1. Perinatal Hepatitis B Lynn Pollock, RN, MSN New York State Department of Health lxp01@health.state.ny.us 518-473-4437

2. Workshop Objectives At the conclusion of the workshop, participants will be able to: Explain the risks for perinatal hepatitis B infection Explain the risks for perinatal hepatitis B infection Outline perinatal hepatitis B prevention activities in New York State Outline perinatal hepatitis B prevention activities in New York State Understand the justification and implementation of public health law 2500-e Understand the justification and implementation of public health law 2500-e

3. Perinatal Hepatitis B Infection and Transmisson

4. Hepatitis B Virus (HBV) Most common liver infection worldwide 350-400 million people chronically infected 1 million deaths annually Large proportion of perinatal acquisition Without appropriate treatment, 1 in 4 chronically infected persons experience liver cancer, cirrhosis or liver failure 80% of primary liver cancer (hepatocellular carcinoma) is caused by chronic hepatitis B infection

5. HBsAg Prevalence High >8% Intermediate 2-7% Low <2% Geographic Distribution of Chronic HBV Infection 1

6. HBV Disease Burden in U.S. ~ 51,000 new infections in 2005 5,494 acute clinical cases reported 2005 Represents a 79% reduction from the pre-vaccine era 1 of 20 persons have been infected with hepatitis B virus (HBV) during their lifetime (about 12.5 million) 1 of 200 persons have chronic HBV infection (~1.25 million) 3,000-5,000 deaths from HBV related chronic liver disease (cirrhosis, liver cancer) *Disease Burden from Hepatitis A, B, and C in the US http://www.cdc.gov/ncidod/diseases/hepatitis/

7. Perinatal Hepatitis B in the U.S. About 24,000 infants were born to HBV-infected mothers in 2005 About 24,000 infants were born to HBV-infected mothers in 2005 Without immunoprophylaxis (vaccine and hepatitis B immune globulin [HBIG]): Without immunoprophylaxis (vaccine and hepatitis B immune globulin [HBIG]): about 9,100 chronically infected with HBV (most asymptomatic) about 9,100 chronically infected with HBV (most asymptomatic) about 2,300 expected to die of chronic liver disease (cirrhosis or liver cancer) about 2,300 expected to die of chronic liver disease (cirrhosis or liver cancer)

8. Natural History of Hepatitis B Virus (HBV) Infection

9. Modes of HBV Transmission in Infancy and Early Childhood Transmission from infected mother to neonate during delivery Transmission from infected mother to neonate during delivery Transmission from infected household contact to child Transmission from infected household contact to child Both modes of transmission can be prevented by vaccination of newborns!

10. Primary Prevention Hepatitis B Virus is preventable with a vaccine that has been available for over 25 years!

11. Perinatal Hepatitis B in the U.S. About 24,000 infants were born to HBV-infected mothers in 2005 About 24,000 infants were born to HBV-infected mothers in 2005 Without immunoprophylaxis (vaccine and hepatitis B immune globulin [HBIG]): Without immunoprophylaxis (vaccine and hepatitis B immune globulin [HBIG]): about 9,100 chronically infected with HBV (most asymptomatic) about 9,100 chronically infected with HBV (most asymptomatic) about 2,300 expected to die of chronic liver disease (cirrhosis or liver cancer) about 2,300 expected to die of chronic liver disease (cirrhosis or liver cancer)

13. STATE OF NEW YORK DEPARTMENT OF HEALTH Cumulative Reported Cases of Confirmed Chronic Hepatitis B New York State State of New York, excluding New York City 10,968,179 54,841 4,152 Label Definition: County name Population (2000 U.S. Census) HBV Estimates (0. 5% of U.S. Population)* * Based on upper limit of CDC estimate range (0.2%-0.5%) Cumulative Reported Chronic Cases

14. Perinatal Hepatitis B Transmission Percutaneous and permucosal exposure to mother’s blood during birth Percutaneous and permucosal exposure to mother’s blood during birth Usually occurs during birth In utero transmission is rare: accounts for ~2% of perinatal infections HBV not transmitted by breastfeeding

15. Symptomatic Infection Chronic Infection Age at Infection Chronic Infection (%) Symptomatic Infection (%) Birth 1-6 months 7-12 months 1-4 years Older Children and Adults 0 20 40 60 80 100 80 60 40 20 0 Outcome of Hepatitis B virus Infection by Age

16. Prevention of Hepatitis B Virus Transmission: (ACIP, 2001) Screening of all pregnant women Routine vaccination of all infants, with the first dose preferably before hospital discharge Vaccination of all children and adolescents (though age 18) Special efforts to vaccinate high risk children and adolescents Vaccination of adults in high-risk groups

17. Perinatal Case Identification Women tested for HBsAg prenatally Delivering women tested for HBsAg at hospital (if not tested previously) HBsAg+ test results reported to health department Health department determines pregnancy status for reports of HBsAg+ women Pregnant women/infants identified for case management

