3,715 results on '"palivizumab"'
Search Results
2. Improvement in Palivizumab Administration Prior to Discharge for Hospitalized Infants with Hemodynamically Significant Congenital Heart Disease: A Quality Improvement Initiative.
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Jones, Andrea L., Campbell, Matthew J., Abernathy, Brittany, Neubert, Stephanie, Hager, Alyssa, Collier, Hailey, Ramsey, Evan Zachary, Simon, Anna, Schachtner, Susan, and Natarajan, Shobha
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RESPIRATORY syncytial virus infections , *STATISTICAL process control , *CONGENITAL heart disease , *ELECTRONIC health records , *RESPIRATORY syncytial virus - Abstract
In this quality improvement initiative, we aimed to increase provider adherence with palivizumab administration guidelines for hospitalized infants with hemodynamically significant congenital heart disease. We included 470 infants over four respiratory syncytial virus (RSV) seasons from 11/2017 to 03/2021 (baseline season: 11/2017–03/2018). Interventions included the following: education, including palivizumab in the sign-out template, identifying a pharmacy expert, and a text alert (seasons 1 and 2: 11/2018–03/2020) that was replaced by an electronic health record (EHR) best practice alert (BPA) in season 3 (11/2020–03/2021). The text alert and BPA prompted providers to add "Need for RSV immunoprophylaxis" to the EHR problem list. The outcome metric was the percentage of eligible patients administered palivizumab prior to discharge. The process metric was the percentage of eligible patients with "Need for RSV immunoprophylaxis" on the EHR problem list. The balancing metric was the percentage of palivizumab doses administered to ineligible patients. A statistical process control P-chart was used to analyze the outcome metric. The mean percentage of eligible patients who received palivizumab prior to hospital discharge increased significantly from 70.1% (82/117) to 90.0% (86/96) in season 1 and to 97.9% (140/143) in season 3. Palivizumab guideline adherence was as high or higher for those with "Need for RSV immunoprophylaxis" on the problem list than for those without it in most time periods. The percentage of inappropriate palivizumab doses decreased from 5.7% (n = 5) at baseline to 4.4% (n = 4) in season 1 and 0.0% (n = 0) in season 3. Through this initiative, we improved adherence with palivizumab administration guidelines for eligible infants prior to hospital discharge. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Empfehlungen der Österreichischen Gesellschaft für Kinder- und Jugendheilkunde zur Prophylaxe einer RSV-Infektion mit Nirsevimab.
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Resch, Bernhard, Strenger, Volker, Zacharasiewicz, Angela, Zwiauer, Karl, Berger, Angelika, Zacharasiewcz, Angela, Redlberger-Fritz, Monika, Wald, Martin, Kiechl-Kohlendorfer, Ursula, Köstenberger, Martin, Dornbusch, Hans Jürgen, Voitl, Peter, and Tebruegge, Marc
- Abstract
Copyright of Pädiatrie & Pädologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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4. Passive Immunization Strategies to Prevent Severe Respiratory Syncytial Virus Infection Among Newborns and Young Infants.
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Suryadevara, Manika
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IMMUNIZATION , *PLACENTA , *MATERNALLY acquired immunity , *RESPIRATORY infections , *MATERNAL age , *HEALTH status indicators , *PALIVIZUMAB , *IMMUNOGLOBULINS , *MOTHERS , *RESPIRATORY syncytial virus infections , *CATASTROPHIC illness , *PREGNANT women , *NUTRITIONAL requirements , *MONOCLONAL antibodies , *GESTATIONAL age , *BIRTH weight , *IMMUNOCOMPETENCE , *DISEASE risk factors , *CHILDREN - Abstract
Newborns and young infants are at risk for severe respiratory syncytial virus (RSV) lower respiratory tract infection. Passive immunity is the mainstay of infection prevention in this cohort. Transplacental transfer of maternal antibodies provides the newborn with immediate protection from life-threatening infections, however, is dependent upon gestational age, birth weight, mother's age, recent maternal vaccination, maternal nutritional status, maternal immunocompetence and medical conditions, and placental integrity. Efficient transplacental transfer of RSV-neutralizing antibodies have led to the development and approval of maternal RSV immunization for the protection of the newborn. Additionally, administration of RSV-specific antibodies to infants leads to high serum titers of RSV-neutralizing antibodies and further protection from severe disease. [ABSTRACT FROM AUTHOR]
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- 2024
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5. A Historical Perspective on Respiratory Syncytial Virus Prevention: A Journey Spanning Over Half a Century From the Setback of an Inactive Vaccine Candidate to the Success of Passive Immunization Strategy.
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Noor, Asif and Krilov, Leonard R
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VACCINE development , *COMMUNICABLE diseases , *PALIVIZUMAB , *PATIENT safety , *IMMUNOGLOBULINS , *VACCINE effectiveness , *RESPIRATORY syncytial virus infections , *MONOCLONAL antibodies , *VIRAL vaccines , *LUNG diseases , *INFLAMMATION , *MEDICAL care costs , *CHILDREN - Abstract
The efforts to prevent respiratory syncytial virus (RSV) infection in infants span over half a century. RSV vaccine development began in the 1960s, and it confronted a significant disappointment after testing a formalin-inactivated RSV (FI RSV) vaccine candidate. This inactivated RSV vaccine was not protective. A large number of the vaccinated RSV-naive children, when subsequently exposed to natural RSV infection from wild-type virus in the community, developed severe lung inflammation termed enhanced respiratory disease. This resulted in a halt in RSV vaccine development. In the 1990s, attention turned to the potential for passive protection against severe RSV disease with immunoglobulin administration. This led to studies on using standard intravenous immunoglobulins in high-risk infants, followed by high-titer RSV immunoglobulin preparation and, subsequently, the development of RSV monoclonal antibodies. Over the past 25 years, palivizumab has been recognized as a safe and effective monoclonal antibody as a prevention strategy for RSV in high-risk children. Its high cost and need for monthly administration, however, has hindered its use to ~2% of the birth cohort, neglecting the vast majority of newborns, including healthy full-term infants who comprise the largest portion of RSV hospitalizations and the greatest part of the burden of RSV disease. Still these efforts, helped pave the way for the present advances in RSV prevention that hold promise for mitigating severe RSV disease for all infants. [ABSTRACT FROM AUTHOR]
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- 2024
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6. Cost-Effectiveness Analysis of Maternal Respiratory Syncytial Virus Vaccine in Protecting Infants from RSV Infection in Japan
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Naruhiko Ishiwada, Rina Akaishi, Yasuhiro Kobayashi, Kanae Togo, Naohiro Yonemoto, Moe Matsuo, Shinnosuke Kaneko, Amy W. Law, and Kazumasa Kamei
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Cost-effectiveness analysis ,Japan ,Palivizumab ,Respiratory syncytial virus ,RSVpreF ,Vaccination ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract Introduction Respiratory syncytial virus (RSV) is one of the major causes of respiratory tract infections among children. Until recently, the monoclonal antibody palivizumab was the only RSV prophylaxis available in Japan. In 2024, the bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved for the prevention of RSV infection in infants by active immunization of pregnant women. In this study, we assessed the cost-effectiveness of a combined strategy of RSVpreF vaccine and palivizumab in Japanese setting. Methods Using a Markov model, we evaluated prevented cases and deaths of medically attended RSV infections from birth to age 11 months for each of the three healthcare settings: inpatient (hospitalization), emergency department visits, and outpatient visits. Incremental cost-effectiveness ratios (ICERs) were calculated from economic outcomes (intervention costs, medication costs, and productivity losses) and quality-adjusted life years (QALYs). Further, we calculated the maximum price of RSVpreF vaccine within which the program would be cost-effective. Results In comparison with the current prophylaxis (palivizumab alone), a combined prophylaxis of year-round RSVpreF vaccination of pregnant women and palivizumab prescription for premature infants born in
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- 2024
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7. Cost-Effectiveness Analysis of Maternal Respiratory Syncytial Virus Vaccine in Protecting Infants from RSV Infection in Japan.
