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Natalia Olchanski, Ryan N Hansen, Elle Pope, Brittany D'Cruz, Jaime Fergie, Mitchell Goldstein, Leonard R Krilov, Kimmie K McLaurin, Barbara Nabrit-Stephens, Gerald Oster, Kenneth Schaecher, Fadia T Shaya, Peter J Neumann, Sean D Sullivan
Respiratory syncytial virus (RSV) infection is the most common cause of lower respiratory tract infection and the leading cause of hospitalization among young children, incurring high annual costs among US children under the age of 5 years. Palivizumab has been found to be effective in reducing hospitalization and preventing serious lower respiratory tract infections in high-risk infants. This paper presents a systematic review of the cost-effectiveness studies of palivizumab and describes the main highlights of a round table discussion with clinical, payer, economic, research method, and other experts...
March 2018: Open Forum Infectious Diseases
Nienke M Scheltema, Elisabeth E Nibbelke, Juliëtte Pouw, Maarten O Blanken, Maroeska M Rovers, Christiana A Naaktgeboren, Natalie I Mazur, Joanne G Wildenbeest, Cornelis K van der Ent, Louis J Bont
BACKGROUND: Respiratory syncytial virus (RSV) infection is associated with subsequent wheeze and asthma. We previously reported on the causal relationship between prevention of RSV infection during infancy and reduced frequency of subsequent wheeze using a double-blind, randomised, placebo-controlled trial (MAKI). We continued follow-up and analysed the effect of RSV prevention during infancy on asthma and lung function at age 6 years. METHODS: We studied 429 infants born at 32-35 weeks of gestation between 2008-10 who had randomly received either palivizumab for RSV immunoprophylaxis or placebo during the RSV season of their first year of life...
February 27, 2018: Lancet Respiratory Medicine
Eric A F Simões, Louis Bont, Paolo Manzoni, Brigitte Fauroux, Bosco Paes, Josep Figueras-Aloy, Paul A Checchia, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV Evidence - A Geographical Archive of the Literature) series has provided a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This seventh and final publication covers the past, present and future approaches to the prevention and treatment of RSV infection among infants and children. METHODS: A systematic review was undertaken of publications between January 1, 1995 and December 31, 2017 across PubMed, Embase and The Cochrane Library...
February 22, 2018: Infectious Diseases and Therapy
Ahva Shahabi, Desi Peneva, Devin Incerti, Kimmie McLaurin, Warren Stevens
BACKGROUND: The variability in cost of palivizumab treatment, indicated for prevention of respiratory syncytial virus (RSV) infections in high-risk infants, has not been robustly estimated in prior studies. This study aimed to determine the cost variations of palivizumab from a US payer perspective for otherwise healthy preterm infants born 29-35 weeks gestational age (wGA) using infant characteristics and applied dosing regimens. METHODS: Fenton Growth Charts were merged with World Health Organization Child Growth Standards to estimate preterm infant growth patterns...
March 2018: PharmacoEconomics Open
Rupal M Patel, Larry K Kociolek, Emily Merrick, Caroline Reuter, Kenny Kronforst, Xiaotian Zheng, Sameer J Patel
Transitioning from administration of monthly palivizumab to a single dose at discharge was associated with substantial pharmacy cost savings. With the concurrent adoption of private hospital rooms and visitor restriction policies, hospital-wide and neonatal intensive care unit healthcare-associated respiratory syncytial virus infections decreased following these changes. Infect Control Hosp Epidemiol 2018;1-4.
February 21, 2018: Infection Control and Hospital Epidemiology
Adam S Walpert, Ian D Thomas, Merlin C Lowe, Michael D Seckeler
OBJECTIVE: The aim of this study was to compare inpatient outcomes and costs for children with respiratory syncytial virus and congenital heart disease before and after the change in management guidelines for respiratory syncytial virus prophylaxis. DESIGN: Hospital discharge data from the Vizient (formerly University HealthSystem Consortium) were queried from October 2012 to June 2014 (Era 1) and July 2014 to April 2016 (Era 2) for patients aged <24 months with an any International Classification of Disease (ICD)-9 or ICD-10 code for congenital heart disease (745-747...
February 13, 2018: Congenital Heart Disease
Ahmad Abushahin, Ibrahim Janahi, Amjad Tuffaha
Objective: The primary objective of this study was to document the hospitalization rate due to respiratory syncytial virus (RSV) and compliance with palivizumab use in preterm infants receiving palivizumab immunoprophylaxis during 2009-2012 RSV seasons. Design: This is a descriptive single-center cohort study. Infants who were ≤35-week gestational age were eligible for enrollment if they received the first palivizumab dose between November 1 and March 31 (2009-2010, 2010-2011, 2011-2012)...
