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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. Outline. Perinatal Hepatitis B Prevention of Perinatal Hepatitis B Epidemiology of Hepatitis B
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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
Outline • Perinatal Hepatitis B • Prevention of Perinatal Hepatitis B • Epidemiology of Hepatitis B • Perinatal Hepatitis B Prevention Program in New York City
Perinatal Hepatitis B Infection • 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
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
Clinical Presentation of Hepatitis B by Age at Infection 100 100 80 80 60 60 Chronic Infection Chronic Infection (carrier) (%) Symptomatic Infection (%) 40 40 20 20 Symptomatic Infection 0 0 Birth 1-4 yrs 1-6 mos 7-12 mos Older Children and Adults CDC
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
Post Exposure Prophylaxis (PEP) HBIG – hepatitis B immune globulin and 1st dose single antigen HBV Within 12 hours after birth* 2nd dose single antigen HBV 1 -2 months of age 3rd 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
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% effectivein preventing perinatal transmission
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
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 2nd three dose series and follow up testing one month after the last dose • Infected - refer to a liver specialist • Indeterminate – repeat blood draw
Epidemiology of HBV Infection • 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
HBsAg Prevalence ³8% - 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
HBsAg-Positive Pregnancies • United States hepatitis B prevalence: < 1% • NYC - ~1.3% • 2nd 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
Number of HBsAg+ Cases by Mother’s Region of Birth NYC, 1995-2005 During this time the number of all live births to Chinese women increased from 3289 to 5889, a 79% increase Number of HBsAg+ cases And the number of all live births to African women increased from 2762 to 4141, a 50% increase Year
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 - 1st 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
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
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
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
Follow up for Infants and Contacts • 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
Case Management Databirths 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
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%
PEP of Infected Infants1995-2005, 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
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
References • A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United StatesRecommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of Infants, Children, and AdolescentsMMWR 12/23/05, 54(RR16);1-23 • http://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.pdf