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Ishiwada, Naruhiko, Akaishi, Rina, Kobayashi, Yasuhiro, Togo, Kanae, Yonemoto, Naohiro, Matsuo, Moe, Kaneko, Shinnosuke, Law, Amy W., and Kamei, Kazumasa
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RESPIRATORY syncytial virus infections , *HUMAN metapneumovirus infection , *RESPIRATORY syncytial virus , *VIRAL vaccines , *EMERGENCY room visits , *INFANTS - Abstract
Introduction: Respiratory syncytial virus (RSV) is one of the major causes of respiratory tract infections among children. Until recently, the monoclonal antibody palivizumab was the only RSV prophylaxis available in Japan. In 2024, the bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved for the prevention of RSV infection in infants by active immunization of pregnant women. In this study, we assessed the cost-effectiveness of a combined strategy of RSVpreF vaccine and palivizumab in Japanese setting. Methods: Using a Markov model, we evaluated prevented cases and deaths of medically attended RSV infections from birth to age 11 months for each of the three healthcare settings: inpatient (hospitalization), emergency department visits, and outpatient visits. Incremental cost-effectiveness ratios (ICERs) were calculated from economic outcomes (intervention costs, medication costs, and productivity losses) and quality-adjusted life years (QALYs). Further, we calculated the maximum price of RSVpreF vaccine within which the program would be cost-effective. Results: In comparison with the current prophylaxis (palivizumab alone), a combined prophylaxis of year-round RSVpreF vaccination of pregnant women and palivizumab prescription for premature infants born in < 32 weeks gestational age (wGA) and all infants with high risk prevented 14,382 medically attended cases of RSV (hospitalization, 7490 cases; emergency department, 2239 cases; outpatient, 4653 cases) and 7 deaths, respectively. From a healthcare payer perspective, when the price of RSVpreF vaccine was equal to or less than ¥23,948 (US $182), a combination prophylaxis was cost-effective under the ICER threshold of ¥5 million per QALY. The other combination prophylaxis of year-round RSVpreF vaccination and palivizumab prescription of premature born in < 32 wGA regardless of risk in infants was a dominant strategy (more effective and less costly). Conclusion: A combined prophylaxis of year-round RSVpreF vaccine and palivizumab could be a cost-effective strategy to protect neonates throughout the infant stage (< 1 years old) in Japan. [ABSTRACT FROM AUTHOR]
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- 2024
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8. RSV Disease Threat and Innovative Prevention Methods in Health Protection: A Review.
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Dąbrowska, Paulina, Żuber, Michał, Bochyński, Karol, Molenda, Katarzyna, Ciubaz, Katarzyna, Borodziuk, Barbara, Borodziuk, Filip, Dacka, Michał, Giżewska, Kamila, and Białogłowski, Konrad
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RESPIRATORY syncytial virus infections ,RESPIRATORY infections ,RESPIRATORY syncytial virus ,RESPIRATORY syncytial virus infection vaccines ,PALIVIZUMAB - Abstract
Respiratory syncytial virus (RSV) causes infections of the lower respiratory tract. A group particularly vulnerable to severe infection are young children under 2 years of age and the elderly. The infection can cause the entire spectrum of respiratory symptoms from upper respiratory tract infections to severe courses requiring assisted breathing. Until recently, the only form of protection against infection was passive immunization, i.e. administration of immunoglobulins. Chief among these are palivizumab and nirsevimab. In May u June 2023, the Food and Drug Administration (FDA) approved for use 2 vaccines against RSV are Arexvy and Abrysvo. In this study, we focus on presenting and describing the clinical evidence supporting the effectiveness of these immunization methods. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Update to: Study Pre-protocol for 'BronchStart - The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations; a Multi-Centre Prospective Observational Cohort Study' [version 3; peer review: 2 approved]
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Mark D. Lyttle, Helen Groves, Thomas C. Williams, Simon B. Drysdale, Ian Sinha, Xinxue Liu, Steve Cunningham, Dalia Iskander, Abigail Maxwell-Hodkinson, Shaun O'Hagan, Olivia V. Swann, Chengetai D. Mpamhanga, Damian Roland, Thomas Waterfield, and Robin Marlow
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COVID-19 ,Respiratory Syncytial Virus ,Bronchiolitis ,Infants ,Children ,Palivizumab ,eng ,Medicine ,Science - Abstract
Background In 2021 we launched the BronchStart study, which collected information on 17,899 presentations in children with serious respiratory tract infections following the release of lockdown restrictions. Our study informed the Joint Committee on Vaccination and Immunisation’s decision to recommend the introduction maternal respiratory syncytial virus (RSV) vaccination, which was introduced in the United Kingdom in August/September 2024. Study question We modified our original protocol to conduct a United Kingdom-wide assessment of maternal vaccination against RSV. Methods and likely impact We will conduct a multi-centre study, utilising the PERUKI network used in the original BronchStart study, to assess the effectiveness of maternal vaccination using a test-negative study design. We will gather detailed clinical information on children admitted with bronchiolitis in the post-RSV vaccination era, and understand possible reasons for incomplete vaccine uptake.
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- 2024
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10. Prévention des infections à virus respiratoire syncytial.
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Coudert, Pascal
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Copyright of Actualités Pharmaceutiques is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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11. Pharmacokinetic Study Comparing MB05 (Proposed Palivizumab Biosimilar), EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
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- 2023
12. A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
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- 2023
13. An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications
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McCormack, James P., Crommelin, Daan J. A., editor, Sindelar, Robert D., editor, and Meibohm, Bernd, editor
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- 2024
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14. Respiratory Morbidity in Prematurely Born Children Receiving Palivizumab Prophylaxis of Respiratory Syncytial Virus Disease
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Milena Bjelica, Gordana Vilotijević Dautović, Slobodan Spasojević, Marija Đermanović, and Milica Plazačić
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bronchopulmonary dysplasia ,palivizumab ,premature birth ,respiratory infections ,wheezing ,Pediatrics ,RJ1-570 - Abstract
Background: Preterm delivery is a risk factor for increased respiratory morbidity in early childhood. This study aimed to quantify respiratory morbidity in preterm survivors, comparing incidence rates among different gestational ages, birth weighst, and current age groups. Additionally, we sought to evaluate variations in respiratory outcomes between groups with and without bronchopulmonary dysplasia (BPD). Methods: Our study included 89 prematurely born children who were receiving palivizumab prophylaxis for respiratory syncytial virus infection. We categorized the patients based on four criteria: 1) current age of less and more than 1 year, 2) gestational age (GA) of less and more than 30 weeks, 3) birth weight (BW) of less than 1000 g, between 1000 g and 1500 g, and more than 1500 g, 4) with and without BPD. We compared these groups in terms of respiratory morbidity and respiratory therapy. Results: The average age was 11.9 months, the average GA was 28.9 weeks and the average BW was 1202.4 g. According to the 28-day definition of BPD 75.3% patients had BPD. Around one-third (35.9%) of patients experienced wheezing episodes, 7.8% had pneumonia, 10.1% were hospitalized due to respiratory exacerbation and just 1.1% had RSV infection. There were no statistically significant differences between the different age, GA, BW, or BPD/non-BPD groups in the number of hospitalizations or pneumonia. On the other hand, children older than 12 months and children with BPD had significantly more wheezing episodes. Fifty-nine (66.3%) patients had been receiving inhaled corticosteroids (ICS), all of whom had BPD. Conclusion: Prematurely-born children receiving palivizumab had significant respiratory morbidity, but majority did not have RSV infection. Further clinical studies are necessary to improve our understanding of the role of ICS in patients with established BPD.
