Abstract
BackgroundOseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. There is scant data on oseltamivir pharmacokinetics (PK) in infants <1 year. We set out to perform PK measurements in infants who received oseltamivir.MethodsThis study was a prospective, uncontrolled, open label evaluation of the pharmacokinetics of oseltamivir metabolism, safety of oseltamivir, viral clearance in infants <12 months diagnosed with influenza by nasopharyngeal influenza nucleic acid antigen test (NAAT). Blood levels of the prodrug oseltamivir and its active carboxylate were measured prior to a dose of oseltamivir and at 4 time points afterwards, to calculate Cmax (ng/mL), Tmax (h), AUC0−t (ng h/mL) and time for AUC (h).ResultsFour children with influenza A received oral oseltamivir, 2.35–3 mg/kg/dose. This dose range produced a target oseltamivir carboxylate plasma concentration in excess of the proposed 12-h target AUC of 3800 ng h/mL, selected from earlier studies to avert resistance. One patient developed GIT adverse event: dry retching.ConclusionOseltamivir was well tolerated at a dose of 2.35–3 mg/kg/dose twice a day in infants under the age of 1 year. In general agreement with earlier data, these doses produced a target oseltamivir carboxylate plasma exposure in excess of the proposed 12-h target exposure of AUC equal to 3800 ng h/mL in two patients. The limited plasma concentration data in the remaining two patients were not inconsistent with the target exposure being reached.
Highlights
Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year
All four patients were infected with influenza A, patients 1–3 were H1N1 and the strain was not documented for the patient 4
The following table presents the pharmacokinetic parameters for oseltamivir in these four patients (Table 1)
Summary
Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. Influenza morbidity in young children and infants ranges from school absenteeism to acute respiratory distress requiring hospitalisation, and can result in death from complications [1]. Oseltamivir is currently the only antiviral treatment recommended in young children, usually for those aged 1–5 years [4,5,6]. It inhibits the envelope protein neuraminidase, blocking release of viral progeny from infected cells, preventing subsequent entry into uninfected cells [7].
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