Compliance with the RSV immunoprophylaxis dosing schedule in the Polish registry for palivizumab (2008-2014).

OBJECTIVE: Background: Respiratory syncytial virus infection causes respiratory diseases in about 90% of the children under 2 years of age. Currently the only way to prevent infection is through immunoprophylaxis based on palivizumab. Aim: The aim of the study was to assess compliance with the recommended prophylaxis regimen in children qualified for the Polish National Programme for Respiratory Syncytial Virus Immunoprophylaxis over six consecutive virus seasons (2008-2014). PATIENTS AND METHODS: Material and methods: A retrospective analysis of data obtained from a multicentre, non-interventional observational study was performed. The prevention programme included 3,780 children aged 4 weeks to 2 years. The analysis included: the course of the neonatal period, clinical features at the time of inclusion in the programme, the immunisation course, and adherence to the palivizumab dosing schedule. RESULTS: Results: During the programme, the children received an average of 3.8 (range 1-5) injections. The highest mean number of injections was recorded in the 2013/14 season (4.3±1), and the lowest in the 2009/10 season (2.7±0.8). Overall, 3,084 children (81.7%) received all of the expected doses, while 2,352 (62.2%) children received injections within the appropriate interdose interval. The probability of non-compliance was higher for males. None of the other demographic, social, or clinical factors seemed to impact compliance. CONCLUSION: Conclusions: Compliance with the monthly dosing schedule of palivizumab is key to achieving the proper immunoprophylaxis efficacy. Education regarding the consequences of non-compliance with the regime and increased doctor-parent communication is recommended in future.

Factors related to compliance with palivizumab prophylaxis for respiratory syncytial virus (RSV) infection - data from Poland.

AIM: To evaluate compliance and health outcomes in children receiving palivizumab prophylaxis and to identify factors that could impact parental compliance with the recommended regimen of palivizumab immunoprophylaxis. MATERIAL AND METHODS: A retrospective, multicentre, non-interventional study of children enrolled in the Polish National Programme for Respiratory Syncytial Virus (RSV) Immunoprophylaxis who received ≥1 dose of palivizumab during two consecutive RSV seasons (I: 2008-2009, II: 2009-2010). For each child qualified to receive palivizumab, the following data were collected: sociodemographic factors, clinical characteristics at enrolment, and in the course of palivizumab prophylaxis. RESULTS: One thousand twenty-one infants were enrolled into the Registry at 29 sites across Poland and received a total of 3,241 palivizumab injections (average: 3.2 doses per child). The incidence of adverse reactions was 3.33%; nervousness was the most frequently reported event (1.23%). Overall, 771 (75.5%) children received all of their expected injections, whereas 635 (62.2%) children received their injections within the appropriate interdose interval. Compliance was lower in male infants. None of the other demographic, social, or clinical factors seemed to impact compliance. Non-compliant children had a higher rate of hospitalisation due to respiratory illness (22% vs 9.9%, p<0.0001, and 18.4% vs 9.5%, p<0.0001, for compliance defined by the number of expected injections received and by the interdose interval, respectively). CONCLUSIONS: Palivizumab prophylaxis was conducted in accordance with recommendations and was well tolerated in at-risk infants. Non-compliance was higher among male infants and was related with a higher rate of hospitalisation due to respiratory illness.