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Tidsskrift For Den Norske Laegeforening... Sep 2000
Topics: Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antiviral Agents; Drug Costs; Humans; Palivizumab; Randomized Controlled Trials as Topic; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses
PubMed: 11070982
DOI: No ID Found -
The Cochrane Database of Systematic... Jul 2016Respiratory syncytial virus infection causes acute lung infection in infants and young children worldwide, resulting in considerable morbidity and mortality. Children... (Review)
Review
BACKGROUND
Respiratory syncytial virus infection causes acute lung infection in infants and young children worldwide, resulting in considerable morbidity and mortality. Children with cystic fibrosis are prone to recurrent lung inflammation, bacterial colonisation and subsequent chronic airway disease, putting them at risk for severe respiratory syncytial virus infections requiring intensive care and respiratory support. No treatment currently exists, hence prevention is important. Palivizumab is effective in reducing respiratory syncytial virus hospitalisation rates and is recommended for prophylaxis in high-risk children with other conditions. It is unclear if palivizumab can prevent respiratory syncytial virus hospitalisations and intensive care unit admissions in children with cystic fibrosis. This is an update of a previously published review.
OBJECTIVES
To determine the efficacy and safety of palivizumab (Synagis(®)) compared with placebo, no prophylaxis or other prophylaxis, in preventing hospitalisation and mortality from respiratory syncytial virus infection in children with cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register and scanned references of the eligible study and related reviews.Date of last search: 05 May 2016.
SELECTION CRITERIA
Randomised and quasi-randomised studies.
DATA COLLECTION AND ANALYSIS
The authors independently extracted data and assessed risk of bias.
MAIN RESULTS
One study (186 infants up to two years old) comparing five monthly doses of palivizumab (N = 92) to placebo (N = 94) over one respiratory syncytial virus season was identified and met our inclusion criteria. We judged there to be a low risk of bias with respect to the concealment of the randomization schedule (although it was not clear how this was generated) and to blinding of participants and study personnel. There is also a low risk of bias with regards to incomplete outcome data. However, we judged there to be a high risk of bias from selective reporting (summary statements presented but no data) and the fact that this industry-supported study has not been published as a full report in a peer-reviewed journal.At six months follow-up, one participant in each group was hospitalised due to respiratory syncytial virus; there were no deaths in either group. In the palivizumab and placebo groups, 86 and 90 children experienced any adverse event, while five and four children had related adverse events respectively. Nineteeen children receiving palivizumab and 16 receiving placebo suffered serious adverse events; one participant receiving palivizumab discontinued due to this. At 12 months follow-up, there were no significant differences between groups in number of Pseudomonas bacterial colonisations or change in weight-to-height ratio.
AUTHORS' CONCLUSIONS
We identified one randomised controlled trial comparing five monthly doses of palivizumab to placebo in infants up to two years old with cystic fibrosis. While the overall incidence of adverse events was similar in both groups, it is not possible to draw firm conclusions on the safety and tolerability of respiratory syncytial virus prophylaxis with palivizumab in infants with cystic fibrosis. Six months after treatment, the authors reported no clinically meaningful differences in outcomes. Additional randomised studies are needed to establish the safety and efficacy of palivizumab in children with cystic fibrosis.
Topics: Antiviral Agents; Cystic Fibrosis; Drug Administration Schedule; Humans; Infant; Palivizumab; Pseudomonas Infections; Pseudomonas aeruginosa; Randomized Controlled Trials as Topic; Respiratory Syncytial Virus Infections
PubMed: 27439110
DOI: 10.1002/14651858.CD007743.pub6 -
The Pediatric Infectious Disease Journal Jul 2016Studies have explored the risk for and impact of respiratory syncytial virus (RSV) infection requiring hospitalization among healthy preterm infants born at 29-35 weeks... (Review)
Review
BACKGROUND
Studies have explored the risk for and impact of respiratory syncytial virus (RSV) infection requiring hospitalization among healthy preterm infants born at 29-35 weeks of gestational age not given RSV immunoprophylaxis. We performed a systematic review and qualitative synthesis of these studies.
METHODS
Two experienced reviewers used prespecified inclusion/exclusion criteria to screen titles/abstracts and full-text studies using MEDLINE, Embase, BIOSIS and Cochrane Library (January 1, 1985, to November 6, 2014). We abstracted data on risk factors for RSV hospitalization, incidence and short- and long-term outcomes of RSV hospitalization. Using standard procedures, we assessed study risk of bias and graded strength of evidence (SOE).
