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Prevention of Perinatal HBV and HCV
Transmission
John W. Ward, M.D.
Director, Division of Viral Hepatitis
Centers for Disease Control and Prevention
Division of Viral Hepatitis
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Natural History of HBV Infection
 Varies depending on age of infection
 Among infected children acute (symptomatic) hepatitis B
rare; likelihood of developing chronic infection high:
Age at infection
<1 year
1-5 years
>5 years
Acute HBV
<1%
5-15%
20-50%
Chronic HBV
90%
25-50%
6-10%
 Morbidity and mortality associated with chronic infection
> 90% of deaths from cirrhosis and hepatocellular
carcinoma
Current Recommendations to Eliminate
HBV Transmission among
Vaccinated Pediatric Cohorts
United States

Universal Birth dose of Hepatitis B vaccine- 70% coverage

Timely completion hepatitis B vaccine series -93% coverage

Maternal HBsAg testing - >90%

Infants of HBsAg+ mothers

HepB vaccine /HBIG < 12 hours of birth
 Post-vaccination serology* (HBsAg and anti-HBs)
 ~1 % of infants become HBsAg+
CDC, MMWR 2012, 2013
4
Hepatitis B Vaccine Policy and Rates of
Acute Hepatitis B, U.S.,1980-2011
Cases/100,000 population
14
Universal maternal HBsAg
testing 1988
12
Ages 0-18
years, 1999
10
8
6
4
2
0
Infants of
HBsAg-positive
women, 1984
High-risk
groups,*
1982
Adults <60
years with
Diabetes
Birth dose,
2006
All US
infants,
1991
Year
*Health care providers, MSM, IDU, hemodialysis patients, household & sexual partners of persons with chronic HBV,
persons in certain institutional settings, e.g, inmates of long-term correctional facilities.
Source: National Notifiable Disease Surveillance System (NNDSS)
5
HepB Vaccination Has Decreased HBV incidence
Protecting Newborns Remains a Challenge
HCV incidence
7
6
7000
6000
5000
4000
3000
2000
1000
0
HepB
vaccination, infants, at risk adults
a
5
Catch-up, older children
4
3
Birth dose
2
Diabetics
1
0
1992
1997
2002
2007
2010
2012
2013
2014
~1000 HBsAg+ newborns/yr.
Improve birth dose coverage
Infant case management
Consider anti-viral prophylaxis
Outcomes of Infants Born to HBsAg+
Women – United States 2008-2013
120%
95%
89%
100%
96%
80%
60%
40%
20%
1%
0%
Total
Foreign born
HepB <12 hrs.95% HBIG <12 hrs.
HBsAg+ infants
17, 951 mother –infant pairs; 11,,335 with data for HBIG/HepB status;
100 HBsAg+ infants
S Schillie, Pediatrics 2015
Interventions to Improve Prevention of
Perinatal HBV Transmission
Case management of HBV exposed infants
- Maternal HBV testing- USPSTF recommendation
- Hepatitis B Perinatal Prevention Coordinators- manage ~50% of
exposed infants
- Addition of pregnancy status to HBV test requisitions
- Medicaid support for case management (discussed with CMS)
Birth dose
- CDC recommendation – for vaccination before hospital discharge
- Standing orders
- Evaluation criteria for licensing of birth facilities
Results of Perinatal Prophylaxis to Prevent Vertical
Transmission of HBV

3353 HBV exposed infants received HBIG, HepB vaccine < 12 hrs of birth

99% of infants protected from HBV infection

25 infants (0.75%) became HBV infected; 0.75/100 births

24/25 born to HBeAg+ mothers; (RR 79.92)

