• Prescrire Int. 2000 Dec 1; 9 (50): 171-2, 174.

Abstract(1) RSV infection, the main cause of bronchiolitis, can necessitate hospitalisation, especially of infants at risk, i.e. those with a history of prematurity or bronchodysplasia. No drug prevention has been available. (2) Palivizumab, a monoclonal antibody directed against respiratory syncytial virus (RSV), is now marketed for preventing respiratory tract infection by RSV in certain infants. (3) The evaluation dossier barely answers the questions raised by the use of this drug. (4) The results of six trials suggest that the optimal dose is 15 mg/kg palivizumab by monthly injection throughout the seasonal epidemic period. (5) A double-blind trial in 1 502 infants either aged less than 6 months and born prematurely (35 weeks of gestation or earlier), or aged under 2 years with a history of bronchopulmonary dysplasia, has shown that, relative to a placebo, palivizumab reduces the hospitalisation rates by 5% in absolute values. It does not influence mortality or the need for mechanical ventilation. (6) Given the lack of relevant trials, we do not know if palivizumab is effective in infants with immunodeficiency or congenital heart diseases. We do not know, either, whether the definition of groups at risk used in the only relevant trial is appropriate. (7) No serious adverse effects attributable to palivizumab were reported in clinical trials. (8) Treatment with palivizumab is costly.

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