Outcomes of Infants Receiving Palivizumab Prophylaxis for Respiratory Syncytial Virus in Canada and Italy

Manzoni, Paolo; Paes, Bosco; Lanctôt, Krista L.; Dall’Agnola, A; Mitchell, Ian; Calabrese, Sara; Maule, Milena; Girardi, E; Harimoto, Tetsuhiro; Li, Abby

doi:10.1097/inf.0000000000001340

Cited by 28 publications

(27 citation statements)

References 26 publications

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“…The medical needs for the prevention of RSVH in infants and children with Down syndrome are high [ 8 – 11 ], and there is growing clinical evidence to support the use of palivizumab in this population. In CARESS, RSVH rates in children with Down syndrome receiving palivizumab have been found to be low [ 88 – 91 ]. Yi et al [ 89 ] compared hospitalization rates due to respiratory tract infection in 532 children with Down syndrome aged < 2 years who received palivizumab during the RSV season in the CARESS registry (2005–2012) with a similar, untreated cohort of 233 children with Down syndrome from the Netherlands (2003–2005) [ 9 ].…”

Section: Resultsmentioning

confidence: 99%

Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children

et al. 2018

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IntroductionThe 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.MethodsA systematic review was undertaken of publications between January 1, 1995 and December 31, 2017 across PubMed, Embase and The Cochrane Library. Studies reporting data on the effectiveness and tolerability of prophylactic and therapeutic agents for RSV infection were included. Study quality and strength of evidence (SOE) were graded using recognized criteria. A further nonsystematic search of the published literature and Clinicaltrials.gov on antiviral therapies and RSV vaccines currently in development was also undertaken.ResultsThe systematic review identified 1441 studies of which 161 were included. Management of RSV remains centered around prophylaxis with the monoclonal antibody palivizumab, which has proven effective in reducing RSV hospitalization (RSVH) in preterm infants < 36 weeks’ gestational age (72% reduction), children with bronchopulmonary dysplasia (65% reduction), and infants with hemodynamically significant congenital heart disease (53% reduction) (high SOE). Palivizumab has also shown to be effective in reducing recurrent wheezing following RSVH (high SOE). Treatment of RSV with ribavirin has conflicting success (moderate SOE). Antibodies with increased potency and extended half-life are currently entering phase 3 trials. There are approximately 15 RSV vaccines in clinical development targeting the infant directly or indirectly via the mother.ConclusionPalivizumab remains the only product licensed for RSV prophylaxis, and only available for high-risk infants. For the general population, there are several promising vaccines and monoclonal antibodies in various stages of clinical development, with the aim to significantly reduce the global healthcare impact of this common viral infection.FundingAbbVie.Electronic supplementary materialThe online version of this article (10.1007/s40121-018-0188-z) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children

et al. 2018

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“…[13] However, such regimen has not been uniformly successful, with persistence of signi cant RSVh risk being reported despite Palivizumab prophylaxis for patients with HsCHD in countries with a distinct RSV season. [22] The applicability of the AAP recommendation is even more questionable in subtropical and tropical areas that often lack a de ned RSV season. [23][24][25] Limited studies have tried to elucidate the e cacy of alternative Palivizumab regimens in such countries.…”

Section: Discussionmentioning

confidence: 99%

Population-based Respiratory Syncytial Virus Hospitalization Disease Burden and Cost Effectiveness of Palivizumab Prophylaxis in Infants with Hemodynamically Significant Congenital Heart Diseases