RESULTS
We identified 4754 records and reviewed 27. Important risk factors for RSV hospitalization included young age during the RSV season, having school-age siblings and day-care attendance, with odds ratios >2.5 in at least one study (high SOE). Incidence rates for RSV hospitalizations ranged from 2.3% to 10% (low SOE). Length of hospital stays ranged from 3.8 to 6.1 days (low SOE). Recurrent wheezing rates ranged from 20.7% to 42.8% 1 to 2 years after RSV hospitalization (low SOE).
CONCLUSIONS
Young chronological age and some environmental risk factors are important clinical indicators of an increased risk of RSV hospitalization in healthy preterm infants 32 to 35 weeks of gestational age. SOE was low for estimates of incidence of RSV hospitalizations, in-hospital resource use and recurrent wheezing in this population. Studies were inconsistent in study characteristics, including weeks of gestational age, age during RSV season and control for confounding factors.
Topics: Gestational Age; Hospitalization; Humans; Incidence; Infant, Premature; Infant, Premature, Diseases; Palivizumab; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human; Risk Factors; Seasons; Treatment Outcome
PubMed: 27093166
DOI: 10.1097/INF.0000000000001163 -
Italian Journal of Pediatrics Jun 2023Bronchiolitis is a major cause of hospitalization in infants, particularly in the first six months of life, with approximately 60-80% of admissions due to respiratory...
BACKGROUND
Bronchiolitis is a major cause of hospitalization in infants, particularly in the first six months of life, with approximately 60-80% of admissions due to respiratory syncytial virus (RSV) infection. Currently, no prophylactic options are available for healthy infants. The present study aimed at describing the demographic, clinical, and epidemiological characteristics of infants hospitalized for bronchiolitis in the Apulia region of Italy in 2021.
METHODS
From January to December 2021, data on children aged 0-12 months admitted for bronchiolitis in nine neonatal or pediatric units covering 61% of pediatric beds of hospitals in the Apulia region of Italy were analyzed. Demographic data, comorbidities, need for oxygen support, length of hospital stay, palivizumab administration, and outcomes were collected. For the purpose of the analysis, patients were divided into those aged 0-3 months and > 3 months. A multivariate logistic regression model was used to explore associations between the need for oxygen support and sex, age, comorbidities, history of prematurity, length of hospital stay, and palivizumab administration.
RESULTS
This study included 349 children aged 0-12 months admitted for bronchiolitis, with a peak of hospitalization in November (7.4 cases/1,000 children). Of these patients, 70.5% were RSV positive, 80.2% were aged 0-3 months, and 73.1% required oxygen support. Moreover, 34.9% required observation in the sub-intensive care unit, and 12.9% in the intensive care unit. Of the infants who required intensive care, 96.9% were aged 0-3 months and 78.8% were born at term. Three patients required mechanical ventilation and one, who required Extra Corporeal Membrane Oxygenation, died. Children aged 0-3 months were more likely to show dyspnea, need oxygen support, and have a longer hospital stay.
CONCLUSIONS
The present study showed that almost all of the children who required intensive care support were aged ≤ 3 months and most were born at term. Therefore, this age group remains the highest risk group for severe bronchiolitis. Preventive measures such as single-dose monoclonal antibody immunoprophylaxis, and maternal and childhood vaccination against RSV, may reduce the high public health burden of bronchiolitis.
Topics: Infant, Newborn; Infant; Humans; Child; Palivizumab; Antiviral Agents; Antibodies, Monoclonal, Humanized; Hospitalization; Bronchiolitis; Respiratory Syncytial Virus Infections; Italy
PubMed: 37280662
DOI: 10.1186/s13052-023-01455-2 -
Journal of the National Medical... Dec 2005Respiratory syncytial virus, the most common cause of bronchiolitis, is the leading cause of infant hospitalization in developed countries and accounts for substantial... (Review)
Review
Respiratory syncytial virus, the most common cause of bronchiolitis, is the leading cause of infant hospitalization in developed countries and accounts for substantial mortality and morbidity in developing countries. Children at increased risk of developing severe bronchiolitis are those <6 weeks of age, those born prematurely and those with an underlying cardiopulmonary disorder or immunodeficiency. Approximately 80% of cases occur in the first year of life. By two years of age, virtually all children have been infected by at least one strain of the virus. Classically, respiratory syncytial virus bronchiolitis manifests as cough, wheezing and respiratory distress. The mainstay of treatment is supportive care, consisting of adequate fluid intake, antipyretics to control fever and use of supplemental oxygen if necessary. Frequent and meticulous hand-washing is the best measure to prevent secondary spread. Treatment of respiratory syncytial virus bronchiolitis beyond supportive care should be individualized. Palivizumab has been shown to be effective in preventing severe respiratory syncytial virus bronchiolitis in high-risk children when given prophylactically. In the majority of cases, the disease is usually self-limited. The mortality rate is <1% and occurs predominantly in children at high risk for severe disease.