18. Basis for Perinatal Prevention Strategy ●Infants born to HBV-infected women at highest risk ~20,000 births to HBsAg+ women each year 10-85% infants become infected Usually asymptomatic infection Risk of chronic infection>90% ●HBV-infected women may be unaware of status or deny risk factors ●Post-exposure prophylaxis (vaccine + HBIG) is extremely effective

19. HBV Serology

20. Serologic Marker Hepatitis B surface antigen (HBsAg) Antibody to HBsAg (Anti-HBs) Indication in Serum -Marker of infectivity -Present in acute & chronic infection -Marker of immunity from resolved infection OR -Previous vaccination

21. HBV Serology Serologic Marker Antibody to core antigen (Total Anti-HBc) IgM antibody to core antigen (IgM anti-HBc) Indication in Serum -Past or present infection -Present in acute, chronic & resolved infection -Subset of total anti-HBc -Present in acute infection -Diagnostic of acute infection

22. HBV Serology Serologic Marker Hepatitis Be antigen (HBeAg) Antibody to HBeAg (Anti-HBe) Indication in Serum -High levels of infectivity -Present in acute infection -Variably present in chronic infection -Present in resolved & chronic infection -Can be present in acute infection

23. Acute Hepatitis B Virus Infection with Recovery

24. Progression to Chronic Hepatitis B Virus Infection

25. CASE STUDY #1

26. Ting Nguyen immigrated to America from Vietnam as an eleven year old girl. After twelve years of living in Kansas, she married her college sweetheart. She became pregnant in the first month of marriage. Included in her first trimester prenatal screening was a serologic test for HBsAg. She was shocked to learn that she was HBsAg positive. Her obstetrician informed her that she was probably chronically infected with HBV and most likely had been infected since birth. Neither Ting or her mother recalled any signs or symptoms of viral hepatitis at any point in the last 20+ years.

27. What additional information should Ting’s doctor provide to Ting and her family? Answer: There is a vaccine and treatment available for her baby at birth to prevent transmission of hepatitis B. The whole family should be tested. Susceptible family members should be vaccinated. Infected individuals should be referred for medical consultation.

28. Should Ting plan to have a C-section? Answer: No, data do not suggest that method of delivery is related to maternal to fetal transmission of hepatitis B. The important thing is that Ting’s baby receive appropriate prophylaxis at birth What is that prophylaxis? Answer: HBIG and first dose of hepatitis B vaccine within 12 hours of birth

29. Can Ting breastfeed her baby? Answer: Yes - just be certain the baby gets prophylaxed within 12 hrs of birth - instruct Ting on good nipple care - she can even put the baby to breast on the delivery table. At what age should Ting’s baby be tested to determine success or failure of prophylaxis ? Answer: At 9-18 months What tests should be performed? Answer: HBsAg and anti-HBs

30. Prevention of HBV Transmission *Hepatitis B Immune Globulin Post-exposure prophylaxis is highly effective in preventing HBV transmission after exposure: Post-exposure prophylaxis is highly effective in preventing HBV transmission after exposure: when given within 24 hours of birth, hepatitis B vaccine and HBIG* is 85%-95% effective when given within 24 hours of birth, hepatitis B vaccine and HBIG* is 85%-95% effective hepatitis B vaccine alone at birth is 70%-95% effective hepatitis B vaccine alone at birth is 70%-95% effective

31. Hepatitis B Vaccine: Two Purposes Administered at birth to an infant born to an HBV-infected mother, hepatitis B vaccine serves as post-exposure prophylaxis Administered at birth to an infant born to an HBV-infected mother, hepatitis B vaccine serves as post-exposure prophylaxis Administered at birth to an infant born to an uninfected mother, hepatitis B vaccine serves as pre-exposure protection Administered at birth to an infant born to an uninfected mother, hepatitis B vaccine serves as pre-exposure protection

32. NYS Public Health Law 2500-e and Regulations Roles and Responsibilities

33. Pregnant Women and State HBsAg Requirements Currently, only 24 states require HBsAg screening of pregnant women in the US 1990 NYSDOH PHL 2500-e Mandated Hep b screening and reporting for all pregnant Goals of PHL 2500-e: All pregnant women screened each pregnancy Treatment of all infants born to HBsAG- positive women Provide STAT testing for women with unknown status and treatment of their infants Require reporting

34. Implementing Protocols for HBV Prevention Screen all pregnant women for HBsAg Identifies infants requiring immunoprophylaxis soon after birth to prevent perinatal HBV infection Identifies household contacts needing vaccination Allows medical follow-up of women and other contacts with chronic HBV infection

35. Infection in unvaccinated infants The mother is HBsAg negative, but the infant is exposed to HBV infection postnatally from another family member or caregiver. This occurs in 2/3 of all childhood transmission cases.