All transmissions at maternal HBV DNA > 5 × 107 IU/mL
Kubo A et al. Ann Intern Med. 2014 Jun 17;160(12):828-35
9
Cost-Effectiveness : HBeAg or HBV DNA Testing
vs. Current Recommendation
Variable
Decrease in perinatal
transmission with
antiviral treatment
ICER
($/QALY saved)
Range
20% - 80%
reduction
Sequential
HBeAg test
Sequential HBV
DNA load test
Cost saving –
4,708
Cost saving –
11,167
L, Fan, Obstet Gynecol. 2014 May
10
UPDATING ACIP RECOMMENDATIONS
FOR HEPATITIS B VACCINATION
Advisory Committee for Immunization Practices
ACIP
October 2016
Updates to ACIP Statement
o Hepatitis B vaccine birth dose administered within 24 hours of birth
for medically stable infants weighing ≥2,000 grams and born to HBsAgnegative mothers
o Testing HBsAg-positive pregnant women for hepatitis B virus (HBV)
DNA to guide the use of maternal antiviral therapy during pregnancy
for prevention of perinatal HBV transmission
o Refer to AASLD recommendation for the use of antiviral therapy
among mothers with HBV DNA >200,000 IU/mL for preventing
perinatal transmission
o Post-vaccination serologic testing for infants whose mother’s HBsAg
status remains unknown indefinitely
o Recommend hepatitis B vaccination for persons with HCV and for
those with chronic liver disease
12
Modes of HCV Transmission
• Unsafe health care – Most common risk globally
• Injection drug use- population with highest HCV prevalence
• Other modes
– Perinatal
– Sexual transmission; rare; HIV infected MSM at highest risk
– Also reported - (e,g inhaled drugs , unregulated tattooing, household)
MSM: Men who have sex with men.
Scheinmann, Drug and Alcohol Dependence 2006. Weinbaum ,MMWR 2003. Gough, BMC Public Health 2010.
Mast, J Infect Dis, 2005. Marincovich B, Sex Transm Infect 2003. Yaphe S, Sex Transm Inf 2012. Bottieau,
Eurosurveillance 2010. Ackerman Z, J Viral Hepat 2000. Tohme RA, CID 2012 ; CDC/hepatitis.gov; CDC MMWR
2001; Hagan, et al, Int J Drug Policy 2007;
Perinatal Transmission of HCV
• Transmission from HCV RNA + mothers
– Mono-infected 6.5%
– HIV –infected- 13.6%
• Transmission risks
– HCV viral load
• < 6 log viral load- 3.9%
• > 6 log viral load – 14.3%
– Prolonged rupture of membranes( > 6 hours; OR 9.3)
– Often cited but poor or no supportive data
• Internal fetal monitoring
• Vaginal versus cesarean delivery
• No risk from breast feeding
• No recommendations for maternal testing
• Role of new antivirals yet to defined
Cottrell E, Ann Int Med 2013; Delotte J, J Matern Fetal Neonatal Med. 2014
Risk of Chronic infection and
Disease Progression in HCV Infected Children
Chronic HCV infection
- Perinatal exposures- 90%
- Older children – 70-75%
Disease progression
- Cause of 110 of 12,439 pediatric liver transplants (1988-2010)
- Children appear to have less progressive disease than adults ( no
alcohol or other co-factors)
- On liver biopsy of 76 HCV+ children
- 35% no fibrosis
- 50%- mild fibrosis
- 4%- moderate/severe fibrosis
- Severity related to age and duration of infection
New HCV meds not yet licensed for children
Abdel-Hady M. J Viral Hepat 2011; Robinso J, Liver Int 2012
3,500
Number of cases
3,000
2,500
2,000
1,500
1,000
500
0
Year
Source: National Notifiable Diseases Surveillance System (NNDSS)
Reported cases/100,000 population
1.6
1.4
Male
1.2
Female
1.0
0.8
0.6
0.4
0.2
0.0
Year
Source: CDC, National Notifiable Diseases Surveillance System (NNDSS)
PROPORTION OF BIRTHS TO HCVINFECTED WOMEN
Proportion* of infants born to hepatitis C
virus (HCV)-infected women† — United States
and Kentucky, 2011–2014
2.0%
1.5%
~1600 infants born with HCV infection in
2014
1 of 67
births
1.0%
1 of 308 births
0.5%
0.0%
2011
2012
2013
YEAR OF INFANT BIRTH
2014
* Proportion calculated annually as infants born to HCV-infected
women
divided by totalKentucky
infants born.
United
States
† HCV infection status of mother is determined by notation on infant’s birth certificate. Birth categorization is based on mother’s place of residence.
Reports of HCV among Pregnant Women, Kentucky
December 2013 – July 2015
HR Sands et al. Perinatal Hepatitis C Surveillance in Kentucky,
Dec 2013-July 2015
Distribution of HCV Among Young Persons
and Location of Syringe Service Programs
29,382 persons 15-29 years with HCV
Syringe Service Program
1 dot = 1 person
HCV Cases: LabCorp and Quest commercial laboratories SSPs:
North American Syringe Exchange Network
Canary L, Hariri S, Campbell C, et al. “Geographic disparities in access to syringe service programs among young people with hepatitis C virus infection in the U.S.” November 2016. In Peer Review.
CDC and USPSTF Updated Recommendations
for HCV Testing
 One time screening test for persons born 1945-1965
 Major risk
 Past or present injection drug use
 Other risks







Received blood/organs prior to June 1992
Received blood products made prior to 1987
Ever on chronic hemodialysis
Infants born to HCV infected mothers
Intranasal drug use
Unregulated tattoo
History of incarceration
 Medical
 Persistently elevated ALT
 HIV
MMWR Aug 2012. Moyer VA, Ann Int Med 2013.
Considerations to Improve Prevention of HCV among
Pregnant Women and their Children
• Improve HCV risk screening or routine testing
– Pregnant women, HCV exposed newborns: improve early identification of HCVinfected infants and linkage of the mother and infant to care and treatment
– Women of reproductive age or in family planning- linkage to care, treatment, and cure
to avoid HCV infection during pregnancy
– Other newborns with illicit drug exposures (e.g. neonatal abstinence syndrome)
– Frequency of testing, regional or national recommendations
Considerations to Improve Prevention of HCV among
Pregnant Women and their Children
Surveillance
• Utilize existing data – birth certificate data
–Cross matching HCV and birth certificate registries ( e.g., Phil)
–Mandated reporting of HCV among pregnant women, exposed
infants and children (e.g, KY)
– Reporting pregnancy status as part of HCV lab-based surveillance
•
• DVH work group formed, expert consultation planned
Considerations to Improve Prevention of HCV among
Pregnant Women and their Children
Next Steps
• Utilize existing data – birth certificate data
–Cross matching HCV and birth certificate registries ( e.g., Phil)
–Mandated reporting of HCV among pregnant women, exposed
infants and children (e.g, KY)
– Reporting pregnancy status as part of HCV lab-based surveillance
•
• DVH work group formed, expert consultation planned
Thank You