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BMC Infectious Diseases Apr 2024Palivizumab has proven effective in reducing hospitalizations, preventing severe illness, improving health outcomes, and reducing healthcare costs for infants at risk of...
AIM
Palivizumab has proven effective in reducing hospitalizations, preventing severe illness, improving health outcomes, and reducing healthcare costs for infants at risk of respiratory syncytial virus (RSV) infection. We aim to assess the value of palivizumab in preventing RSV infection in high-risk infants in Colombia, where RSV poses a significant threat, causing severe respiratory illness and hospitalizations.
METHODS
We conducted a decision tree analysis to compare five doses of palivizumab with no palivizumab. The study considered three population groups: preterm neonates (≤ 35 weeks gestational age), infants with bronchopulmonary dysplasia (BPD), and infants with hemodynamically significant congenital heart disease (CHD). We obtained clinical efficacy data from IMpact-RSV and Cardiac Synagis trials, while we derived neonatal hospitalization risks from the SENTINEL-1 study. We based hospitalization and recurrent wheezing management costs on Colombian analyses and validated them by experts. We estimated incremental cost-effectiveness ratios and performed 1,000 Monte Carlo simulations for probabilistic sensitivity analyses.
RESULTS
Palivizumab is a dominant strategy for preventing RSV infection in preterm neonates and infants with BPD and CHD. Its high efficacy (78% in preventing RSV in preterm infants), the substantial risk of illness and hospitalization, and the high costs associated with hospitalization, particularly in neonatal intensive care settings, support this finding. The scatter plots and willingness-to-pay curves align with these results.
CONCLUSION
Palivizumab is a cost-saving strategy in Colombia, effectively preventing RSV infection in preterm neonates and infants with BPD and CHD by reducing hospitalizations and lowering healthcare costs.
Topics: Infant; Infant, Newborn; Humans; Palivizumab; Respiratory Syncytial Virus Infections; Cost-Benefit Analysis; Colombia; Antiviral Agents; Infant, Premature; Antibodies, Monoclonal, Humanized; Respiratory Syncytial Virus, Human; Heart Defects, Congenital; Hospitalization
PubMed: 38641577
DOI: 10.1186/s12879-024-09300-5 -
Cardiology in the Young Apr 2024Adherence to palivizumab prophylaxis programmes is crucial to protect infants with CHD against respiratory syncytial virus infections. We analysed the effectiveness of...
OBJECTIVES
Adherence to palivizumab prophylaxis programmes is crucial to protect infants with CHD against respiratory syncytial virus infections. We analysed the effectiveness of two nudge interventions in increasing adherence.
METHODS
Our study included 229 infants, and their caregivers, from five centers in Turkey in the 2020-2021 respiratory syncytial virus season. We randomly allocated caregivers to a control and two intervention groups. Caregivers in all groups were informed about the prophylaxis programme and provided a schedule. Additionally, caregivers in Intervention 1 were called two days before appointments (default bias) and were asked to plan the appointment day (implementation intention), whereas caregivers in Intervention 2 received biweekly text messages informing them about the programme's benefits (availability bias) and current adherence rate (social norm).
RESULTS
Caregivers in Intervention 1 had a significantly higher adherence rate than Control (97.3% versus 90.9%) (p = 0.014). Both interventions had a significant effect on participants in their first prophylaxis season (p = 0.031, p = 0.037). Families where the father was employed had a 14.2% higher adherence rate (p = 0.001). Every additional child was associated with a 2.2% decrease in adherence rate (p = 0.02). In control, ICU admission history was associated with an 18.8% lower adherence rate (p = 0.0001), but this association disappeared in intervention groups.
CONCLUSION
This is the first prospective interventional study which, in the context of palivizumab prophylaxis, analyses the effectiveness of nudge interventions based on established cognitive biases by comparing randomly generated intervention and control groups. We found that default bias and implementation intention have significant effects on adherence.Clinical trial, in the name and number "Adherence of palivizumab prophylaxis, NCT05778240" registered retrospectively. https://clinicaltrials.gov/ct2/show/NCT05778240.