2018: International Journal of General Medicine
Deni Hardiansyah, Chee Meng Ng
PURPOSE: The aim of this study was to develop a two-pore minimum physiologically-based pharmacokinetic (mPBPK) model in describing the pharmacokinetic (PK) of therapeutic monoclonal antibody (TMAb) in human subjects. METHODS: PK data used in this study were endogenous/exogenous native IgG and two TMAbs (palivizumab and Motavizumab-YTE) in normal volunteer or familial hypercatabolic hypoproteinemia (FIHH) patient. Several important components were implemented to overcome the limitations of the early mPBPK model, e...
February 6, 2018: Pharmaceutical Research
Jiri Beran, Jason D Lickliter, Tino F Schwarz, Casey Johnson, Laurence Chu, Joseph B Domachowske, Pierre Van Damme, Kanchanamala Withanage, Laurence A Fissette, Marie-Pierre David, Koen Maleux, Alexander C Schmidt, Marta Picciolato, Ilse Dieussaert
Background: Respiratory syncytial virus (RSV) causes bronchiolitis and pneumonia in neonates and infants. RSV vaccination during pregnancy could boost pre-existing neutralizing antibody titers, providing passive protection to newborns. Methods: Two observer-blind, controlled studies (RSV F-020 [NCT02360475], RSV F-024 [NCT02753413]) evaluated immunogenicity and safety of an investigational RSV vaccine in healthy, non-pregnant 18-45-year-old women. Both studies used licensed Tdap vaccine as control...
February 1, 2018: Journal of Infectious Diseases
H Torchin, J Rousseau, L Marchand-Martin, P Truffert, P-H Jarreau, P-Y Ancel
BACKGROUND: Several countries, including France, have restricted the indications for monoclonal antibodies directed against respiratory syncytial virus (RSV) compared to the marketing authorization (MA). No new data concerning use of palivizumab on a national scale have been published since the 2007 update of the national guidelines. OBJECTIVES: To describe palivizumab administration for RSV prophylaxis during the first RSV season in infants born prematurely in France in 2011...
January 27, 2018: Archives de Pédiatrie: Organe Officiel de la Sociéte Française de Pédiatrie
Shuenn-Nan Chiu, Jieh-Neng Wang, Yun-Ching Fu, Hung-Tao Chung, Ling-Yin Chang, Mei-Hwan Wu, Yu-Chuan Hua, Ming-Tai Lin, Chun-Wei Lu, Chun-An Chen, Jing-Ming Wu, Jou-Kou Wang
OBJECTIVE: To analyze the efficacy of a novel palivizumab protocol for hemodynamically significant congenital heart disease (hsCHD) in subtropical areas without clear respiratory syncytial virus seasonality. STUDY DESIGN: Since July 2013, the National Health Insurance program has provided reimbursement for palivizumab prophylaxis with a novel monthly protocol in selected patients with hsCHD under 1 year of age. We performed a multicenter study to assess the trend of respiratory syncytial virus hospitalizations in patients with hsCHD from 2010 to 2016 during the prepalivizumab, transition, and postpalivizumab periods, and compared treatment and propensity-matched control groups...
January 29, 2018: Journal of Pediatrics
Xunyan Ye, Obinna P Iwuchukwu, Vasanthi Avadhanula, Letisha O Aideyan, Trevor J McBride, Laura L Ferlic-Stark, Kirtida D Patel, Felipe-Andres Piedra, Dimpy P Shah, Roy F Chemaly, Pedro A Piedra
Background: Most RSV vaccine candidates include fusion (F) protein in different conformations. Antigenic site II found in the different F conformations is the target of palivizumab, the only FDA approved monoclonal antibody (mAb). Serum palivizumab-like antibody (PLA) is a potential serologic correlate of immunity. The objective was to determine if different conformations of F protein in a palivizumab competitive antibody (PCA) assay affect the PLA concentrations. Methods: Four PCA assays were standardized using mAbs...
January 22, 2018: Journal of Infectious Diseases
Ralph Schmidt, Istvan Majer, Natalia García Román, Alejandra Rivas Basterra, ElizaBeth Grubb, Constancio Medrano López
BACKGROUND: Respiratory syncytial virus (RSV) infection remains one of the major reasons of re-hospitalization among children with congenital heart disease (CHD). This study estimated the cost-effectiveness of palivizumab prophylaxis versus placebo, in Spain, from the societal perspective, using a novel cost-effectiveness model reflecting evidence-based clinical pathways. METHODS: A decision-analytic model, combining a decision tree structure in the first year and a Markov structure in later years, was constructed to evaluate the benefits and costs associated with palivizumab versus no prophylaxis among children with CHD...
