title: Efficacy and long-term outcomes of palivizumab prophylaxis to prevent respiratory syncytial virus infection in infants with cystic fibrosis in Northern Ireland.
abstract: BACKGROUND
  RSV causes considerable morbidity and mortality in children. In cystic fibrosis (CF) viral infections are associated with worsening respiratory symptoms and bacterial colonization. Palivizumab is effective in reducing RSV hospitalization in high risk patient groups. Evidence regarding its effectiveness and safety in CF is inconclusive. CF screening in N. Ireland enabled timely palivizumab prophylaxis, becoming routine in 2002.
  
  
  OBJECTIVE
  To determine the effect of palivizumab on RSV-related hospitalization and compare lung function and bacterial colonization at age 6 years for those born pre- and post-introduction of palivizumab prophylaxis.
  
  
  METHODS
  A retrospective audit was conducted for all patients diagnosed with CF during the period from 1997 to 2007 inclusive. RSV-related hospitalization, time to Pseudomonas aeruginosa (PA) 1st isolate, lung function and growth parameters were recorded. Comparisons were made for outcomes pre- and post-introduction of routine palivizumab administration in 2002. A cost evaluation was also performed.
  
  
  RESULTS
  Ninety-two children were included; 47 pre- and 45 post-palivizumab introduction. The overall RSV-positive hospitalization rate was 13%. The relative risk of RSV infection in palivizumab non-recipients versus recipients was 4.78 (95%CI: 1.1-20.7), P = 0.027. Notably, PA 1st isolate was significantly earlier in the palivizumab recipient cohort versus non-recipient cohort (median 57 vs. 96 months, P < 0.025) with a relative risk of 2.5. Chronic PA infection at 6 years remained low in both groups, with similar lung function and growth parameters. Total costs were calculated at £96,127 ($151,880) for the non-recipient cohort versus £137,954 ($217,967) for the recipient cohort.
  
  
  CONCLUSIONS
  Palivizumab was effective in reducing RSV-related hospitalization infection in CF patients. Surprisingly, we found a significantly earlier time to 1st isolate of PA in palivizumab recipients which we could not explain by altered or improved diagnostic tests.
authors.affiliation: Department of Paediatrics, Royal Belfast Hospital for Sick Children, Belfast, United Kingdom.
authors.forename: H E
authors.initials: HE
authors.lastname: Groves
authors.affiliation: Department of Cystic Fibrosis, Royal Belfast Hospital for Sick Children, Belfast, United Kingdom.
authors.forename: L
authors.initials: L
authors.lastname: Jenkins
authors.affiliation: Department of Cystic Fibrosis, Royal Belfast Hospital for Sick Children, Belfast, United Kingdom.
authors.forename: M
authors.initials: M
authors.lastname: Macfarlane
authors.affiliation: Department of Cystic Fibrosis, Royal Belfast Hospital for Sick Children, Belfast, United Kingdom.
authors.forename: A
authors.initials: A
authors.lastname: Reid
authors.affiliation: School of Nursing and Midwifery, Queen's University Belfast, Belfast, United Kingdom.
authors.forename: F
authors.initials: F
authors.lastname: Lynn
authors.affiliation: Department of Paediatrics, Queens University of Belfast, Belfast, United Kingdom.
authors.forename: M D
authors.initials: MD
authors.lastname: Shields
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003550:Cystic Fibrosis / Q000150:complications* / Q000503:physiopathology; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D009660:Northern Ireland / Q000453:epidemiology; D000069455:Palivizumab / Q000627:therapeutic use*; D011552:Pseudomonas Infections / Q000517:prevention & control; D011550:Pseudomonas aeruginosa / Q000302:isolation & purification; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000069455:Palivizumab
keywords: bronchiolitis; children; cystic fibrosis; palivizumab; respiratory syncytial virus