Kimberlin - Red Book Update - American Academy of Pediatrics

Report
Red Book Update:
What To Expect in 2015
David W. Kimberlin, M.D.
Editor, Red Book: Report of the Committee on Infectious Diseases
Disclosures
• I have the following financial relationships with
the manufacturer(s) of any commercial product(s)
and/or provider of commercial services.
– Research Support from: Gilead, GlaxoSmithKline
• I do intend to discuss an unapproved/investigative
use of a commercial product/device in my
presentation.
Author: Committee on Infectious
Diseases
David W. Kimberlin, MD, FAAP,
Editor
Michael T. Brady, MD, FAAP,
Associate Editor
Mary Anne Jackson, MD, FAAP,
Associate Editor
Sarah S. Long, MD, FAAP,
Associate Editor
AAP Committee on Infectious Diseases
(Red Book Committee)
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12 Committee Members (voting)
1 Section on Infectious Diseases Member (voting)
4 Ex Officio Members (Red Book editor and associate editors)
12 Liaisons
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Canadian Paediatric Society (2)
CDC (2)
National Vaccine Program (2)
NIH
FDA (2)
American Thoracic Society
COPAM
Pediatric Infectious Diseases Society
AAP Committee on Infectious Diseases
(Red Book Committee)
• Committee members appointed for 6 year terms
• Selection influenced by expertise and geography
– AAP District and Chapter involvement
• Spring and Fall meetings
• Committee members serve as liaisons to ACIP
Working Groups
AAP Committee on Infectious Diseases
Red Book Development Process
Red Book published every 3 years
Work on next edition begins immediately
Chapters distributed to primary authors for revision
CDC, FDA, and AAP Committees and Sections
review
• Two designated COID members review
• Marathon Meeting in Spring of year prior to
publication for discussion of each chapter by full
COID
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AAP Committee on Infectious Diseases
Red Book Development Process
• 2015 Edition
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263 documents (chapters)
150 Primary Reviewers, 62% of whom are new
253 CDC reviewers
68 FDA reviewers
43 AAP Internal Review committees
AAP Committee on Infectious Diseases
Red Book Development Process
• Purpose of the Red Book:
– Composite summary of current AAP recommendations
representing the policy of the AAP on various aspects of
infectious diseases
– Recommendations represent a consensus of opinions based on
consideration of the best available evidence by members of the
COID, in conjunction with liaison representatives from CDC,
FDA, NIH, National Vaccine Program Office, Pediatric
Infectious Diseases Society, Canadian Paediatric Society,
American Thoracic Society, Red Book consultants, and
numerous collaborators
Respiratory Syncytial Virus
Immunoprophylaxis With Palivizumab
Viral Bronchiolitis, 2007-2010
2,207 Hospitalized Patients < 2 yoa
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RSV
Human rhinoviruses
Adenoviruses
Coronaviruses
Human metapneumoviruses
Enteroviruses
Parainfluenza viruses 1,2,3
Influenza A, B
Human bocavirus
Co-infection
73%
26%
8%
7%
7%
5%
3%
1%
NA
32%
Arch Pediatr Adolesc Med 2012:166(8):700
Palivizumab Binding
of RSV Fusion Protein
AAP Guidance
Regarding RSV Immunoprophylaxis
• January 1996
• April 1997
RespiGam licensed by FDA
AAP Statement: RSV-IVIG Indications
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Palivizumab licensed by FDA
AAP Statement: Indications for use of palivizumab
AAP Statement: Revised indications for palivizumab
Revised indications
Revised indications
AAP Statement: Revised indications for palivizumab
No major changes
Updated Guidance for palivizumab prophylaxis*
June 1998
November 1998
December 2003
2006 Red Book
2009 Red Book
December 2009
2012 Red Book
August 2014
* Pediatrics 2014:134(2):415-420
Pediatrics 2014:134(2):e620-e638
Rationale for Revisions to
AAP Guidance
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Data on seasonality of RSV circulation
Data showing risk of RSV hospitalization by gestational age
Data regarding palivizumab pharmacokinetics
Data showing a decline in incidence of bronchiolitis hospitalizations
Data showing no difference in RSV hospitalization rates or RSV attack rates between
African-American and white children <24 m of age
Data showing mortality rates among children hospitalized with RSV are lower than
previously estimated
Data showing a statistically significant but clinically limited impact on episodes of
wheezing
Reports indicating little benefit from prophylaxis among children with Down
syndrome and cystic fibrosis
Reports describing palivizumab resistant RSV isolates among children hospitalized
with breakthrough RSV infection
Independently conducted cost-analyses demonstrating high cost versus limited benefit
Need to simplify guidance
Goals of AAP Recommendations
• Target infants at highest risk for severe disease
with risk factors that are most consistent and
predictive
• Optimize balance of benefit and cost
• Simplify approach for providers
Participants in
2014 AAP Guidance Revisions
• AAP Bronchiolitis Guidelines Committee
• AAP Committee on Infectious Diseases
• 21 Committees, Councils, Sections, and Advisory Groups
within the AAP
• Outside Groups
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American Academy of Family physicians
American College of Chest Physicians
American College of Emergency Physicians
American Thoracic Society
Emergency Nurses Association
Society of Hospital Medicine
• Data presented to AAP by the manufacturer
Preterm Infants
Without Chronic Lung Disease
• Updated guidance
– In the first year of life, palivizumab prophylaxis is
recommended for infants born before 29 weeks 0 days gestation
– Palivizumab prophylaxis is not recommended for otherwise
healthy infants born at or after 29 weeks 0 days gestation
• Previous guidance
– Previously, prophylaxis was recommended for infants with preterm birth
before 32 weeks gestation. Infants with certain risk factors born between 32
weeks 0 days through 34 weeks 6 days were eligible.
