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Human respiratory syncytial virus and other viral infections in infants receiving palivizumab.

ABSTRACT: BACKGROUND:Palivizumab is a humanized monoclonal antibody that prevents severe human respiratory syncytial virus (HRSV) infections. OBJECTIVES:We determined the etiology of respiratory viral infections in palivizumab recipients, and monitored the clinical outcome and HRSV genotype in HRSV-infected infants. STUDY DESIGN:Nasopharyngeal aspirates (NPAs) were collected from children receiving palivizumab who consulted or were hospitalized for acute respiratory tract infection (ARTI) during the 2004-2005 season. Viral cultures and multiplex RT-PCR for influenza A/B, HRSV and human metapneumovirus were performed. The fusion (F) gene of HRSV amplicons was also sequenced. RESULTS:Among 116 enrolled patients, 51 (44%) had > or = 1 episode of ARTI for a total of 93 visits. At least one virus was identified in 33 (36%) of the 93 NPA samples; HRSV accounted for 11 (33%) of confirmed viral etiologies. Compared to subjects who had other viral ARTI, HRSV-positive subjects had less fever (p=0.01) and tended to have more bronchiolitis (p=0.07). Ten subjects (11 visits) developed HRSV infection, although only one was hospitalized. HRSV was detected after a median of 5.5 palivizumab doses and a median of 14 days after the last dose. One of the 11 HRSV strains tested had a F mutation located in the palivizumab-binding site. CONCLUSION:HRSV is still a major cause of ARTI in children receiving palivizumab, although the outcome of infected children appears mild.

SUBMITTER: Boivin G

PROVIDER: S-EPMC7172843 | biostudies-literature | 2008 May

REPOSITORIES: biostudies-literature

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Human respiratory syncytial virus and other viral infections in infants receiving palivizumab.

Boivin Guy G Caouette Georges G Frenette Line L Carbonneau Julie J Ouakki Manale M De Serres Gaston G

Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology 20080227 1

<h4>Background</h4>Palivizumab is a humanized monoclonal antibody that prevents severe human respiratory syncytial virus (HRSV) infections.<h4>Objectives</h4>We determined the etiology of respiratory viral infections in palivizumab recipients, and monitored the clinical outcome and HRSV genotype in HRSV-infected infants.<h4>Study design</h4>Nasopharyngeal aspirates (NPAs) were collected from children receiving palivizumab who consulted or were hospitalized for acute respiratory tract infection ( ...[more]

PMID: 18164233

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Project description:IntroductionPalivizumab 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.MethodsInfants born July 1, 2003 through June 30, 2013 were identified in the MarketScan® Multistate Medicaid and Commercial claims databases. Infants with ≥ 18 months of continuous medical insurance enrollment with pharmacy benefits after birth and evidence of chronic lung disease of prematurity (CLDP), congenital heart disease (CHD), or preterm birth without CLDP or CHD were studied. Palivizumab use and demographic and clinical characteristics were measured in infant subgroups. Outpatient palivizumab utilization rates were calculated for each seasonal year (July-June) and for each infant subgroup.ResultsIn total, 29,350 (2.1%) Medicaid-insured and 9589 (2.5%) commercially insured infants received palivizumab and had CLDP, CHD, or were born at < 37 weeks gestational age (wGA). Infants with CLDP (82%) and those < 29 wGA (78%) had the highest utilization. Decreases in utilization rates between the 2003-2004 and 2012-2013 seasons were seen among Medicaid-insured infants born at 29-36 wGA (all P < .0001), and commercially insured infants born at 31-32 wGA (P < .0001), 33-34 wGA (P = .055), 35-36 wGA (P < .0001), and with CHD (P = .003). Utilization by month was consistent across subgroups among Medicaid- and commercially insured infants, with most doses administered from November to March.ConclusionPalivizumab use is targeted to a small percentage of infants who are at highest risk of hospitalization for RSV disease. Utilization declined in recent years in both Medicaid- and commercially insured infant groups. Most palivizumab doses were administered from November to March, with most infants receiving ≤ 5 doses.FundingAstraZeneca.

