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Journal of Mother and Child Mar 2022The aim of this research is to determine the specific characteristics of the immunized children during a 15-year period and the readmissions to hospital due to potential...
AIM
The aim of this research is to determine the specific characteristics of the immunized children during a 15-year period and the readmissions to hospital due to potential infections of the respiratory tract.
MATERIAL AND METHODS
This retrospective cohort study was conducted in the period from October 2008 to March 2022. The test group consists of 222 infants who met the strict criteria for immunization.
RESULTS
The study observed 222 infants who were immunized with palivizumab during the 14-year period. 124 (55.9%) infants were preterm (< 32 weeks) and 69 (31.1%) were infants with congenital heart defects, whereas 29 (13.1%) exhibited other individual risk factors. 38 (17.1%) were re-admitted to the pulmonary ward. Upon re-admission, a quick test to diagnose for RSV infections was conducted and only one infant tested positive.
RESULTS
The conclusion of our 14-year study is that palivizumab prophylaxis has truly proven itself effective for infants at risk in our region during the research time period. Over the years, the immunization season has not changed and the number of doses hasremained the same, as have the indications for immunization. What has changed, however, is an increase in the number of immunized infants without a significant increase in the number of re-admissions to hospital on account of respiratory disorders.
Topics: Infant, Newborn; Humans; Child; Palivizumab; Antiviral Agents; Retrospective Studies; Respiratory Syncytial Virus Infections; Immunization
PubMed: 36811495
DOI: 10.34763/jmotherandchild.20222601.d-22-00049 -
Human Vaccines & Immunotherapeutics Sep 2017Respiratory syncytial virus (RSV) accounts for about 20% of all respiratory infections in children below the age of 5 y. It is associated with up to 63% of all acute... (Review)
Review
Respiratory syncytial virus (RSV) accounts for about 20% of all respiratory infections in children below the age of 5 y. It is associated with up to 63% of all acute respiratory infections and up to 81% of all viral lower respiratory tract infections causing hospitalization in infants and young children. RSV leads to seasonal epidemics between November and April in the northern hemisphere. Most severe infections (RSV accounts for 50 to 80% of all cause bronchiolitis) affect infants younger than 6 months of age and high-risk infants including those born preterm with or without bronchopulmonary dysplasia and those with hemodynamically significant congenital heart disease up to an age of 24 months. Palivizumab, a highly potent RSV-neutralizing monoclonal antibody (Mab), has been licensed in 1998 for prophylactic use to prevent RSV associated hospitalizations in high-risk infants. This Mab is given by monthly intramuscular injection at a dose of 15 mg/kg over the RSV season (up to 5 times). Palivizumab proved to be safe and well-tolerated in this population. Concerns have been raised regarding cost-effectiveness of palivizumab and thus, palivizumab prophylaxis is mainly limited to selected high-risk infants for the first RSV season. Long-lasting Mabs will be the next future approach in the prophylaxis of RSV hospitalization until a vaccine is developed.
Topics: Antiviral Agents; Cost-Benefit Analysis; Female; Hospitalization; Humans; Infant; Infant, Newborn; Male; Palivizumab; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human; Risk Factors
PubMed: 28605249
DOI: 10.1080/21645515.2017.1337614 -
JAMA Pediatrics Apr 2015Infection with the respiratory syncytial virus (RSV) is the leading cause of hospitalizations in children, accounting for more than 90,000 hospitalizations every year in...
IMPORTANCE
Infection with the respiratory syncytial virus (RSV) is the leading cause of hospitalizations in children, accounting for more than 90,000 hospitalizations every year in the United States. For children who are at risk for severe RSV infections, the American Academy of Pediatrics recommends immunoprophylaxis with a series of up to 5 injections of the antibody palivizumab administered monthly, beginning on November 1 of each year. However, many practitioners initiate injections at the onset of RSV season as indicated by local surveillance.
OBJECTIVES
To evaluate the effectiveness of current regimens for palivizumab injections across different cities and to design an optimized regimen.
DESIGN, SETTING, AND PARTICIPANTS
We performed a mathematical modeling study of the risk for hospitalization due to RSV infection. The model accounted for the pharmacokinetics of the antibody, the timing of the injections, and seasonal patterns of RSV, including geographic and year-to-year variability. We used the model to estimate the efficacy of current regimens, including the American Academy of Pediatrics recommendation, and to design a more effective injection regimen, the optimized fixed start (OFS), which uses city-specific initiation dates. Participants were the approximately 700,000 individuals who had specimens tested for RSV by National Respiratory and Enteric Virus Surveillance System laboratories in 18 US cities from July 1, 1994, through June 30, 2011 (a total of 725,741 tests).
