Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease.
OBJECTIVE
To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD).


METHODS
A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization.


RESULTS
Palivizumab recipients had a 45% relative reduction in RSV hospitalizations (P=.003), a 56% reduction in total days of RSV hospitalization per 100 children (P=.003), and a 73% reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P=.014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3%) in the palivizumab group and 27 (4.2%) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups.


CONCLUSIONS
Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.
Feltes
Timothy F
TF
Ohio State University and The Children's Hospital, 700 Children's Drive, ED622, Columbus, OH 43205, USA. tfeltes@chi.osu.edu
Cabalka
Allison K
AK
Meissner
H Cody
HC
Piazza
Franco M
FM
Carlin
David A
DA
Top
Franklin H
FH
Connor
Edward M
EM
Sondheimer
Henry M
HM
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents / Q000627:therapeutic use*; D015897:Comorbidity; D004311:Double-Blind Method; D006330:Heart Defects, Congenital / Q000453:epidemiology* / Q000601:surgery; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D000069455:Palivizumab; D012121:Respiration, Artificial; D018357:Respiratory Syncytial Virus Infections / Q000453:epidemiology* / Q000517:prevention & control* / Q000628:therapy; D012307:Risk Factors
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D000069455:Palivizumab