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Palivizumab prophylaxis for RSV requires more definitive data
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NEW YORK — In light of the AAP’s recent recommendations on palivizumab for prevention of respiratory syncytial virus, benefits and disadvantages of the treatment were discussed during a keynote address at the 2014 Infectious Diseases in Children Symposium.
H. Cody Meissner, MD, an Infectious Diseases in Children Editorial Board member, led the discussion, touching on the overall burden of RSV among all age groups, historical background on the treatment of RSV and the AAP’s guidance regarding RSV immunoprophylaxis.
H. Cody Meissner
Meissner discussed the differences between the AAP’s most recent recommendations, published in July 2014, and previous guidance for palivizumab published in 2012.
Previously, prophylaxis was recommended for infants who were either born before 32 weeks gestation or between 32 weeks and 35 weeks gestation if they exhibited additional risk factors.
“There are new data that have enabled the AAP to make more precise recommendations for use of prophylaxis. Now Synagis (MedImmune) is only recommended in the first year of life for infants born before 29 weeks, 0 days gestation,” Meissner said during the presentation.
Prior recommendations did not define chronic lung disease. The most recent recommendations endorse palivizumab prophylaxis for preterm infants with chronic lung disease who require 28 days of supplemental oxygen starting at birth.
Palivizumab may be administered during the first year of life among infants with congenital heart disease, according to the most recent guidelines, whereas previous recommendations stated palivizumab should be given during the first and second year of life. Prophylaxis is not recommended for infants with cyanotic heart disease except in special circumstances.
Prior guidance included specific dosing recommendations for some infants, stating they should receive fewer than 5 monthly doses. Current guidelines state physicians may administer a maximum of 5 monthly doses of palivizumab to infants who qualify for treatment within the first year of life.
Palivizumab is not recommended during the second year of life. Prior guidance had recommended two seasons of palivizumab.
Updated guidance also states that monthly palivizumab treatment should cease if a child develops a breakthrough RSV hospitalization, whereas previously, continued prophylaxis was recommended if a child was hospitalized with a breakthrough RSV infection.
In addition to differences between previous and updated guidance, Meissner addressed downsides to palivizumab prophylaxis, most notably that palivizumab has not been proven to reduce ICU admissions or mortality.
“One cost-effectiveness analysis, published in the Archives of Pediatric and Adolescent Medicine in 2011, studied prophylaxis among the Medicaid population in the state of Florida,” Meissner said. “The authors found that it required over $300,000 to prevent one RSV hospitalization that costs less than $10,000. This brings us to the issue of financial stewardship, similar to the concept of antibiotic stewardship. Because of the very limited efficacy of palivizumab prophylaxis, what is society getting in return for this enormous amount of money?”
Additionally, palivizumab prophylaxis is not recommended for the prevention of nosocomial disease or health care-associated RSV disease. Meissner also noted that while children with Down syndrome exhibited a slightly increased risk of hospitalization due to RSV, data do not support a recommendation for palivizumab prophylaxis for this patient population.
“While the impact of RSV hospitalization on a family is more than just financial cost, administration of palivizumab to a large number of children to prevent one RSV hospitalization exacts a cost on a number of families each month in terms of time and exposure of an infant to other infectious patients in a physician’s office,” he concluded. “Approximately 20 infants must receive prophylaxis to prevent one hospitalization, or 100 monthly doses must be administered to prevent one RSV hospitalization.”
For more information:
Meissner HC. “RSV a persistent pathogen.” Presented at: IDC NY 2014; November 22-23, 2014; New York.
Disclosure: Meissner reports no relevant financial disclosures.