Background There is doubt about the criteria for selection of patients eligible to receive palivizumab prophylaxis for respiratory syncytial virus (RSV) and the potential therapeutic failures.

Purpose To estimate the rate of therapeutic failure with palivizumab and drug use profile in the study centre.

Material and methods Observational, retrospective study. Patients who received palivizumab in 3 seasons (2006–2009) were selected and medical records were reviewed.

Variables:

• Dependent: Rate of therapeutic failure with palivizumab.

• Independent: Profile of drug use in the study centre.

Results Data were obtained from 104 patients: 15/104 were children <2 years with hemodynamically significant congenital heart disease, 10/104 children <2 years with bronchopulmonary dysplasia (BPD), 65/104 patients were preterm born before the 35th week of gestation and 14/104 patients did not fit the approved indications.

In 100% of patients, palivizumab was prescribed according to the recommended dosage, and the number of doses prescribed was correct in 99% of cases. 81.7% of patients received all prescribed doses.

Other risk factors analysed:

• 66/104 were male.

• 13/104 had a chronological age <10 weeks at the start of the season and 9/104 were born in the first 10 weeks of the season.

• 40/99 had low birth weight (1,500–2,500 g), 45/99 very low birth weight (<1,500 g), 14/99 the right birth weight, 5/104 unknown birth weight.

• Breastfeeding was continued for at least 2 months in 42/93 patients.

The rate of therapeutic failure with palivizumab was 3.8%, of the total 104 patients receiving prophylaxis with palivizumab, 4 required hospitalisation for RSV infection.

Conclusion

• The drug use profile in the study centre matched the licensed indications in the SmPC. A protocol that allows an annual review of the criteria for selecting patients for treatment with palivizumab was developed.

• The rate of therapeutic failure in our study context was very low, so the drug can be considered effective.

References and/or Acknowledgements No conflict of interest.