Beyond randomized controlled trials: A “real life” experience of respiratory syncytial virus infection prevention in infancy with and without palivizumab

Abstract

A population-based study of the impact of palivizumab on confirmed Respiratory Syncytial Virus (RSV) hospitalizations over a 7-year period within and between two similar health regions . Clinicians in Calgary implemented palivizumab prophylaxis for high-risk infants during the last four RSV seasons; clinicians in Edmonton did not. The two cities are part of a unified health care system and similar sociodemographics. Infants <36 weeks (wk) of gestational age (GA) were identified. RSV prophylaxis data and RSV-hospitalizations for high-risk infants eligible for prophylaxis were reviewed, as well as that of moderate-risk infants (33-35 weeks GA) for whom RSV prophylaxis was not given a high priority in the recommendations published by the Canadian Paediatric Society (CPS). Prevalence of RSV hospitalization before and after palivizumab was determined (1995-1998 and 1999-2002, respectively). There were 411 high-risk infants eligible for palivizumab prior to its provision (Pre) and 496 during the prophylaxis program (Post) in Calgary. There were 401 Pre and 425 Post in Edmonton, where no such prophylaxis program was implemented. In Calgary where palivizumab was offered (Post), RSV hospitalization was significantly reduced: 7.3% Pre versus 3.0% Post (OR, 2.53, 95% CI, 1.34, 4.76). No reduction was observed in Edmonton where palivizumab was not offered: 5.0% Pre versus 7.1% Post (OR, 1.45, 95% CI, 0.81, 2.59; P = 0.212). RSV hospitalizations did not change for moderate-risk infants not receiving palivizumab in Calgary (OR, 1.26, 95% CI, 0.75, 2.12; P = 0.389). An RSV prevention program with palivizumab for high-risk infants reduced RSV hospitalizations, providing "real life" evidence of the benefits of this prophylaxis strategy. Further research is required to determine if specific sub-sets of moderate-risk infants would also benefit from an RSV prophylaxis program with palivizumab.

Respiratory syncytial virus associated hospitalizations in preterm infants of 29 to 32 weeks gestational age using a risk score tool for palivizumab prophylaxis

“…Preterm infants born 29 to 32 weeks of GA without BPD who received palivizumab prophylaxis had a low 1.8% incidence of RSV-related hospitalizations in a European multicenter study enrolling infants younger than 6 months of chronological age over the 2000/2001 RSV season [24] — a finding comparable to that observed in the pivotal trial conducted in North America and the UK [18]. The RSV rehospitalization rate in our non-prophylaxed group was astonishingly low compared to other studies reporting on rates ranging from 5.0% to 13.3% [18, 20, 25, 26]. …”

Chest physiotherapy using passive expiratory techniques does not reduce bronchiolitis severity: a randomised controlled trial

“…The start and the end of the RSV season were defined when ≥2 admissions were due to RSV infection during two consecutive 7-day periods and when ≤1 such admission occurred during two consecutive 7-day periods, respectively [11,14]. Patients with comorbidities such as cystic fibrosis, neuromuscular disease or congenital heart disease, or patients admitted directly to the intensive care unit, were excluded from the study.…”

Human PIV-2 recombinant Sendai virus (rSeV) elicits durable immunity and combines with two additional rSeVs to protect against hPIV-1, hPIV-2, hPIV-3, and RSV

“…A major mediator of viral protection is the virus-specific antibody, as is best demonstrated by the capacity of licensed anti-RSV-F monoclonal and polyclonal antibodies to control lower respiratory tract viral disease in clinical pediatrics [58–65]. Antibodies provide a first line of defense against infection by preventing virus entry into target host cells [32;66;67].…”