INTERVENTIONS
Different palivizumab injection regimens.
MAIN OUTCOMES AND MEASURES
The primary outcome measure was reduction in hospitalizations due to RSV infections. The secondary measures were cost (number of palivizumab doses) and duration of protection (in days).
RESULTS
The American Academy of Pediatrics-recommended 5-injection regimen is expected to reduce hospitalization risk by a median of 2.7% (range, -2.2% to 6.1%) compared with the conventional regimen based on RSV surveillance. The 5-injection OFS regimen is expected to further reduce risk by a median of 6.8% (range, 4.9% to 14.8%), and the 4-injection OFS regimen is expected to achieve efficacy comparable to that of the conventional 5-injection regimen while reducing costs by 20%.
CONCLUSIONS AND RELEVANCE
Modified palivizumab regimens can improve protection for children at risk for severe outcomes of RSV infection and thereby lower rates of hospitalization due to RSV.
Topics: Antibodies, Monoclonal, Humanized; Antibodies, Viral; Antiviral Agents; Child, Preschool; Drug Costs; Hospitalization; Humans; Immunization Schedule; Infant; Infant, Premature; Models, Theoretical; Palivizumab; Population Surveillance; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses; United States
PubMed: 25706618
DOI: 10.1001/jamapediatrics.2014.3804 -
Medicine Nov 2021Respiratory syncytial virus (RSV) infection is an important cause of hospitalization in infants and young children. Monthly administration of palivizumab during the RSV... (Observational Study)
Observational Study
Respiratory syncytial virus (RSV) infection is an important cause of hospitalization in infants and young children. Monthly administration of palivizumab during the RSV season is effective in preventing severe infections in children with comorbidities. However, determining the onset of the RSV season for starting palivizumab is often challenging. The present study aimed to evaluate the ideal timing to start palivizumab and its effect on hospitalization in the real world.We performed a retrospective, observational study to identify the relationship between the timing of the first dose of palivizumab administration and RSV-related hospitalization. Medical records from 2015 to 2019 were reviewed. We included patients who had indications for palivizumab as of July 1 in each year. We counted the proportion of children receiving palivizumab and the number of RSV infection-related hospitalizations each month. We also evaluated the differences in background and underlying disease between children with and without hospitalization.A total of 498 patients were included, and 105 (21.0%) completed the first dose in July when the RSV season usually begins in Japan. Twenty-three (4.6%) patients were hospitalized for RSV infection during the observation period, with 13 (56.5%) hospitalizations before their first dose of palivizumab. The remaining 10 patients were hospitalized after receiving 1 or more doses of palivizumab. Children living with siblings and children with cyanosis originating from congenital heart disease had a higher risk of RSV with odds ratios of 5.1 (95% confidence interval 1.48-17.6, P < .01) and 3.3 (95% confidence interval 1.33-7.94, P < .01), respectively.Delays in administering palivizumab at the beginning of the season increases the rate of RSV infection-related hospitalization. To maximize prophylactic effectiveness, administering the first dose as early as possible in the RSV season is crucial, with priority for cyanotic children or those with siblings.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antiviral Agents; Child; Child, Preschool; Female; Hospitalization; Humans; Infant; Male; Palivizumab; Respiratory Syncytial Virus Infections; Retrospective Studies; Treatment Outcome
PubMed: 34964779
DOI: 10.1097/MD.0000000000027952 -
Molecular Medicine (Cambridge, Mass.) Apr 2020Human respiratory syncytial virus (hRSV) is the most important etiological agent causing hospitalizations associated with respiratory diseases in children under 5 years... (Review)
Review
Human respiratory syncytial virus (hRSV) is the most important etiological agent causing hospitalizations associated with respiratory diseases in children under 5 years of age as well as the elderly, newborns and premature children are the most affected populations. This viral infection can be associated with various symptoms, such as fever, coughing, wheezing, and even pneumonia and bronchiolitis. Due to its severe symptoms, the need for mechanical ventilation is not uncommon in clinical practice. Additionally, alterations in the central nervous system -such as seizures, encephalopathy and encephalitis- have been associated with cases of hRSV-infections. Furthermore, the absence of effective vaccines or therapies against hRSV leads to elevated expenditures by the public health system and increased mortality rates for the high-risk population. Along these lines, vaccines and therapies can elicit different responses to this virus. While hRSV vaccine candidates seek to promote an active immune response associated with the achievement of immunological memory, other therapies -such as the administration of antibodies- provide a protective environment, although they do not trigger the activation of the immune system and therefore do not promote an immunological memory. An interesting approach to vaccination is the use of virus-neutralizing antibodies, which inhibit the entry of the pathogen into the host cells, therefore impairing the capacity of the virus to replicate. Currently, the most common molecule targeted for antibody design against hRSV is the F protein of this virus. However, other molecular components of the virus -such as the G or the N hRSV proteins- have also been explored as potential targets for the control of this disease. Currently, palivizumab is the only monoclonal antibody approved for human use. However, studies in humans have shown a protective effect only after the administration of at least 3 to 5 doses, due to the stability of this vaccine. Furthermore, other studies suggest that palivizumab only has an effectiveness close to 50% in high-risk infants. In this work, we will review different strategies addressed for the use of antibodies in a prophylactic or therapeutic context and their ability to prevent the symptoms caused by hRSV infection of the airways, as well as in other tissues such as the CNS.
