Preventing hospitalizations for respiratory syncytial virus infection

Abstract

EPIDEMIOLOGyRespiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections (LRTIs) in young children worldwide, with almost all experiencing their first RSV infection by two years of age. In developed countries, 1% to 3% of all infants are hospitalized with RSV infection. In Canada, the RSV season typically begins in November or December and persists for four to five months. The present statement replaces four previous position statements from the Canadian Paediatric Society on this topic(1-4) because there is evidence that the risk of RSV hospitalization does not warrant the use of palivizumab in many children for whom it was previously recommended. PREVENTING RSV HOSPITALIZATIONS Instructions for parentsYoung infants (and their siblings) should not be in contact with individuals with respiratory tract infections whenever practical. A Cochrane review suggests that hand hygiene in the home decreases the spread of respiratory tract infections in children. (5) Breastfeeding and avoidance of cigarette smoke are also presumed to decrease the incidence and/or severity of viral respiratory tract infections. PalivizumabPalivizumab, a humanized murine monoclonal immunoglobulin G-1 directed against an epitope on the F glycoprotein of RSV, is produced by recombinant DNA technology, and has 95% human and 5% murine amino acid sequences. Rare cases of anaphylaxis are the only recognized serious adverse event. Standard dosing is 15 mg/kg administered intramuscularly every 30 days during RSV season for a maximum of five doses. Some Canadian programs administer the second dose 20 days after the first dose to prevent a low trough level;(6,7) however, there are no data showing an increased RSV hospitalization rate before the second dose. Palivizumab is available in 50 mg or 100 mg vials. Drug costs for five doses of palivizumab for an infant with a mean weight of 5 kg are approximately $5,600, assuming no waste.Palivizumab use in Canada is directed by provincial or territorial programs. When practitioners have questions about eligibility, they should contact their local program; contact information is available through neonatal care units. Some programs routinely begin prophylaxis in November or December. Others use laboratory surveillance from local laboratories or from the national Respiratory Virus Detection Surveillance System (www.phac-aspc. gc.ca/bid-bmi/dsd-dsm/rvdi-divr/index-eng.php) to determine when to start palivizumab. The latter strategy is more complicated to organize than having a uniform start and stop date, but has been demonstrated to save drug costs in a recent Canadian study.(8) Table 1 summarizes the results of randomized controlled trials (RCTs) investigating palivizumab, demonstrating a reduction in hospitalizations of approximately 80% in infants with prematurity but without chronic lung disease of prematurity (CLD), of 40% in infants with CLD, and of 45% in children with congenital heart disease (CHD). Efficacy was not demonstrated in the CHD subgroup with cyanotic heart...

Consensus conference on the appropriateness of palivizumab prophylaxis in respiratory syncytial virus disease

“…However, the few very preterm infants (<30 weeks’ gestation) had a RSV hospitalization rate significantly greater than that for both early preterm (30–33 weeks’ gestation) and late‐preterm (34–36 weeks’ gestation) infants . Similar results were found in a more recent study …”

“…Some literature data does not agree about the increased risk of hospitalization of these preterm infants compared to those born at term . Moreover, an increased risk of hospitalization in Intensive Care Unit is not demonstrated in this specific sub‐group of children.…”

Practice variation among Dutch paediatricians in palivizumab prescription rates: the importance of parental counselling approach

“…Bronchiolitis-associated hospitalisations were found in 20.0% of nonimmunised children and in 11.3% of immunised children. Although not statistically significant, our findings are in agreement with current literature (13).…”

Risk stratification of immunocompromised children, including pediatric transplant recipients at risk of severe respiratory syncytial virus disease

“…In the above context, risk factors for severe disease have been well defined for non‐immunocompromised patients, and form the basis of guidelines for immunoprophylaxis against RSV in these populations . Both humoral and cell‐mediated immune responses are involved in the control of RSV infection .…”

“…The use of immunoprophylaxis in non‐immunocompromised patients is based on data from randomized placebo‐controlled trials that show the benefit of immunoprophylaxis in preventing RSV admissions, a proxy for severe RSV disease. Comparable data are not available for immunocompromised patients and will likely not be generated, for reasons relating to the feasibility of enrolling such patients in placebo‐controlled trials.…”