Chen

Chiu

Lee

et al. 2020

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Abstract Background Infants with hemodynamically significant congenital heart disease (HsCHD) are at risk of respiratory syncytial virus hospitalization (RSVh) and Palivizumab has been shown to be effective in preventing RSVh in regions with a distinct RSV season. However, the incidence of RSVh in HsCHD patients and the cost-effectiveness of Palivizumab in regions with year-round RSV activity is largely unknown. Methods All HsCHD patients < 12 months of age referred to the only tertiary pediatric cardiology center in Hong Kong during 1 Jan 2014 to 31 Dec 2016 were included. RSVh rate, Palivizumab efficacy and cost-effectiveness were assessed using a 5 or 6 monthly dose regimen starting from first hospital discharge. Results Twenty-six RSVh (11%) were identified out of 236 HsCHD patients. 222 patients were included for further analysis of Palivizumab efficacy and cost-effectiveness. The number needed to treat to prevent RSVh using 5 and 6 dose regimen was 54.9 and 38, respectively, with a wide year-to-year variation from 25 to 166.6. RSVh cost without Palivizumab was $379,436; while palivizumab program cost for 5 and 6 dose were $727,481 and $849,888 respectively. Incremental cost-effective ratio per hospital admission prevented was $85,937 and $80,419 for 5 and 6 dose regimen, respectively, with a wide year-to-year variation from $40,410 to $277,367. Conclusion This is one of the first population-based studies in infants with HsCHD demonstrating a high RSVh burden in a region with round the year circulation of RSV. Palivizumab program was assessed to be not cost-effective in preventing RSVh in such a locality.

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“…36 A Canadian-Italian group questioned whether children with hs-CHD need higher doses of immunoprophylaxis because of their increased inherent risks. 37 Numerous studies have shown the safety and efficacy of RSV immunoprophylaxis and its long-term benefit in children with HD. 6,30,[38][39][40] It is therefore imperative to establish similar guidelines in Hong Kong.…”

Section: Discussionmentioning

confidence: 99%

Epidemiology of respiratory syncytial virus infection and its effect on children with heart disease in Hong Kong: a multicentre review

et al. 2019

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C M E disease. Predictors of severe RSV infection in patients with heart disease were heart failure, pulmonary hypertension, and severe airway abnormalities associated with congenital heart disease. Conclusions: Respiratory syncytial virus infection occurs mainly in spring and summer in Hong Kong, and is related to meteorological conditions. Respiratory syncytial virus infection poses a heavy disease burden on children with heart disease. A local guideline on RSV immunoprophylaxis for these children is therefore needed. This article was published on 9 Oct 2019 at www.hkmj.org. New knowledge added by this study • This study reviewed the epidemiology and impact of respiratory syncytial virus (RSV) infection on children with heart disease (HD) in Hong Kong. • RSV infections are common in Hong Kong, and the incidence peaks from March to August; prevalence is greatest in children aged <1 year, and there is a mild male preponderance. Infection is favoured by high relative humidity, low wind speed, and low atmospheric pressure. • HD, both congenital and acquired, is a distinct risk factor for severe RSV infection in terms of hospital length of stay, reinfection, complication, respiratory failure, and the requirements for intensive care unit care and mechanical ventilation. Implications for clinical practice or policy • A local guideline on RSV immunoprophylaxis is needed for children with HD. • In Hong Kong, an RSV immunoprophylaxis scheme administered monthly for 5 months, beginning in the first year of life, should be considered in children with HD who exhibit any of the following severity predictors: heart failure, pulmonary hypertension, and severe airway abnormalities associated with congenital HD. • The optimal timing for immunoprophylaxis may be during the local peak of infection, from March to August.

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Outcomes of Infants Receiving Palivizumab Prophylaxis for Respiratory Syncytial Virus in Canada and Italy

Abstract: RSVH rates are higher in infants given palivizumab for reasons other than prematurity. It is uncertain whether these findings relate to inadequate current palivizumab dosing protocols or to a specific increased RSVH risk inherent in infants with severe underlying comorbidities.

Cited by 28 publications

References 26 publications

Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children

Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children

Population-based Respiratory Syncytial Virus Hospitalization Disease Burden and Cost Effectiveness of Palivizumab Prophylaxis in Infants with Hemodynamically Significant Congenital Heart Diseases

Epidemiology of respiratory syncytial virus infection and its effect on children with heart disease in Hong Kong: a multicentre review

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