December 19, 2017: Health Economics Review
Daiyin Tian, Michael B Battles, Syed M Moin, Man Chen, Kayvon Modjarrad, Azad Kumar, Masaru Kanekiyo, Kevin W Graepel, Noor M Taher, Anne L Hotard, Martin L Moore, Min Zhao, Zi-Zheng Zheng, Ning-Shao Xia, Jason S McLellan, Barney S Graham
A licensed vaccine for respiratory syncytial virus (RSV) is unavailable, and passive prophylaxis with the antibody palivizumab is restricted to high-risk infants. Recently isolated antibodies 5C4 and D25 are substantially more potent than palivizumab, and a derivative of D25 is in clinical trials. Here we show that unlike D25, 5C4 preferentially neutralizes subtype A viruses. The crystal structure of 5C4 bound to the RSV fusion (F) protein reveals that the overall binding mode of 5C4 is similar to that of D25, but their angles of approach are substantially different...
November 30, 2017: Nature Communications
Maarten O Blanken, Geert W Frederix, Elisabeth E Nibbelke, Hendrik Koffijberg, Elisabeth A M Sanders, Maroeska M Rovers, Louis Bont
The objective of the paper is to assess the cost-effectiveness of targeted respiratory syncytial virus (RSV) prophylaxis based on a validated prediction rule with 1-year time horizon in moderately preterm infants compared to no prophylaxis. Data on health care consumption were derived from a randomised clinical trial on wheeze reduction following RSV prophylaxis and a large birth cohort study on risk prediction of RSV hospitalisation. We calculated the incremental cost-effectiveness ratio (ICER) of targeted RSV prophylaxis vs...
November 22, 2017: European Journal of Pediatrics
Melissa Pavilack, Robert A Clifford, Tara Gonzales, Amanda M Kong, Sally Wade, Kimmie K McLaurin
INTRODUCTION: Palivizumab is indicated for the prevention of respiratory syncytial virus (RSV) infection in high-risk children. Previous palivizumab utilization studies examined prior authorization claims but did not examine utilization within insured populations as a whole. This study describes outpatient palivizumab utilization trends and characterizes high-risk infants receiving palivizumab within Medicaid- and commercially insured populations. METHODS: Infants born July 1, 2003 through June 30, 2013 were identified in the MarketScan(®) Multistate Medicaid and Commercial claims databases...
November 17, 2017: Infectious Diseases and Therapy
Sophie K Wong, Abby Li, Krista L Lanctôt, Bosco Paes
Palivizumab is a humanized monoclonal antibody used for respiratory syncytial virus (RSV) prophylaxis. RSV is the primary cause of lower respiratory tract infection in children aged <2 years, and can give rise to high-burden hospitalization and respiratory complications in later life. Adherence to a monthly dosing regimen, both in timing and injection number, is essential to sustain therapeutic levels of palivizumab and maintain protective status. Deviation from the approved dosing schedule may reduce the efficacy of palivizumab and increase the risk of breakthrough RSV infection and hospitalization...
January 2018: Expert Review of Respiratory Medicine
Ralph A Tripp, Ultan F Power, Peter J M Openshaw, Lawrence M Kauvar
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection (LRTI) annually affecting >2 million children in the US <5 years old. In the elderly (>65 years old), RSV results in ∼175,000 hospitalizations annually in the US with worldwide incidence ∼34 million. There is no approved RSV vaccine and treatments are limited. Recently, a Phase 3 trial in the elderly using a recombinant RSV F protein vaccine failed to meet its efficacy objectives, namely prevention of moderate-to-severe RSV-associated LRTI and reduced incidence of acute respiratory disease...
November 8, 2017: Journal of Virology
Shing-Yan Robert Lee, Ka Li Kwok, Daniel Kwok Keung Ng, Kam Lun Hon
Aim: To evaluate the cost-effectiveness of palivizumab prophylaxis for premature infants born <29 weeks in Hong Kong. Method: We evaluated the hospitalization rate for respiratory syncytial virus (RSV) infection within the first 12 months of discharge of a cohort of preterm infants born between 2010 and 2014 at two local hospitals. Results: In total, 40 of 135 infants were given palivizumab. The hospitalization rate for premature infants <29 weeks was reduced from 15...
November 2, 2017: Journal of Tropical Pediatrics
Torsten Joerger, Shannon Chan, Sanjeev K Swami, Lori K Handy
No abstract text is available yet for this article.
October 31, 2017: Journal of the Pediatric Infectious Diseases Society
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