Abstract
Background: Palivizumab is indicated for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants.Aims: The purpose of the study was to assess the real-world effectiveness and safety of palivizumab in children at high risk for serious RSV disease during the 2014−2015 RSV season in the Russian Federation.Methods: A prospective, observational, multicentre, cohort study was conducted in a population of infants at high-risk for serious RSV illness: infants born ≤35 weeks of gestation and infants ≤24 months with bronchopulmonary dysplasia (BDP) or congenital heart disease (CHD), who were administered palivizumab immunoprophylaxis in routine clinical settings. The study was conducted at 16 investigational sites of European Russia and Western Siberia.Results: A total of 359 infants were enrolled (180 boys and 179 girls). Of them, 148 (41.2%) infants had BDP, 45 (12.5%) infants had hemodynamically significant CHD, and 166 (46.2%) children of prematurity were at the risk of RSV. The majority of infants (86.9%) received three or more injections during the course of study. Of the 359 participants enrolled, 11 (3.1%; 95% CI 1.5−5.4) patients were hospitalized for lower respiratory tract infection. A RSV diagnostic test was performed in 9 infants, and RSV was detected in one patient giving an overall incidence of RSV hospitalization as 0.3% (95% CI 0.0−1.5).Conclusions: This study showed that immunoprophylaxis with palivizumab was associated with a low rate of RSV hospitalization. Overall, therapy with palivizumab was well-tolerated and showed a favourable benefit-risk profile.
Highlights
Palivizumab is indicated for the prevention of serious respiratory syncytial virus (RSV) disease in high-risk infants
A prospective, observational, multicentre, cohort study was conducted in a population of infants at high-risk for serious RSV illness: infants born ≤35 weeks of gestation and infants ≤24 months with bronchopulmonary dysplasia (BDP) or congenital heart disease (CHD), who were administered palivizumab immunoprophylaxis in routine clinical settings
148 (41.2%) infants had BDP, 45 (12.5%) infants had hemodynamically significant CHD, and 166 (46.2%) children of prematurity were at the risk of RSV
Summary
Паливизумаб предназначен для профилактики тяжелых форм респираторной синцитиальной вирусной (РСВ) инфекции у детей групп высокого риска. Ключевые слова: паливизумаб, иммунопрофилактика, респираторный синцитиальный вирус, дети грудного возраста из групп высокого риска тяжелого течения РСВ инфекции. (Для цитирования: Чубарова А.И., Давыдова И.В., Виноградова И.В., Дегтярёва Е.А., Кешишян Е.С., Сафина А.И., Нестеренко Э.В. Проведенное в центральном, северо-западном и восточном регионах Российской Федерации во время эпидемического сезона РСВ инфекции 2008/2009 г., показало, что из 519 детей в возрасте ≤2 лет, госпитализированных по причине ИНДП, у 38% обнаружен респираторный синцитиальный вирус [7]. Ретроспективное исследование заболеваемости гриппом и другими острыми респираторными заболеваниями, проведенное на базе 49 исследовательских центров в Российской Федерации с 2009 по 2013 г., показало, что РСВ инфекция являлась наиболее распространенной респираторной инфекцией у детей в возрасте от 0 до 2 лет. Effectiveness of Palivizumab in Preventing RSV Hospitalization in High-Risk Children:
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
