Open AccessEffectiveness of palivizumab immunoprophylaxis in infants with respiratory syncytial virus disease in Colombia
Author(s) -
Juan Gabriel Piñeros,
José De la Hoz-Valle,
Clara Galvis,
A. Guerra García de Celis,
Oscar Ovalle,
Carmen Sandoval,
Jaime Orrego,
Saby Vides,
Iader Rojas,
Hernando Bustamante,
Carlos Gallón,
Jaime Alberto Mesa
Publication year - 2021
Publication title -
journal of infection in developing countries
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.322
H-Index - 49
eISSN - 2036-6590
pISSN - 1972-2680
DOI - 10.3855/jidc.12561
Subject(s) - palivizumab , bronchopulmonary dysplasia , medicine , pediatrics , gestation , observational study , population , gestational age , respiratory system , pregnancy , biology , environmental health , genetics
Respiratory syncytial virus (RSV) is one of the most important childhood infections. Objective: To evaluate the effectiveness and safety of palivizumab immunoprophylaxis in preterm infants at a high risk of severe respiratory syncytial virus infection during the RSV season in Colombia.
Methodology: A prospective observational non-comparative multicenter study in six Colombian cities. At the beginning of the RSV infection season, palivizumab prophylaxis, up to five doses, was administered to infants born at ≤32 weeks of gestation, infants younger than six months, infants under one year of age with bronchopulmonary dysplasia (BPD), infants one year or less of age with hemodynamically significant acyanotic and non-acyanotic congenital heart disease (CHD), and with follow-up during the immunoprophylaxis until one month after the last dose.
Results: The study enrolled 600 patients, 91.8% of which were born at ≤ 32 weeks of gestation. BPD was observed in 54.9% of infants. 49% were born at < 32 weeks gestation and presented BPD. 6.9% had hemodynamically significant acyanotic and non-acyanotic CHD 53.3% received three or more doses of palivizumab. The mean interval between doses was 39.6 days. 1.8% of patients were hospitalized due to a confirmed RSV infection. Overall mortality was 1.2%, whereas the mortality by RSV in infants undergoing prophylaxis was 0.2%.
Conclusions: Palivizumab was a clinically effective, well-tolerated treatment in the Colombian population. The safety profile of palivizumab reflects the findings from previous studies in developed countries.