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Objective: This study examined the rate, severity, and cost of respiratory syncytial virus (RSV) hospitalizations among preterm infants 29 to 34 weeks gestational age (wGA) versus term infants before and after a 2014 change in the American Academy of Pediatrics policy for RSV immunoprophylaxis., Study Design: Preterm (29-34 wGA) and term infants born from July 2011 to March 2017 and aged < 6 months were identified in a U.S. commercial administrative claims database. RSV hospitalization (RSVH) rate ratios, severity, and costs were evaluated for the 2011 to 2014 and 2014 to 2017 RSV seasons. Postpolicy changes in RSVH risks for preterm versus term infants were assessed with difference-in-difference (DID) modeling to control for patient characteristics and temporal trends., Results: In the DID analysis, prematurity-associated RSVH risk was 55% greater in 2014 to 2017 versus 2011 to 2014 (relative risk = 1.55, 95% confidence interval: 1.10-2.17, p  = 0.011). RSVH severity increased among preterm infants after 2014 and was highest among those aged < 3 months. Differences in mean RSVH costs for preterm infants in 2014 to 2017 versus 2011 to 2014 were not statistically significant., Conclusion: RSVH risk for preterm versus term infants increased after the policy change, confirming previous national analyses. RSVHs after the policy change were more severe, particularly among younger preterm infants., Competing Interests: L.R.K. has received research funding from AstraZeneca. J.F. has served as a consultant for and on the speaker's bureau of AstraZeneca. M.G. has received grant/research support from AstraZeneca/MedImmune and served on the AstraZeneca Speaker's Bureau. L.B. is an employee of AstraZeneca and a shareholder in Sonic Healthcare (Sydney, Australia)., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr. Krilov has consulted for Pfizer and has received clinical trial support from AstraZeneca (MedImmune) and Regeneron. Dr. Krilov is site principal investigator for an unrelated multi-centered pediatric vaccine trial sponsored by Sanofi Pasteur with all monies paid to his institution.

Background: Infection 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., Methods: Claims 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., Results: Of 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)., Conclusions: RSV-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.

Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections in infants and young children, accounting for more than 100,000 hospitalizations per year in the USA. The majority of hospitalizations occur in infants less than 1 year of age. Worldwide, RSV is associated with an annual mortality rate of 160,000-600,000 deaths. Premature infants, and infants with congenital heart disease, neuromuscular disease, structural airway abnormalities and immunodeficiencies are at increased risk for severe RSV disease. Despite the magnitude of RSV disease, treatment remains primarily supportive. Trials of bronchodilators, corticosteroids and montelukast have not demonstrated conclusive clinical benefit. The antiviral drug ribavirin has demonstrated only marginal clinical benefit and is not routinely indicated in treatment of RSV disease. Palivizumab is beneficial in prophylaxis for infants at high-risk for severe RSV infection although optimal indications based on cost-effectiveness considerations have not been defined. Future directions in treatment and prevention of RSV infections likely include the second-generation monoclonal antibody motavizumab, more potent antiviral compounds and more unique anti-inflammatory agents. Vaccination against RSV is in development but not eminent.

Background: During the period of this study, the American Academy of Pediatrics (AAP) 2006 guidelines recommended respiratory syncytial virus (RSV) prophylaxis for infants 32 to 35 weeks gestation age (wGA) with two or more of five risk factors (RFs). New recommendations have recently been published in 2009. The cost implications of expanding this list of RFs to include other evidence-based RFs like passive smoke exposure (PSE), crowded living conditions (CLCs), and young chronological age (YCA) are unclear., Methods: We estimated the prevalence of RSV RFs in a US sample of infants 32 to 35 wGA referred for prophylaxis from nine specialty pharmacy providers during the 2007-2008 season. We estimated the percent eligible for RSV prophylaxis under various potential RF coverage policies. Using a budget impact model, we calculated the per-member-per-month (PMPM) cost for each policy in 2007 USD for a hypothetical one million member plan., Results: Infants 32 to 35 wGA represented 0.08% of the plan. Approximately 20.2% of these infants met at least two or more of five AAP RFs. Expanding this list to include one additional RF of PSE, CLC, or YCA increased the percent of infants potentially prophylaxed to 29.9%, 23.9%, and 47%, respectively. Adding all three RFs to the list (two or more of eight) increased the percent of infants potentially prophylaxed to 55.6%, and increased payer costs by 9 cents PMPM., Conclusion: Expanding the AAP RF criteria to include PSE, CLC, and YCA would identify more 32 to 35 wGA infants at high risk for severe RSV disease at an acceptable budget impact.

Respiratory syncytial virus (RSV) infection is the leading cause of lower respiratory tract infection in infants and young children. Premature infants and infants with underlying lung disease are at increased risk for severe RSV infection in the first 1 - 2 years of life. Monthly prophylaxis with palivizumab (Synagis) during RSV season has been proven safe and effective in this population and these effects have persisted over the 4 years since the drug was approved by the US FDA in 1998. Issues remain regarding the optimal candidates for palivizumab prophylaxis and whether additional groups of high-risk individuals, for example infants with congenital heart disease or cystic fibrosis, and immunocompromised hosts, might benefit from such preventive therapy. It is possible that palivizumab in combination with antiviral or anti-inflammatory agents might also prove to be beneficial in the treatment of RSV disease. Newer monoclonal antibodies to RSV in development may offer the potential for less frequent dosing, increased efficacy and a role in treatment of RSV disease, but pending further evaluation of such products palivizumab provides significant protection for high-risk infants against a major pathogen.

Background: Hospitalization for respiratory syncytial virus (RSV) bronchiolitis is considered a risk factor for reactive airway disease and/or abnormal pulmonary function tests (PFTs) later in childhood. This study attempted to assess this observation with newer PFTs and to determine whether ribavirin therapy of initial RSV infection may affect the long term outcome., Methods: Medical records of all infants hospitalized with RSV infection in 1986 and 1987 at six institutions (North Shore University Hospital, Children's Hospital of Buffalo, University Florida-Gainesville, University of Connecticut, Children's Hospital National Medical Center, Denver Children's Hospital) were requested. Patients who could be contacted were recalled in 1993 and 1994 for PFTs and given a pulmonary status questionnaire., Results: One hundred patients were evaluated. Overall PFTs were within normal ranges. There was less "bronchitis" over the interval years in the ribavirin-treated patients (13 of 33) vs. those who did not receive ribavirin (44 of 67, P < 0.01). There was no difference for the diagnosis of reactive airway disease (15 of 33 ribavirin vs. 36 of 67 no ribavirin). Patients who received ribavirin were then matched by age (within 2 weeks) at initial RSV infection and underlying risk factor (bronchopulmonary dysplasia, heart disease). Of the 27 patients matched, the ribavirin patients had longer intensive care unit stays (median (25 to 75% interquartile range): 2 (0 to 7) vs. 0 (0 to 0), P < 0.05). On follow-up evaluation there were no significant differences in PFTs or reactive airway disease between the 2 groups. There was a trend toward lower forced expiratory volume at 1 s and midexpiratory flow rate (25 to 75%) in the ribavirin-treated group, and there were more reported pneumonias on follow-up in the ribavirin patients., Conclusion: During our 5- to 6- year follow-up of children, status post bronchiolitis, we noted a good long term prognosis. No long term adverse effects on pulmonary function were detected. Despite being potentially sicker at presentation as assessed by intensive care unit stay, ribavirin recipients were doing equally well at the time of follow-up.