One-year observational study of palivizumab prophylaxis on infants at risk for respiratory syncytial virus infection in Latin America

Castillo, Leandro Martin; Bugarin, Gabriela; Arias, Juan Carlos; Rangel, Jairo Israel Barajas; Serra, M. Elina; Vain, Néstor E.

doi:10.1016/j.jped.2016.11.006

Cited by 14 publications

(17 citation statements)

References 26 publications

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“…The average number of doses of palivizumab injections during the study period was 3.5 doses/child, similar to that reported in Korea (3.7 doses) [18], Latin America (3.8 doses) [19] and in São Paulo (4 doses) [17]. Five doses of palivizumab were given to 34.6% of children, a percentage higher than reported in São Paulo (22.7%) [17] but lower than in Latin America (43.7%) [19]. Since palivizumab is only administered during the HRSV epidemic season (January to June in the North region of Brazil), the reduced number of doses could be a result of the difficulties of countryside children travelling to Belém in order to take their medication.…”

Section: Discussionsupporting

confidence: 83%

Incidence of respiratory syncytial virus infection in children with congenital heart disease undergoing immunoprophylaxis with palivizumab in Pará state, north region of Brazil

et al. 2019

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Background Palivizumab prophylaxis for the human respiratory syncytial virus (HRSV) has been reported to reduce the risk of hospital admissions related to HRSV in children with congenital heart disease (CHD). These children are at high risk of developing severe lower respiratory tract infection (LRTI) due to HRSV infection. Our goal was to evaluate the incidence of HRSV infection in children with CHD after being submitted to immunoprophylaxis with palivizumab in Pará state, North region of Brazil. Methods A prospective and observational cohort study was performed in children ≤2 years of age with CHD who received palivizumab immunoprophylaxis between January 1 and June 31, 2016. A questionnaire about basic non-medical care measures was applied to parents/legal representatives. Data on patients’ demographic characteristics, household environment, and respiratory infections were evaluated. HRSV infection was determined by qPCR. Results There were 104 children enrolled in this investigation and the results showed a mean age of 10.6 months, an average weight of 7.3 kg and 3.5 doses of palivizumab per children during seasonality of HRSV. Respiratory infection was observed in 27.9% of cases, of which 9.6% were LRTI. No case of children who received palivizumab immunoprophylaxis and developed influenza-like symptoms tested positive for HRSV. Conclusion Although the lack of a control group doesn’t allow to affirm the effectiveness of HRSV passive immunization, the immunoprophylaxis with palivizumab appeared to be totally efficient in preventing respiratory infection by HRSV in children up to two years of age with CHD.

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Section: Discussionsupporting

confidence: 83%

Incidence of respiratory syncytial virus infection in children with congenital heart disease undergoing immunoprophylaxis with palivizumab in Pará state, north region of Brazil

et al. 2019

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“…The only study carried out previously in Mexican children that has been published was done as part of a multi‐national analysis of infants who received palivizumab . Because no separate data for participants from each country are provided, and because all children received palivizumab, it is difficult to compare our results with those reported in that study.…”

Section: Discussionmentioning

confidence: 96%

Respiratory syncytial virus acute respiratory infection‐associated hospitalizations in preterm Mexican infants: A cohort study

Benítez‐Guerra

Piña‐Flores

Zamora‐López

et al. 2020

Influenza Resp Viruses

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Background Respiratory syncytial virus (RSV) is the leading cause of severe acute respiratory infections (ARI) in preterm infants. The incidence of RSV‐associated hospitalizations has not been defined in Mexico. Objectives To determine the incidence of ARI‐ and RSV‐associated hospitalizations in preterm infants during the first year of life. Methods Prospective cohort study of 294 preterm infants followed up through monthly telephone calls and routine outpatient visits. Hospitalized children were identified through daily visits to pediatric wards of participating hospitals and through telephone calls. Respiratory samples were tested for RSV by RT‐PCR. Results Mean gestational age of participating infants was 33 weeks. Ninety‐six infants were diagnosed with bronchopulmonary dysplasia (BPD) and 17 with congenital heart disease (CHD); 11 had both conditions. There were 71 hospitalization episodes in 53 infants. Respiratory samples for RSV detection were available in 44 hospitalization episodes, and the result was positive in 16 (36.3%). At least one hospitalization for ARI was recorded in 33 of 96 participants with BPD, in seven of 17 with CHD, and 18 of 192 infants without these diagnoses. Five (71.4%) of CHD infants who required admission also had BPD. RSV‐confirmed hospitalization rates were 9.4%, 5.9%, and 2.6% for infants with BPD, CHD, and otherwise healthy preterm infants, respectively. Attributable RSV admission frequencies were estimated to be 13.6%, 16.5%, and 4.1%, respectively. Conclusions Mexican preterm infants, particularly those with BPD, have high rates of ARI‐ and RSVassociated hospitalizations. Specific interventions to reduce the incidence of severe infections in this highrisk group are required.

