Farmacoriflessioni
La profilassi dell’infezione da virus respiratorio sinciziale: dal palivizumab al nirsevimab
Prophylaxis of respiratory syncytial virus infection: from palivizumab to nirsevimab, what evidence?
Michela Servadio1, Valeria Belleudi1, Federico Marchetti2, Antonio Addis1
1Dipartimento di Epidemiologia della Regione Lazio, ASL Roma 1, Roma
2UOC di Pediatria e Neonatologia, Ospedale di Ravenna, AUSL della Romagna
Dicembre 2022 - pagg. 632 -639 | DOI: 10.53126/MEB41632
Abstract
The Respiratory Syncytial Virus (RSV) is considered the leading cause of lower respiratory tract infections (LRTI) in children aged < 2 years. In high-risk children, including preterm infants, or in children with bronchopulmonary dysplasia (BPD) and infants with congenital heart diseases (CHD), RSV infections may lead to severe consequences that often require hospitalizations. The typical seasonality of RSV is going through some changes and as consequence the healthcare management of serious infections is facing some difficulties. In this context and in light of the worldwide economic, political and healthcare debate around treatment of RSV infections, this article aims to inform physicians and healthcare professionals about evidence regarding the two drugs licensed for passive prophylaxis against RSV, namely palivizumab and nirsevimab. According to the 1998 IMpact study, palivizumab administration (5 monthly doses) was able to reduce the incidence of RSV hospitalizations in infants born preterm and in those with BPD. However, over the years, several studies found questionable cost-effectiveness evidence regarding the use of palivizumab in preterm infants born at ≥ 29 weeks of gestation. Differently from palivizumab, one single dose of nirsevimab is able to protect over an entire RSV season. This drug was able to reduce hospitalizations and medically attended RSV-associated LRTI in infants born preterm and without comorbidities, but none similar efficacy was found in reducing hospitalizations in healthy infants born at term (born at ≥ 35 weeks of gestation). As such, while future interventions in the clinical management of RSV infections and related consequences are warranted, new evidence about nirsevimab and palivizumab use will be essential to define which population will benefit the most from passive prophylaxis.
Riassunto
Il virus respiratorio sinciziale (VRS) è la prima causa di infezioni del tratto respiratorio inferiore (ITRI) nei primi anni di vita, tali infezioni possono provocare nei bambini a rischio conseguenze gravi, incluso il ricovero. Considerando le alterazioni che sta recentemente subendo la tipica stagionalità del VRS, con ripercussioni nella gestione sanitaria dei casi più gravi di infezione, e alla luce del dibattito economico, politico e sanitario che accompagna da anni la lotta al virus, questo articolo ha l’obiettivo di riportare le evidenze riguardanti i due farmaci attualmente autorizzati per le profilassi passiva contro il VRS: il palivizumab e il nirsevimab. Secondo lo studio IMpact del 1998, il palivizumab ha ridotto in maniera statisticamente significativa le ospedalizzazioni successive a infezione da VRS nei bambini nati pretermine e in quelli con displasia broncopolmonare, tuttavia le evidenze riguardanti i pretermine con un’età gestazione ≥ 29 settimane, sono state costellate negli anni da risultati di dubbia costo-efficacia, aspetto sostenuto anche dalle linee guida dell’American Academy of Pediatrics, pubblicate nel 2014. Il nirsevimab, in grado di proteggere durante un’intera stagione VRS con un’unica dose, anziché le 5 dosi raccomandate per il palivizumab, si è mostrato efficace nel ridurre le ospedalizzazioni e le ITRI più gravi nei bambini nati pretermine e senza comorbidità, ma non si è mostrato altrettanto efficace nel ridurre le ospedalizzazioni in bambini sani nati a termine (con età gestazionale ≥ 35 settimane). Alla luce di questi risultati e considerando che le recenti alterazioni della stagionalità del VRS richiederanno un intervento nella gestione delle infezioni e delle relative conseguenze, sarà essenziale in futuro affiancare l’utilizzo del nirsevimab e del palivizumab a un maggior numero di evidenze, al fine di definire quale popolazione può realmente beneficiare della profilassi passiva.
Parole chiave
Classificazione MeSH
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Corrispondenza: a.addis@deplazio.it