Topics: Adrenal Cortex Hormones; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bronchiolitis; Bronchodilator Agents; Child, Preschool; Humans; Infant; Infant, Newborn; Infant, Premature; Palivizumab; Prognosis; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses
PubMed: 16396064
DOI: No ID Found -
Expert Review of Anti-infective Therapy Apr 2017Respiratory viruses (influenza, parainfluenza, respiratory syncytial virus, coronavirus, human metapneumovirus, and rhinovirus) represent the most common causes of... (Review)
Review
Respiratory viruses (influenza, parainfluenza, respiratory syncytial virus, coronavirus, human metapneumovirus, and rhinovirus) represent the most common causes of respiratory viral infections in immunocompromised patients. Also, these infections may be more severe in immunocompromised patients than in the general population. Early diagnosis and treatment of viral infections continue to be of paramount importance in immunocompromised patients; because once viral replication and invasive infections are evident, prognosis can be grave. Areas covered: The purpose of this review is to provide an overview of the main antiviral agents used for the treatment of respiratory viral infections in immunocompromised patients and review of the new agents in the pipeline. Expert commentary: Over the past decade, important diagnostic advances, specifically, the use of rapid molecular testing has helped close the gap between clinical scenarios and pathogen identification and enhanced early diagnosis of viral infections and understanding of the role of prolonged shedding and viral loads. Advancements in novel antiviral therapeutics with high resistance thresholds and effective immunization for preventable infections in immunocompromised patients are needed.
Topics: Acids, Carbocyclic; Amantadine; Antiviral Agents; Coronavirus Infections; Cyclopentanes; Guanidines; Humans; Immunocompromised Host; Influenza, Human; Oseltamivir; Palivizumab; Paramyxoviridae Infections; Picornaviridae Infections; Respiratory Syncytial Virus Infections; Respiratory Tract Infections; Ribavirin; Zanamivir
PubMed: 28067078
DOI: 10.1080/14787210.2017.1279970 -
Breathe (Sheffield, England) Dec 2021https://bit.ly/3ikzwZD.
https://bit.ly/3ikzwZD.
PubMed: 35035568
DOI: 10.1183/20734735.0110-2021 -
Human Vaccines & Immunotherapeutics Dec 2024Respiratory syncytial virus (RSV) is a highly contagious virus that affects the lungs and respiratory passages of many vulnerable people. It is a leading cause of lower...
Respiratory syncytial virus (RSV) is a highly contagious virus that affects the lungs and respiratory passages of many vulnerable people. It is a leading cause of lower respiratory tract infections and clinical complications, particularly among infants and elderly. It can develop into serious complications such as pneumonia and bronchiolitis. The development of RSV vaccine or immunoprophylaxis remains highly active and a global health priority. Currently, GSK's Arexvy™ vaccine is approved for the prevention of lower respiratory tract disease in older adults (>60 years). Palivizumab and currently nirsevimab are the approved monoclonal antibodies (mAbs) for RSV prevention in high-risk patients. Many studies are ongoing to develop additional therapeutic antibodies for preventing RSV infections among newborns and other susceptible groups. Recently, additional antibodies have been discovered and shown greater potential for development as therapeutic alternatives to palivizumab and nirsevimab. Plant expression platforms have proven successful in producing recombinant proteins, including antibodies, offering a potential cost-effective alternative to mammalian expression platforms. Hence in this study, an attempt was made to use a plant expression platform to produce two anti-RSV fusion (F) mAbs 5C4 and CR9501. The heavy-chain and light-chain sequences of both these antibodies were transiently expressed in plants using a geminiviral vector and then purified using single-step protein A affinity column chromatography. Both these plant-produced mAbs showed specific binding to the RSV fusion protein and demonstrate effective viral neutralization activity . These preliminary findings suggest that plant-produced anti-RSV mAbs are able to neutralize RSV .