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- 2024
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15. Cost-utility analysis of palivizumab for preventing respiratory syncytial virus in preterm neonates and infants in Colombia
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Jaime E. Ordóñez and Victor M. Huertas
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Respiratory syncytial viruses ,Premature birth ,Bronchopulmonary dysplasia ,Congenital heart defects ,Palivizumab ,Respiratory sounds ,Infectious and parasitic diseases ,RC109-216 - Abstract
Abstract 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.
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- 2024
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16. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29–34 6/7 weeks' gestation in the United States
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Tianzhou Yu, William V. Padula, Leah Yieh, and Cynthia L. Gong
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Cost-effectiveness analysis ,Palivizumab ,Premature birth ,Respiratory syncytial viruses ,Pediatrics ,RJ1-570 - Abstract
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.
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- 2024
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17. RSV (Respiratory Syncytial Virus)
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Palivizumab ,Lung diseases -- Risk factors ,Infants (Premature) - Abstract
What is RSV? Respiratory syncytial virus (RSV) is a common virus that affects your lungs and makes it difficult to breathe. The virus is common in children under 2, however, [...]
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- 2024
18. Respiratory syncytial virus immunization patterns in Germany, 2015–2020
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Moritz Wick, Roman Kliemt, Anahita Poshtiban, Nils Kossack, Gerhard-Paul Diller, Samira Soudani, Mathieu Bangert, Rolf Kramer, and Oliver Damm
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Respiratory syncytial virus ,infants ,immunization ,palivizumab ,claims analysis ,Germany ,Immunologic diseases. Allergy ,RC581-607 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children worldwide. Using routine statutory health insurance claims data including patients from all regions of Germany, we investigated the health-care resource use and costs associated with RSV prophylaxis with palivizumab in Germany. In the database, infants from the birth cohorts 2015–2019 eligible for palivizumab immunization were identified using codes of the 10th revision of the International Classification of Diseases (ICD-10). Health-care resource use and costs related to immunization were determined by inpatient and outpatient administrations. Over the study period, only 1.3% of infants received at least one dose of palivizumab in their first year of life. The mean number of doses per immunized infant was 4.6. From a third-party payer perspective, the mean costs of palivizumab per infant who received at least one dose in the first year of life was €5,435 in the birth cohorts 2015–2019. Despite the substantial risk of severe RSV infection, we found low rates of palivizumab utilization. Novel preventive interventions, featuring broader indications and single-dose administration per season, contribute to mitigating the burden of RSV disease across a more extensive infant population.
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- 2024
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19. Immune Prophylaxis Targeting the Respiratory Syncytial Virus (RSV) G Protein
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Bergeron, Harrison C, Murray, Jackelyn, Arora, Aakash, Castrejon, Ana M Nuñez, DuBois, Rebecca M, Anderson, Larry J, Kauvar, Lawrence M, and Tripp, Ralph A
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Microbiology ,Biological Sciences ,Prevention ,Pediatric ,Vaccine Related ,Pneumonia & Influenza ,Lung ,Biotechnology ,Immunization ,Infectious Diseases ,Pneumonia ,Development of treatments and therapeutic interventions ,5.1 Pharmaceuticals ,Infection ,Mice ,Humans ,Animals ,Aged ,Palivizumab ,Antibodies ,Viral ,Viral Fusion Proteins ,Respiratory Syncytial Virus ,Human ,Respiratory Syncytial Virus Infections ,Antibodies ,Monoclonal ,Epitopes ,RSV ,G protein ,F protein ,mAb ,3D3 ,2D10 ,palivizumab - Abstract
The respiratory syncytial virus (RSV) causes significant respiratory disease in young infants and the elderly. Immune prophylaxis in infants is currently limited to palivizumab, an anti-RSV fusion (F) protein monoclonal antibody (mAb). While anti-F protein mAbs neutralize RSV, they are unable to prevent aberrant pathogenic responses provoked by the RSV attachment (G) protein. Recently, the co-crystal structures of two high-affinity anti-G protein mAbs that bind the central conserved domain (CCD) at distinct non-overlapping epitopes were solved. mAbs 3D3 and 2D10 are broadly neutralizing and block G protein CX3C-mediated chemotaxis by binding antigenic sites γ1 and γ2, respectively, which is known to reduce RSV disease. Previous studies have established 3D3 as a potential immunoprophylactic and therapeutic; however, there has been no similar evaluation of 2D10 available. Here, we sought to determine the differences in neutralization and immunity to RSV Line19F infection which recapitulates human RSV infection in mouse models making it useful for therapeutic antibody studies. Prophylactic (24 h prior to infection) or therapeutic (72 h post-infection) treatment of mice with 3D3, 2D10, or palivizumab were compared to isotype control antibody treatment. The results show that 2D10 can neutralize RSV Line19F both prophylactically and therapeutically, and can reduce disease-causing immune responses in a prophylactic but not therapeutic context. In contrast, 3D3 was able to significantly (p < 0.05) reduce lung virus titers and IL-13 in a prophylactic and therapeutic regimen suggesting subtle but important differences in immune responses to RSV infection with mAbs that bind distinct epitopes.
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- 2023
20. Cost-utility analysis of palivizumab for preventing respiratory syncytial virus in preterm neonates and infants in Colombia.
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Ordóñez, Jaime E. and Huertas, Victor M.
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PREMATURE infants , *RESPIRATORY syncytial virus , *NEONATAL nursing , *COST effectiveness , *PALIVIZUMAB , *RESPIRATORY syncytial virus infections - Abstract
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. [ABSTRACT FROM AUTHOR]
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- 2024
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21. Formulary Drug Reviews: Nirsevimab.
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Levien, Terri L. and Baker, Danial E.
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THERAPEUTIC use of immunoglobulins , *THERAPEUTIC use of monoclonal antibodies , *DRUG efficacy , *PHARMACOLOGY , *MONOCLONAL antibodies , *MEDICAL protocols , *PALIVIZUMAB , *DRUG interactions , *DRUG monitoring , *PHARMACY information services , *RESPIRATORY syncytial virus infections , *DRUG storage , *PATIENT safety , *CHILDREN - Abstract
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. [ABSTRACT FROM AUTHOR]
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- 2024
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22. Respiratory Morbidity in Prematurely Born Children Receiving Palivizumab Prophylaxis of Respiratory Syncytial Virus Disease.
