Association Between Updated Guideline-Based Palivizumab Administration and Hospitalizations for Respiratory Syncytial Virus Infections

Carlina J. Grindeland, PharmD, BCPS; Clifford T. Mauriello, MD; David D. Leedahl, PharmD, BCPS, BCCCP; Lisa M. Richter, PharmD, BCPS; Anne C. Meyer, PharmD, BCPS, CACP


Pediatr Infect Dis J. 2016;35(7):728-732. 

In This Article

Abstract and Introduction


Background: Since its introduction, palivizumab has been used to prevent respiratory syncytial virus (RSV) infection in high-risk populations. Recommendations for palivizumab administration changed in 2014. We examined whether adherence to 2014 palivizumab guidelines affected RSV hospitalization rates.

Methods: This was a retrospective sequential period analysis comparing the incidence of RSV hospitalization in patients younger than 2 years of age before and after implementation of 2014 palivizumab use criteria. Hospitalization data were prospectively collected through age-based surveillance for the post-2014 guideline period (November 1, 2014 to April 1, 2015 RSV season). Comparative data were collected retrospectively for hospitalizations during the pre-2014 guideline period of 2 previous RSV seasons (November 1, 2012 to April 1, 2013 and November 1, 2013 to April 1, 2014). The primary outcome was RSV hospitalization rate, and number of palivizumab doses administered was analyzed as a secondary outcome.

Results: During the study period, 194 RSV hospitalizations occurred. The rate of RSV hospitalization was 5.37 per 1000 children <24 months in the pre-2014 guideline period versus 5.78 per 1000 children <24 months in the post-2014 guideline period (difference of +0.4, 95% confidence interval: -1.2 to +2, P = 0.622). During the pre-2014 guideline period, 21.7 doses per 1000 children <24 months of palivizumab were administered, which decreased to 10.3 doses per 1000 children <24 months in the post-2014 guideline period, yielding a reduction of 11.4 doses per 1000 children <24 months (95% confidence interval: 14.3–8.4, P < 0.001).

Conclusions: The implementation of 2014 palivizumab use criteria was not associated with an increased incidence of RSV hospitalization for children younger than 2 years of age but was associated with significantly less use of palivizumab.


Respiratory syncytial virus (RSV) bronchiolitis is a leading cause of hospitalization in young children and a public health priority.[1–3] The risk of RSV hospitalization decreases during the first 2 years of life but is reported to be as high as 16.9 hospitalizations per 1000 children 0–5 months of age.[4] The consequence of RSV disease can be severe, as an estimated 150–500 RSV-associated deaths occur each year among children in the United States.[5]

Palivizumab, a humanized murine monoclonal antibody that targets the virus fusion protein, is the main pharmacologic agent active in preventing RSV infections.[6] Palivizumab immunoprophylaxis has been shown to be effective in the prevention of hospitalization in high-risk populations.[7–9] The Impact-RSV study demonstrated that monthly intramuscular administration of palivizumab throughout the RSV season to premature infants and infants with chronic lung disease resulted in a 55% reduction in hospitalizations for RSV disease compared with infants receiving placebo (4.8% vs. 10.6%; P < 0.001).[10] Subsequent analyses of palivizumab utilization have been used to identify populations that benefit from palivizumab immunoprophylaxis. These populations of interest are primarily children born prematurely,[11–14] with chronic lung disease,[12,13] or with congenital heart disease.[15,16]

Palivizumab is expensive, with an estimated cost of as much as $4458 per child per season,[17] and cost-efficacy analyses of palivizumab administration have produced inconsistent results.[18–21] No trial to date has demonstrated a mortality benefit when comparing prophylaxis groups to placebo, which prevents the use of life-years gained as a measure for financial analyses.[22]

Since the introduction of palivizumab, the American Academy of Pediatrics (AAP) has published and revised recommendations for its administration.[7–9,23] The evidence supporting the eligibility of certain populations for receipt of palivizumab has been fiercely debated.[24] In 2014, the AAP published its most recent recommendations for RSV immunoprophylaxis, but the impact of adherence to these guidelines is largely unknown. The aim of this study was to determine the impact of adherence to the 2014 guidelines on hospitalization rates for RSV.