436. Tolerability of oseltamivir in infants aged
Session: Poster Abstract Session: Pediatric Infections
Thursday, October 3, 2013
Room: The Moscone Center: Poster Hall C
Background: In 2012, oseltamivir was approved in the U.S. for treatment of influenza in infants aged 2 weeks-11 months, but data on oseltamivir tolerability in this age group are limited.  This analysis presents data on oseltamivir tolerability in infants aged <1 year from an on-going randomized, double-blind, placebo-controlled efficacy trial of empiric oseltamivir treatment in children aged <10 years hospitalized with influenza at 5 tertiary care hospitals in El Salvador and Panama.

Methods: Children hospitalized <7 days after symptom onset with cough or sore throat plus tachypnea were eligible. Participants had respiratory specimens tested for influenza viruses, were randomized 1:1 to receive oseltamivir suspension (3mg/kg/dose for infants aged <1 year) or placebo twice daily for 10 doses, and were followed through 7-9 days after discharge.  The proportion of children with adverse events (AEs) was a secondary endpoint.  AEs were defined as any unfavorable effect that developed during trial participation, regardless of causal relationship; conditions present at enrollment were not considered AEs.    AEs were categorized by severity (grades I-V) and relatedness to study drug (unrelated, unlikely, possible, probable, or definite) using standardized scales. Blinding was maintained for this analysis, as enrollment will continue through October 2013.

Results: During September-October 2012 and April 2013, 102 participants were enrolled, of whom 51 (50%) were aged <1 year.  Of the 51 infants, the median age was 6 months (IQR 3-9 months), 7 (14%) had >=1 medical conditions, 1 (2%) required intensive care and mechanical ventilation, and 1 of 31 tested (3%) had laboratory-confirmed influenza.  Three (6%) infants had >=1 non-serious AEs, including 2 with vomiting and 1 with rash, irritability, and palpebral edema.  Of the 5 non-serious AEs, all were of grade I or II severity, and 4 were deemed possibly related to study drug while 1 was deemed unlikely to be related.  One infant had respiratory failure resulting in death which was deemed a serious AE that was unrelated to study drug.

Conclusion: Preliminary analyses of blinded data suggest that oseltamivir is well-tolerated among infants aged <1 year. Vomiting was the most common AE among infants receiving oseltamivir or placebo, consistent with data in older children.

Fatimah S. Dawood, MD1, Jorge Jara, MD2, Rosalba González, MD3, Juan Miguel Castillo, MD4, Dora I. Estripeaut, MD5, Tirza De León, MD6, Kathia Luciani, MD7, Sujey Brizuela, MD8, Carlos A. Daza, MD6, Mariana Rodríguez, MD5, Magda Rojas, MD7, Dinora De Viana, MD4, Alicia M. Fry, MD, MPH1, Wilfrido Clara, MD9, Eduardo Azziz-Baumgartner, MD, MPH1 and Marc-Alain Widdowson, VetMB, MSc1, (1)Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, (2)Centro de Estudios en Salud, Universidad Del Valle De Guatemala, Guatemala City, Guatemala, (3)Gorgas Memorial Institute for Health Studies, Panama City, Panama, (4)Hospital San Juan De Dios, Santa Ana, El Salvador, (5)Hospital Del Niño, Panama City, Panama, (6)Hospital Materno Infantil José Domingo De Obaldía, David, Panama, (7)Hospital De Especialidades Pediátricas Omar Torrijos, Panama City, Panama, (8)Hospital San Juan De Dios, San Miguel, El Salvador, (9)CDC-Central American Regional Office, San Salvador, El Salvador

Disclosures:

F. S. Dawood, None

J. Jara, None

R. González, None

J. M. Castillo, None

D. I. Estripeaut, None

T. De León, None

K. Luciani, None

S. Brizuela, None

C. A. Daza, None

M. Rodríguez, None

M. Rojas, None

D. De Viana, None

A. M. Fry, None

W. Clara, None

E. Azziz-Baumgartner, None

M. A. Widdowson, None

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