Olsetamivir for Children 1-3 Years of Age
Olsetamivir for Children 1-3 Years of Age
Abstract & Commentary
By Hal B. Jenson, MD, FAAP, Professor of Pediatrics, Tufts University School of Medicine, and Chief Academic Officer, Baystate Medical Center, Springfield, MA, is Associate Editor for Infectious Disease Alert.
Dr. Jenson reports no financial relationships relevant to this field of study.
Synopsis: Oseltamivir treatment initiated within 24 hours of onset of influenza symptoms among children 1-3 years of age provides significant benefits for resolution of illness, and reduces the risk for development of acute otitis media if started within 12 hours.
Source: Heinonen S, et al. Early oseltamivir treatment of influenza in children 1-3 years of age: A randomized controlled trial. Clin Infect Dis. 2010;51:887-894.
A randomized, double-blind, placebo-controlled trial of the efficacy of oral oseltamivir twice daily started within 24 hours of onset of influenza symptoms (fever, plus cough, rhinitis, or sore throat) was conducted in children 1-3 years of age at a single primary care study site in Finland during the 2007-2008 and 2008-2009 influenza seasons. Of 208 children who were enrolled, (oseltamivir, 203; placebo, 205), 98 had laboratory-confirmed influenza (influenza A, 79; influenza B, 19). The mean age of these 98 children was 2.4 years, and 13 (13.3%) had received influenza vaccine for the season.
When started within 24 hours of onset of symptoms, oseltamivir shortened the median time to resolution of symptoms by 3.5 days (3.0 vs. 6.5 days, p = 0.002) in vaccinated children and by 4.0 days in unvaccinated children (3.4 vs. 7.3 days, p = 0.006), and reduced parental work absenteeism by 3.0 days. When started within 12 hours of onset of symptoms of influenza A, oseltamivir decreased the incidence of acute otitis media by 85% (95% CI, 25-97%), with no significant difference if started 12-24 hours after onset of symptoms. There were too few cases of influenza B to demonstrate efficacy.
Commentary
Influenza is an important childhood disease, with rates of influenza-associated hospitalization among children < 2 years of age comparable to other high-risk groups, such as adults ≥ 65 years of age, pregnant women, and persons with chronic pulmonary or cardiac disease. The burden of influenza is significant, with estimates that medical visits among children < 5 years of age with influenza account for 10%-19% of office visits and 6%-29% of emergency department visits.
Oseltamivir, formulated as capsules or oral suspension (Tamiflu), is FDA-approved for prophylaxis and empiric treatment of influenza in patients ≥ 12 months of age. The FDA issued an Emergency Use Authorization for oseltamivir prophylaxis in patients < 12 months of age as part of the public health emergency declaration in 2009 for H1N1 influenza, which expired June 23, 2010.
This study demonstrates that oseltamivir treatment initiated within 24 hours of onset of influenza symptoms provides significant benefits for resolution of illness, and reduces the risk for development of acute otitis media if started within 12 hours. There is also a significant corresponding reduction of parental-work absenteeism. This is an important economic and social consideration for clinicians in these times with both parents in many families working outside the home, as well as with many single-parent families.
The diagnosis of influenza in children requires much interpretation of symptoms by the clinician. For example, the criteria used in this study for influenza symptoms included rhinitis and cough; objective measures for these symptoms in young children are not clearly established and remain subjectively applied. The study criteria also included "sore throat." Since only the patient can determine if the throat is "sore," it seems wildly optimistic to expect a child 1-3 years of age to convey this with precision and accuracy, let alone the clinician's dilemma of understanding what a 3-year-old child might mean if they do answer yes to having a "sore throat." In children, other viruses, such as respiratory syncytial virus and parainfluenza viruses, lead to the same symptoms, as evidenced in this study, with one-quarter (24.7%) of enrolled patients meeting symptom criteria having laboratory-confirmed influenza A or B. Nevertheless, even with these inherent limitations, this study demonstrated utility in empiric oseltamivir treatment. Development and availability of better rapid diagnostic tests for influenza viruses and other respiratory tract pathogens are needed to facilitate prompt diagnosis and appropriate management.
A randomized, double-blind, placebo-controlled trial of the efficacy of oral oseltamivir twice daily started within 24 hours of onset of influenza symptoms (fever, plus cough, rhinitis, or sore throat) was conducted in children 1-3 years of age at a single primary care study site in Finland during the 2007-2008 and 2008-2009 influenza seasons.Subscribe Now for Access
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