Topics: Antibodies, Monoclonal; Drug Development; Humans; Immunization Programs; Immunization, Passive; Immunoglobulin A, Secretory; Immunoglobulin G; Premedication; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human
PubMed: 32303184
DOI: 10.1186/s10020-020-00162-6 -
Journal of Medical Economics Dec 2020Respiratory syncytial virus (RSV) is a common cause of respiratory infection in infants and severe infection can result in hospitalization. The passive immunization,... (Review)
Review
AIMS
Respiratory syncytial virus (RSV) is a common cause of respiratory infection in infants and severe infection can result in hospitalization. The passive immunization, palivizumab, is used as prophylaxis against RSV, however, use in the UK is restricted to populations at high risk of hospitalization. This study assesses the cost-effectiveness (CE) of palivizumab in premature infants with and without risk factors for hospitalization (congenital heart disease [CHD], bronchopulmonary dysplasia [BPD]).
METHODS
A decision tree model, based on earlier CE analyses, was updated using data derived from targeted literature reviews and advice gained from a Round Table meeting. All costs were updated to 2019 prices. One-way and probabilistic sensitivity analyses were performed to assess the degree of uncertainty surrounding the results.
RESULTS
Palivizumab is dominant (i.e. clinically superior and cost saving) when used in premature infants born ≤35 weeks gestational age (wGA) without CHD or BPD and aged <6 months at the start of the RSV season, infants aged <24 months with CHD and infants aged <24 months requiring treatment for BPD within the last 6 months.
LIMITATIONS
One-way sensitivity analysis suggests that these results are highly sensitive to the efficacy of prophylaxis, number of doses, impact of long-term respiratory sequalae, rate of hospitalization and mortality due to RSV. A conservative approach has been taken toward long-term respiratory sequalae due to uncertainty around epidemiology and etiology and a lack of recent cost and utility data.
CONCLUSIONS
Palivizumab prophylaxis is cost-effective in preventing severe RSV infection requiring hospital admission in a wider population than currently recommended in UK guidelines. Prophylaxis in premature infants born <29 wGA, 29-32 wGA and 33-35 wGA without CHD or BPD aged <6 months at the start of the RSV season is not funded under current guidance, however, prophylaxis has been demonstrated to be cost-effective in this analysis.
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antiviral Agents; Cost-Benefit Analysis; Hospitalization; Humans; Infant; Infant, Newborn; Palivizumab; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses; United Kingdom
PubMed: 33107769
DOI: 10.1080/13696998.2020.1836923 -
Journal of Perinatology : Official... Jul 2021To compare medications dispensed during the first 2 years in children born preterm and full-term.
OBJECTIVE
To compare medications dispensed during the first 2 years in children born preterm and full-term.
STUDY DESIGN
Retrospective analysis of claims data from a commercial national managed care plan 2008-2019. 329,855 beneficiaries were enrolled from birth through 2 years, of which 25,408 (7.7%) were preterm (<37 weeks). Filled prescription claims and paid amount over 2 years were identified.
RESULTS
In preterm children, the number of filled prescriptions was 1.4 times and cost was 3.8 times that of full-term children. Number and cost of medications were inversely related to gestational age. Differences peak at 4-9 months and resolve by 19 months after discharge. Palivizumab, ranitidine, albuterol, lansoprazole, budesonide, and prednisolone had the greatest differences in utilization.
CONCLUSION
Prescription medication utilization among preterm children under 2 years is driven by palivizumab, anti-reflux, and respiratory medications, despite little evidence regarding efficacy for many medications and concern for harm with certain classes.
Topics: Child; Gestational Age; Humans; Infant; Infant, Newborn; Retrospective Studies
PubMed: 33547407
DOI: 10.1038/s41372-021-00930-0 -
Frontiers in Pharmacology 2020Current prevention and/or treatment options for respiratory syncytial virus (RSV) infections are limited as no vaccine is available. Prophylaxis with palivizumab is very...
