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Clinical Transplantation Sep 2019These updated guidelines from the Infectious Diseases Community of Practice of the American Society of Transplantation review the diagnosis, prevention, and management...
These updated guidelines from the Infectious Diseases Community of Practice of the American Society of Transplantation review the diagnosis, prevention, and management of RNA respiratory viral infections in the pre- and post-transplant period. Viruses reviewed include influenza, respiratory syncytial virus (RSV), parainfluenza, rhinovirus, human metapneumovirus (hMPV), and coronavirus. Diagnosis is by nucleic acid testing due to improved sensitivity, specificity, broad range of detection of viral pathogens, automatization, and turnaround time. Respiratory viral infections may be associated with acute rejection and chronic lung allograft dysfunction in lung transplant recipients. The cornerstone of influenza prevention is annual vaccination and in some cases antiviral prophylaxis. Treatment with neuraminidase inhibitors and other antivirals is reviewed. Prevention of RSV is limited to prophylaxis with palivizumab in select children. Therapy of RSV upper or lower tract disease is controversial but may include oral or aerosolized ribavirin in some populations. There are no approved vaccines or licensed antivirals for parainfluenza, rhinovirus, hMPV, and coronavirus. Potential management strategies for these viruses are given. Future studies should include prospective trials using contemporary molecular diagnostics to understand the true epidemiology, clinical spectrum, and long-term consequences of respiratory viruses as well as to define preventative and therapeutic measures.
Topics: Anti-Infective Agents; Humans; Organ Transplantation; Practice Guidelines as Topic; RNA Viruses; Respiratory Tract Infections; Societies, Medical; Transplant Recipients
PubMed: 30817023
DOI: 10.1111/ctr.13511 -
The Journal of Infectious Diseases Aug 2022Respiratory syncytial virus (RSV) is associated with substantial morbidity in the United States, especially among infants. Nirsevimab, an investigational long-acting...
BACKGROUND
Respiratory syncytial virus (RSV) is associated with substantial morbidity in the United States, especially among infants. Nirsevimab, an investigational long-acting monoclonal antibody, was evaluated as an immunoprophylactic strategy for infants in their first RSV season and for its potential impact on RSV-associated, medically attended lower respiratory tract illness (RSV-MALRTI) and associated costs.
METHODS
A static decision-analytic model of the US birth cohort during its first RSV season was developed to estimate nirsevimab's impact on RSV-related health events and costs; model inputs included US-specific costs and epidemiological data. Modelled RSV-related outcomes included primary care and emergency room visits, hospitalizations including intensive care unit admission and mechanical ventilations, and RSV-related mortality.
RESULTS
Under current standard of care, RSV caused 529 915 RSV-MALRTIs and 47 281 hospitalizations annually, representing $1.2 billion (2021 US dollars [USD]) in costs. Universal immunization of all infants with nirsevimab is expected to reduce 290 174 RSV-MALRTI, 24 986 hospitalizations, and expenditures of $612 million 2021 USD.
CONCLUSIONS
An all-infant immunization strategy with nirsevimab could substantially reduce the health and economic burden for US infants during their first RSV season. While this reduction is driven by term infants, all infants, including palivizumab-eligible and preterm infants, would benefit from this strategy.
Topics: Antibodies, Monoclonal, Humanized; Humans; Immunization; Infant; Infant, Newborn; Infant, Premature; Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus, Human; Seasons; United States
PubMed: 35968866
DOI: 10.1093/infdis/jiac216 -
Pediatrics Jul 2022To examine the relationship between changes in American Academy of Pediatrics (AAP) guidance and palivizumab use for infants admitted to the NICU. We hypothesized that...
OBJECTIVE
To examine the relationship between changes in American Academy of Pediatrics (AAP) guidance and palivizumab use for infants admitted to the NICU. We hypothesized that each change in guidance would be associated with a change in palivizumab usage.
METHODS
This is a retrospective repeated cross-sectional study of palivizumab usage in defined subgroups of infants discharged between 1999 and 2020 using the Pediatrix Clinical Data Warehouse.
RESULTS
Palivizumab utilization increased in all groups between 1999 and 2003 and remained stable until 2013. Large changes in palivizumab use occurred between 2013 and 2015 followed by slower changes from 2016 to 2020. The largest decrease was in infants born between 29 0/7 and 31 6/7 weeks' gestational age without chronic lung disease (decreased from 87% to 21%; P < .001). The second largest absolute decrease was infants born at 32 0/7 to 34 6/7 weeks' gestational age without chronic lung disease and no major anomalies (decreased from 52% to 6%; P < .001). The decrease in term infants with major congenital heart problem was smaller (25 to 17%; P < .001). Even in the most vulnerable infants born between 22 0/7 and 28 6/7 estimated gestational age, palivizumab use declined (88% in 2013 to 74% in 2020; P < .001).
CONCLUSIONS
Early AAP guidelines had minor impacts on palivizumab use in infants discharged from the hospital from the NICU. The 2014 guidelines resulted in major changes in palivizumab use and extended into populations for which the AAP guidance remained unchanged.
