The American College of Obstetricians & Gynecologists recommends that all HBsAg-positive pregnant persons and pregnant persons with chronic hepatitis B be tested for HBV DNA, ideally between week 26-28 of pregnancy, to guide the use of maternal anti-viral therapy during pregnancy. Infants born to pregnant persons with high viral loads are at greatest risk for infection despite receipt of hepatitis B vaccine and HBIG.

• If HBV DNA level is >20,000 IU/mL: Refer to a gastroenterologist or infectious disease specialist for evaluation. Fill out the HBV DNA Results Form; send via secure email to VPDC-PHB@ph.lacounty.gov or fax to 213-351-2781.
• If HBV DNA level is >200,000 IU/mL: Refer to a gastroenterologist or infectious disease specialist for evaluation.
  • The American Association for the Study of Liver Diseases (AASLD) recommends prescribing tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) starting at gestational week 28 until the end of the pregnancy to reduce vertical transmission risk.
  • Fill out the HBV DNA Results Form; send via secure email to VPDC-PHB@ph.lacounty.gov or fax to 213-351-2781.

1. If pregnant patient has a positive HBsAg result followed by a negative HBsAg result during the same pregnancy, order the following tests to verify or rule out a hepatitis B diagnosis:
   • HBV DNA
   • Total anti-HBc
   • IgM anti-HBc
   • Anti-HBs
2. Follow the table Interpretation of Hepatitis B Virus (HBV) Markers of Infection Following Discrepant Hepatitis B Surface Antigen (HBsAg) Lab Results During Pregnancy to determine whether to rule out or confirm hepatitis B in this pregnant patient based on these additional lab results.
3. If you are unable to order the above tests and/or the pregnant person does not submit for these tests, or only some tests are performed, follow the flowchart Algorithm for Managing Pregnant Persons with Discrepant HBsAg Results.

NOTE: If initial positive HBsAg result was ≤14 days after receipt of a dose of hepatitis B vaccine, a negative HBsAg 1+ month after that dose is sufficient to rule out a hepatitis B diagnosis.

• Pregnancy Verification Form (LACDPH)
• HBV DNA Results Form (LACDPH)
• Interpretation of Hepatitis B Virus (HBV) Markers of Infection Following Discrepant Hepatitis B Surface Antigen (HBsAg) Lab Results During Pregnancy (LACDPH)
• Algorithm for Managing Pregnant Persons with Discrepant HBsAg Results (LACDPH)
• Guidelines for Prenatal Care Physicians(CDPH)
• Antiviral therapy in chronic hepatitis B viral infection during pregnancy (AASLD)
• Screening and Referral Workflow for Hepatitis B Virus (HBV) Infection Among Pregnant People (CDPH)

1. Alert the nursery staff that the newborn is high risk and will need post-exposure prophylaxis – both hepatitis B vaccine and hepatitis B immune globulin (HBIG) – within 12 hours of birth to prevent maternal-infant transmission of hepatitis B.
2. Counsel the birth parent on the importance of post-exposure prophylaxis as medical treatment to prevent hepatitis B virus infection. Provide birth parent with Hepatitis B Vaccine Information Statement before vaccine administration. Hepatitis B Vaccine Information Statements are available in most languages.
   • If parents refuse PEP: If, after education, parents continue to refuse PEP for their infant, parents should be informed that refusal of PEP may be considered medical neglect and will be reported to Child Protective Services (per WIC § 300(b)(1)(C) and PEN § 11165.2 (a)).
     1. If the infant is still hospitalized, the hospital or pediatrician should report the situation to Child Protective Services (CPS) and may be able to obtain an emergency court order to administer PEP.
     2. If the infant has already been discharged, the pediatrician or coordinator may make a report to CPS.
     3. Proceed to section Post-Exposure Prophylaxis Errors.

3. Provide prophylaxis to the newborn. Administer monovalent/single-antigen hepatitis B vaccine (ENGERIX-B or RECOMBIVAX HB®, 0.5 mL) and HBIG (Nabi-HB®) in separate limbs intramuscularly (IM) within 12 hours of birth.
   • If PEP was administered more than 12 hours after birth (whether HBIG, Hepatitis B birth dose, or both), proceed to section Post-Exposure Prophylaxis Errors.
4. Document the hepatitis B vaccine and HBIG dose in the newborn’s medical record, including the date, time, and site of administration, and the vaccine lot number. Report this information to CAIR within a week of administration.
5. Provide further advice to the birth parent. Counsel the parent that they may breast-feed the infant upon delivery. Explain the importance of completing the hepatitis B vaccine series to protect the baby. Educate them that blood tests (HBsAg and anti-HBs) need to be drawn from the baby 1-2 months after completion of the hepatitis B vaccine series, and no earlier than 9 months of age. Explain that anyone susceptible who is a household, sexual, and/or needle-sharing contact should be tested for hepatitis B and vaccinated if they do not already have it. Advise that the birth parent should be medically evaluated for chronic hepatitis B if they have not already.
6. Report birth to the Los Angeles County Department of Public Health’s Perinatal Hepatitis B Prevention Unit, using the Hospital Delivery Report. Fill out and send via secure email to VPDC-PHB@ph.lacounty.gov, or fax to 213-351-2781.
7. Notify the infant’s planned pediatrician of the infant’s birth, the date and time of HBIG and hepatitis B vaccine dose administered, and the importance of additional on-time vaccination and post-vaccine serology testing of the infant for both HBsAg and anti-HBs after completion of the hepatitis B vaccine series to assess the hepatitis B status of the infant after vaccination.

