Hepatitis B – Monitoring the infant hepatitis B
immunisation programme and provision of a
Dried Blood Spot testing service
Mr Philip Keel
Scientist (Epidemiology)
Immunisation Hepatitis and Blood Safety Department, National Infection Service, PHE Colindale
30th October 2015
Global prevalence of
chronic hepatitis B, 2006
Source: CDC, Yellow Book
UK epidemiology of hepatitis B
• Low prevalence: 0.3-0.4%
• Incidence of acute hepatitis B low and stable (lab reports): 0.77 per
100,000 (2013)
• Heterogeneous distribution of risk
Adults
Chronic burden mostly among migrants who acquired infection during
childhood in country of origin
Transmission: sex, injecting drugs
Children
Transmission: mother to child, horizontal, exposure overseas
Selective Vaccination Programmes3 Hepatitis B - Dried Blood Spot Testing
Risk of mother to child transmission
• Risk of mother to child transmission high around birth (without
intervention)
• For infants of women who are HBeAg +ve: 73-88% become infected
• For infants of women who are HBeAg –ve: 7-14% become infected
• 90% infected babies become chronically infected (risk of liver cirrhosis
and liver cancer)
• Almost all infections will be asymptomatic in infancy: unrecognised
unless HBsAg testing performed
4 Hepatitis B - Dried Blood Spot Testing
Effectiveness of neonatal vaccination
• Efficacy of timely vaccination: 72-92%
• Booster dose at 12 months gives longer term protection
• HBIG marginal impact over and above vaccination
• Benefit of HBIG only in highest risk infants (a further 50% reduction)
5 Hepatitis B - Dried Blood Spot Testing
UK hepatitis B immunisation policy
• Selective: vaccination of high risk groups
• Since April 2000
• All pregnant women offered antenatal screening
• All infants born to hepatitis B positive mothers receive a complete course
of hepatitis B vaccine (0,1, 2 & 12 months)
• At around 12 months infants also tested for evidence of chronic infection
• If infected infant referred early to specialist for assessment and care
• Co-ordinated management and delivery of programme
• Regular monitoring and local audits
COST SAVING TO THE NHS
6 Hepatitis B - Dried Blood Spot Testing
Prevalence of hepatitis B among
pregnant women in England, 2013
Region Number tested
Antenatal
prevalence %
East Midlands 40,315 0.26
East of England 80,770 0.44
London 148,684 1.46
North East 30,702 0.17
North West 91,970 0.34
South East 105,810 0.29
South West 57,286 0.16
West Midlands 66,992 0.55
Yorkshire & Humber 68,301 0.32
ENGLAND 690,760 0.58
Source: Data Tables for National Antenatal Infections Screening and Monitoring (NAISM) Programme 2013 (HPA & NSC)
Indications for hepatitis B immunoglobulin
(HBIG)
8
Irrespective of mother’s markers, if infant’s birth weight is <=1500grams – requires HBIG
Source; Green Book, Immunisation against infectious disease
Hepatitis B - Dried Blood Spot Testing
Monitoring the infant hepatitis B vaccination
programme
9
PHE enhanced surveillance of high risk infants
PREGNANCY
•HBIG issue
received after
antenatal
booking
•HBIG sent 6-8
weeks before
EDD
•Maternal HBV
markers
collected
BIRTH
•HBIG and 1st
dose of
vaccine
administered
•Birth details
collected
•Maternal
antiviral
treatment data
collected
INFANT
•Reminder
letters to GP /
paediatrician
before each
vaccine dose
•Vaccination
uptake data
collected
1 YEAR OLD
•DBS kit or
venepuncture
kit sent to GP
/paediatrician
•Infants with
chronic
infection
identified
•Putative
vaccine failure
investigated
10 Hepatitis B - Dried Blood Spot Testing
Challenges in follow-up of at-risk infants
Data
• Incomplete reporting to COVER
• Denominator and numerator discrepancies
• Lack of outcome info on low-risk infants
Technical
• Difficulties obtaining venous blood samples in primary care: additional visit to
secondary care for testing
Communication
• Health practitioner engagement and patient understanding
Logistical
• Mobile population
11 Hepatitis B - Dried Blood Spot Testing
National dried blood spot (DBS) testing service
• Aim: improve uptake of 12 months testing by providing
alternative to venepuncture
• Intended use in primary care (no need for hospital referral)
• Dried blood spot testing (DBS) to test for evidence of infection
• Validated assay to detect HBsAg and anti-HBcore antibody
