Quelle est la place du Nirsévimab dans le traitement immunoprophylactique du Virus Respiratoire Syncytial chez les nourrissons ?

(2025)

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Abstract
Respiratory Syncytial Virus (RSV) is a major cause of respiratory infections in infants. In winter, it represents a burden for the healthcare systems and leads to several hospitalisations. Due to the lack of a safe and effective vaccine, immunoprophylaxis has become an essential strategy for preventing these infections. Nirsevimab (Beyfortus®) approved for prophylaxis in infants, is a long-acting monoclonal antibody targeting the RSV fusion protein. This thesis analyses the results of clinical trials (Phase2b, MELODY, MEDLEY) and real-world studies (HARMONIE, NIRSE-GAL) that demonstrate a good safety profile and efficacy of Nirsevimab in reducing hospitalisations related to LRTI-RSV. Its single injection makes immunisation simpler compared to Palivizumab another monoclonal antibody that requires monthly injections. Viral conservation studies show that the target of the Nirsevimab is highly conserved. It limits the risk of resistance. In pharmacoeconomics, analyses suggest that Nirsevimab is cost-effective for healthcare systems. In conclusion, Nirsevimab represents a promising advance in the prevention of RSV in infants.