1. Persons admitted for delivery without a documented HBsAg result from this pregnancy should have blood drawn and tested as soon as possible. This is required by law (HSC § 125090 (d)). Instruct the laboratory to call Labor & Delivery and the nursery unit with the newly obtained HBsAg test result as soon as possible.
   • If infant weighs ≥2000 grams (4.4 pounds): Administer monovalent/single-antigen hepatitis B vaccine (ENGERIX-B or RECOMBIVAX HB®) within 12 hours of birth. Do not wait for test results to administer this birth dose.
     • If the pregnant person’s HBsAg test is positive, administer HBIGto the infant as soon as possible within 7 days of birth.
   • If infant weighs <2000 grams (4.4 pounds): Administer HBIG and monovalent/single-antigen hepatitis B vaccine (ENGERIX-B or RECOMBIVAX HB®) within 12 hours of birth. Do not wait for test results to administer this birth dose and HBIG.
2. If HBsAg result is negative and hepatitis B vaccine and/or HBIG have not yet been administered, proceed to section Infants Born to Persons with Negative HBsAg.
3. If it is not possible to determine the birth parent’s HBsAg status (e.g., parent safely surrenders infant, parent is unable to be contacted), treat infant as if birth parent is HBsAg positive. Follow instructions in section Infants Born to Persons with Positive HBsAg or Chronic Hepatitis B.

1. Repeat HBsAg testing on HBsAg-negative persons if the person now has clinical hepatitis or has been at risk for hepatitis B exposure during pregnancy (e.g., recent IV drug use, HBsAg-positive sex partner, >1 sex partner in the past 6 months, is being treated or evaluated for a sexually transmitted infection). Instruct the laboratory to call Labor & Delivery and the nursery with the HBsAg test results as soon as possible.
   • If HBsAg result is negative, proceed with the instructions in this section.
   • If HBsAg result is positive, follow instructions in section Infants Born to Persons with Positive HBsAg or Chronic Hepatitis B.
2. If infant weighs ≥2000 grams (4.4 pounds): Administer a dose of monovalent/single-antigen hepatitis B vaccine (ENGERIX-B or RECOMBIVAX HB®) within 24 hours of birth.
3. If infant weighs <2000 grams (4.4 pounds): Administer the first dose of hepatitis B vaccine at chronological age 1 month or hospital discharge (whichever is earlier, even if weight is still <2000 grams at 1 month of age).

A post-exposure prophylaxis error occurs when:

• Any infant born to an HBsAg positive person does not receive HBIG and/or hepatitis B vaccine within 12 hours of birth
• Any infant weighing <2000 grams born to an HBsAg unknown person does not receive HBIG and/or hepatitis B vaccine within 12 hours of birth
• Any infant weighing ≥2000 grams born to an HBsAg unknown person does not receive the hepatitis B vaccine within 12 hours of birth and/or HBIG within 7 days of birth

Report all PEP errors using the Post-Exposure Prophylaxis (PEP) Error Form to the Los Angeles County Department of Public Health Perinatal Hepatitis B Prevention Unit within five (5) business days. Send a secure email to VPDC-PHB@ph.lacounty.gov or fax to 213-351-2781.

• Algorithm for Managing Pregnant Persons with Discrepant HBsAg Results (LACDPH)
• Hospital Delivery Report Form (LACDPH)
• Post-Exposure Prophylaxis (PEP) Error Form (LACDPH)
• Guidelines for Labor and Delivery Hospitals (CDPH)
• Developing Admission Orders in Newborn Units for the Hepatitis B Vaccine Birth Dose (CDPH)
• Vaccine Information Statement for Hepatitis B (Immunize.org)
• Labor & Delivery HBsAg Admission Checklist for Birthing Mother (Immunize.org)

Infants born to someone who does not have hepatitis B are still at risk for contracting it from other close contacts who may not know their status. Follow the guidelines in the below tables to adequately vaccinate infants born to persons with negative HBsAg status. Report all administered vaccines to CAIR as soon as possible. This is a requirement by law (AB 1797, HSC § 120440). PVST is not routinely recommended for infants in this category.

Table 3. Hepatitis B Protection Schedule for Infants Who Weigh <2000 Grams at Birth and are Born to an HBsAg Negative Person

*PEDIARIX and VAXELIS should not be administered before 6 weeks (42 days) of age.

