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The respiratory syncytial virus (RSV) is responsible for a great deal of lower respiratory tract infections in infants, which result in hospitalizations and death in extreme cases. Almost all children have been infected by the time they turn two years old, but the most vulnerable to developing medical complications are preemies and infants with congenital heart diseases. Understanding the function of RSV F (fusion) protein turned out to be crucial in developing immunoprophylactic drugs, such as Palivizumab and Nirsevimab. Due to limited options of treatment, the search for optimal prophylactic strategy is expanding. This includes monoclonal antibodies and mRNA vaccines. Bringing attention to these methods of treatment will help expand the knowledge of healthcare providers, especially pediatricians and general practitioners. [ABSTRACT FROM AUTHOR]

The respiratory syncytial virus (RSV) is responsible for a great deal of lower respiratory tract infections in infants, which result in hospitalizations and death in extreme cases. Almost all children have been infected by the time they turn two years old, but the most vulnerable to developing medical complications are preemies and infants with congenital heart diseases. Understanding the function of RSV F (fusion) protein turned out to be crucial in developing immunoprophylactic drugs, such as Palivizumab and Nirsevimab. Due to limited options of treatment, the search for optimal prophylactic strategy is expanding. This includes monoclonal antibodies and mRNA vaccines. Bringing attention to these methods of treatment will help expand the knowledge of healthcare providers, especially pediatricians and general practitioners.

Respiratory Syncytial Virus (RSV) poses a severe threat to infants, particularly preterm infants. Palivizumab, the standard preventive prophylaxis, is primarily utilized in high-risk newborns due to its cost. This study assessed palivizumab's effectiveness in preventing RSV infections in predominantly very preterm infants during their first year of life. Serum samples from a prospective multicentre cohort study in the Netherlands were analyzed to assess RSV infection rates by measuring IgG levels against three RSV proteins: nucleoprotein, pre-fusion, and post-fusion protein. Infants were stratified based on gestational age (GA), distinguishing very preterm (≤32 weeks GA) from moderate/late preterm (>32 to ≤36 weeks GA). In very preterm infants, palivizumab prophylaxis significantly reduced infection rates (18.9% vs. 48.3% in the prophylaxis vs. non-prophylaxis group. Accounting for GA, sex, birth season, and birth weight, the prophylaxis group showed significantly lower infection odds. In infants with >32 to ≤36 weeks GA, the non-prophylaxis group (55.4%) showed infection rates similar to the non-prophylaxis ≤32-week GA group, despite higher maternal antibody levels in the moderate/late preterm infants. In conclusion, palivizumab prophylaxis significantly reduces RSV infection rates in very premature infants. Future research should explore clinical implications and reasons for non-compliance, and compare palivizumab with emerging prophylactics like nirsevimab aiming to optimize RSV prophylaxis and improve preterm infant outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background In children with congenital heart disease (CHD) respiratory syncytial virus (RSV) infection may have a severe course, with increased risk of morbidity and mortality, requiring hospital admission and intensive care. The aim of the present study was to evaluate the effect of prophylaxis with palivizumab in preventing RSV-associated hospitalization in infants with CHD. Methods We carried out an observational, retrospective study in a paediatric cardiology division at a secondary-care centre in Italy, extracting from the database children with CHD who, from November 2004 to March 2022, matched the criteria for palivizumab prophylaxis, to evaluate the hospitalization rate in CHD patients with and without palivizumab prophylaxis and their RSV-related hospitalization characteristics compared with a group of children without CHD and no other underlying clinical conditions (control group, CG), hospitalized for RSV infection. Results One hundred twenty-eight children with CHD were enrolled in the study, mainly (71.9%) with increased pulmonary flow, and received palivizumab prophylaxis. Twenty-seven received hospital care for bronchiolitis. Almost all CHD patients hospitalized for bronchiolitis (26 out of 27) received partial prophylaxis (≤ 3 doses). CHD patients with bronchiolitis stay longer in the hospital than control (14.4 ± 21.7 days vs 6.2 ± 2.3 days) some of which require intensive care (n = 4). Conclusions Our study provides evidence of the efficacy of palivizumab in protecting patients with hemodynamically significant CHD under the age of 2 years from RSV disease and its life-threatening complications. Reducing hospitalisation rate, morbidity, and mortality in this category of patients, passive immune prophylaxis with palivizumab may impact healthcare resource availability and utilisation.

