1. Prevention of Perinatal Hepatitis B in New York City Julie E. Lazaroff, MPH Unit Chief Perinatal Hepatitis B Prevention Unit Bureau of Immunization NYC DOHMH

2. Outline Perinatal Hepatitis B Prevention of Perinatal Hepatitis B Epidemiology of Hepatitis B Perinatal Hepatitis B Prevention Program in New York City

3. Perinatal Hepatitis B Infection

4. HBsAg (+) status, infant aged >1-24 months, born to an HBsAg-positive mother Transmission of hepatitis B virus occurs during birth from mother to infant (vertical transmission) Transmission route is mucosal exposure to infected blood and other body fluids containing virus

5. Risk of Infection Up to 90% of infants born to HBsAg (+) mothers will become infected with HBV without intervention –90% of HBV infected infants will develop chronic HBV infection –Higher risk if mother is HBeAg+ –High viral load Risk continues to the uninfected -~40% of unvaccinated children living with hepatitis B carriers will be infected by 4 years of age

6. Chronic Infection (carrier) (%) Symptomatic Infection (%) 100 Symptomatic Infection Chronic Infection Birth 1-6 mos 7-12 mos 1-4 yrs Older Children and Adults 0 20 40 60 80 60 40 20 0 Clinical Presentation of Hepatitis B by Age at Infection CDC

7. Prevention of Perinatal Hepatitis B

8. Hepatitis B Vaccine 1970: Hepatitis B virus first identified 1981: Hepatitis B vaccine (plasma derived) approved for use 1986: Hepatitis B vaccine licensed (recombinant) Monovalent – single antigen Combination vaccines –Pediarix –Comvax

9. Post Exposure Prophylaxis (PEP) HBIG – hepatitis B immune globulin and 1 st dose single antigen HBV  Within 12 hours after birth* 2 nd dose single antigen HBV  1 -2 months of age 3 rd dose HBV (may be combination HBV)  At 6 months of age (not before 24 wks) *If missed, HBIG must be given within 7 days of birth in order to be effective

10. Impact of PEP on Newborns The recommended PEP for infants born to HBsAg (+) mothers is estimated to be 90-95% effective at preventing perinatal transmission of HBV Administering the 3-dose schedule without HBIG is still estimated to be 70-90% effective in preventing perinatal transmission

11. Universal Hepatitis B Birth Dose All infants, without regard for the mother’s HBsAg status should receive the first dose of hepatitis B vaccine at birth* –“Safety net” for infants whose mother’s HBsAg+ status was unknown or incorrect at time of birth –Minimizes risk of horizontal transmission after birth –Increased likelihood that overall immunization series will be completed on time –Only 60% of newborns in NYC received a birth dose in 2010

12. Post Vaccination Serology (PVS) Testing for HBsAg (antigen) and anti-HBs (antibody) Timing –After 3 doses of hepatitis B –At 9 months of age, (not earlier) –At least one month after final dose of HBV Outcomes –Immune –Susceptible - administer a 2 nd three dose series and follow up testing one month after the last dose –Infected - refer to a liver specialist –Indeterminate – repeat blood draw

13. Epidemiology of HBV Infection

14. Worldwide 350 million persons living with chronic HBV infection Highly endemic regions - >7% -infections during infancy or childhood Low endemic regions - <4% infections during adolescence/adulthood in persons with other risk factors

15. HBsAg Prevalence  8% - High 2-7% - Intermediate <2% - Low Distribution of Chronic HBV Infection CDC Source: WHO data, 1996 (unpublished). Department of Immunization, Vaccines and Biologicals (IVB); Date of slide: 7 July 2004

16. HBsAg-Positive Pregnancies United States hepatitis B prevalence: < 1% NYC - ~1.3% –2 nd highest number of reported cases in the US (1800/yr on average) ~ 85% of cases are foreign born Reported cases increased from 1457 in 1995 to 2100 in 2007 2008, 2009 and 2010 - there were 2054, 1766 and 1843 reported cases, respectively

