Respiratory Syncytial Virus Prophylaxis The 2010-2011 criteria Chuck Hui MD FRCPC Paediatric Infectious Diseases Assistant Professor of Paediatrics 1

Objectives Review the basics of RSV Understand the ways to prevent RSV transmission Discuss the MOHLTC Ontario criteria for palivizumab approval

What is RSV? RNA paramyxovirus Humans are only source 2 strains – A and B Often circulate concurrently Humans are only source Almost all children infected at least once by 2yrs of age Re-infection is common Presents as a common URI in older children and adults

Epidemiology Annual season in Canada Viral shedding 3-8 days November to April Viral shedding 3-8 days May be longer in young and immunosuppressed Incubation period 2-8 days Supportive care, no good treatment

Burden of RSV in Young Children Population based study in children < 5yrs ER (2000-2004); Pediatric offices (2002-2004) 5067 enrolled; 919(18%) RSV infections; RSVH overall (11%) RSV associated with: 18% ER visits 15% office visits (3X ER) Average RSVH: 17/1000 <6 months of age 3/1000 < 5 years of age Hall CB et al. NEJM 2009;360:588-598

Burden of RSV in Young Children Majority of children had no underlying medical illness Only risk factors identified: < 2 years of age, history of prematurity Under 5 yrs of age RSV results in: 1 of 38 visits to the ER 1 of 13 visits to a primary care (FD) office Hall CB et al. NEJM 2009;360:588-598

How can we prevent RSV transmission?

RSV nosocomial outbreaks recognized 1970s transmission established 1981!! Hall and Douglas, J Pediatr 1981;99:100-102 3 plausible routes: aerosol, droplet, contact 31 volunteers: cuddlers, touchers, sitters 71% of cuddlers, 40% touchers, 0% sitters developed culture confirmed infection RSV – illness first described in 1941 (Adams, JAMA); virus identified 1961 Hall – 7 cuddlers (gowns only), 10 touchers, 14 sitters (gowns, gloves, no masks)

RSV 107 virus particles per mL of nasal discharge in children infectious dose - ?? survives on inanimate objects for prolonged periods of time Goldman PIDJ 2000;19:S97-102

Risk factors for RSV hospitalization worldwide Exposure Age at start of RSV season Siblings Crowding at home Day care attendance Day care attendance of siblings Discharge between October and December Social Factors Breast feeding Physiologic Factors Low birth weight Male sex Family history of wheezing CLD Neurologic problems Birth order >2nd Eur J Clin Microbiol Infect Dis (2008) 27:891–899

Background Palivizumab Efficacy IMPACT Pediatrics 1998

Efficiencies of Sharing Vials Palivizumab is expensive! 50mg - $752.26 100mg - $1,504.51 The Cost and Safety of Multidose Use of Palivizumab Vials 446 vials - $37 410 savings One vial had bacterial contamination 16% cost savings Gooding J et al. Clin Pediatr (Phila) 2008 Mar;47(2):160-3. Wills S Arch. Dis. Child. 2006;91;717

Requests that Satisfy the Recommendations of NACI 2003 and CPS 2009 Infants born prematurely at ≤ 32 completed weeks gestation and aged ≤ 6 months at the start of, or during, the local RSV season Children < 24 months of age with bronchopulmonary dysplasia (BPD)/chronic lung disease (CLD) AND who required oxygen and/or medical therapy within the 6 months preceding the RSV season Children < 24 months of age with hemodynamically significant cyanotic or acyanotic congenital heart disease (requiring corrective surgery or on cardiac medication for hemodynamic considerations).

Infants who live in isolated communities Requests that Satisfy the Advice from the Ontario RSV Prophylaxis for High-Risk Infants Advisory Group Infants in the 33-35 Completed Weeks (33 weeks and 0 days to 35 weeks and 6 days) Gestational Age Cohort and Aged ≤ 6 Months at the start/during the local RSV season Infants who live in isolated communities Infants who do not live in isolated communities Requests for these infants (33-35 completed weeks) must include a completed Risk Assessment Tool signed by the requesting physician. Siblings in the Same Multiple Birth Set of a High-Risk Infant Infants with Down Syndrome/Trisomy 21

Variables in the final Logistic Regression Model (Risk Scoring Tool- PICNIC Study) Variable Score SGA (GA <10%) [ Yes/No ] 12 Gender (Male/Female) 11 Birth Month (Nov,Dec,Jan) 25 Subject or Siblings in Day Care [ Yes/No ] 17 Family History without eczema [ Yes/No ] 12 >5 individuals in the home counting the subject [ Yes/No ] 13 Two or more smokers in the house [Yes/No ] 10 Total 100

CONSIDERATION OF SPECIAL CLINICAL CIRCUMSTANCE Individual Patient Case Reviews Requests for high-risk infants that do not satisfy the above approval criteria will be considered by the ministry’s expert clinicians in RSV prophylaxis These requests must state the patient’s specific medical illness, include a letter from the requesting physician detailing the clinical rationale, AND a supporting letter from either an infectious disease specialist or a neonatologist or a respirologist Potential special requests: Upper airway diseases Immunodeficiency Cystic fibrosis

Hema Quebec Guidelines Same <33 wks BPD/CLD CHD 33-35 wk RAT moderate or high Different Yes Transplant patients Down syndrome – special request

Wash your hands!