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Bjelica, Milena, Dautović, Gordana Vilotijević, Spasojević, Slobodan, Đermanović, Marija, and Plazačić, Milica
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RESPIRATORY syncytial virus infections , *PALIVIZUMAB , *BRONCHOPULMONARY dysplasia , *GESTATIONAL age , *PREMATURE labor - Abstract
Background: Preterm delivery is a risk factor for increased respiratory morbidity in early childhood. This study aimed to quantify respiratory morbidity in preterm survivors, comparing incidence rates among different gestational ages, birth weighst, and current age groups. Additionally, we sought to evaluate variations in respiratory outcomes between groups with and without bronchopulmonary dysplasia (BPD). Methods: Our study included 89 prematurely born children who were receiving palivizumab prophylaxis for respiratory syncytial virus infection. We categorized the patients based on four criteria: 1) current age of less and more than 1 year, 2) gestational age (GA) of less and more than 30 weeks, 3) birth weight (BW) of less than 1000 g, between 1000 g and 1500 g, and more than 1500 g, 4) with and without BPD. We compared these groups in terms of respiratory morbidity and respiratory therapy. Results: The average age was 11.9 months, the average GA was 28.9 weeks and the average BW was 1202.4 g. According to the 28-day definition of BPD 75.3% patients had BPD. Around one-third (35.9%) of patients experienced wheezing episodes, 7.8% had pneumonia, 10.1% were hospitalized due to respiratory exacerbation and just 1.1% had RSV infection. There were no statistically significant differences between the different age, GA, BW, or BPD/non-BPD groups in the number of hospitalizations or pneumonia. On the other hand, children older than 12 months and children with BPD had significantly more wheezing episodes. Fifty-nine (66.3%) patients had been receiving inhaled corticosteroids (ICS), all of whom had BPD. Conclusion: Prematurely-born children receiving palivizumab had significant respiratory morbidity, but majority did not have RSV infection. Further clinical studies are necessary to improve our understanding of the role of ICS in patients with established BPD. [ABSTRACT FROM AUTHOR]
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- 2024
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23. Monoclonal antibodies targeting sites in respiratory syncytial virus attachment G protein provide protection against RSV-A and RSV-B in mice.
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Lee, Youri, Klenow, Laura, Coyle, Elizabeth M., Grubbs, Gabrielle, Golding, Hana, and Khurana, Surender
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MONOCLONAL antibodies ,RESPIRATORY syncytial virus ,G proteins ,RESPIRATORY syncytial virus infections ,CHIMERIC proteins ,PALIVIZUMAB - Abstract
Currently, only Palivizumab and Nirsevimab that target the respiratory syncytical virus (RSV) fusion protein are licensed for pre-treatment of infants. Glycoprotein-targeting antibodies may also provide protection against RSV. In this study, we generate monoclonal antibodies from mice immunized with G proteins from RSV-A2 and RSV-B1 strains. These monoclonal antibodies recognize six unique antigenic classes (G0-G5). None of the anti-G monoclonal antibodies neutralize RSV-A2 or RSV-B1 in vitro. In mice challenged with either RSV-A2 line 19 F or RSV-B1, one day after treatment with anti-G monoclonal antibodies, all monoclonal antibodies reduce lung pathology and significantly reduce lung infectious viral titers by more than 2 logs on day 5 post-RSV challenge. RSV dissemination in the lungs was variable and correlated with lung pathology. We demonstrate new cross-protective anti-G monoclonal antibodies targeting multiple sites including conformation-dependent class G0 MAb 77D2, CCD-specific class G1 MAb 40D8, and carboxy terminus of CCD class G5 MAb 7H11, to support development of G-targeting monoclonal antibodies against RSV. Effective antibodies targeting various respiratory syncytial virus (RSV) proteins are needed to address public health burden of RSV. Here the authors shows that in addition to the currently approved F-targeting monoclonal antibodies, anti-G cross-reactive monoclonal antibodies to RSV-A and RSV-B strains can provide cross-protection and prevent from RSV disease. [ABSTRACT FROM AUTHOR]
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- 2024
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24. Inhaled "Muco‐Trapping" Monoclonal Antibody Effectively Treats Established Respiratory Syncytial Virus (RSV) Infections.
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McSweeney, Morgan D., Alnajjar, Sarhad, Schaefer, Alison M., Richardson, Zach, Wolf, Whitney, Stewart, Ian, Sriboonyapirat, Pun, McCallen, Justin, Farmer, Ellen, Nzati, Bernadette, Lord, Sam, Farrer, Brian, Moench, Thomas R., Kumar, Priya A., Arora, Harendra, Pickles, Raymond J., Hickey, Anthony J., Ackermann, Mark, and Lai, Samuel K.
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RESPIRATORY syncytial virus , *LUNGS , *MONOCLONAL antibodies , *VIRAL load , *BRONCHOALVEOLAR lavage , *PALIVIZUMAB , *RESPIRATORY infections , *PHEROMONE traps - Abstract
Respiratory syncytial virus (RSV) causes substantial morbidity and mortality in infants, the immunocompromised, and the elderly. RSV infects the airway epithelium via the apical membrane and almost exclusively sheds progeny virions back into the airway mucus (AM), making RSV difficult to target by systemically administered therapies. An inhalable "muco‐trapping" variant of motavizumab (Mota‐MT), a potent neutralizing mAb against RSV F is engineered. Mota‐MT traps RSV in AM via polyvalent Fc‐mucin bonds, reducing the fraction of fast‐moving RSV particles in both fresh pediatric and adult AM by ≈20–30‐fold in a Fc‐glycan dependent manner, and facilitates clearance from the airways of mice within minutes. Intranasal dosing of Mota‐MT eliminated viral load in cotton rats within 2 days. Daily nebulized delivery of Mota‐MT to RSV‐infected neonatal lambs, beginning 3 days after infection when viral load is at its maximum, led to a 10 000‐fold and 100 000‐fold reduction in viral load in bronchoalveolar lavage and lung tissues relative to placebo control, respectively. Mota‐MT‐treated lambs exhibited reduced bronchiolitis, neutrophil infiltration, and airway remodeling than lambs receiving placebo or intramuscular palivizumab. The findings underscore inhaled delivery of muco‐trapping mAbs as a promising strategy for the treatment of RSV and other acute respiratory infections. [ABSTRACT FROM AUTHOR]
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- 2024
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25. An epidemiological investigation of high-risk infants for Respiratory Syncytial Virus infections: a retrospective cohort study.
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Servadio, Michela, Finocchietti, Marco, Vassallo, Chiara, Cipelli, Riccardo, Heiman, Franca, Di Lucchio, Giulia, Oresta, Bianca, Addis, Antonio, and Belleudi, Valeria
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RISK assessment , *MEDICAL care use , *PEARSON correlation (Statistics) , *RESPIRATORY syncytial virus , *PALIVIZUMAB , *RESEARCH funding , *FISHER exact test , *RESPIRATORY syncytial virus infections , *RETROSPECTIVE studies , *DISEASE prevalence , *CHI-squared test , *DESCRIPTIVE statistics , *NEWBORN infants , *LONGITUDINAL method , *HOSPITAL care of newborn infants , *SYMPATHOMIMETIC agents , *SOCIODEMOGRAPHIC factors , *HEALTH outcome assessment , *CONFIDENCE intervals , *DATA analysis software , *GLUCOCORTICOIDS - Abstract
Background: Respiratory Syncytial Virus (RSV) infections may lead to severe consequences in infants born preterm with breathing problems (such as bronchopulmonary dysplasia (BPD) and respiratory distress syndrome (RDS)) or congenital heart diseases (CHD). Since studies investigating the influence of different gestational age (WGA) and concomitant specific comorbidities on the burden of RSV infections are scarce, the present study aimed to better characterize these high-risk populations in the Italian context. Methods: This retrospective, longitudinal and record-linkage cohort study involved infants born between 2017 and 2019 in Lazio Region (Italy) and is based on data extracted from administrative databases. Each infant was exclusively included in one of the following cohorts: (1) BPD-RDS (WGA ≤35 with or without CHD) or (2) CHD (without BPD and/or RDS) or (3) Preterm (WGA ≤35 without BPD (and/or RDS) or CHD). Each cohort was followed for 12 months from birth. Information related to sociodemographic at birth, and RSV and Undetermined Respiratory Agents (URA) hospitalizations and drug consumption at follow-up were retrieved and described. Results: A total of 8,196 infants were selected and classified as 1,084 BPD-RDS, 3,286 CHD and 3,826 Preterm. More than 30% of the BPD-RDS cohort was composed by early preterm infants (WGA ≤ 29) in contrast to the Preterm cohort predominantly constitute by moderate preterm infants (98.2%), while CHD infants were primarily born at term (83.9%). At follow-up, despite the cohorts showed similar proportions of RSV hospitalizations, in BPD-RDS cohort hospitalizations were more frequently severe compared to those occurred in the Preterm cohort (p<0.01), in the BPD-RDS cohort was also found the highest proportion of URA hospitalizations (p<0.0001). In addition, BPD-RDS infants, compared to those of the remaining cohorts, received more frequently prophylaxis with palivizumab (p<0.0001) and were more frequently treated with adrenergics inhalants, and glucocorticoids for systemic use. Conclusions: The assessment of the study clinical outcomes highlighted that, the demographic and clinical characteristics at birth of the study cohorts influence their level of vulnerability to RSV and URA infections. As such, continuous monitoring of these populations is necessary in order to ensure a timely organization of health care system able to respond to their needs in the future. [ABSTRACT FROM AUTHOR]
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- 2024
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26. Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children: Rationale and Progress to Date.
