Bronchiolitis: the effectiveness of Beyfortus called into question - In the news

2023-10-09 14:55:12

October 9, 2023

While Beyfortus, a preventive treatment for bronchiolitis, is no longer available in the city, a victim of its success, a press release from the National College of Teaching General Practitioners calls for a better evaluation of the drug. Explanations.

A justified success? On September 15, the infant immunization campaign against bronchiolitis began, with Beyfortus, this preventive treatment recommended for babies born after February 6, 2023. On September 29, a document from the General Directorate of Health (DGS) announced the interruption of delivery from pharmacies in doses of Beyfortus 100 mg, i.e. the dose for babies weighing 5 kg and more. The DGS also recommends no longer prescribing nirsevemab 100 mg – the Beyfortus molecule – in the city. The drug is therefore only available in hospitals. In question ? “Strong demand from parents and adherence to treatment higher than what was anticipated at the start of the year”, notes the DGS in its letter.

The same day, Friday September 29, the National College of General Practitioners pointed out a lack of evidence concerning the effectiveness of Beyfortus for babies without an identified risk of developing a serious form of the disease.. “In the light of published scientific data, the CNGE scientific council notes that Beyfortus is effective against RSV infections (virus respiratory syncytial, editor’s note)but that this effectiveness has not been demonstrated (to date) in reducing hospitalizations in the general population of low-risk infants,” write the doctors in a press release. High-risk newborns are not the only ones likely to develop a serious form since « 2 to 3% of children under one year old, 87% of whom without identified risk factors would be hospitalized for severe bronchiolitis. note with CNGE.

What does the High Authority of Health (HAS) say?

In an article posted online on August 1, the HAS estimated that the actual benefit was low for high-risk infants – they already have access to palivizumab (Synagis), a preventive treatment available only in hospital – and, considered moderate “in newborns and infants with or without risk factors and not eligible for palivizumab, during their first season of RSV circulation”. As for the improvement in the service provided, it is considered minor for newborns not eligible for palivizumab and absent for those who were.

Opinion of the Scientific Council of @CNGE_France “Nirsevimab (#Beyfortus®) for the prevention of respiratory infections #VRS” @Sante_Gouv @HAS_sante 1/ pic.twitter.com/EYE3gGTtQJ

— CNGE (@CNGE_France) September 29, 2023

The national college of teaching general practitioners recalls that Beyfortus has proven itself for infants at high risk of serious forms but it considers that “ It is essential that a therapy intended for the general population benefits from a medico-economic evaluation and is rigorously and scientifically evaluated in the population in which it is indicated.”

A more convincing study is awaited. The Harmonie study, carried out in a real situation and the results of which were partly revealed by Sanofi last May, shows that Beyfortus reduces the risk of hospitalization of infants due to RSV by 83%. The final results should be available in 2024. “These results are highly anticipated, but the absence of a blinding procedure (parents and caregivers knew which baby had received the treatment) greatly reduces the level of proof of this trial,” immediately warns the CNGE.

Source : DGS, temporary suspension of deliveries of Beyfortus 100 MG (nirsevimab), September 29, 2023 – HAS opinion on Beyfortus, August 1, 2023 – Nirsevimab for the prevention of respiratory illnesses in VRS, National College of General Teachers, September 29, 2023.
Written by : Dorothée Duchemin – Edited by Emmanuel Ducreuzet