Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis

Robinson, Karen A.; Odelola, Olaide A; Saldanha, Ian J.

doi:10.1002/14651858.cd007743.pub5

Cited by 18 publications

(18 citation statements)

References 41 publications

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“…203,204 Available studies indicate the incidence of RSV hospitalization in children with cystic fibrosis is low and unlikely to be different from children without cystic fibrosis. No evidence suggests a benefit from palivizumab prophylaxis in patients with cystic fibrosis.…”

Section: Cystic Fibrosismentioning

confidence: 99%

Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis

Ralston¹,

Lieberthal²,

Meissner³

et al. 2014

Pediatrics

1,349

1,654

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This guideline is a revision of the clinical practice guideline, “Diagnosis and Management of Bronchiolitis,” published by the American Academy of Pediatrics in 2006. The guideline applies to children from 1 through 23 months of age. Other exclusions are noted. Each key action statement indicates level of evidence, benefit-harm relationship, and level of recommendation. Key action statements are as follows:

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Section: Cystic Fibrosismentioning

confidence: 99%

Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis

Ralston¹,

Lieberthal²,

Meissner³

et al. 2014

Pediatrics

1,349

1,654

View full text Add to dashboard Cite

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“…Efficacy was not demonstrated in the CHD subgroup with cyanotic heart disease. (9)(10)(11) Observational studies demonstrate effectiveness in the 'real world', where clinicians, in conjunction with parents, decide who should receive palivizumab and where compliance is often lower than in RCTs. A recent systematic review summarized 20 published observational palivizumab studies.…”

Section: Palivizumabmentioning

confidence: 99%

“…Results of two small, (11,51) and one large(52) study of palivizumab in children with cystic fibrosis were inconclusive. RSV admission rates were low.…”

Section: Children With Upper Airway Obstruction or Pulmonary Disease mentioning

confidence: 99%

Preventing hospitalizations for respiratory syncytial virus infection

Robinson¹,

Saux²

2015

Paediatrics &Amp; Child Health

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EPIDEMIOLOGyRespiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections (LRTIs) in young children worldwide, with almost all experiencing their first RSV infection by two years of age. In developed countries, 1% to 3% of all infants are hospitalized with RSV infection. In Canada, the RSV season typically begins in November or December and persists for four to five months. The present statement replaces four previous position statements from the Canadian Paediatric Society on this topic(1-4) because there is evidence that the risk of RSV hospitalization does not warrant the use of palivizumab in many children for whom it was previously recommended. PREVENTING RSV HOSPITALIZATIONS Instructions for parentsYoung infants (and their siblings) should not be in contact with individuals with respiratory tract infections whenever practical. A Cochrane review suggests that hand hygiene in the home decreases the spread of respiratory tract infections in children. (5) Breastfeeding and avoidance of cigarette smoke are also presumed to decrease the incidence and/or severity of viral respiratory tract infections. PalivizumabPalivizumab, a humanized murine monoclonal immunoglobulin G-1 directed against an epitope on the F glycoprotein of RSV, is produced by recombinant DNA technology, and has 95% human and 5% murine amino acid sequences. Rare cases of anaphylaxis are the only recognized serious adverse event. Standard dosing is 15 mg/kg administered intramuscularly every 30 days during RSV season for a maximum of five doses. Some Canadian programs administer the second dose 20 days after the first dose to prevent a low trough level;(6,7) however, there are no data showing an increased RSV hospitalization rate before the second dose. Palivizumab is available in 50 mg or 100 mg vials. Drug costs for five doses of palivizumab for an infant with a mean weight of 5 kg are approximately $5,600, assuming no waste.Palivizumab use in Canada is directed by provincial or territorial programs. When practitioners have questions about eligibility, they should contact their local program; contact information is available through neonatal care units. Some programs routinely begin prophylaxis in November or December. Others use laboratory surveillance from local laboratories or from the national Respiratory Virus Detection Surveillance System (www.phac-aspc. gc.ca/bid-bmi/dsd-dsm/rvdi-divr/index-eng.php) to determine when to start palivizumab. The latter strategy is more complicated to organize than having a uniform start and stop date, but has been demonstrated to save drug costs in a recent Canadian study.(8) Table 1 summarizes the results of randomized controlled trials (RCTs) investigating palivizumab, demonstrating a reduction in hospitalizations of approximately 80% in infants with prematurity but without chronic lung disease of prematurity (CLD), of 40% in infants with CLD, and of 45% in children with congenital heart disease (CHD). Efficacy was not demonstrated in the CHD subgroup with cyanotic heart...

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“…This recommendation is consistent with findings from previous studies showing that RSV contributes to early lung injury among infants with cystic fibrosis and that it is the leading pathogen among children with cystic fibrosis hospitalized for persistent or severe respiratory disease. 13 Similarly, pediatric specialists suggested use in children who have a history of mechanical ventilation, Down syndrome with CHD, 14,15 and congenital diaphragmatic hernia as well as in situations where cardiac surgery or hemodynamic decompensation is anticipated. These areas are in need of study.…”

Section: Clinical Practice Beyond the Aap Guidancementioning

confidence: 99%

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

Friedman

Domachowske

Wong

et al. 2015

Clin Pediatr (Phila)

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This study was conducted to assess the perception of US pediatric specialists of respiratory syncytial virus (RSV) disease risk and determine their clinical practices regarding immunoprophylaxis for high-risk children. Separate surveys were sent to neonatologists, pediatricians, pediatric pulmonologists, and pediatric cardiologists. Data were collected using structured questions requiring quantitative responses. Most neonatologists and pediatricians (>82.7%) reported a high clinical need for RSV immunoprophylaxis in preterm infants <32 weeks' gestational age. Pediatric pulmonologists and pediatric cardiologists suggested that health conditions indicative of chronic lung disease of prematurity and hemodynamically significant congenital heart disease, respectively, confer eligibility for RSV immunoprophylaxis. Agreement with the changes in the 2014 American Academy of Pediatrics guidance for RSV immunoprophylaxis was mixed among respondents from the 4 specialties. Survey findings may provide a basis to improve education about risk for severe RSV disease and evaluate changes in physician use of RSV immunoprophylaxis based on the 2014 guidance.

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Palivizumab for prophylaxis against respiratory syncytial virus infection in children with cystic fibrosis

Cited by 18 publications

References 41 publications

Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis

Clinical Practice Guideline: The Diagnosis, Management, and Prevention of Bronchiolitis

Preventing hospitalizations for respiratory syncytial virus infection

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

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