PubMed: 38664919
DOI: 10.1017/S1047951124024946 -
JAMA Jun 2024
Topics: Humans; Respiratory Syncytial Virus Infections; Antiviral Agents; Infant; Palivizumab
PubMed: 38814625
DOI: 10.1001/jama.2024.7406 -
European Journal of Pediatrics Jun 2024We aimed to describe differences in the epidemiology, management, and outcomes existing between centers located in countries which differ by geographical location and... (Observational Study)
Observational Study
UNLABELLED
We aimed to describe differences in the epidemiology, management, and outcomes existing between centers located in countries which differ by geographical location and economic status during to post-pandemic bronchiolitis seasons. This was a prospective observational cohort study performed in two academic centers in Latin America (LA) and three in Italy. All consecutive children with a clinical diagnosis of bronchiolitis were included, following the same data collection form. Nine hundred forty-three patients have been enrolled: 275 from the two Latin American Centers (San Jose, 215; Buenos Aires, 60), and 668 from Italy (Rome, 178; Milano, 163; Bologna, 251; Catania, 76). Children in LA had more frequently comorbidities, and only rarely received palivizumab. A higher number of patients in LA had been hospitalized in a ward (64% versus 23.9%, p < 0.001) or in a PICU (16% versus 6.2%, p < 0.001), and children in LA required overall more often respiratory support, from low flow oxygen to invasive mechanical ventilation, except for CPAP which was more used in Italy. There was no significant difference in prescription rates for antibiotics, but a significantly higher number of patients treated with systemic steroids in Italy.
CONCLUSIONS
We found significant differences in the care for children with bronchiolitis in Italy and LA. Reasons behind such differences are unclear and would require further investigations to optimize and homogenize practice all over the world.
WHAT IS KNOWN
• Bronchiolitis is among the commest cause of morbidity and mortality in infants all over the world.
WHAT IS NEW
• There are significant differences on how clinicians care for bronchiolitis in different centers and continents. Differences in care can be principally due to different local practices than differences in patients severity/presentations. • Understanding these differences should be a priority to optime and standardize bronchiolitis care globally.
Topics: Humans; Italy; Prospective Studies; Infant; Male; Female; Bronchiolitis; Latin America; Infant, Newborn; Treatment Outcome; Hospitalization; Child, Preschool; Palivizumab
PubMed: 38554172
DOI: 10.1007/s00431-024-05530-6 -
Pathogens (Basel, Switzerland) Jun 2024Nirsevimab is approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV...
BACKGROUND
Nirsevimab is approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season and in children aged ≤24 months who remain vulnerable to severe RSV disease through their second RSV season. We summarize a pre-specified analysis of nirsevimab safety data from three randomized controlled trials: Phase 2b (NCT02878330; healthy infants born ≥29 to <35 weeks' gestational age [wGA]); Phase 3 MELODY (NCT03979313; healthy infants born ≥35 wGA); and Phase 2/3 MEDLEY (NCT03959488; infants with congenital heart disease [CHD] and/or chronic lung disease of prematurity [CLD] or born ≤35 wGA).
METHODS
Participants (randomized 2:1) received a single intramuscular dose of nirsevimab or comparator (placebo, Phase 2b/MELODY; 5× once-monthly palivizumab, MEDLEY) before their first RSV season (recipients < 5 kg, nirsevimab 50 mg; ≥5 kg, nirsevimab 100 mg). In MEDLEY, children with CHD/CLD continued to a second RSV season: first-season nirsevimab recipients received nirsevimab 200 mg; first-season palivizumab recipients were re-randomized 1:1 to receive nirsevimab 200 mg or 5× once-monthly palivizumab.
RESULTS
The incidence, severity, and nature of AEs were similar across treatments (nirsevimab, = 3184; placebo, = 1284; palivizumab, = 304). Most AEs were mild to moderate in severity, with ≥98% unrelated to treatment. AEs of special interest occurred infrequently (<1%): no anaphylaxis or thrombocytopenia were treatment-related, and no immune complex disease was reported. Deaths (incidence < 1.0%) were all unrelated to treatment.
