scholarly journals Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants

2020 ◽  
Author(s):  
Eric A F Simões ◽  
Eduardo Forleo-Neto ◽  
Gregory P Geba ◽  
Mohamed Kamal ◽  
Feng Yang ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Preterm Infants ◽  
Primary Endpoint ◽  
Dose Group ◽  
Human Monoclonal Antibody ◽  
Double Blind ◽  
Treatment Groups ◽  
Relative Risks ◽  
Nominal Significance ◽  
Syncytial Virus

Abstract Background Respiratory syncytial virus (RSV) is a major cause of childhood medically attended respiratory infection (MARI). Methods We conducted a randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2 doses of suptavumab, a human monoclonal antibody that can bind and block a conserved epitope on RSV A and B subtypes, for the prevention of RSV MARI. The primary endpoint was proportion of subjects with RSV-confirmed hospitalizations or outpatient lower respiratory tract infection (LRTI). Results There were no significant differences between primary endpoint rates (8.1%, placebo; 7.7%, 1-dose; 9.3%, 2-dose). Suptavumab prevented RSV A infections (relative risks, .38; 95% confidence interval [CI], .14–1.05 in the 1-dose group and .39 [95% CI, .14–1.07] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .0499), while increasing the rate of RSV B infections (relative risk 1.36 [95% CI, .73–2.56] in the 1-dose group and 1.69 [95% CI, .92–3.08] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .12). Sequenced RSV isolates demonstrated no suptavumab epitope changes in RSV A isolates, while all RSV B isolates had 2–amino acid substitution in the suptavumab epitope that led to loss of neutralization activity. Treatment emergent adverse events were balanced across treatment groups. Conclusions Suptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts. Clinical Trials Registration NCT02325791. https://clinicaltrials.gov/ct2/show/NCT02325791

Respiratory syncytial virus-specific immunoglobulins in preterm infants

1993 ◽  
Vol 122 (5) ◽  
pp. 787-791 ◽  
Author(s):  
Teresa Murguia de Sierra ◽  
Mary L. Kumar ◽  
Thomas E. Wasser ◽  
Brian R. Murphy ◽  
E. Kanta Subbarao
Keyword(s):  
Respiratory Syncytial Virus ◽  
Preterm Infants ◽  
Syncytial Virus

scholarly journals A randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus

2010 ◽  
Vol 107 (19) ◽  
pp. 8800-8805 ◽  
Author(s):  
J. DeVincenzo ◽  
R. Lambkin-Williams ◽  
T. Wilkinson ◽  
J. Cehelsky ◽  
S. Nochur ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Syncytial Virus

A Survey of Parental Knowledge of Respiratory Syncytial Virus and Other Respiratory Infections in Preterm Infants

2021 ◽  
Vol 40 (1) ◽  
pp. 14-24
Author(s):  
Marianne Bracht ◽  
Fabiana Bacchini ◽  
Bosco Paes
Keyword(s):  
Respiratory Syncytial Virus ◽  
Preterm Infants ◽  
Disease Risk ◽  
Respiratory Infections ◽  
Parental Knowledge ◽  
Good Knowledge ◽  
Sources Of Information ◽  
Eligibility Criteria ◽  
Additional Information ◽  
Syncytial Virus

PurposeEvaluate parental knowledge of respiratory syncytial virus (RSV) and other respiratory infections in preterm infants.DesignSurvey.SampleFive hundred and eighty-three parents of preterm infants with generalized, Canadian provincial representation.Main OutcomeKnowledge of RSV infection, sources of information, and parental understanding of disease risk.Results97.9 percent (571/583) of the parents had heard about RSV, since they all had a preterm infant. Sixty-one percent reported having good knowledge of RSV; 19.4 percent had very good knowledge; 19.7 percent had little or no awareness of RSV-related infection. Most (86.3 percent) believed that RSV illness was a very serious condition; 13 percent recognized that it could be a major problem for their child. Principal sources of information were the nurse, doctor and pamphlets. Over 480 participants cited 3 or more sources of additional information—Internet, social media platforms, and educational sessions. Respiratory syncytial virus prophylaxis was a priority, but knowledge regarding the eligibility criteria for prophylaxis is essential.