Respiratory Syncytial Virus (RSV) poses a severe threat to infants, particularly preterm infants. Palivizumab, the standard preventive prophylaxis, is primarily utilized in high-risk newborns due to its cost. This study assessed palivizumab’s effectiveness in preventing RSV infections in predominantly very preterm infants during their first year of life. Serum samples from a prospective multicentre cohort study in the Netherlands were analyzed to assess RSV infection rates by measuring IgG levels against three RSV proteins: nucleoprotein, pre-fusion, and post-fusion protein. Infants were stratified based on gestational age (GA), distinguishing very preterm (≤32 weeks GA) from moderate/late preterm (>32 to ≤36 weeks GA). In very preterm infants, palivizumab prophylaxis significantly reduced infection rates (18.9% vs. 48.3% in the prophylaxis vs. non-prophylaxis group. Accounting for GA, sex, birth season, and birth weight, the prophylaxis group showed significantly lower infection odds. In infants with >32 to ≤36 weeks GA, the non-prophylaxis group (55.4%) showed infection rates similar to the non-prophylaxis ≤32-week GA group, despite higher maternal antibody levels in the moderate/late preterm infants. In conclusion, palivizumab prophylaxis significantly reduces RSV infection rates in very premature infants. Future research should explore clinical implications and reasons for non-compliance, and compare palivizumab with emerging prophylactics like nirsevimab aiming to optimize RSV prophylaxis and improve preterm infant outcomes.

Background: In children with congenital heart disease (CHD) respiratory syncytial virus (RSV) infection may have a severe course, with increased risk of morbidity and mortality, requiring hospital admission and intensive care. The aim of the present study was to evaluate the effect of prophylaxis with palivizumab in preventing RSV-associated hospitalization in infants with CHD. Methods: We carried out an observational, retrospective study in a paediatric cardiology division at a secondary-care centre in Italy, extracting from the database children with CHD who, from November 2004 to March 2022, matched the criteria for palivizumab prophylaxis, to evaluate the hospitalization rate in CHD patients with and without palivizumab prophylaxis and their RSV-related hospitalization characteristics compared with a group of children without CHD and no other underlying clinical conditions (control group, CG), hospitalized for RSV infection. Results: One hundred twenty-eight children with CHD were enrolled in the study, mainly (71.9%) with increased pulmonary flow, and received palivizumab prophylaxis. Twenty-seven received hospital care for bronchiolitis. Almost all CHD patients hospitalized for bronchiolitis (26 out of 27) received partial prophylaxis (≤ 3 doses). CHD patients with bronchiolitis stay longer in the hospital than control (14.4 ± 21.7 days vs 6.2 ± 2.3 days) some of which require intensive care (n = 4). Conclusions: Our study provides evidence of the efficacy of palivizumab in protecting patients with hemodynamically significant CHD under the age of 2 years from RSV disease and its life-threatening complications. Reducing hospitalisation rate, morbidity, and mortality in this category of patients, passive immune prophylaxis with palivizumab may impact healthcare resource availability and utilisation. [ABSTRACT FROM AUTHOR]

The objective of this study was to evaluate the impact of palivizumab prophylaxis on respiratory syncytial virus (RSV) hospitalizations among children with hemodynamically significant congenital heart disease (CHD). In 2003, the American Academy of Pediatrics (AAP) revised the bronchiolitis policy statement and recommended the use of palivizumab in children

