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. 2017 Aug 14;43(1):71.
doi: 10.1186/s13052-017-0390-8.

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

Antonino Capizzi  1 , Michela Silvestri  1 , Andrea Orsi  2 , Renato Cutrera  3 , Giovanni A Rossi  1 , Oliviero Sacco  1
Affiliations

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

Antonino Capizzi et al. Ital J Pediatr. .

Abstract

Following the most recent modification by the American Academy of Pediatrics, based on American studies on RSV epidemiology, the Italian Drug Agency (AIFA) decided to limit the total financial coverage of the palivizumab prescription by the National Health Service only to the < 29 wGA group and age ≤ 12 months at the beginning of the RSV epidemic season. However, the vulnerability of otherwise healthy premature infants ≥ 29 wGA has been demonstrated in Italian analyses. We retrospectively reviewed records from children ≤ 1 years of age admitted for RSV-induced ALRI at the Gaslini Hospital, over three consecutive RSV epidemic seasons (RES) (2014-2017). We found that the prescription limitation on RSV immunoprophylaxis in preterms was associated in the 2016-2017 RES with: a) a high proportion of admission for the < 36 wGA infants, the great majority born at 33- < 36 wGA and a chronological age of < 6 months; b) a high proportion of preterms treated with high flow nasal cannula ventilation. These results strongly point to a need to reevaluate the role of palivizumab prophylaxis in the >= 29 wGA subpopulation when specific risk factors are present.

Keywords: Palivizumab; Preterm; Prophylaxis; Respiratory syncytial virus.

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Conflict of interest statement

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interest

AC, AO, OS declare that they have no competing interests, MS and GAR served as a consultant for AbbVie S.r.l.

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Figures

Fig. 1
Fig. 1
Circulation of respiratory viruses detected by the Liguria regional reference laboratory in the three RSV epidemic seasons (2014–2015, 2015–2016 and 2016–2017): data related to RSV are reported in green columns
Fig. 2
Fig. 2
Admission for RSV infection in infants. a Number of infants admitted in the three RSV epidemic seasons (2014–2015, 2015–2016 and 2016–2017). b Proportion of preterms (29- < 36 wGA) admitted in each RSV epidemic season. c Proportion of preterms (33- < 36 wGA) admitted in each RSV epidemic season
Fig. 3
Fig. 3
Proportion of infants (panel a and b) or of preterms (panel c and d) admitted for RSV infection in the three RSV epidemic seasons (2014–2015, 2015–2016 and 2016–2017). a and c Infants < 6 months of age; (b and d). Subgroup of infants < 3 months of age
Fig. 4
Fig. 4
Frequency of treatment with high flow nasal cannula (HFNC) ventilation among preterms in the three RSV epidemic seasons (2014–2015, 2015–2016 and 2016–2017). a Whole preterm population. b The 29- < 33 wGA subgroup. c The 33- < 36 wGA subgroup
See this image and copyright information in PMC

References

    1. Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009;360(6):588–598. doi: 10.1056/NEJMoa0804877. - DOI - PMC - PubMed
    1. Bollani L, Baraldi E, Chirico G, Dotta A, Lanari M, Del Vecchio A, et al. Revised recommendations concerning palivizumab prophylaxis for respiratory syncytial virus (RSV) It J Ped. 2015;41:97. doi: 10.1186/s13052-015-0203-x. - DOI - PMC - PubMed
    1. Baraldi E, Lanari M, Manzoni P, Rossi GA, Vandini S, Rimini A, et al. Inter-society consensus document on treatment and prevention of bronchiolitis in newborns and infants. Ital J Pediatr. 2014;40:65. doi: 10.1186/1824-7288-40-65. - DOI - PMC - PubMed
    1. American Academy of Pediatrics Committee on Infectious Diseases. American Academy of Pediatrics Bronchiolitis Guidelines Committee Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):e620–e638. doi: 10.1542/peds.2014-1666. - DOI - PubMed
    1. Gazzetta Ufficiale della Repubblica Italiana. GU Serie Generale n.221 del 21–9 2016. http://www.gazzettaufficiale.it/eli/gu/2016/09/21/221/sg/pdf. Accessed 10 Aug 2017.

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