title: One-year observational study of palivizumab prophylaxis on infants at risk for respiratory syncytial virus infection in Latin America.
abstract: OBJECTIVE
  This study aims to describe real world palivizumab use and effectiveness in high-risk Latin American infants and young children.
  
  
  METHODS
  Prospective, multicenter observational study with infants at risk for severe RSV infection who received palivizumab according to routine clinical practice. Subjects were followed for one year with monthly visits after the first dose of palivizumab. An infant was considered adherent if receiving all the expected injections or five or fewer injections within appropriate inter-dose intervals. Annual incidence rates and risk factors of lower respiratory tract infection (LRTI) hospitalization were determined through Poisson regression models (α=0.05).
  
  
  RESULTS
  The study enrolled 458 children from seven countries in Latin America, from February 2011 to September 2012. The majority (98%) were born <36 weeks gestation. Overall, patients received 83.7% of their expected injections and 86.7% completed one year of follow-up. Of the 61 LRTI hospitalizations, 12 episodes were due to RSV infection. The RSV-associated hospitalization rate was 2.9 per 100 patient-years. Bronchopulmonary dysplasia was identified as an independent risk factor for LRTI hospitalization. A total of 1165 adverse events were recorded during one year of follow-up. One hundred and two patients (22.3%) had a total of 135 serious adverse events, but no events were considered to be related to palivizumab.
  
  
  CONCLUSIONS
  The rate of RSV hospitalization in high-risk infants in Latin America was low and aligned with those observed in randomized control trials and observational studies. Palivizumab prophylaxis appeared effective and had a good safety profile in this population.
authors.affiliation: AbbVie Inc., Buenos Aires, Argentina.
authors.forename: Leandro Martin
authors.initials: LM
authors.lastname: Castillo
authors.affiliation: AbbVie Inc., Buenos Aires, Argentina. Electronic address: gabriela.bugarin@abbvie.com.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Bugarin
authors.affiliation: Casa Madre Canguro Alfa S.A., Cali, Colombia.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Arias
authors.affiliation: Hospital General Regional de León, León, Guanajuato, Mexico.
authors.forename: Jairo Israel
authors.initials: JI
authors.lastname: Barajas Rangel
authors.affiliation: FUNDASAMIN Fundación para la Salud Materno Infantil, Buenos Aires, Argentina.
authors.forename: Maria Elina
authors.initials: ME
authors.lastname: Serra
authors.affiliation: FUNDASAMIN Fundación para la Salud Materno Infantil, Buenos Aires, Argentina; Sanatorio de la Trinidad Palermo, Buenos Aires, Argentina.
authors.forename: Nestor
authors.initials: N
authors.lastname: Vain
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007843:Latin America; D008297:Male; D000069455:Palivizumab / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000517:prevention & control*; D012307:Risk Factors; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D000069455:Palivizumab
keywords: América Latina; Infecção do trato respiratório inferior; Latin America; Lower respiratory tract infection; Palivizumab; Palivizumabe; Profilaxia; Prophylaxis; Respiratory syncytial virus; Vírus sincicial respiratório