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Verwey, Charl, Dangor, Ziyaad, and Madhi, Shabir A.
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RESPIRATORY syncytial virus infections , *MONOCLONAL antibodies , *RESPIRATORY infections , *PALIVIZUMAB , *RESPIRATORY syncytial virus - Abstract
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, and is associated with long-term pulmonary sequelae for up to 30 years after infection. The mainstay of RSV management is supportive therapy such as supplemental oxygen. Palivizumab (Synagis™–AstraZeneca), a monoclonal antibody targeting the RSV F protein site II, has been licensed for the prevention of RSV in high-risk groups since 1998. There has been recent promising progress in preventative strategies that include vaccines and long-acting, high-potency monoclonal antibodies. Nirsevimab (Beyfortus™–AstraZeneca/Sanofi), a monoclonal antibody with an extended half-life, has recently been registered in the European Union and granted licensure by the US Food and Drug Administration. Furthermore, a pre-fusion sub-unit protein vaccine has been granted licensure for pregnant women, aimed at protecting their young infants, following established safety and efficacy in clinical trials (Abrysvo™–Pfizer). Also, multiple novel antiviral therapeutic options are in early phase clinical trials. The next few years have the potential to change the landscape of LRTI through improvements in the prevention and management of RSV LRTI. Here, we discuss these new approaches, current research, and clinical trials in novel therapeutics, monoclonal antibodies, and vaccines against RSV infection in infants and children. [ABSTRACT FROM AUTHOR]
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- 2024
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27. Effects of palivizumab prophylaxis on respiratory syncytial virus (RSV) infections in Montenegro.
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Lekic, Envera, Dragas, Ljubinka, Nikcevic, Drasko, Lekic, Jasmina, Dedic, Ana, and Sulovic, Ljiljana
- Abstract
Background. Respiratory syncytial virus (RSV) is one of the most common pathogens causing severe lower respiratory tract disease in infancy and childhood. In newborns, young infants, and in infants with co-morbidities, the risk of severe infection is increased. Current protection against severe RSV infection is immunoprophylaxis with the monoclonal antibody palivizumab. The study aimed to assess the effects of palivizumab prophylaxis in the Republic of Montenegro in comparison to the pre-prophylaxis period. Methods. The study was conducted in prospective/retrospective single center format in Montenegro in the Clinical Center of Podgorica, for the period 2009-2019. Results. A total of 104 high-risk infants in the palivizumab prophylaxis program (2014-2019 RSV seasons) and 168 high-risk children without palivizumab prophylaxis (2009-2013 RSV seasons) were enrolled. A total of 51 children (49.0%) received prophylaxis for prematurity, 33 (31.7%) for bronchopulmonary dysplasia (BPD), 13 (12.5%) for hemodynamically significant heart disease/defect (HSCHD), and 7 (6.8%) for "miscellaneous" indications. In the control group most children had prematurity (101, 60.1%), followed by BPD (59, 35.1%), HSCHD (3, 1.8%), and "miscellaneous" (5, 3.4%) conditions. Readmission to the pediatric intensive care units (PICU) due to RSV infection was significantly lower in prophylaxis group (0.0 vs 16.1%, p<0.001). No lethal outcomes were observed in high-risk children with palivizumab prophylaxis compared to 2.4% in the control group. Conclusions. The introduction of RSV immunoprophylaxis as well as other new protective treatment strategies for high-risk newborns led to significant improvements in infant and childcare in Montenegro. This is the first report on palivizumab prophylaxis in Montenegro, demonstrating the effectiveness and safety of palivizumab use in clinical settings. [ABSTRACT FROM AUTHOR]
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- 2024
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28. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29–34 6/7 weeks' gestation in the United States.
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Yu, Tianzhou, Padula, William V., Yieh, Leah, and Gong, Cynthia L.
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PREMATURE infants ,RESPIRATORY syncytial virus ,PALIVIZUMAB ,COST effectiveness ,PREVENTIVE medicine - Abstract
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. 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. 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. 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. [ABSTRACT FROM AUTHOR]
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- 2024
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29. Balanced on the Biggest Wave: Nirsevimab for Newborns.
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McPherson, Christopher, Lockowitz, Christine R., and Newland, Jason G.
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THERAPEUTIC use of monoclonal antibodies ,CONTINUING education units ,MEDICAL protocols ,PATIENT safety ,RESPIRATORY syncytial virus ,PALIVIZUMAB ,VIROLOGY ,BRONCHIOLE diseases ,IMMUNOTHERAPY ,RESPIRATORY syncytial virus infections ,MONOCLONAL antibodies ,DRUG efficacy ,COMORBIDITY ,CHILDREN - Abstract
Respiratory syncytial virus (RSV) is the leading cause of hospitalization in infancy in the United States. Nearly all infants are infected by 2 years of age, with bronchiolitis requiring hospitalization often occurring in previously healthy children and long-term consequences of severe disease including delayed speech development and asthma. Incomplete passage of maternal immunity and a high degree of genetic variability within the virus contribute to morbidity and have also prevented successful neonatal vaccine development. Monoclonal antibodies reduce the risk of hospitalization from severe RSV disease, with palivizumab protecting high-risk newborns with comorbidities including chronic lung disease and congenital heart disease. Unfortunately, palivizumab is costly and requires monthly administration of up to five doses during the RSV season for optimal protection. Rapid advances in the past two decades have facilitated the identification of antibodies with broad neutralizing activity and allowed manipulation of their genetic code to extend half-life. These advances have culminated with nirsevimab, a monoclonal antibody targeting the Ø antigenic site on the RSV prefusion protein and protecting infants from severe disease for an entire 5-month season with a single dose. Four landmark randomized controlled trials, the first published in July 2020, have documented the efficacy and safety of nirsevimab in healthy late-preterm and term infants, healthy preterm infants, and high-risk preterm infants and those with congenital heart disease. Nirsevimab reduces the risk of RSV disease requiring medical attention (number needed to treat [NNT] 14–24) and hospitalization (NNT 33–63) with rare mild rash and injection site reactions. Consequently, the Centers for Disease Control and Prevention has recently recommended nirsevimab for all infants younger than 8 months of age entering or born during the RSV season and high-risk infants 8–19 months of age entering their second season. Implementing this novel therapy in this large population will require close multidisciplinary collaboration. Equitable distribution through minimizing barriers and maximizing uptake must be prioritized. [ABSTRACT FROM AUTHOR]
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- 2024
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30. Clinical, Genomic, and Immunological Characterization of RSV Surge in Sydney, Australia, 2022.
