Partial palivizumab prophylaxis and increased risk of hospitalization due to respiratory syncytial virus in a Medicaid population: a retrospective cohort analysis

Abstract

BackgroundInfection with respiratory syncytial virus (RSV) is common among young children insured through Medicaid in the United States. Complete and timely dosing with palivizumab is associated with lower risk of RSV-related hospitalizations, but up to 60% of infants who receive palivizumab in Medicaid population do not receive full prophylaxis. The purpose of this study was to evaluate the association of partial palivizumab prophylaxis with the risk of RSV hospitalization among high-risk Medicaid-insured infants.MethodsClaims data from 12 states during 6 RSV seasons (October 1st to April 30th in the first year of life in 2003–2009) were analyzed. Inclusion criteria were birth hospital discharge before October 1st, continuous insurance eligibility from birth through April 30th, ≥ one palivizumab administration from August 1st to end of season, and high-risk status (≤34 weeks gestational age or chronic lung disease of prematurity [CLDP] or hemodynamically significant congenital heart disease [CHD]). Fully prophylaxed infants received the first palivizumab dose by November 30th with no gaps >35 days up to the first RSV-related hospitalization or end of follow-up. All other infants were categorized as partially prophylaxed.ResultsOf the 8,443 high-risk infants evaluated, 67% (5,615) received partial prophylaxis. Partially prophylaxed infants were more likely to have RSV-related hospitalization than fully prophylaxed infants (11.7% versus 7.9%, p< 0.001). RSV-related hospitalization rates ranged from 8.5% to 24.8% in premature, CHD, and CLDP infants with partial prophylaxis. After adjusting for potential confounders, logistic regression showed that partially prophylaxed infants had a 21% greater odds of hospitalization compared with fully prophylaxed infants (odds ratio 1.21, 95% confidence interval 1.09-1.34).ConclusionsRSV-related hospitalization rates were significantly higher in high-risk Medicaid infants with partial palivizumab prophylaxis compared with fully prophylaxed infants. These findings suggest that reduced and/or delayed dosing is less effective.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-2431-14-261) contains supplementary material, which is available to authorized users.

The 2014–2015 National Impact of the 2014 American Academy of Pediatrics Guidance for Respiratory Syncytial Virus Immunoprophylaxis on Preterm Infants Born in the United States

“…These databases have been used in more than 1,000 peer-reviewed articles, 14 including several manuscripts related to RSV. 15 16 17 18 The data were previously collected and statistically de-identified, and are compliant with the conditions set forth in Sections 164.514(a)–(b)(1)ii of the Health Insurance Portability and Accountability Act of 1996 Privacy Rule; therefore, approval from an institutional review board was not required.…”

Avaliação do programa de uso da imunoglobulina palivizumabe no Estado de São Paulo, Brasil

“…Outro estudo americano 26 teve por foco situações em que há imunização parcial, em decorrência de falha no procedimento de aplicação: é o caso de coorte retrospectiva realizada entre 2003 e 2009, com 8.443 crianças de alto risco, sendo que dois terços delas receberam profilaxia apenas parcial.…”

Effectiveness of Palivizumab in Preventing RSV Hospitalization in High-Risk Children: A Prospective Observational Multicenter Study

“…Учитывая, что протоколом исследования рекомендовалось выполнение как минимум трех инъекций паливизумаба, предполагается, что вышеописанный фактор не оказал существенного влияния на результаты исследования. Однако стоит отметить, что ретроспективные исследования показали более высокий риск РСВ-ассоциированной госпитализации среди детей с частичным соблюдением рекомендуемой схемы иммунопрофилактики паливизумабом по сравнению с детьми, которые получили полный курс препарата [26,27]. В связи с тем, что данное исследование являлось наблюдательным и не включало группу контроля, не представлялось возможным провести сравнительный анализ эффективности препарата.…”