scholarly journals A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein

2019 ◽  
Vol 64 (2) ◽  
Author(s):  
John DeVincenzo ◽  
Dereck Tait ◽  
John Efthimiou ◽  
Julie Mori ◽  
Young-In Kim ◽  
...  
Keyword(s):  
Viral Load ◽  
Respiratory Syncytial Virus ◽  
Adverse Events ◽  
Disease Severity ◽  
Controlled Trial ◽  
Primary Analysis ◽  
Double Blind ◽  
Challenge Virus ◽  
F Protein ◽  
Syncytial Virus

ABSTRACT Effective treatments for respiratory syncytial virus (RSV) infection are lacking. Here, we report a human proof-of-concept study for RV521, a small-molecule antiviral inhibitor of the RSV-F protein. In this randomized, double-blind, placebo-controlled trial, healthy adults were challenged with RSV-A Memphis-37b. After infection was confirmed (or 5 days after challenge virus inoculation), subjects received RV521 (350 mg or 200 mg) or placebo orally every 12 h for 5 days. The primary endpoint was area under the curve (AUC) for viral load, as assessed by reverse transcriptase quantitative PCR (RT-qPCR) of nasal wash samples. The primary efficacy analysis set included subjects successfully infected with RSV who received ≥1 dose of study drug. A total of 66 subjects were enrolled (n = 22 per group); 53 were included in the primary analysis set (RV521 350 mg: n = 16; 200 mg: n = 18; placebo: n = 19). The mean AUC of RT-qPCR-assessed RSV viral load (log10 PFU equivalents [PFUe]/ml · h) was significantly lower with RV521 350 mg (185.26; standard error [SE], 31.17; P = 0.002) and 200 mg (224.35; SE, 37.60; P = 0.007) versus placebo (501.39; SE, 86.57). Disease severity improved with RV521 350 mg and 200 mg versus placebo (P = 0.002 and P = 0.009, respectively, for AUC total symptom score [score × hours]). Daily nasal mucus weight was significantly reduced (P = 0.010 and P = 0.038 for RV521 350 mg and 200 mg, respectively, versus placebo). All treatment-emergent adverse events were grade 1 or 2. No subjects discontinued due to adverse events. There was no evidence of clinically significant viral resistance, and only three variants were detected. RV521 effectively reduced RSV viral load and disease severity in humans and was well tolerated. (This study has been registered at ClinicalTrials.gov under registration no. NCT03258502.)

Health Care Resource Utilization of Late Premature Versus Term Infants With Bronchiolitis

2020 ◽  
Vol 59 (8) ◽  
pp. 778-786
Author(s):  
David Greenberg ◽  
Ron Dagan ◽  
Eilon Shany ◽  
Shalom Ben-Shimol ◽  
Noga Givon-Lavi
Keyword(s):  
Health Care ◽  
Respiratory Syncytial Virus ◽  
Preterm Infants ◽  
Resource Utilization ◽  
Health Care Resource ◽  
Term Infants ◽  
Late Preterm Infants ◽  
Health Care Resource Utilization ◽  
Duration Of Hospitalization ◽  
Syncytial Virus

It is controversial whether it is cost-beneficial for late preterm infants to receive respiratory syncytial virus prophylaxis. This study compares community and hospital health care resource utilization (HCRU) of late premature infants (33-36 weeks gestational age) with term infants (>36 weeks gestational age) hospitalized with bronchiolitis. This was a retrospective, population-based, observational study spanning a 9-year period (2004-2012). HCRU data were obtained from the Health Maintenance Organization “Clalit” and included duration of hospitalization, physician visits, laboratory tests, and treatments. Compared with term infants, late preterm infants had significantly longer duration of hospitalization and higher admission rates to pediatric intensive care unit. They also had higher rates of mean outpatients clinic visits, total outpatient clinic and specialist visits, blood chemistry, and virology testing. HCRU of term infants with bronchiolitis was also substantial, indicating that they also can greatly benefit from respiratory syncytial virus prophylaxis. These findings can guide stakeholders in decisions concerning the prevention of bronchiolitis and will be useful in performing further cost-benefit analysis.

scholarly journals Caregiver Impact of Respiratory Syncytial Virus Hospitalizations Among United States Preterm Infants 29–35 Weeks' Gestational Age

2016 ◽  
Vol 3 (suppl_1) ◽  
Author(s):  
Robin M. Pokrzywinski ◽  
Laura L. Swett ◽  
Jumi Yi ◽  
Veena R. Kumar ◽  
Kimmie K. McLaurin ◽  
...  
Keyword(s):  
United States ◽  
Respiratory Syncytial Virus ◽  
Preterm Infants ◽  
Gestational Age ◽  
Syncytial Virus
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