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Walker, Gregory J., Foster, Charles S. P., Sevendal, Andrea, Domazetovska, Ana, Kamalakkannan, Abbish, Williams, Phoebe C. M., Ki Wook Kim, Condylios, Anna, Stelzer-Braid, Sacha, Bartlett, Adam W., and Rawlinson, William
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THERAPEUTIC use of monoclonal antibodies , *RESPIRATORY syncytial virus , *SEQUENCE analysis , *GENETIC mutation , *PHYLOGENY , *IMMUNOGLOBULINS , *MEDICAL care use , *COMPARATIVE studies , *ANTIBODY formation , *ARTIFICIAL respiration , *GENOMICS , *GENOMES , *HOSPITAL care , *RESPIRATORY therapy , *PALIVIZUMAB , *GENOTYPES , *DESCRIPTIVE statistics , *RESEARCH funding , *RESPIRATORY syncytial virus infections , *VIRAL antibodies , *COVID-19 pandemic , *CHILDREN - Abstract
OBJECTIVES: The 2022 seasonal respiratory syncytial virus (RSV) epidemic in Sydney, Australia saw an unprecedented number of RSV detections. We aimed to characterize genomic and immunologic factors associated with the surge in RSV cases. METHODS: Whole genome sequences of RSV were generated from 264 RSV-infected infants and linked to case-matched clinical data from the 2022 southern hemisphere RSV season. We then performed an immunologic analysis of baseline RSV-specific humoral immunity in women of childbearing age before and throughout the coronavirus disease 2019 pandemic. RESULTS: Clinical analysis revealed a high burden of disease across patients of all health backgrounds. More than one-half of RSV-related health care visits by infants resulted in hospitalization, and one-quarter required high-flow respiratory support or a higher level of care. Viral phylogenetic analyses revealed that 2022 Sydney RSV sequences were closely related to viruses that had been circulating globally since 2017, including those detected in recent US outbreaks. Nonsynonymous mutations within the palivizumab and nirsevimab binding sites were detected at low frequencies. There was no difference in baseline RSV-neutralizing antibody titers between 2020 and 2022. CONCLUSIONS: Collectively, these findings suggest that neither the emergence of a novel RSV genotype nor hypothesized immune debt was associated with the surge of RSV cases and hospitalizations in 2022. Continued genomic and immunologic surveillance is required to further understand the factors driving outbreaks of RSV globally, and to inform guidelines for the roll-out and ongoing use of recently developed immunotherapeutics and vaccines. [ABSTRACT FROM AUTHOR]
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- 2024
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31. Prevention and Potential Treatment Strategies for Respiratory Syncytial Virus.
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Sun, Bo-Wen, Zhang, Peng-Peng, Wang, Zong-Hao, Yao, Xia, He, Meng-Lan, Bai, Rui-Ting, Che, Hao, Lin, Jing, Xie, Tian, Hui, Zi, Ye, Xiang-Yang, and Wang, Li-Wei
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RESPIRATORY syncytial virus , *INFANTS , *PALIVIZUMAB , *MOLECULAR structure , *RESPIRATORY infections , *IMMUNOCOMPROMISED patients , *NITROGEN cycle - Abstract
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. [ABSTRACT FROM AUTHOR]
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- 2024
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32. Efficacy of Palivizumab Immunoprophylaxis for Reducing Severe RSV Outcomes in Children with Immunodeficiencies: A Systematic Review.
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Reicherz, Frederic, Abu-Raya, Bahaa, Akinseye, Omolabake, Rassekh, Shahrad Rod, Wiens, Matthew O, and Lavoie, Pascal M
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MORTALITY prevention , *DRUG efficacy , *MEDICAL information storage & retrieval systems , *IMMUNOCOMPROMISED patients , *RESPIRATORY infections , *PALIVIZUMAB , *HOSPITAL care , *RESEARCH funding , *DESCRIPTIVE statistics , *DATA analysis software , *MEDLINE , *ACUTE diseases , *CHILDREN - Abstract
Background Palivizumab is recommended for prevention of severe respiratory syncytial virus (RSV) disease in immunocompromised children, despite a lack of strong supporting evidence. The recent approval of substitute RSV-neutralizing monoclonal antibodies against RSV, offers an opportunity to synthesize the most current evidence supporting the palivizumab standard of care. Objective To evaluate the efficacy of palivizumab in preventing acute respiratory tract infection- or RSV-related hospitalization, or mortality in immunocompromised children. Methods We searched Ovid MEDLINE and EMBASE for published clinical studies that investigated outcomes of palivizumab use in children. We included clinical trials, cohort studies, and case–control studies. The primary outcomes were RSV-related or respiratory viral infection-related hospitalizations, or RSV-related mortality. This systematic review was registered in PROSPERO (ID CRD42021248619) and is reported in accordance with the PRISMA guidelines. Results From the 1993 records, six studies were eligible and included, for a total of 625 immunocompromised children with an heterogeneous composition of primary and acquired immunodeficiencies enrolled from palivizumab programs. There were no intervention studies. None of the studies included a control group. RSV hospitalizations were infrequent (0%–3.1% of children). Most children included received palivizumab, although one study (n = 56) did not specify how many received palivizumab. RSV mortality was neither observed, in three studies, nor reported, in three other studies. Conclusions The evidence supporting the use of palivizumab for prevention of severe RSV disease in immunocompromised children remains extremely limited and appears insufficient to justify prioritizing this intervention as the current standard of care over alternative interventions. [ABSTRACT FROM AUTHOR]
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- 2024
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33. RSV-Prophylaxe.
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Resch, Bernhard and Sever-Yildiz, Gülsen
- Abstract
Copyright of Pädiatrie & Pädologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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- 2024
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34. Breakthroughs in the prevention of RSV disease among infants
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Barbieri, Robert L.
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United States. Food and Drug Administration ,United States. Centers for Disease Control and Prevention ,Pfizer Inc. ,Palivizumab ,Children -- Diseases ,Respiratory tract diseases -- Prevention ,Infants ,Public health ,Vaccines ,Pharmaceutical industry ,Health - Abstract
RSV disease is a major public health problem among infants younger than age 8 months, causing 100 to 300 deaths annually. In 2023, two new treatments, nirsevimab and RSVPreF vaccine, [...]
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- 2023
35. RSV vaccination during pregnancy: Finally ready for prime time: FDA approved in August of this year, the new bivalent RSV prefusion F vaccine represents a major and welcomed breakthrough, as an effective vaccine for women during pregnancy and for infant protection has eluded scientists and clinicians for 50 years
- Author
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Duff, Patrick
- Subjects
United States. Food and Drug Administration ,Palivizumab ,Vaccination ,Respiratory tract diseases -- Drug therapy ,Pregnancy ,Infection -- Drug therapy ,Drug approval ,Scientists ,Pregnant women -- Drug therapy ,Virus diseases in pregnancy -- Drug therapy ,Infants (Newborn) -- Drug therapy ,Virus diseases -- Drug therapy ,Health - Abstract
CASE Pregnant woman asks about the RSV vaccine A 28-year-old primigravid woman at 30 weeks' gestation inquires about the new vaccine to protect her newborn baby against respiratory syncytial virus [...]