Table 4A. Hepatitis B Protection Schedule for Infants Who Weigh ≥2000 Grams at Birth, are Born to an HBsAg Negative Person, and are Receiving Single Antigen Vaccine ONLY

Table 4B. Hepatitis B Protection Schedule for Infants Who Weigh ≥2000 Grams at Birth, are Born to an HBsAg Negative Person, and are Receiving Single Antigen AND Combination Vaccines

*PEDIARIX and VAXELIS should not be administered before 6 weeks (42 days) of age.

• Post-Vaccination Serology Test (PVST) Results Form (LACDPH)
• Guidelines for Pediatricians (CDPH)
• Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger (AAP)
• Vaccine Information Statement for Hepatitis B (Immunize.org)
• Package Inserts (FDA):
  • Nabi-HB®
  • ENGERIX-B
  • RECOMBIVAX HB®
  • PEDIARIX
  • VAXELIS®

1. If positive HBsAg is followed by a negative HBsAg in the same pregnancy: Send Discrepant Lab Results Letter and Algorithm for Managing Pregnant Persons with Discrepant HBsAg Results to prenatal care physician with instructions on additional tests needed. Since some of these additional tests are not reported automatically to Public Health, the physician will need to send the original lab reports via email or fax.
2. About two months before estimated date of delivery: Send Estimated Date of Delivery Letter and Hospital Delivery Report Form to the pregnant person’s planned delivery hospital, including guidance on providing timely post-exposure prophylaxis to protect the infant.

• Once estimated date of delivery has passed, if we have not yet received the Hospital Delivery Report, contact the labor & delivery hospital to remind them to submit the report within 24 hours of birth.
• If a post-exposure prophylaxis (PEP) error occurred, send the Post-Exposure Prophylaxis (PEP) Error Form to the labor & delivery hospital to fill out.
• After birth has been reported:
  • Send Pediatrician Hepatitis B Protection Letter to the infant’s planned pediatrician; this includes guidance on hepatitis B protection schedules based on the infant’s birthweight and vaccines used, and on timing of post-vaccination serology testing (PVST).
  • Send Parent Hepatitis B Protection Letter to the parent or guardian after entering the dates that hepatitis B vaccines and PVST are due based on the infant’s date of birth and birthweight (follow tables under Infants Born to Persons with Positive or Unknown HBsAg for guidance).
• After vaccine series has been completed:
  • Send Pediatrician PVST Reminder Letter and Post-Vaccination Serology Test (PVST) Results Form to the infant’s pediatrician.
  • Once 5 weeks have passed since the last dose, send the Parent PVST Reminder Letter and Post-Vaccination Serology Test (PVST) Results Form to the infant’s parent or guardian.
• After PVST lab results have been reported:
  • If infant’s anti-HBs result is ≥10 mIU/mL and HBsAg is negative/non-reactive: This infant is protected against perinatal hepatitis B. Close out records for mother and infant in surveillance system. Under Reason for Closure, select “Vaccine Completed”.
  • If infant’s anti-HBs result is <10 mIU/mL and HBsAg is negative/non-reactive: This infant does not have perinatal hepatitis B, but is not protected against it and could still contract it. Send the Pediatrician Vaccine Non-Responder Letter and Post-Vaccination Serology Test (PVST) Results Form to the infant’s pediatrician, and send the Parent Vaccine Non-Responder Letter to the infant’s parent or guardian.
  • If infant’s HBsAg is positive/reactive, regardless of anti-HBs result: This infant has contracted perinatal hepatitis B. Open a Perinatal Hepatitis B Virus Infection record in surveillance system. Report to CDPH using the CDPH Perinatal Hepatitis B Case Report Form and the CDPH Hepatitis B Infected Infants Supplemental Form.

DPH Letters (Internal)

• Pregnancy Verification Letter
• Hepatitis B in Pregnancy Letter
• HBV DNA Testing Letter
• Discrepant Lab Results Letter
• Estimated Date of Delivery Letter
• Pediatrician Hepatitis B Protection Letter
• Parent Hepatitis B Protection Letter
• Pediatrician PVST Reminder Letter
• Parent PVST Reminder Letter
• Pediatrician Vaccine Non-Responder Letter
• Parent Vaccine Non-Responder Letter

Forms for Physician Reporting (External)

• Pregnancy Verification Form
• HBV DNA Results Form
• Hospital Delivery Report Form
• Post-Exposure Prophylaxis (PEP) Error Form
• Post-Vaccination Serology Test (PVST) Results Form

Forms for Reporting to CDPH

• CDPH Perinatal Hepatitis B Case Report Form
• CDPH Hepatitis B Infected Infants Supplemental Form

Additional Guidance

• Algorithm for Managing Pregnant Persons with Discrepant HBsAg Results (LAC DPH)
• Interpretation of Hepatitis B Virus (HBV) Markers of Infection Following Discrepant Hepatitis B Surface Antigen (HBsAg) Lab Results During Pregnancy (LAC DPH)
• Guidelines for Prenatal Care Physicians (CDPH)
• Guidelines for Labor and Delivery Hospitals (CDPH)
• Guidelines for Pediatricians (CDPH)