Respiratory syncytial virus prophylaxis with monoclonal antibodies (palivizumab) in congenital cardiopathies: critical review of efficacy, effectiveness, efficiency and safety

Introduction and objectives. The most used immunoprophylaxis against respiratory syncytial virus (SRV) bronchiolitis are monoclonal antibodies (palivizumab), that already has been used in preterm infants and, recently, its use has began in newborns and infants with congenital cardiopathies (CC). The aim of this study is to make a systematic and critical review to the structured clinical question: is the palivizumab prophylaxis against RSV in infants with CC a good clinical practice in terms of efficacy, effectiveness, efficiency and safety? Methods. Structured review of biomedical bibliography, as much primary as secondary databases, and critical appraisal by means of methodology of the Evidence Based Medicine Working Group. Results. The efficacy is verified with the only clinical trial that exist, that although a 45% relative risk reduction in hospitalization is described, only a 4,4% absolute risk reduction is calculated with a number needed to treat ?NNT? of 23 (95% CI 16-67), with worse results in cyanotic (NNT = 43, 95% CI 17-72) than acyanotic cardiopathies (NNT = 15, 95% CI 9-40). Effectiveness is lower in clinical practice, depending on the basal rate of SRV admissions. Efficiency is based on a theoretical economic model, that assumes costs of 100,338 $/life-year saved and 114,337 $/QALY, clearly non cost-effective. Safety of palivizumab in the short-term is correct, although there is not experience about the long-term safety. Conclusions. The possible indications of palivizumab in CC seem limited. In any case, it must carefully incorporate criteria of effectiveness and efficacy, ant to promote a rational use of this biotechnological drug.