The impact of the recent AAP changes in palivizumab authorization on RSV-induced bronchiolitis severity and incidence
© The Author(s). 2017
Received: 30 May 2017
Accepted: 3 August 2017
Published: 14 August 2017
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.
This trend was observed also in preterms admitted with a chronological age of < 6 months (66.7%, 50% and 81.8%, respectively; Fig. 3c) and in the < 3 month subgroup (55.6%, 50% and 81.8%, respectively (Fig. 3d).
Therefore, the prescription limitation on RSV immunoprophylaxis in preterms was associated in the 2016–2017 RSV epidemic season with: a) a high proportion of admission for the < 36 wGA infants, the great majority born at 33- < 36 wGA and with chronological age of < 6 months; b) a high proportion of preterms treated with HFNC ventilation, mostly in the at 33- < 36 wGA subgroup. The major limitation of the study is that, since the data were collected in a single tertiary level paediatric hospital, the numbers of preterm infants was very small, precluding a reliable statistical analysis. This is a common problem in these kind of reports since preterms represent only a very small proportion in the general infant population, as shown also in studies that have been cited by the American Academy of Pediatrics in the guidance for palivizumab prophylaxis [8, 9]. Data collection on national records involving other tertiary level paediatric hospitals could provide a sample size large enough to perform a reliable statistical analysis. However, our results on RSV hospitalization and HFNC treatment clearly highlight the vulnerability of young preterms, especially in this last RSV season and point to a need to reevaluate the role of palivizumab prophylaxis in the > 29 wGA subpopulation when specific risk factors are present.
The authors declare that they have not received any funding for this analysis.
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All the authors equally contributed in collecting, analyzing, interpreting data and in writing the manuscript. All the authors read and approved the final manuscript.
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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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- 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):588–98.View ArticlePubMedPubMed CentralGoogle Scholar
- 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.View ArticleGoogle Scholar
- 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.View ArticlePubMedPubMed CentralGoogle Scholar
- 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):e620–38.View ArticleGoogle Scholar
- 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.
- Silvestri M, Marando F, Costanzo AM, di Luzio PU, Rossi GA. Respiratory Syncytial virus-associated hospitalization in premature infants who did not receive palivizumab prophylaxis in Italy: a retrospective analysis from the Osservatorio study. Ital J Pediatr. 2016;42:40.View ArticlePubMedPubMed CentralGoogle Scholar
- Zuccotti GV, Fabiano V. Indications to respiratory syncytial virus immunoprophylaxis in the 29-32 wGA group: is there still room for debating? Ital J Pediatr. 2017;43:17.View ArticlePubMedPubMed CentralGoogle Scholar
- Stevens TP, Sinkin RA, Hall CB, Maniscalco WM, McConnochie KM. Respiratory syncytial virus and premature infants born at 32 weeks’ gestation or earlier: hospitalization and economic implications of prophylaxis. Arch Pediatr Adolesc Med. 2000;154:55–61.PubMedGoogle Scholar
- Hall CB, Weinberg GA, Blumkin AK, Edwards KM, Staat MA, Schultz AF, et al. Respiratory syncytial virus-associated hospitalizations among children less than 24 months of age. Pediatrics. 2013;132:e341–8.View ArticlePubMedGoogle Scholar