Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease

Prevention of hospitalization due to respiratory syncytial virus: results from the Palivizumab Outcomes Registry

“…13 In another study, palivizumab reduced RSV-related hospitalizations by 45% (P ¼ 0.003) in infants and young children with hemodynamically significant CHD. 14 In both trials, monthly prophylaxis with palivizumab was well tolerated, with associated adverse events similar to those reported for placebo. 13,14 Compared with the FDA-approved indicated populations, the guidelines published by the American Academy of Pediatrics (AAP) in 1998 limited their recommendations for prophylaxis with palivizumab to children <2 years of age with CLD who required medical therapy for their CLD within 6 months before the RSV season, infants born at 32 weeks' gestation or earlier without CLD and infants born between 32 and 35 weeks' gestation with the presence of additional medical or environmental factors, including anticipated heart surgery, the availability and proximity of hospital care, child-care attendance, exposure to tobacco smoke, the number of young siblings and underlying conditions that predisposed the infants to respiratory infection.…”

“…The number of infants with CHD more than doubled from the first to the fourth season, with physicians listing this diagnosis as the most common reason for prophylaxis in the gestational age group older than 35 weeks. This change most likely reflects study findings showing the benefits of palivizumab prophylaxis in infants with CHD that were published during the last season of the registry, 14 with subsequent addition of this indication to the palivizumab-prescribing information and inclusion in the updated AAP guidelines. 16 The primary benefit of palivizumab immunoprophylaxis in a high-risk population is a reduction in the rate of RSV-associated hospitalizations.…”

“…13,25 In controlled clinical trials of high-risk subjects, RSV hospitalization rates were approximately 10% in infants given placebo and 5% in those given prophylaxis with palivizumab. 13,14 In observational studies of subjects given prophylaxis with palivizumab, hospitalization rates ranged from 2 to 4%. [25][26][27] Although hospitalization rates for our observational registry data over the four seasons also were low, ranging from 0.7 to 2.9%, these rates may be underestimated because only those hospitalizations that were confirmed with virology testing were captured.…”

Tailored management approach for late presenters and critically sick children with congenital heart disease

“…Doing this, as has been shown elsewhere, will alert the parents that their children need urgent attention by a specialist. Other issues would be to improve in the vaccination program offered to this community, especially in regard to the RSV, which has been shown that it can have a deleterious effect on infants with congenital heart disease [12].…”

Perceived Risk of Severe Respiratory Syncytial Virus Disease and Immunoprophylaxis Use Among US Pediatric Specialists

“…6 Palivizumab has been shown to significantly reduce the frequency of hospitalizations resulting from severe RSV disease in preterm infants (born at ≤ 35 weeks' gestational age [wGA]) and high-risk children with bronchopulmonary dysplasia (BPD)/chronic lung disease of prematurity (CLDP) or hemodynamically significant congenital heart disease (HS-CHD). 3,7 Palivizumab is FDA approved for use in preterm infants born at ≤ 35 wGA (≤ 6 months of age at the start of the RSV season), children ≤ 24 months of age who have BPD/CLDP, and children ≤ 24 months of age with HS-CHD. 6 The 2012 AAP guidance regarding RSV immunoprophylaxis included recommendations for use among preterm infants ≤ 34 wGA and children with BPD/ CLDP or HS-CHD.…”