Project description:IntroductionChildhood respiratory syncytial virus (RSV) infection is a global phenomenon that can lead to fatal respiratory illness. Palivizumab is a drug that is routinely used in affluent countries as a prophylaxis against RSV infection; nevertheless, breakthrough infections are often reported. In light of new findings on potential RSV resistance to palivizumab, an up-to-date synthesis of evidence on effectiveness is needed. Furthering existing reviews, a broadened scope to better reflect effectiveness in a 'real world' clinical context is also important. This systematic review and meta-analysis will enhance our understanding of the effectiveness of palivizumab in varying populations of children. Findings from this review will inform recommendations for best practices regarding palivizumab use for childhood RSV infection as well as research priorities in RSV vaccine development.Methods and analysisWe will conduct a systematic review of primary population-based studies that examine the incidence of palivizumab breakthrough infections in children, published between 1997 to present. In collaboration with a research librarian, four electronic databases (MEDLINE, Embase, Cochrane Library, Web of Science) and additional sources will be searched. Study screening and quality assessment will be performed in duplicate. Data will be extracted by one reviewer, with partial and random verification by a second reviewer. The primary outcomes to assess breakthrough RSV infection will be hospitalisation, length of stay and the need for intensive care unit admission and mechanical ventilation in children receiving palivizumab. The secondary outcome will be RSV-associated mortality. We will conduct a meta-analysis using pooled effectiveness data, and include subgroup analyses by patient comorbidities and drug compliance. Sensitivity analyses for risk of bias and study design will also be performed.Ethics and disseminationThis systematic review will only include data from previously published literature and is therefore exempt from ethics approval. Final results will be disseminated through peer-reviewed publication and presented at academic conferences and scientific meetings engaging paediatric researchers and healthcare providers. Should findings from this review necessitate updates to current clinical practice guidelines, we intend to establish a working group to engage relevant health administrators and decision makers.Prospero registration numberCRD42019122120.

Project description:ImportanceInfection with the respiratory syncytial virus (RSV) is the leading cause of hospitalizations in children, accounting for more than 90,000 hospitalizations every year in the United States. For children who are at risk for severe RSV infections, the American Academy of Pediatrics recommends immunoprophylaxis with a series of up to 5 injections of the antibody palivizumab administered monthly, beginning on November 1 of each year. However, many practitioners initiate injections at the onset of RSV season as indicated by local surveillance.ObjectivesTo evaluate the effectiveness of current regimens for palivizumab injections across different cities and to design an optimized regimen.Design, setting, and participantsWe performed a mathematical modeling study of the risk for hospitalization due to RSV infection. The model accounted for the pharmacokinetics of the antibody, the timing of the injections, and seasonal patterns of RSV, including geographic and year-to-year variability. We used the model to estimate the efficacy of current regimens, including the American Academy of Pediatrics recommendation, and to design a more effective injection regimen, the optimized fixed start (OFS), which uses city-specific initiation dates. Participants were the approximately 700,000 individuals who had specimens tested for RSV by National Respiratory and Enteric Virus Surveillance System laboratories in 18 US cities from July 1, 1994, through June 30, 2011 (a total of 725,741 tests).InterventionsDifferent palivizumab injection regimens.Main outcomes and measuresThe primary outcome measure was reduction in hospitalizations due to RSV infections. The secondary measures were cost (number of palivizumab doses) and duration of protection (in days).ResultsThe American Academy of Pediatrics-recommended 5-injection regimen is expected to reduce hospitalization risk by a median of 2.7% (range, -2.2% to 6.1%) compared with the conventional regimen based on RSV surveillance. The 5-injection OFS regimen is expected to further reduce risk by a median of 6.8% (range, 4.9% to 14.8%), and the 4-injection OFS regimen is expected to achieve efficacy comparable to that of the conventional 5-injection regimen while reducing costs by 20%.Conclusions and relevanceModified palivizumab regimens can improve protection for children at risk for severe outcomes of RSV infection and thereby lower rates of hospitalization due to RSV.

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Human respiratory syncytial virus and other viral infections in infants receiving palivizumab.

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Human respiratory syncytial virus and other viral infections in infants receiving palivizumab.

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