• DBS kits provided by and tested at PHE-Colindale free of charge
• Request form collects maternal hepatitis markers and infant
vaccination history
• Results of testing to requesting clinician (GP) and nominated
coordinator (cc to HP Team)
12 Hepatitis B - Dried Blood Spot Testing
DBS Kits
14
www.gov.uk/government/collections/hepatitis-b-guidance-data-and-
analysis#infants-born-to-hepatitis-b-infected-mothers
Hepatitis B - Dried Blood Spot Testing
Implementation of DBS service
• Pilot
• Scheme launched September 2013
• DBS Training materials
• YouTube video
• Pictorial instructions
• Webpage
http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/HepatitisB/NationalHepatitisBDriedBloodSpotService/
• Information for parents and for coordinators
• Information for joining the scheme
• Coordinators can enrol via website and email hepatitisbbabies@phe.gov.uk
• Data collection and feedback
• Data requirements to interpret test and evaluate program
• Data return to coordinators
• Round table discussion
• Bulletin –coming soon
Other initiatives to improve infant outcome
• Contribute to evidence base for interventions to prevent MTCT
through follow up of high risk infants
• Birth DBS to determine if infection at 12 months is due to true vaccine
failure or in utero transmission
• Link in with NSC/UCL audit of management of hepatitis B pregnant
women to provide outcome data on infants
• Mapping neonatal hepB pathways - with screening and immunisation
teams (NHSE) and Health Protection teams (PHE)
• Hepatitis B in England report…coming soon
16 Hepatitis B - Dried Blood Spot Testing
Universal hepatitis B infant immunisation
JCVI recommendation (October 2014): a universal infant
immunisation programme for hepatitis B should be
introduced if can be procured at a cost-effective price
Acknowledgements
Samreen Ijaz
John Parry
Justin Shute
Screening and Immunisation Teams
Health Protection Teams
DBS coordinators
Sharon Webb
Glenn Armitage
Sema Mandal
Matthew Olley
Gayatri Amirthalingam
Mary Ramsay
Miranda Mindlin
Sarah Collins
Yojna Handoo-Das
Darshna Makwana
18 Hepatitis B - Dried Blood Spot Testing

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6 Hepatitis b newborn dried bloodspots Philip Keel

  • 1. Hepatitis B – Monitoring the infant hepatitis B immunisation programme and provision of a Dried Blood Spot testing service Mr Philip Keel Scientist (Epidemiology) Immunisation Hepatitis and Blood Safety Department, National Infection Service, PHE Colindale 30th October 2015
  • 2. Global prevalence of chronic hepatitis B, 2006 Source: CDC, Yellow Book
  • 3. UK epidemiology of hepatitis B • Low prevalence: 0.3-0.4% • Incidence of acute hepatitis B low and stable (lab reports): 0.77 per 100,000 (2013) • Heterogeneous distribution of risk Adults Chronic burden mostly among migrants who acquired infection during childhood in country of origin Transmission: sex, injecting drugs Children Transmission: mother to child, horizontal, exposure overseas Selective Vaccination Programmes3 Hepatitis B - Dried Blood Spot Testing
  • 4. Risk of mother to child transmission • Risk of mother to child transmission high around birth (without intervention) • For infants of women who are HBeAg +ve: 73-88% become infected • For infants of women who are HBeAg –ve: 7-14% become infected • 90% infected babies become chronically infected (risk of liver cirrhosis and liver cancer) • Almost all infections will be asymptomatic in infancy: unrecognised unless HBsAg testing performed 4 Hepatitis B - Dried Blood Spot Testing
  • 5. Effectiveness of neonatal vaccination • Efficacy of timely vaccination: 72-92% • Booster dose at 12 months gives longer term protection • HBIG marginal impact over and above vaccination • Benefit of HBIG only in highest risk infants (a further 50% reduction) 5 Hepatitis B - Dried Blood Spot Testing
  • 6. UK hepatitis B immunisation policy • Selective: vaccination of high risk groups • Since April 2000 • All pregnant women offered antenatal screening • All infants born to hepatitis B positive mothers receive a complete course of hepatitis B vaccine (0,1, 2 & 12 months) • At around 12 months infants also tested for evidence of chronic infection • If infected infant referred early to specialist for assessment and care • Co-ordinated management and delivery of programme • Regular monitoring and local audits COST SAVING TO THE NHS 6 Hepatitis B - Dried Blood Spot Testing