OBJECTIVE
Current prevention and/or treatment options for respiratory syncytial virus (RSV) infections are limited as no vaccine is available. Prophylaxis with palivizumab is very expensive and requires multiple intramuscular injections over the RSV season. Here we present proof-of-concept data using nebulized palivizumab delivery as a promising new approach for the prevention or treatment of severe RSV infections, documenting both aerosol characteristics and pulmonary deposition patterns in the lungs of lambs.
DESIGN
Prospective animal study.
SETTING
Biosecurity Control Level 2-designated large animal research facility at the Murdoch Children's Research Institute, Melbourne, Australia.
SUBJECTS
Four weaned Border-Leicester/Suffolk lambs at 5 months of age.
INTERVENTIONS
Four lambs were administered aerosolized palivizumab conjugated to Tc-99m, under gaseous anesthesia, using either the commercially available AeroNeb Go or the investigational HYDRA device, placed in-line with the inspiratory limb of a breathing circuit. Lambs were scanned in a single-photon emission computed tomography (SPECT/CT) scanner in the supine position during the administration procedure.
MEASUREMENTS AND MAIN RESULTS
Both the HYDRA and AeroNeb Go produced palivizumab aerosols in the 1-5 µm range with similar median (geometric standard deviation and range) aerosol droplet diameters for the HYDRA device (1.84 ± 1.40 μm, range = 0.54-5.41μm) and the AeroNeb Go (3.07 ± 1.56 μm, range = 0.86-10 μm). Aerosolized palivizumab was delivered to the lungs at 88.79-94.13% of the total aerosolized amount for all lambs, with a small proportion localized to either the trachea or stomach. No difference between devices were found. Pulmonary deposition ranged from 6.57 to 9.25% of the total dose of palivizumab loaded in the devices, mostly in the central right lung.
CONCLUSIONS
Aerosolized palivizumab deposition patterns were similar in all lambs, suggesting a promising approach in the control of severe RSV lung infections.
PubMed: 32973520
DOI: 10.3389/fphar.2020.01291 -
Scientific Reports Aug 2021Respiratory syncytial virus (RSV) infection is a common cause of hospitalisation in infants and the elderly. Palivizumab prophylaxis is the only approved treatment...
Respiratory syncytial virus (RSV) infection is a common cause of hospitalisation in infants and the elderly. Palivizumab prophylaxis is the only approved treatment modality but is costly and only offered to select vulnerable populations. Here, we investigated gene delivery approaches via recombinant adeno-associated virus (rAAV2/8) and simian immunodeficiency virus (rSIV.F/HN) vectors to achieve sustained in vivo production of palivizumab in a murine model. Delivery of palivizumab-expressing vectors 28 days prior to RSV challenge resulted in complete protection from RSV-induced weight loss. This approach offers prophylaxis against RSV infection, allowing for wider use and reduction in treatment costs in vulnerable populations.
Topics: Animals; Antibodies, Monoclonal, Humanized; Dependovirus; Disease Models, Animal; Female; Gene Expression; Gene Transfer Techniques; Genetic Engineering; Genetic Therapy; Genetic Vectors; Injections, Intramuscular; Lentivirus; Mice; Palivizumab; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses; Transduction, Genetic; Treatment Outcome
PubMed: 34344952
DOI: 10.1038/s41598-021-95150-z -
Blood Mar 2011Respiratory syncytial virus (RSV) is a common cause of seasonal respiratory viral infection in patients who have undergone hematopoietic stem cell transplantation. RSV... (Review)
Review
Respiratory syncytial virus (RSV) is a common cause of seasonal respiratory viral infection in patients who have undergone hematopoietic stem cell transplantation. RSV usually presents as an upper respiratory tract infection in this patient population but may progress rapidly to lower respiratory tract infection. Available therapies that have been used for the treatment of RSV infections are limited to ribavirin, intravenous immunoglobulin, and palivizumab. The use of aerosolized ribavirin, alone or in combination with either palivizumab or intravenous immunoglobulin, remains controversial. In this comprehensive review, we present and discuss the available literature on management of RSV infections in adult hematopoietic stem cell transplantation recipients with a focus on therapeutic modalities and outcomes.
Topics: Adult; Animals; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antiviral Agents; Clinical Trials as Topic; Hematopoietic Stem Cell Transplantation; Humans; Immunocompromised Host; Immunoglobulins, Intravenous; Palivizumab; Respiratory Syncytial Virus Infections; Ribavirin
PubMed: 21139081
DOI: 10.1182/blood-2010-08-263400