FAQs for Healthcare Providers

Perinatal Hepatitis B Prevention Program

1. Is hepatitis B a reportable disease?

   Yes. Hepatitis B and hepatitis B surface antigen (HBsAg)-positive results in pregnant women are notifiable diseases of public health significance reported to the Florida Department of Health. As such, they are to be reported by the laboratory conducting the test and by the physician who orders the test. Reporting should be made to the County Health Department (CHD) in the county in which the woman resides. This allows for the follow-up of the woman to the Perinatal Hepatitis B Prevention Program Coordinator. Refer to Chapter 381.0031, 384.25 and 384.33, Florida Statutes (FS), along with Chapters 64D-3.040 and 64D-3.042, Florida Administrative Codes (FAC).

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   • Title XXIX, Chapter 381.0031, FS Report of Diseases of Public Health Significance to Department
   • Title XXIX, Chapter 384.25, FS Sexually Transmissible Diseases; Reporting Required
   • Title XXIX, Chapter 384.33, FS Sexually Transmissible Diseases; Rules
   • Chapter 64D-3.040, FAC Procedures for Control of Specific Communicable Diseases
   • Chapter 64D-3.042, FAC STD Testing of Pregnant Women
   • Reportable Diseases/Conditions in Florida
     • Reportable Diseases/Conditions in Florida Practitioner List
     • Florida Department of Health - Practitioner Disease Report Form
     • Healthcare Practitioner Reporting Guidelines of Notifiable Diseases or Conditions in Florida
     • Laboratory Reporting Guidelines for Notifiable Diseases or Conditions in Florida

2. How can the Perinatal Hepatitis B Prevention Program (PHBPP) help?

   The PHBPP offers free hepatitis B testing for household/sexual contacts, free Hepatitis B Immune Globulin (HBIG) and hepatitis B vaccine as needed. The program provides case management of the pregnant woman to increase the likelihood of completion of the vaccination series by her baby followed by testing to assure immunity. Contact your CHD or PHBPP Coordinator for more information.

3. Is it necessary to test every pregnant woman with each pregnancy?

   Yes. The American College of Obstetrics and Gynecology, American Academy of Pediatrics, Advisory Committee on Immunization Practices (ACIP), and American Academy of Family Practice highly recommend that all pregnant women routinely be tested for HBsAg during an early prenatal visit, of each pregnancy. Assuming a woman is not high-risk because she was negative for HBsAg with a prior pregnancy puts the infant at risk. She may have contracted the virus since the last testing. See Chapter 64D-3.042, FAC.

4. If the pregnant woman has been diagnosed as having chronic hepatitis B, is there a risk for the unborn baby?

   Yes. Chronicity indicates infectious status. The infant will be exposed to the mother’s blood during the birth process. Exposed infants have a 75% or greater chance of developing the disease and 90% of those will become chronic carriers of hepatitis B. Those with chronic hepatitis B have a much higher incidence of developing liver cancer or cirrhosis.

5. What blood tests should be used to screen a pregnant woman for hepatitis B?

   HBsAg is the ONLY test that indicates that a woman has an active HBV infection that can be transmitted to her infant. If a woman is found to be HBsAg-positive, the most useful additional test would be the IgM antibody subclass of Antibody to hepatitis B core antigen (IgM anti-HBc) with a repeat HBsAg which would tell if the woman has an acute infection or if she is chronically infected. Chronicity can also be determined by two positive HBsAg tests six months, or more, apart.

   • Hepatitis B Facts: Testing and Vaccination
   • Patient notification letter regarding hepatitis B test results
   • Guidelines for Standing Orders in Labor & Delivery & Nursery Units to Prevent Hepatitis B Virus (HBV) Transmission to Newborns

6. Should any recommendations be made for household/sexual contacts of the HBsAg-positive woman?

   Ideally, all household/sexual contacts should be tested for HBsAg, vaccinated, and counseled as needed. Women of child-bearing age need to be informed that any other children should receive the three-dose hep B vaccine series, as well as post-vaccine serology to determine the development of antibody response or disease (unless it can be documented that the woman was negative for HBsAg with the prior pregnancies). Contacts should also be counseled on ways to prevent further spread of hepatitis B, such as not sharing razors, toothbrushes or needles, and practicing safe sex using condoms.

• Perinatal Hepatitis B Intervention

7. Can Comvax® be used with the high-risk hepatitis B child?

   Comvax® must not be used for doses at birth or one month of age for a child on a 0-1-6 month hepatitis B vaccine schedule. It is not recommended because the dosing schedule does not match the high-risk schedule of 0, 1, 6 months. (However, the use of Comvax® is not a conflict for Universal Dosing [first dose of hepatitis B vaccine in the hospital for infants at low-risk for hep B] as the child will receive four doses of hepatitis B vaccine without adverse affects.)

1. If a person is hepatitis B "e" antigen (HBeAg)-negative and HBsAg-positive, are they infectious?

   Yes. HBeAg indicates high viral replication activity. An individual who is actively replicating hepatitis B virus (HBV) will be highly infectious. If a person is HBsAg-positive and HBeAg-negative viral replication exists, but at a less intense level than if the patient were HBeAg-positive. Therefore, a person who is HBsAg-positive IS infectious.

2. The hospital OB staff tell me they need the date of the HBsAg on the pregnant woman. Why is this necessary?

   See question 3 above. If the woman’s HBsAg status is unknown, the infant is to be treated as high-risk for hepatitis B exposure. If not tested with the current pregnancy, it is recommended the woman be tested for HBsAg on admission for delivery.

3. The 2003 Report of the Committee on Infectious Diseases (Red Book) states hepatitis B vaccine should be given within 12 hours of birth and HBIG can be administered up to seven days after birth if the mother’s HBsAg status is unknown. Why do you say it should be given sooner?

   The Red Book bases this on the high cost of HBIG. Florida provides the HBIG and hepatitis B vaccine free of charge to all birthing facilities enrolled in the Vaccines for Children (VFC) Program. Also, the HBIG insert states, “Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery…Hepatitis B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed beyond 48 hours.”

4. When should the Post Vaccine Serology (PVS) be done, and what does it consist of?

   Infants should have PVS done three months after the last dose of hepatitis B vaccine, but no sooner than 9 months of age. A HBsAg and Hepatitis B Surface Anti-body (HBsAB also written anti-HBs) should be drawn at the same time. This will determine if the infant has sero-converted or developed the disease.

5. How are the results of the PVS interpreted?

   • HBsAg (-) and anti-HBs (+) = sero-conversion
   • HBsAg (-) and anti-HBs (-) = additional vaccine needed
   • HBsAg (+) and anti-HBs (-) = infant has hepatitis B virus

6. If additional vaccine is needed, what schedule is followed?

   Additional vaccine can be administered one of two ways:

   • Give one to three additional doses of hepatitis B vaccine, on a 0, 1, and 4 months of age schedule followed by a PVS, one month after each dose
   • Repeat the entire three-dose series on a 0, 1, and 4 months of age schedule followed by a PVS one month after the last dose.

7. Can Pediarix® be used for the birth dose of the hep B vaccine series?

   No. The minimum age for the first dose of Pediarix® is 6 weeks. Pediarix® is also approved for three doses at 2, 4, and 6 months of age.