Topics: Antiviral Agents; Child; Cross-Sectional Studies; Hospitalization; Humans; Infant; Infant, Newborn; Intensive Care Units, Neonatal; Lung Diseases; Palivizumab; Respiratory Syncytial Virus Infections; Retrospective Studies
PubMed: 35730329
DOI: 10.1542/peds.2021-055607 -
Pediatric Pulmonology Dec 2021
Topics: Antiviral Agents; Hospitalization; Humans; Infant; Palivizumab; Respiratory Syncytial Virus Infections
PubMed: 34547834
DOI: 10.1002/ppul.25634 -
MMW Fortschritte Der Medizin Jun 2024
Topics: Humans; Respiratory Syncytial Virus Infections; Infant; Infant, Newborn; Antiviral Agents; Palivizumab; Antibodies, Monoclonal, Humanized; Respiratory Syncytial Virus Vaccines
PubMed: 38806929
DOI: 10.1007/s15006-024-3993-1 -
Vaccines Nov 2023Respiratory syncytial virus (RSV) is a well-known infant pathogen transmitted mainly by droplets. It is a leading cause of upper respiratory tract infections in... (Review)
Review
Respiratory syncytial virus (RSV) is a well-known infant pathogen transmitted mainly by droplets. It is a leading cause of upper respiratory tract infections in children, usually with a mild course of illness. RSV has also been a threat to older people, especially those with underlying medical conditions. For a long time, prevention was limited to passive immunoprophylaxis with palivizumab for high-risk infants. There was a strong need to find other treatment or prevention methods against RSV infections. In addition, after the coronavirus disease 2019 (COVID-19) pandemic, some significant changes in RSV epidemiology have been observed. Researchers noticed the shift in RSV seasonality and age distribution and the increased number of cases in older infants and adults. All of these made the need to find other medical options even stronger. Fortunately, two protein-based vaccines against RSV have successfully passed all phases of clinical trials and have been approved for use by adults and older people. One of them is also approved for infants from birth to 6 months of age (after maternal immunisation during pregnancy) and for pregnant women between 24 and 36 weeks of pregnancy. Also, a new passive immunisation option named nirsevimab (a highly potent monoclonal antibody with a long half-life) is now available for the paediatric group. In this review, we will discuss the previous and current RSV prevention methods in the light of structural discoveries of RSV antigens.
PubMed: 38140201
DOI: 10.3390/vaccines11121797 -
JAMA Network Open Jun 2024Respiratory syncytial virus (RSV) transmission was disrupted worldwide following the COVID-19 pandemic, and further study is required to better understand these changes.
IMPORTANCE
Respiratory syncytial virus (RSV) transmission was disrupted worldwide following the COVID-19 pandemic, and further study is required to better understand these changes.
OBJECTIVE
To compare observed and expected RSV hospital and intensive care unit (ICU) admission rates and characteristics of admitted children during the 2021-2022 and 2022-2023 seasons.
DESIGN, SETTING, AND PARTICIPANTS
A population-based cohort study of all children aged younger than 5 years in Ontario, Canada, July 1, 2017, through March 31, 2023, was conducted.
EXPOSURES
Individual and neighborhood-level sociodemographic and clinical characteristics were identified from administrative data, including age, palivizumab eligibility, complex medical conditions, rurality, and living in a marginalized neighborhood.
MAIN OUTCOMES AND MEASURES
The main outcome was RSV-associated hospitalization. Secondary outcomes included ICU admissions, mechanical ventilation, extracorporeal membrane oxygenation, and in-hospital death. Poisson generalized estimating equations were used to model weekly age- and sex-specific hospitalization rates and estimate expected rates in the postpandemic era; adjusted rate ratios (RRs) and 95% CIs are reported.
RESULTS
This cohort study included approximately 700 000 children per study year. Compared with prepandemic years (2017-2018, 2018-2019, and 2019-2020), the 2021-2022 RSV season peaked slightly earlier, but overall admission rates were comparable (289.1 vs 281.4-334.6 per 100 000, or approximately 2000 admissions). The 2022-2023 season peaked a month earlier and resulted in more than twice as many hospitalizations (770.0 per 100 000; n = 4977 admissions). The proportion of children admitted to an ICU in 2022-2023 (13.9%) was slightly higher than prepandemic (9.6%-11.4%); however, the population-based rate was triple the prepandemic levels (106.9 vs 27.6-36.6 per 100 000 children in Ontario). With the exception of palivizumab-eligible children, all sociodemographic and health status characteristics were associated with lower-than-expected RSV hospitalization rates in 2021-2022. In contrast, older age of patients was associated with higher-than-expected rates in 2022-2023 (ie, 24-59 months: RR, 1.90; 95% CI, 1.35-2.66).
