The impact of the recent AAP changes in palivizumab authorization on RSV-induced bronchiolitis severity and incidence

Antonino Capizzi1, Michela Silvestri1, Andrea Orsi2

  • 1Department of Pediatrics, Pulmonology and Allergy Unit and Cystic Fibrosis Center, Istituto Giannina Gaslini, Genoa, Italy.

Insights

Italian guidelines restrict palivizumab for premature infants born after 29 weeks gestational age (wGA). This study shows these infants, especially those <36 wGA needing respiratory support, are still vulnerable to RSV-induced ALRI, warranting guideline reevaluation.

Area of Science:

  • Pediatric Pulmonology
  • Infectious Diseases
  • Neonatology

Background:

  • The Italian Drug Agency (AIFA) restricted palivizumab coverage to infants <29 weeks gestational age (wGA) and ≤12 months old, based on US RSV epidemiology data.
  • Italian studies indicate that premature infants ≥29 wGA remain vulnerable to severe respiratory syncytial virus (RSV) disease.

Discussion:

  • A retrospective analysis of RSV-induced acute lower respiratory infection (ALRI) admissions (2014-2017) at Gaslini Hospital was conducted.
  • The study examined the impact of restricted palivizumab prophylaxis in premature infants during the 2016-2017 RSV season.
  • Infants <36 wGA, particularly those born at 33-35 wGA and under 6 months old, represented a significant proportion of admissions.

Key Insights:

  • Restricted palivizumab prescription was associated with a high admission rate for premature infants <36 wGA.
  • A notable number of these admitted premature infants required high-flow nasal cannula ventilation.
  • The findings highlight the continued risk of RSV-induced ALRI in premature infants ≥29 wGA, especially with specific risk factors.

Outlook:

  • Reevaluation of palivizumab prophylaxis guidelines for premature infants ≥29 wGA with identified risk factors is strongly suggested.
  • Further research should focus on refining risk stratification for RSV immunoprophylaxis in vulnerable preterm populations.
  • This study underscores the need for Italy-specific data to inform national guidelines on RSV prevention in preterm infants.

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