It is controversial whether it is cost-beneficial for late preterm infants to receive respiratory syncytial virus prophylaxis. This study compares community and hospital health care resource utilization (HCRU) of late premature infants (33-36 weeks gestational age) with term infants (>36 weeks gestational age) hospitalized with bronchiolitis. This was a retrospective, population-based, observational study spanning a 9-year period (2004-2012). HCRU data were obtained from the Health Maintenance Organization "Clalit" and included duration of hospitalization, physician visits, laboratory tests, and treatments. Compared with term infants, late preterm infants had significantly longer duration of hospitalization and higher admission rates to pediatric intensive care unit. They also had higher rates of mean outpatients clinic visits, total outpatient clinic and specialist visits, blood chemistry, and virology testing. HCRU of term infants with bronchiolitis was also substantial, indicating that they also can greatly benefit from respiratory syncytial virus prophylaxis. These findings can guide stakeholders in decisions concerning the prevention of bronchiolitis and will be useful in performing further cost-benefit analysis. [ABSTRACT FROM AUTHOR]

Background Several countries, including France, have restricted the indications for monoclonal antibodies directed against respiratory syncytial virus (RSV) compared to the marketing authorization (MA). No new data concerning use of palivizumab on a national scale have been published since the 2007 update of the national guidelines. Objectives To describe palivizumab administration for RSV prophylaxis during the first RSV season in infants born prematurely in France in 2011. Methods Infants from the national population-based cohort EPIPAGE-2 born at ≤ 34 weeks’ gestation, discharged home before 31 March 2012 and followed-up at 1 year were included. The RSV season ran from 1 October 2011 to 31 March 2012. Prophylaxis was deemed “initiated” if the infant had received at least one dose of palivizumab during this period and “complete” if it had received at least five doses or as many doses as the number of exposed months. The reference documents were the MA and French Transparency Committee guidelines (TC). Results Prophylaxis was indicated in 3586 of 3608 infants (99.7%) according to the MA and 1315 of 3608 (16.7%) according to the TC. A total of 1906 infants (26.6%) received at least one dose of palivizumab. The overall rate of conformity with TC indications was 85%, but was lower for infants born at 27–32 weeks’ gestation. The rate of complete prophylaxis was 77.2%. The factors associated with prophylaxis initiation were low gestational age, low birthweight, high maternal educational level, type of neonatal unit, and date at discharge. Factors associated with complete prophylaxis were respiratory impairment, high educational level, and characteristics related to living conditions (absence of siblings at home, type of childcare). Conclusions Palivizumab administration in France generally conformed with TC guidelines, but could be further improved for infants born at 27–32 weeks’ gestation without bronchopulmonary dysplasia. [ABSTRACT FROM AUTHOR]

Respiratory Syncytial Virus (RSV) is a very frequent cause of respiratory infections in the first two years of life. Symptoms of­ten are mild to moderate, but in some high-risk categories of infants, particularly prematures and children with bronchopulmonary dysplasia or congenital heart disease, RSV can cause severe lower respiratory tract infections with need of hospitalisation, and, sometimes, even death. No effective treatment is available, and specific vaccines, despite several attempts during the last decades, do not exist. Palivizumab is a humanised monoclonal antibody targeting specific viral mechanisms controlling infection. If administered intramuscularly monthly during the RSV season as prophylaxis to high risk patients < 2 years of age, this antibody effectively reduces hospitalisation rates and severity of RSV infection. Based on the data from the two main phase III trials conducted so far, palivizumab prophylaxis results in 45% to 55% reduction of hospitalisation rate, with a very satisfactory profile of tolerability as most commonly reported adverse events where transient and mild irritability, diar­rhoea or fever.

Background: Palivizumab is indicated for respiratory syncytial virus (RSV) prophylaxis in high-risk children. Methods: Observational study, based on 4 sites in Bosnia and Herzegovina (B&H), with institutional reports of infants at high risk for RSV who received at least 1 dose of palivizumab during the 2008-2013 RSV seasons. Results: Across 6 RSV seasons, from 2008/9 to 2013/14, 589 infants were enrolled (0.29% of livebirths population). Of all infants, 290 (49.2%) were enrolled for prematurity only, 82 (13.9%) for bronchopulmonary dysplasia/chronic lung disease (BPD/CLD), 201 (34.1%) for congenital heart disease (CHD), and 13 (2.2%) for other reasons; 365 (61.9%) infants in total were born before 33 weeks. Average gestational age of preterm infants enrolled for prematurity only was 30.2 ± 3.2 weeks; for preterm infants with BPD/CLD it was 28.3 ± 3.7 weeks. Overall average of palivizumab injections was 4.1 ± 1.0. Hospitalization rate related to severe lower respiratory infections (LRI) during the period of protection by palivizumab was 1.2%. Respiratory infections which deserved medical attention were observed in 3.7% infants included in palivizumab prophylaxis. Conclusion: RSV prophylaxis in B&H is provided systematically and successfully, following the national guidance established in 2009, with the aim of achieving a good cost-benefit ratio, with very low hospitalization rate for severe LRI in prophylaxed infants. New randomized controlled trials (RCTs) and American Academy of Pediatrics (AAP) guidance revised in 2014 will be taken into account in establishing a new national recommendation.