CONCLUSIONS
A single dose per season of nirsevimab for the prevention of RSV disease had a favorable safety profile, irrespective of wGA or comorbidities.
PubMed: 38921800
DOI: 10.3390/pathogens13060503 -
Tropical Medicine and Infectious Disease Dec 2023Respiratory syncytial virus (RSV) is the most common cause of upper and lower respiratory tract infections in infants and young children. Virus-specific monoclonal...
Respiratory syncytial virus (RSV) is the most common cause of upper and lower respiratory tract infections in infants and young children. Virus-specific monoclonal antibodies (mAbs) can be used for diagnosis, prophylaxis, and research of RSV pathogenesis. A panel of 16 anti-RSV mAbs was obtained from mice immunized by RSV strain Long. Half of them had virus-neutralizing activity. According to Western blot all of these mAbs effectively bound native oligomeric (homodimeric and homotrimeric) forms of the RSV fusion (F) protein. Only five of the mAbs interacted with the monomeric form, and only one of these possessed neutralizing activity. None of these mAbs, nor the commercial humanized neutralizing mAb palivizumab, reacted with the denaturated F protein. Thus, interaction of all these mAbs with F protein had clear conformational dependence. Competitive ELISA and neutralization assays allowed the identification of nine antigenic target sites for the interaction of mAb with the F protein. Five partially overlapping sites may represent a complex spatial structure of one antigenic determinant, including one neutralizing and four non-neutralizing epitopes. Four sites (three neutralizing and one non-neutralizing) were found to be distinct. As a result of virus cultivation RSV-A, strain Long, in the presence of a large amount of one of the neutralizing mAbs, an escape mutant with a substitution, N240S, in the F protein, was obtained. Thus, it was shown for the first time that position 240 is critical for the protective effect of an anti-RSV antibody. To assess the ability of these mAbs to interact with modern RSV strains circulating in St. Petersburg (Russia) between 2014 and 2022, 73 RSV-A and 22 RSV-B isolates were analyzed. Six mAbs were directed to conserved epitopes of the F protein as they interacted most efficiently with both RSV subtypes in a fixed cell-ELISA and could be used for diagnostic assays detecting RSV.
PubMed: 38276631
DOI: 10.3390/tropicalmed9010001 -
Pediatric Pulmonology Apr 2024
Topics: Humans; Infant; United States; Seasons; Antibodies, Monoclonal, Humanized; Palivizumab; Centers for Disease Control and Prevention, U.S.; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human; Antiviral Agents
PubMed: 38240360
DOI: 10.1002/ppul.26841 -
Infection & Chemotherapy Mar 2024We aimed to evaluate the clinical features of respiratory syncytial virus (RSV) infection and risk factors for severe RSV disease among Korean children in 2022/2023. A...
We aimed to evaluate the clinical features of respiratory syncytial virus (RSV) infection and risk factors for severe RSV disease among Korean children in 2022/2023. A total of 235 children were identified, and 84.3% were hospitalized. Patients under 3 months and 2 years of age accounted for 20.9% and 54.5%, respectively. Pneumonia was diagnosed in 40.9% of children and bronchiolitis in 23.8%. Respiratory support and intensive care were required in 43.4% and 7.7% of patients, respectively. nasopharyngeal colonization and the presence of underlying disease showed a significant correlation with severity indicators. The clinical impact of RSV infection was high on infants and toddlers, even those having no underlying disease or not being indicated for palivizumab.
PubMed: 38527782
DOI: 10.3947/ic.2023.0076 -
Hong Kong Medical Journal = Xianggang... Dec 2023
Topics: Child; Humans; Infant; Palivizumab; Cost-Benefit Analysis; Hong Kong; Antiviral Agents; Respiratory Syncytial Virus Infections; Hospitalization
PubMed: 38148655
DOI: No ID Found -
American Family Physician Jun 2024
Topics: Humans; Respiratory Syncytial Virus Infections; Antiviral Agents; Antibodies, Monoclonal, Humanized; Infant; Palivizumab; Viral Vaccines; Respiratory Syncytial Virus Vaccines
PubMed: 38905561
DOI: No ID Found