CONCLUSIONS AND RELEVANCE
There were notable differences in RSV epidemiologic characteristics in Ontario following the COVID-19 pandemic. It is not yet clear whether and how long atypical RSV epidemics may persist. Clinicians and program planners should consider the potential for ongoing impacts to health care capacity and RSV immunization programs.
Topics: Humans; Respiratory Syncytial Virus Infections; Hospitalization; Infant; Male; Female; Child, Preschool; Ontario; COVID-19; SARS-CoV-2; Intensive Care Units; Cohort Studies; Infant, Newborn; Respiration, Artificial; Pandemics; Palivizumab
PubMed: 38861259
DOI: 10.1001/jamanetworkopen.2024.16077 -
Pediatrics Jul 2023Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy...
Guidance from the American Academy of Pediatrics (AAP) for the use of palivizumab prophylaxis against respiratory syncytial virus (RSV) was first published in a policy statement in 1998. AAP recommendations have been updated periodically to reflect the most recent literature regarding children at greatest risk of severe RSV disease. Since the last update in 2014, which refined prophylaxis guidance to focus on those children at greatest risk, data have become available regarding the seasonality of RSV circulation, the incidence and risk factors associated with bronchiolitis hospitalizations, and the potential effects of the implementation of prophylaxis recommendations on hospitalization rates of children with RSV infection. This technical report summarizes the literature review by the Committee on Infectious Diseases, supporting the reaffirmation of the 2014 AAP policy statement on palivizumab prophylaxis among infants and young children at increased risk of hospitalization for RSV infection. Review of publications since 2014 did not support a change in recommendations for palivizumab prophylaxis and continues to endorse the guidance provided in the 2021 Red Book.
Topics: Infant; Child; Humans; Child, Preschool; Palivizumab; Respiratory Syncytial Virus Infections; Antiviral Agents; Antibodies, Monoclonal, Humanized; Respiratory Syncytial Viruses; Hospitalization
PubMed: 37357729
DOI: 10.1542/peds.2023-061803 -
Molecules (Basel, Switzerland) Jan 2024Respiratory syncytial virus (RSV) is a significant viral pathogen that causes respiratory infections in infants, the elderly, and immunocompromised individuals.... (Review)
Review
Respiratory syncytial virus (RSV) is a significant viral pathogen that causes respiratory infections in infants, the elderly, and immunocompromised individuals. RSV-related illnesses impose a substantial economic burden worldwide annually. The molecular structure, function, and in vivo interaction mechanisms of RSV have received more comprehensive attention in recent times, and significant progress has been made in developing inhibitors targeting various stages of the RSV replication cycle. These include fusion inhibitors, RSV polymerase inhibitors, and nucleoprotein inhibitors, as well as FDA-approved RSV prophylactic drugs palivizumab and nirsevimab. The research community is hopeful that these developments might provide easier access to knowledge and might spark new ideas for research programs.
Topics: Humans; Infant; Aged; Antiviral Agents; Palivizumab; Respiratory Syncytial Virus, Human; Respiratory Syncytial Virus Infections; Anti-Retroviral Agents
PubMed: 38338343
DOI: 10.3390/molecules29030598 -
Pediatrics and Neonatology Mar 2024Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born...
BACKGROUND
Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born ≥29 0/7 weeks' gestational age (GA) without additional risk factors. A novel drug candidate, nirsevimab, has been developed for this population. We analyzed the cost-effectiveness of palivizumab/nirsevimab vs. no prophylaxis in this population.
METHODS
A hybrid-Markov model predicted the RSV clinical course in the first year of life and sequelae in the subsequent four years for preterm infants from the healthcare and societal perspectives. Model parameters were derived from the literature. We calculated costs and quality-adjusted life-years (QALYs) to produce an incremental cost-effectiveness ratio (ICER) evaluated at a willingness-to-pay threshold of $150,000/QALY. Sensitivity analyses assessed model robustness. A threshold analysis examined nirsevimab pricing uncertainty.
RESULTS
Compared to no prophylaxis, palivizumab costs $9572 and $9584 more from the healthcare and societal perspectives, respectively, with 0.0019 QALYs gained per patient over five years, resulting in ICERs >$5 million per QALY from each perspective. Results were robust to parameter uncertainties; probabilistic sensitivity analysis revealed that no prophylaxis had a 100% probability of being cost-effective. The threshold analysis suggested that nirsevimab is not cost-effective when compared to no prophylaxis if the price exceeds $1962 from a societal perspective.
CONCLUSION
Palivizumab is dominated by no prophylaxis for preterm infants 29 0/7-34 6/7 weeks' GA with no additional risk factors. Relevant stakeholders should consider alternatives to palivizumab for this population that are both effective and economical.
Topics: Infant; Infant, Newborn; Humans; United States; Pregnancy; Female; Palivizumab; Infant, Premature; Cost-Benefit Analysis; Gestational Age; Antiviral Agents; Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses; Hospitalization; Antibodies, Monoclonal, Humanized
PubMed: 37758594
DOI: 10.1016/j.pedneo.2023.04.015