RSV Hospitalizations Among
Children < 24 Months of Age
Pediatrics 2013;132:e341
Hall et al, Pediatrics
2013:132(2):e341-e348
Average RSV Hospitalization Rates
For Children < 24 months (2000-2005)
Children < 24 months
N
Rates of RSV
Hospitalization/1,000
95% CI
All infants regardless of gestational age
559
5.2
4.8-5.7
All term infants (≥ 37 week)
479
5.3
4.9-5.8
All preterm infants (< 37 wk)
56
4.6
3.4-5.8
≥ 35 week gestation
494
5.1
4.7-5.5
32-34 week gestation
23
6.9
4.3-10.1
29-31 week gestation
6
6.3
2.0-12.4
< 29 week gestation
12
19.3
8.4-34.0
All very preterm (< 30 week)
15
18.7
10.0-30.0
Hall et al, Pediatrics 2013:132(2):e341-e348
RSV Hospitalizations Among 1,029
Infants Born ≤ 32 Weeks Gestation
Gestational
Age (weeks)
# of
Infants
# of RSV
%
Admissions Admitted
P-value versus
30-32 Weeks’
Gestation
≤ 26
165
23
13.9
<.001
27-28
> 28-30
171
240
17
18
9.9
7.5
.007
.12
> 30-32
453
20
4.4
Comparator
Total
1029
78
7.6
Not Applicable
Stevens et al, Arch Pediatr Adolesc Med 2000;154:55-61
RSV Hospitalization for Children < 24
Months by Gender and Race, 2000–2005
No difference in hospitalizations rates
by race within first 6 months of life
Hall et al, Pediatrics 2013:132(2):e341-e348
No Difference in Rates of RSV Hospitalization
Between African-American and White Children
Striped bars: Black children 0 to 5 months Dashed bars: White children 0 to 5 months
Black bars: Black children 6 to 59 months White bars: White children 6 to 59 months
Iwane et al, Am J Epidemiol 2013:177(7):656-665
RSV Hospitalizations/1,000 Children
from > 248,000 Child-Years of Follow-up
Age/Risk Group
0 to <6
months
6 to <12
months
12 to 24
months
IRR (95% CI)
for 0 to <6
months
Low risk infants
44.1
15.0
3.7
comparator
Infants with CHD
120.8
63.5
18.2
2.7 (2.2-3.4)
Infants with CLD
562.5
214.3
73.4
12.8 (9.3-17.2)
≤28 week gestation
93.8
46.1
30.0
2.1 (1.4-3.1)
29 to <33 week gestation
81.8
50.0
8.4
1.9 (.4-2.4)
33 to <36 week gestation
79.8
34.5
10.8
2.8 (2.1-3.1)
Boyce et al, J Pediatr 2000:137(6):865-870
Preterm Infants
With Chronic Lung Disease
• Updated guidance
– In the first year of life, palivizumab prophylaxis is
recommended for preterm infants with chronic lung
disease of prematurity defined as < 32 weeks, 0 days'
gestation and a requirement for > 21% oxygen for at
least 28 days after birth
• Previous guidance
– Previously no definition of chronic lung disease was provided.
Infants With
Congenital Heart Disease
• Updated guidance
– Clinicians may administer palivizumab prophylaxis in the
first year of life to infants with acyanotic,
hemodynamically significant heart disease.
– Consultation with a cardiologist is recommended for
patients with cyanotic heart disease for decisions about
prophylaxis.
• Previous guidance
– Previously prophylaxis was recommended in the second year of life
for this cohort.
Palivizumab Cardiac Study
Incidence of RSV Hospitalization
Absolute
Percent
Reduction
4.4%
Placebo
n=648
9.7%
n=63
Palivizumab
n=639
5.3%
n=34
Cyanotic group
7.9%
n=27
5.6%
n=19
2.3%
0.285
Acyanotic group
11.8%
n=36
5.0%
n=15
6.8%
0.003
Primary analysis:
p-value
0.003
Feltes et al, J Pediatr 2003:143(4):532-540
Number of Monthly Doses
• Updated guidance
– Clinicians may administer up to a maximum of 5 monthly doses
of palivizumab during the RSV season to infants who qualify
for prophylaxis in the first year of life (including Florida).
Qualifying infants born during the RSV season will require
fewer doses. For example, infants born in January would
receive their last dose in March.
– Maximum 5 monthly doses for all states
• Previous guidance
– Previously, fewer than 5 monthly doses were recommended for some infants
Simulated Palivizumab
Concentration-Time Profiles
40µg/mL
Robbie et al, Antimicrob Agents Chemother 2012:56(9):4927-4936

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