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- 2023
36. Effect of an In-Home Palivizumab Administration Program for Children with Medical Complexity
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Hina Emanuel, Aravind Yadav, Julie C. Eapan, Maria Caldas-Vasquez, Tomika S. Harris, Katrina McBeth, Fatima Boricha, Janice John, Ivan G. Magana Ceballos., Giuseppe N. Colasurdo, Maria E. Tellez, Tina Reddy, Wilfredo De Jesús-Rojas, and Ricardo A. Mosquera
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children with medical complexity ,respiratory syncytial virus ,palivizumab ,Pediatrics ,RJ1-570 - Abstract
Background: In-home palivizumab administration programs (PH) have shown promise in reducing RSV-associated infections. These programs may be particularly beneficial for children with medical complexity (CMC) by limiting their exposure to healthcare-associated infections (HAIs) from non-RSV-related pathogens during transportation and visits to medical facilities. Methods: In this prospective study, 41 children with CMC less than 2 years of age were randomized by their health insurance to receive PH or in the clinic (PC) during the RSV season (October 2018–April 2019). Patients were stratified by home ventilation. The primary outcome was the total number of face-to-face encounters. Secondary outcomes were unscheduled clinic visits and hospitalizations secondary to the non-RSV LRTIs. Standard frequentist and Bayesian analyses were performed. Results: All demographic factors and strata were matched between PH (“n” = 13, mean age 22 mo. SD ± 1), and PC (“n” = 28, mean age: 18 mo. SD ± 1). There was a decrease in the number of total face-to-face encounters (adjusted for mechanical ventilation and baseline diagnosis) [(4.5 vs. 8.8), (RR: 1.8, 95% CI: 1.3–2.5, p = 0.001)], and hospitalizations [(0.3 vs. 1.25), (RR: 3.8, 95% CI: 1.3–11.3, p = 0.016)], in the PH vs PC groups. Bayesian analysis showed a 93% probability of benefit in favor of fewer face-to-face encounters in the PH group. Conclusions: This study suggests that PH administration may reduce healthcare utilization in CMC. Minimizing exposure to healthcare facilities and supporting home-based interventions are promising strategies for this population.
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- 2024
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37. Researchers at Medical University of Warsaw Release New Data on Respiratory Syncytial Viruses (Respiratory syncytial virus - current treatment options and future possibilities for prophylaxis)
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Palivizumab ,Respiratory tract diseases -- Care and treatment ,Physical fitness ,Health - Abstract
2024 JUL 6 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- New research on respiratory syncytial viruses is the subject of a new [...]
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- 2024
38. AstraZeneca Pharma net profit grows to Rs. 39.5 crore in Q4FY24
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Palivizumab ,Rivaroxaban ,Dapagliflozin ,Apixaban ,Company earnings/profit ,Pharmaceuticals and cosmetics industries - Abstract
Byline: Our Bureau AstraZeneca Pharma India Ltd has witnessed its net profit for the quarter ended March 31, 2024 doubling to Rs. 39.48 crore, as compared to Rs. 17.27 crore [...]
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- 2024
39. Personalized Tool Can Predict Infants at Increased Risk for RSV
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Palivizumab ,Respiratory tract diseases -- Drug therapy ,Health - Abstract
HealthDay News — A personalized tool can predict infants at increased risk for severe respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) who would benefit most from RSV prevention [...]
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- 2024
40. Consenso formal basado en la evidencia y opinión de expertos en inmunoprofilaxis con palivizumab en pacientes con cardiopatía congénita.
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Guzmán-Bustamante, Mónica I., Arévalo-Leal, Óscar G., Portilla-Ibarra, Alejandra J., Madrid-Pinilla, Antonio J., Palomino-Rodríguez, Arnaldo A., Ponce-Bravo, Luis E., Maza-Caneva, Olga C., Flórez-Muñoz, Sandra, Chávez-Bejarano, Diana R., Zuluaga-Peña, Juan P., Barrios-Taibel, Heidy T., Castro-Monsalve, Javier M., Franco-Rivera, Jaime A., Padilla-Castro, Andrea T., Pinto-Martínez, Iván A., Staper-Ortega, Claudia M., and Figueroa-Reyes, Aída L.
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CONGENITAL heart disease , *RESPIRATORY syncytial virus - Abstract
Introduction. Infants with congenital heart disease (CHD) constitute a patient cohort at risk of serious infections due to respiratory syncytial virus. The rate of respiratory infection complications in these patients is high compared with other groups. Given the high staff and economic burden of respiratory syncytial virus infection in high-risk groups, prevention of this infection is recommended. Method. The document was constructed in the following stages: a) defining the research questions; b) searching for, screening, evaluating and selecting the evidence; c) synthesizing the evidence to answer the research questions; d) conducting a GRADE evaluation; e) discussing in formal panels; f) establishing recommendations and expert opinion; and g) drafting, developing and reviewing the consensus document. Results. The 15 participants arrived at a consensus and framed 16 recommendations which, over the course of the consensus, were combined to ultimately leave 13. The certainty of the evidence ranged from low to moderate; the rating was lowered by the risk of bias and imprecision, and the recommendations were weakly in favor, indicating that the desirable consequences probably outweigh the undesirable consequences. The most important elements for this decision were the ratio of the effect size to damage, social availability and cost. Conclusion. The recommendations should serve as a guideline to facilitate immunoprophylaxis in infants with congenital heart disease. As new evidence emerges, these recommendations may need to be reconsidered and carefully reviewed. [ABSTRACT FROM AUTHOR]
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- 2024
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41. Protecting Infants from RSV: Understanding Guidance on New Prevention Tools.
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Hepworth, Susan, Hopkins, Bob, Jones, Jefferson, and Crowley, Karen
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RESPIRATORY syncytial virus , *RESPIRATORY diseases , *PNEUMONIA , *SAFETY , *PREMATURE infants , *HEALTH facilities , *PSYCHOLOGY of parents , *IMMUNIZATION , *MENTAL health , *RESPIRATORY infections , *MEDICAL protocols , *INTRAMUSCULAR injections , *VACCINE effectiveness , *WEBINARS , *INTERPROFESSIONAL relations , *AT-risk people , *COUGH , *BRONCHIOLE diseases , *PALIVIZUMAB , *HOSPITAL care , *RESPIRATORY syncytial virus infections , *WORLD Wide Web , *SYMPTOMS , *EVALUATION , *CHILDREN - Abstract
The article focuses on a webinar titled "Protecting Infants from RSV: Understanding Guidance on New Prevention Tools," hosted by the National Coalition for Infant Health, with speakers from the Association of Women's Health, Obstetric and Neonatal Nurses, CDC, and the National Foundation for Infectious Diseases.
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- 2023
42. Respiratory Syncytial Virus Infection: An Update.
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Soni, Akshita, Kabra, S. K., and Lodha, Rakesh
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Respiratory syncytial virus (RSV) is a highly contagious respiratory virus that can cause mild to severe illness in children. It is the leading cause of lower respiratory tract infections (LRTI) in children under the age of one year, and it can also affect older children and adults, especially those with underlying medical conditions. In the post-COVID period, there seems to be an increase in the incidence, possibly due to 'immunity debt'. Symptoms of RSV infection in children may include fever, runny nose, and cough. In severe cases, it can lead to bronchiolitis (inflammation of the small airways in the lungs) or pneumonia (infection of the lungs). Most children with RSV infection recover within a week or two, but some may require hospitalization, especially those who are premature or have underlying medical conditions. As there is no specific treatment for RSV infection, supportive care is the mainstay of management. In severe cases, oxygen therapy or mechanical ventilation may be necessary. High flow nasal cannula seems to be beneficial. There have been promising advances in development of RSV vaccines; few trials in adults and pregnant women have reported encouraging results. The US FDA has approved two RSV vaccines for use in older adults (GSK's Arexvy and Pfizer's ABRYSVO) [ABSTRACT FROM AUTHOR]
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- 2023
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43. Effect of Palivizumab Prophylaxis on Respiratory Syncytial Virus Infection in Very Preterm Infants in the First Year of Life in The Netherlands.