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“…This work differs from earlier work by Wang et al 24,25 and Bentley et al 27 since the base case considers a lower number of doses of palivizumab (3.7 doses versus 5 doses). We believe that this is an appropriate approach for a number of reasons: it reflects real world evidence in the UK 33 and world-wide, [34][35][36][37] advice from UK clinicians supports this approach and the seasonality of the virus means that patients born in season and those in neonatal ICU in season will require fewer doses. 10…”

Section: Strengths and Limitationsmentioning

confidence: 90%

“…However, in this iteration of the model we chose to assume a dose of 3.7 reflecting the seasonality of infection and real-world evidence. 3,10,[33][34][35][36][37] The JCVI guidelines recommend that palivizumab is given from the beginning of the RSV season (October) and that infants in hospital should only receive palivizumab on discharge from the neonatal unit. 3 Recent consensus guidelines 10 state that children born during the RSV season will require fewer doses than those born before the season, which is confirmed by work we carried out around the seasonality of RSV for this publication.…”

Section: Number Of Dosesmentioning

confidence: 99%

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Updated cost-effectiveness analysis of palivizumab (Synagis) for the prophylaxis of respiratory syncytial virus in infant populations in the UK

Narayan

Bentley

Mowbray

et al. 2020

Journal of Medical Economics

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Aims: Respiratory syncytial virus (RSV) is a common cause of respiratory infection in infants and severe infection can result in hospitalization. The passive immunization, palivizumab, is used as prophylaxis against RSV, however, use in the UK is restricted to populations at high risk of hospitalization. This study assesses the cost-effectiveness (CE) of palivizumab in premature infants with and without risk factors for hospitalization (congenital heart disease [CHD], bronchopulmonary dysplasia [BPD]). Methods: A decision tree model, based on earlier CE analyses, was updated using data derived from targeted literature reviews and advice gained from a Round Table meeting. All costs were updated to 2019 prices. One-way and probabilistic sensitivity analyses were performed to assess the degree of uncertainty surrounding the results. Results: Palivizumab is dominant (i.e. clinically superior and cost saving) when used in premature infants born 35 weeks gestational age (wGA) without CHD or BPD and aged <6 months at the start of the RSV season, infants aged <24 months with CHD and infants aged <24 months requiring treatment for BPD within the last 6 months. Limitations: One-way sensitivity analysis suggests that these results are highly sensitive to the efficacy of prophylaxis, number of doses, impact of long-term respiratory sequalae, rate of hospitalization and mortality due to RSV. A conservative approach has been taken toward long-term respiratory sequalae due to uncertainty around epidemiology and etiology and a lack of recent cost and utility data. Conclusions: Palivizumab prophylaxis is cost-effective in preventing severe RSV infection requiring hospital admission in a wider population than currently recommended in UK guidelines. Prophylaxis in premature infants born <29 wGA, 29-32 wGA and 33-35 wGA without CHD or BPD aged <6 months at the start of the RSV season is not funded under current guidance, however, prophylaxis has been demonstrated to be cost-effective in this analysis.

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One-year observational study of palivizumab prophylaxis on infants at risk for respiratory syncytial virus infection in Latin America

Abstract: The rate of RSV hospitalization in high-risk infants in Latin America was low and aligned with those observed in randomized control trials and observational studies. Palivizumab prophylaxis appeared effective and had a good safety profile in this population.

Cited by 14 publications

References 26 publications

Incidence of respiratory syncytial virus infection in children with congenital heart disease undergoing immunoprophylaxis with palivizumab in Pará state, north region of Brazil

Incidence of respiratory syncytial virus infection in children with congenital heart disease undergoing immunoprophylaxis with palivizumab in Pará state, north region of Brazil

Respiratory syncytial virus acute respiratory infection‐associated hospitalizations in preterm Mexican infants: A cohort study

Updated cost-effectiveness analysis of palivizumab (Synagis) for the prophylaxis of respiratory syncytial virus in infant populations in the UK

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