir. Median hospital and ICU stays were 6 and 7.5 days.
- Median viral load reduction was -1.81 log10 copies/mL after 2 days; zanamivir exposures were comparable to adult levels.
Conclusions:
- Investigational IV zanamivir demonstrated a favorable safety profile in pediatric influenza patients.
- The majority of children achieved virologic response and clinical improvement.
- Systemic exposure of zanamivir in children was consistent with that observed in adults.
Background:
Children with severe influenza infection may require parenteral therapy if oral or inhaled therapies are ineffective or cannot be administered. Results from a study investigating intravenous (IV) zanamivir for the treatment of hospitalized infants and children with influenza are presented.
Methods:
This phase II, open-label, multicenter, single-arm study assessed the safety of investigational IV zanamivir in hospitalized children with influenza. Safety outcomes included treatment-emergent adverse events (TEAEs), clinical laboratory measurements, and vital signs. Clinical outcomes, pharmacokinetics, and virologic efficacy data were collected as key secondary outcomes.
Results:
In total, 71 children received treatment with investigational IV zanamivir (exposure comparable to 600 mg twice daily in adults). TEAEs and serious TEAEs (STEAEs) were reported in 51 (72%) and 15 (21%) patients, respectively. The mortality rate was 7%, and median durations of hospital and ICU stays were 6 and 7.5 days, respectively. No STEAEs or deaths were considered related to IV zanamivir treatment, and no patterns of TEAEs, laboratory abnormalities, or vital signs were observed. The mean zanamivir exposures from 34 patients with normal renal function who received 12 mg/kg, 14 mg/kg, or 600 mg of IV zanamivir ranged from 64.5 to 110 hour·µg/mL. The median change from baseline in the viral load was -1.81 log10 copies per mL after 2 days of treatment.
Conclusions:
The safety profile of IV zanamivir was favorable, with no drug-related STEAEs reported. The majority of children experienced virologic response and clinical improvement during the treatment course. Systemic zanamivir exposures in children were consistent with adults.
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