Topics: Infant; Animals; Humans; Infant, Newborn; Aged; Palivizumab; Nicotiana; Respiratory Syncytial Virus Infections; Antibodies, Monoclonal; Antibodies, Viral; Respiratory Syncytial Virus, Human; Antibodies, Neutralizing; Viral Fusion Proteins; Respiratory Syncytial Virus Vaccines; Mammals
PubMed: 38508690
DOI: 10.1080/21645515.2024.2327142 -
Vaccine Nov 2022Respiratory Syncytial Virus (RSV) is a major cause of acute lower respiratory tract infections (ALRI) in infants. There are no licensed vaccines and only one monoclonal...
INTRODUCTION
Respiratory Syncytial Virus (RSV) is a major cause of acute lower respiratory tract infections (ALRI) in infants. There are no licensed vaccines and only one monoclonal antibody available to protect infants from disease. A new and potentially longer-lasting monoclonal antibody, Nirsevimab, showed promising results in phase IIb/III trials. We evaluate the cost-effectiveness of Nirsevimab intervention programmes in England and Wales.
METHODS
We used a dynamic model for RSV transmission, calibrated to data from England and Wales. We considered a suite of potential Nirsevimab programmes, including administration to all neonates (year-round); only neonates born during the RSV season (seasonal); or neonates born during the RSV season plus infants less than six months old before the start of the RSV season (seasonal + catch-up).
RESULTS
If administered seasonally to all infants at birth, we found that Nirsevimab would have to be priced at £63 or less per dose for at least 50% certainty that it could cost-effectively replace the current Palivizumab programme, using an ICER threshold of £20,000/QALY. An extended seasonal programme which includes a pre-season catch-up becomes the optimal strategy at a purchasing price of £32/dose or less for at least 50% certainty. At a purchasing price per dose of £5-32, the annual implementation costs of a seasonal programme could be as high as £2 million before a switch to a year-round strategy would be optimal.
DISCUSSION
Nirsevimab has the potential to be cost-effective in England and Wales not only for use in high-risk infants.
Topics: Infant; Infant, Newborn; Humans; Respiratory Syncytial Virus Infections; Wales; Antiviral Agents; Palivizumab; Respiratory Syncytial Virus, Human; Antibodies, Monoclonal; England
PubMed: 36328884
DOI: 10.1016/j.vaccine.2022.10.041 -
The Pediatric Infectious Disease Journal Nov 2018Palivizumab provides passive immunity for respiratory syncytial virus (RSV), but poor adherence compromises protection. A hospital initiative promoted administration of...
BACKGROUND
Palivizumab provides passive immunity for respiratory syncytial virus (RSV), but poor adherence compromises protection. A hospital initiative promoted administration of first palivizumab doses at an outpatient clinic immediately after discharge. The objectives of this study were to evaluate the impact of the initiative on location and timing of first palivizumab dose, patient adherence, reimbursement, acquisition cost and RSV-positive hospital readmissions.
METHODS
This retrospective cohort study included pediatric patients who received palivizumab from 2012 to 2016. Three groups were compared: "before initiative," "transition" and "after initiative." Patients who did not qualify for palivizumab or who were eligible for palivizumab in previous RSV seasons were excluded. Multivariable logistic and linear regressions adjusted for patients' characteristics were used in outcome analysis.
RESULTS
After adjusting for patients' characteristics, there was a 13.5-fold (95% confidence interval: 5.9-30.5, P < 0.0001) increase in odds that patients would receive outpatient administration of palivizumab and 2.7-fold (95% confidence interval: 1.3-5.7, P = 0.0103) increase in odds of receiving the second dose within 35 days after initiative implementation compared with before. Although there was no significant difference in reimbursement percentage after initiative implementation (32% ± 30% after initiative and 31% ± 22% before), calculated palivizumab acquisition costs were 20.8% lower. RSV readmissions were not significantly different.
CONCLUSIONS
Implementation of an initiative with defined workflow, multidisciplinary collaboration, and early case management efforts to obtain insurance authorization increased outpatient administration of first palivizumab doses. Patient adherence improved as demonstrated by more timely receipt of the second palivizumab dose. There was no difference in reimbursement; however, acquisition cost decreased which is valuable considering low reimbursement rates. RSV-positive readmissions did not change significantly.
Topics: Ambulatory Care Facilities; Antiviral Agents; Drug Administration Schedule; Female; Hospitals; Humans; Infant; Insurance, Health, Reimbursement; Male; Medication Adherence; Palivizumab; Patient Discharge; Regression Analysis; Respiratory Syncytial Virus Infections; Retrospective Studies
PubMed: 29570593
DOI: 10.1097/INF.0000000000001999