36. The woman is tested early in pregnancy and found to be HBsAg negative. She develops HBV infection later in pregnancy but it is not detected, even though it is recommended that high-risk women be tested later in pregnancy. The infection is not clinically detected so the infant does not receive hepatitis B vaccine or HBIG at birth. Infection in unvaccinated infants

37. A chronically infected pregnant woman is tested but with the wrong test, HBsAb (antibody to hepatitis B surface antigen) instead of HBsAg. This is a common error because the abbreviations for these two tests differ by only one letter. Her incorrectly ordered test result is “negative” so her doctor believes her baby does not need prophylaxis. Infection in unvaccinated infants

38. The pregnant woman is tested and found to be HBsAg positive, but her status is not communicated to the newborn nursery.. The infant receives neither hepatitis B vaccine nor HBIG protection at birth. Infection in unvaccinated infants

39. The pregnant woman is not tested for HBsAg either prenatally, or in the hospital at the time of delivery. Her infant does not receive hepatitis B vaccine in the hospital even though the vaccine is recommended within 12 hours of birth for infants whose mothers’ test results are unknown. Infection in unvaccinated infants

40. The pregnant woman is HBsAg positive but her test results are misinterpreted or mistranscribed into her prenatal record or her infant’s chart. Her infant does not receive HBIG or hepatitis B vaccine. ALL OF THESE ERRORS HAVE OCCURRED IN NEW YORK STATE Infection in unvaccinated infants

41. “Medical Errors put infants at risk for chronic hepatitis B virus infection– 6 case reports in NYS” www.health.state.ny.us/diseases/communicable/ hepatitis/infants_hepb.htm

42. CASE STUDY #2

43. In September 1999, a woman of Southeast Asian descent who tested negative for hepatitis B gave birth to a seemingly healthy baby girl. In December, the 3 month-old infant was hospitalized following 5 days of fever, diarrhea and jaundice. Hepatitis B serology was performed on admission with the following results: HBsAg: positive HBsAg: positive IgM anti-HBc: positive IgM anti-HBc: positive ALT: 693; T. bili: 16.6 ALT: 693; T. bili: 16.6 The mother was tested at the same time and was found to be HBsAg positive. What is the diagnosis? What is the diagnosis?

44. Answer: acute hepatitis B infection What happened and how could this have been prevented? At the time of birth, the mother’s test result was falsely communicated as “hepatitis negative” to the hospital where the infant was born The baby died 4 days after hospitalization from fulminant hepatic failure secondary to hepatitis B infection This could have been prevented by routine administration of birth dose regardless of mother’s reported HBsAg status

45. Other Lessons HBsAg status should always be communicated to the mother along with its importance HBsAg status should always be communicated to the mother along with its importance Women should have screening done for each separate pregnancy regardless of results from a prior pregnancy Women should have screening done for each separate pregnancy regardless of results from a prior pregnancy Providers at the time of labor & delivery should obtain actual lab report, not just verbal communication or a result copied from one chart to another – mistakes do occur Providers at the time of labor & delivery should obtain actual lab report, not just verbal communication or a result copied from one chart to another – mistakes do occur

46. Improving our Prevention Efforts Improving our Prevention Efforts Ensure prenatal screening of all pregnant women for HBsAg Ensure prenatal screening of all pregnant women for HBsAg Ensure reporting of all HBsAg+ pregnant women Ensure reporting of all HBsAg+ pregnant women Improve electronic medical information systems Improve electronic medical information systems

47. Improving our Prevention Efforts Testing and vaccination of susceptible household contacts Testing and vaccination of susceptible household contacts Post-vaccination testing of infants born to infected mothers Post-vaccination testing of infants born to infected mothers Standardization of birth dose: “Safety Net” Standardization of birth dose: “Safety Net”

48. Vaccinations & Breastfeeding Mothers who are breastfeeding can and should be vaccinated Infants who breastfeed can and should be vaccinated ACIP, 2007

49. Vaccinations & Breastfeeding  Neither inactivated nor live vaccines affect the safety of breast feeding for infants of mothers  Breastfeeding is not a contraindication for any vaccine  Vaccinate infants who breastfeed ACIP, 2007

50. Breast Milk and Vaccines  Only rubella has been detected in breast milk with no illness or symptoms of disease in infant  No adverse effect on future response to 12 month rubella vaccine  Increased immune response by breast feeding infants to Hib, DT, OPV ACIP, 2007

51. Sources of information on HBV & vaccination CDC: www.cdc.gov/hepatitis Hotline: 1-888-4HEPCDC www.cdc.gov/hepatitis Schedule: http://www.cdc.gov/nip/recs/child-schedule.htm#Printable http://www.cdc.gov/nip/recs/child-schedule.htm#Printable Recommendations: http://www.cdc.gov/nip/publications/ACIP-list.htm http://www.cdc.gov/nip/publications/ACIP-list.htm General & Vaccine Safety - NIP http://www.cdc.gov/nip http://www.cdc.gov/nip National Network for Immunization Info: www.immunizationinfo.org Immunization Action Coalition: www.immunize.org www.immunize.org Viral Hepatitis Prevention Board: http://www.vhpb.org Institute of Medicine Immunization Safety Review: www.iom.edu/IOM/IOMHome.nsf/Pages/immunization+safety+review

52. Acknowledgements Kimberly Noyes Kimberly Noyes Debra Blog Debra Blog Geri Naumiac Geri Naumiac Cindy Schulte Cindy Schulte Betsy Herlihy Betsy Herlihy