The authors comment on whether the results of the sufficient clinical significance of respiratory syncytial virus (RSV) palivizumab prophylaxis justify the cost of the expensive intervention. They argue that cost should not be the sole determinant of any intervention and that assessments of quality of life, though difficult to measure, must be considered. They believe that a physician is obliged to act as a patient advocate and to make decisions that offers maximum benefit to patients.

Abstract: Respiratory syncytial virus (RSV) is a common disease in pediatrics. Certain subpopulations of children are at greatest risk for serious disease. However, previously healthy children also may become critically ill. In the clinic or the intensive care unit, children with RSV pose the challenge of how to treat a disease when evidence to support therapeutic options is severely limited. Prophylaxis is an option for certain children, although many do not qualify. RSV has been implicated in continued wheezing and the subsequent development of asthma. While evidence for this implication is still being sought, researchers are working on finding new ways to treat and prevent RSV. [Copyright &y& Elsevier]

Background: Respiratory syncytial virus (RSV) specific immune globulin is now being marketed for prevention of RSV infection in ex-preterm infants. However, there are no published UK data on the morbidity or mortality from RSV in these infants.Aims: To determine the morbidity and mortality from RSV infection in a cohort of infants previously treated at a regional neonatal unit, and compare the cost of hospitalisation for RSV with the potential cost of administering RSV immune globulin (RSV-IG) prophylaxis.Methods: Infants born at a gestation of less than 32 weeks were studied. Details of admissions for respiratory illness in the first two years of life were collected from hospital records, referring hospitals, and general practitioners.Results: Data on 82 infants were collected. Up to three RSV seasons were encountered. The hospitalisation rate for confirmed RSV infection for the first season encountered was 4%. Rates of ward and paediatric intensive care unit admission were higher for infants with chronic lung disease. There were no deaths from RSV. RSV-IG would not have been cost effective for most infants.Conclusion: The morbidity and mortality rates from RSV observed in this group do not support the widespread introduction of RSV-IG prophylaxis for ex-preterm infants. [ABSTRACT FROM AUTHOR]

The aim was to compare incidences of respiratory syncytial virus (RSV) bronchiolitis in late preterm vs. term infants (33–36 vs. >36 weeks of gestational age (WGA)). This was a population-based retrospective study including all infants <12 months hospitalized at Soroka medical centre with bronchiolitis between 2004 and 2012. Infants with comorbidities were excluded. RSV bronchiolitis rates were calculated by extrapolating the proportion of positive tests among tested infants. Population denominator for incidence rates was calculated from hospital records. During the study, 374 late preterm and 2948 term infants were hospitalized with bronchiolitis. Out of 229 (61.2%) late preterm infants and 1738 (59%) term infants tested for RSV, 164 (71.6%) and 1266 (72.8%) were positive for RSV respectively. The mean yearly incidences per 1000 children of RSV bronchiolitis hospitalizations of late preterm and term infants were 35.8 ± 13.0 and 19.6 ± 4.1 respectively (p 0.009). During RSV seasons the mean incidence rate ratio between groups was 1.82 (95% CI 1.60–2.08). Duration of hospitalization was 4.8 ± 7.0 and 3.9 ± 4.9 in late preterm and term infants, respectively (p 0.003). Late preterm-born infants (33–36 WGA) had a higher rate of hospitalization for overall and RSV bronchiolitis during the first year of life compared to those born at term. [ABSTRACT FROM AUTHOR]