  • 7. Prevalence of hepatitis B among pregnant women in England, 2013 Region Number tested Antenatal prevalence % East Midlands 40,315 0.26 East of England 80,770 0.44 London 148,684 1.46 North East 30,702 0.17 North West 91,970 0.34 South East 105,810 0.29 South West 57,286 0.16 West Midlands 66,992 0.55 Yorkshire & Humber 68,301 0.32 ENGLAND 690,760 0.58 Source: Data Tables for National Antenatal Infections Screening and Monitoring (NAISM) Programme 2013 (HPA & NSC)
  • 8. Indications for hepatitis B immunoglobulin (HBIG) 8 Irrespective of mother’s markers, if infant’s birth weight is <=1500grams – requires HBIG Source; Green Book, Immunisation against infectious disease Hepatitis B - Dried Blood Spot Testing
  • 9. Monitoring the infant hepatitis B vaccination programme 9
  • 10. PHE enhanced surveillance of high risk infants PREGNANCY •HBIG issue received after antenatal booking •HBIG sent 6-8 weeks before EDD •Maternal HBV markers collected BIRTH •HBIG and 1st dose of vaccine administered •Birth details collected •Maternal antiviral treatment data collected INFANT •Reminder letters to GP / paediatrician before each vaccine dose •Vaccination uptake data collected 1 YEAR OLD •DBS kit or venepuncture kit sent to GP /paediatrician •Infants with chronic infection identified •Putative vaccine failure investigated 10 Hepatitis B - Dried Blood Spot Testing
  • 11. Challenges in follow-up of at-risk infants Data • Incomplete reporting to COVER • Denominator and numerator discrepancies • Lack of outcome info on low-risk infants Technical • Difficulties obtaining venous blood samples in primary care: additional visit to secondary care for testing Communication • Health practitioner engagement and patient understanding Logistical • Mobile population 11 Hepatitis B - Dried Blood Spot Testing
  • 12. National dried blood spot (DBS) testing service • Aim: improve uptake of 12 months testing by providing alternative to venepuncture • Intended use in primary care (no need for hospital referral) • Dried blood spot testing (DBS) to test for evidence of infection • Validated assay to detect HBsAg and anti-HBcore antibody • DBS kits provided by and tested at PHE-Colindale free of charge • Request form collects maternal hepatitis markers and infant vaccination history • Results of testing to requesting clinician (GP) and nominated coordinator (cc to HP Team) 12 Hepatitis B - Dried Blood Spot Testing
  • 15. Implementation of DBS service • Pilot • Scheme launched September 2013 • DBS Training materials • YouTube video • Pictorial instructions • Webpage http://www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/HepatitisB/NationalHepatitisBDriedBloodSpotService/ • Information for parents and for coordinators • Information for joining the scheme • Coordinators can enrol via website and email hepatitisbbabies@phe.gov.uk • Data collection and feedback • Data requirements to interpret test and evaluate program • Data return to coordinators • Round table discussion • Bulletin –coming soon
  • 16. Other initiatives to improve infant outcome • Contribute to evidence base for interventions to prevent MTCT through follow up of high risk infants • Birth DBS to determine if infection at 12 months is due to true vaccine failure or in utero transmission • Link in with NSC/UCL audit of management of hepatitis B pregnant women to provide outcome data on infants • Mapping neonatal hepB pathways - with screening and immunisation teams (NHSE) and Health Protection teams (PHE) • Hepatitis B in England report…coming soon 16 Hepatitis B - Dried Blood Spot Testing
  • 17. Universal hepatitis B infant immunisation JCVI recommendation (October 2014): a universal infant immunisation programme for hepatitis B should be introduced if can be procured at a cost-effective price
  • 18. Acknowledgements Samreen Ijaz John Parry Justin Shute Screening and Immunisation Teams Health Protection Teams DBS coordinators Sharon Webb Glenn Armitage Sema Mandal Matthew Olley Gayatri Amirthalingam Mary Ramsay Miranda Mindlin Sarah Collins Yojna Handoo-Das Darshna Makwana 18 Hepatitis B - Dried Blood Spot Testing