AAP: Palivizumab RSV Prophylaxis Guidelines Updated

Laurie Barclay, MD

July 28, 2014

Palivizumab prophylaxis for respiratory syncytial virus (RSV) should be limited to infants born before 29 weeks' gestation and to infants with chronic illness such as congenital heart disease or chronic lung disease, according to an evidence review and updated guidelines by the American Academy of Pediatrics (AAP). This update, the fourth since approval of the drug in 1998 by the US Food and Drug Administration, replaces the recommendations found in the 2012 Red Book and is published in the August issue of Pediatrics.

"The updated recommendations in this policy statement reflect new information regarding the seasonality of RSV circulation, palivizumab pharmacokinetics, the changing incidence of bronchiolitis hospitalizations, the effect of gestational age and other risk factors on RSV hospitalization rates, the mortality of children hospitalized with RSV infection, the effect of prophylaxis on wheezing, and palivizumab-resistant RSV isolates," write Michael T. Brady, MD, FAAP, and colleagues from the AAP.

The technical report summarizes a comprehensive literature review. Although RSV infection is common in young children and usually causes only mild upper respiratory symptoms, premature infants and those with chronic disease are likely to be more severely affected. Black and white children younger than 24 months do not differ in overall rate of RSV hospitalization, according to multiple studies.

The main risk factor for RSV hospitalization is chronologic age, with more than 58% to 64% of pediatric RSV hospitalizations occurring in the first 5 months after birth, and most of these hospitalizations occurring before 90 days of age.

The degree of risk varies among studies regarding comorbidities such as prematurity, chronic lung disease, or hemodynamically significant congenital heart disease.

Other reported host risk factors have a limited and inconsistent effect. Environmental risk factors of limited and variable effect include environmental pollution, living in crowded conditions or at increased altitude, weather, low parental education or socioeconomic status, and child care attendance. After adjusting for other covariates, only preterm birth and young chronologic age independently correlated with more severe RSV disease.

Available evidence suggests that prophylaxis with palivizumab, a monoclonal antibody given in a series of doses during the RSV season, has a limited effect on decreasing the rate of RSV hospitalizations, but not of RSV-related mortality or subsequent wheezing or asthma.

Regardless of palivizumab prophylaxis, the rate of RSV hospitalizations has fallen since 1998, when the drug was first licensed, thanks to overall advances in neonatal care and better health of preterm infants. New information also helped identify children at greatest risk for RSV hospitalization.

Specific AAP Recommendations

  • Give palivizumab prophylaxis in the first year of life only to infants born before 29 weeks' gestation or to those with congenital heart disease, chronic lung disease, or other chronic illnesses.

  • Give infants who qualify for prophylaxis in the first year of life no more than 5 monthly doses of palivizumab (15 mg/kg per dose) during the RSV season.

  • Qualifying infants born during the RSV season may require fewer doses.

  • In the second year of life, palivizumab prophylaxis is recommended only for children who needed supplemental oxygen for 28 days or more after birth and who continue to need medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy).

  • Discontinue monthly prophylaxis in any child who is hospitalized for RSV.

  • Clinicians may consider prophylaxis for children younger than 24 months if they will be profoundly immunocompromised during the RSV season.

  • Broader use of palivizumab for RSV prevention may be appropriate in Alaska Natives, and possibly in selected other American Indian populations, given the burden of RSV disease and costs associated with transport from remote locations.

  • The AAP does not recommend palivizumab prophylaxis to prevent healthcare-associated RSV disease.

  • To reduce the risk for RSV and other viral infections, all infants, especially preterm infants, should be offered breast milk and should avoid smoke exposure, attendance in large group child care during the first winter season, and contact with ill people.

  • In addition, household members should be immunized against influenza and practice good hand and cough hygiene.

"The vast majority of RSV hospitalizations occur among healthy term infants," the technical report concludes. "Immunoprophylaxis remains an option for a very small number of children, but palivizumab immunoprophylaxis will continue to have only a minimal effect on the burden of RSV disease. Effort should be made to avoid prophylaxis among infants and young children who do not qualify for prophylaxis, as outlined in the accompanying AAP policy statement."

The statement and report authors filed conflict of interest statements with the AAP, and any conflicts were resolved through a process approved by the Board of Directors. The AAP neither solicited nor accepted any commercial involvement in the development of the content of the statement or report.

Pediatrics. 2014;134:415-420, e620-e638.

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