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Schepp, Rutger M., Kaczorowska, Joanna, van Gageldonk, Pieter G. M., Rouers, Elsbeth D. M., Sanders, Elisabeth A. M., Bruijning-Verhagen, Patricia C. J., and Berbers, Guy A. M.
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RESPIRATORY syncytial virus infections ,PREMATURE infants ,PALIVIZUMAB ,BIRTH weight ,PREVENTIVE medicine - Abstract
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]
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- 2023
- Full Text
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44. Aerosol Delivery of Palivizumab in a Neonatal Lamb Model of Respiratory Syncytial Virus Infection.
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Edirisinghe, Hasindu S., Rajapaksa, Anushi E., Royce, Simon G., Sourial, Magdy, Bischof, Robert J., Anderson, Jeremy, Sarila, Gulcan, Nguyen, Cattram D., Mulholland, Kim, Do, Lien Anh Ha, and Licciardi, Paul V.
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RESPIRATORY syncytial virus infections , *PALIVIZUMAB , *LAMBS , *RESPIRATORY syncytial virus , *INTRAMUSCULAR injections , *IMMUNOGLOBULINS , *MONOCLONAL antibodies - Abstract
(1) Background: Palivizumab has been an approved preventative monoclonal antibody for respiratory syncytial virus (RSV) infection for over two decades. However, due to its high cost and requirement for multiple intramuscular injections, its use has been limited mostly to high-income countries. Following our previous study showing the successful lung deposition of aerosolised palivizumab in lambs, this current study evaluated the "proof-of-principle" effect of aerosolised palivizumab delivered as a therapeutic to neonatal lambs following RSV infection. (2) Methods: Neonatal lambs were intranasally inoculated with RSV-A2 on day 0 (day 3 post-birth) and treated with aerosolised palivizumab 3 days later (day 3 post-inoculation). Clinical symptoms, RSV viral load and inflammatory response were measured post-inoculation. (3) Results: Aerosolised therapeutic delivery of palivizumab did not reduce RSV viral loads in the nasopharynx nor the bronchoalveolar lavage fluid, but resulted in a modest reduction in inflammatory response at day 6 post-inoculation compared with untreated lambs. (4) Conclusions: This proof-of-principle study shows some evidence of aerosolised palivizumab reducing RSV inflammation, but further studies using optimized protocols are needed in order to validate these findings. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
- View/download PDF
45. Respiratory syncytial virus–approved mAb Palivizumab as ligand for anti-idiotype nanobody-based synthetic cytokine receptors.
- Author
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Ettich, Julia, Wittich, Christoph, Moll, Jens M., Behnke, Kristina, Floss, Doreen M., Reiners, Jens, Christmann, Andreas, Lang, Philipp A., Smits, Sander H. J., Kolmar, Harald, and Scheller, Jürgen
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SYNTHETIC receptors , *CYTOKINE receptors , *PALIVIZUMAB , *INTERLEUKIN-6 receptors , *CELL physiology , *IMMUNOGLOBULINS - Abstract
Synthetic cytokine receptors can modulate cellular functions based on an artificial ligand to avoid off-target and/or unspecific effects. However, ligands that can modulate receptor activity so far have not been used clinically because of unknown toxicity and immunity against the ligands. Here, we developed a fully synthetic cytokine/cytokine receptor pair based on the antigen-binding domain of the respiratory syncytial virus– approved mAb Palivizumab as a synthetic cytokine and a set of anti-idiotype nanobodies (AIPVHH) as synthetic receptors. Importantly, Palivizumab is neither cross-reactive with human proteins nor immunogenic. For the synthetic receptors, AIPVHH were fused to the activating interleukin-6 cytokine receptor gp130 and the apoptosis-inducing receptor Fas. We found that the synthetic cytokine receptor AIPVHHgp130 was efficiently activated by dimeric Palivizumab single-chain variable fragments. In summary, we created an in vitro nonimmunogenic full-synthetic cytokine/cytokine receptor pair as a proof of concept for future in vivo therapeutic strategies utilizing nonphysiological targets during immunotherapy. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
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46. RSV Disease Threat and Innovative Prevention Methods in Health Protection: A Review
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Paulina Dąbrowska, Michał Żuber, Karol Bochyński, Katarzyna Molenda, Katarzyna Ciuba, Barbara Borodziuk, Filip Borodziuk, Michał Dacka, Kamila Giżewska, and Konrad Białogłowski
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Respiratory syncytial virus (RSV) ,Bronchitis ,RSV prevention ,Palivizumab ,Nirsevimab ,RSV vaccine ,Education ,Sports ,GV557-1198.995 ,Medicine - Abstract
Respiratory syncytial virus (RSV) causes infections of the lower respiratory tract. A group particularly vulnerable to severe infection are young children under 2 years of age and the elderly. The infection can cause the entire spectrum of respiratory symptoms from upper respiratory tract infections to severe courses requiring assisted breathing. Until recently, the only form of protection against infection was passive immunization, i.e. administration of immunoglobulins. Chief among these are palivizumab and nirsevimab. In May u June 2023, the Food and Drug Administration (FDA) approved for use 2 vaccines against RSV are Arexvy and Abrysvo. In this study, we focus on presenting and describing the clinical evidence supporting the effectiveness of these immunization methods.
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- 2024
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47. Review of the Safety, Efficacy and Tolerability of Palivizumab in the Prevention of Severe Respiratory Syncytial Virus (RSV) Disease
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O'Hagan S, Galway N, Shields MD, Mallett P, and Groves HE
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rsv ,palivizumab ,efficacy ,safety ,future directions ,Medicine (General) ,R5-920 - Abstract
Shaun O’Hagan,1,2 Niamh Galway,3 Michael D Shields,3,4 Peter Mallett,1,4 Helen E Groves1,2 1Paediatric Infectious Diseases, Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland; 2Wellcome-Wolfson Institute for Experimental Medicine, Queen’s University Belfast, Belfast, Northern Ireland; 3Paediatric Respiratory Medicine, Royal Belfast Hospital for Sick Children, Belfast, Northern Ireland; 4Centre for Medical Education, Queen’s University Belfast School of Medicine, Belfast, Northern IrelandCorrespondence: Helen E Groves, Email h.groves@qub.ac.ukAbstract: Respiratory Syncytial Virus (RSV) is a major global cause of childhood morbidity and mortality. Palivizumab, a monoclonal antibody that provides passive immunity against RSV, is currently licensed for prophylactic use in specific “high-risk” populations, including congenital heart disease, bronchopulmonary dysplasia and prematurity. Available research suggests palivizumab use in these high-risk populations can lead to a reduction in RSV-related hospitalization. However, palivizumab has not been demonstrated to reduce mortality, adverse events or length of hospital stay related to RSV. In this article, we review the management of RSV, indications for palivizumab prophylaxis, the safety, cost-effectiveness and efficacy of this preventative medication, and emerging therapeutics that could revolutionize future prevention of this significant pathogen.Keywords: RSV, palivizumab, efficacy, safety, future directions
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- 2023
48. La discusión por traer a Colombia un nuevo medicamento para los niños
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- 2024
49. Niños menores de 2 años recibirán vacuna de anticuerpo contra el virus sincitial en el HSMA
- Published
- 2024
50. Vaccine for pregnant women against bronchiolitis arrives in Brazil and can cost R$1760
- Published
- 2024
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