17. Number of HBsAg+ Cases by Mother’s Region of Birth NYC, 1995-2005 Number of HBsAg+ cases Year During this time the number of all live births to Chinese women increased from 3289 to 5889, a 79% increase And the number of all live births to African women increased from 2762 to 4141, a 50% increase

18. Perinatal Hepatitis B Prevention (PHBP) Program

19. Perinatal Hepatitis B Prevention Program, NYCDOHMH CDC recommended universal screening of pregnant women in 1990 Established a national program providing grants to all health jurisdictions NYC program founded in 1986 NYS Public Health Law (PHL) Section 2500-e: –In 1990 - 1 st US state to pass such a law –Mandates prenatal screening of all pregnant women and reporting positive HBsAg test results to the health department –Requires testing for women with unknown status and return of results within 24 hours Targeted testing in Labor and Delivery –Those at risk for HBV infection during pregnancy (e.g., more than one sexual partner in previous 6 months, evaluation for an STD, IVDU, or HBsAg-positive sex partner –Those with clinical hepatitis since previous testing

20. Program Mission and Activities Mission: To prevent perinatal hepatitis B infections and horizontal transmission to household, sexual or needle-sharing contacts –Conduct case surveillance –Educate cases about their own hepatitis B disease and preventing transmission to others –Maximize immunization and testing of infants and contacts Activities: –Communicate testing and reporting laws to healthcare providers and laboratories –Conduct case management for mothers, newborns and contacts –Collect data on maternal characteristics, vaccination dates and testing results –Maintain electronic database, conduct data analysis and reporting

21. Case Surveillance Mandated HBsAg screening and reporting laws Multiple reporting sources –Prenatal care providers –Newborn nurseries –Laboratories –Newborn screening card data –Other jurisdictions –Communicable Disease acute investigations

22. Case Investigation Staff investigate cases individually –letters, phone calls, home visits, chart reviews Data Collection –Maternal demographic, risk factor, medical data Health education –hepatitis B disease, healthy lifestyle choices, modes of transmission, PEP and PVS testing for newborns Identify Contacts –All household members and sexual partners –Refer for testing and vaccination Refer cases and contacts for screening for liver disease –ALT and AFP tests every 6 months –Ultrasound once a year

23. Staff ensures administration of PEP and PVS testing –Phone calls and reminder letters to mothers and pediatricians Obtains documentation of vaccinations and laboratory reports from providers Data is entered into a centralized database to monitor completion and outcomes Follow up for Infants and Contacts

24. Case Management Data births 5 /1/2008 -11/30/2009, NYC 2885 births to HBsAg (+) mothers – 78% (n=2263)/2885) received three valid doses of hepatitis B vaccine 18% (407/2263) had the final dose administered in China –58% (n=1666) had PVS testing 18% (300/1666) were tested in China –Of the infants tested 93% (n=1554) were immune 1.3% (n=22) were infected 3.6% (n=61) were susceptible 1.7% (n=29) were indeterminate

25. Infants in China –~60% of cases are women who were born in China –40% of their infants around age 3 months move to China before case management is complete Unit obtains documentation on completion of the 3 dose series in China for ~50% and completion of PVS testing for ~40%

26. PEP of Infected Infants 1995-2005, n=240 HBIG/HBV rates among infected infants (pooled 1995-2005 data) –99% received HBIG (237/240) –100% received a birth dose < 72 hrs –16 did not receive 3 doses (224/240)* * Vaccination records may not be fully updated

27. Take Home Messages Vaccinate all newborns, with rare exception Screen all pregnant women for HBsAg –Re-screen at time of delivery if high risk or status is unknown For infants born to HBsAg (+) women –HBIG and vaccine <12 hours of birth –Complete 3 dose series according to schedule –Conduct PVS testing at 9 months of age

28. References A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and Adolescents MMWR 12/23/05, 54(RR16);1-23 –http://www.cdc.gov/mmwr/PDF/rr/rr5416.pdfhttp://www.cdc.gov/mmwr/PDF/rr/rr5416.pdf A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: Immunization of Adults MMWR 12/8/06, 55(RR16);1-25 –http://www.cdc.gov/mmwr/PDF/rr/rr5516.pdfhttp://www.cdc.gov/mmwr/PDF/rr/rr5516.pdf