What intervention should be done for a pregnant woman with chronic Hepatitis B (HBV) infection?

From the Guidelines

For a pregnant woman with chronic hepatitis B infection, the primary intervention should be administration of hepatitis B immune globulin (HBIG) and the hepatitis B vaccine to the newborn within 12 hours of birth, along with antiviral therapy with tenofovir disoproxil fumarate (TDF) if the mother's HBV DNA level is greater than 200,000 IU/mL. This approach is supported by the most recent and highest quality study, which found that antiviral therapy in the third trimester is associated with a 70% reduction in mother-to-child transmission (MTCT) compared with no antiviral therapy 1. The American Association for the Study of Liver Diseases recommends that all women be tested for hepatitis B surface antigen (HBsAg) with prenatal labs, with HBV-DNA testing performed if positive, and that antiviral therapy be considered for women with high HBV DNA levels 1. Key points to consider in the management of pregnant women with chronic hepatitis B infection include:

• Monitoring of liver function tests and viral load measurements throughout pregnancy
• Administration of HBIG and hepatitis B vaccine to the newborn within 12 hours of birth
• Antiviral therapy with TDF (300 mg daily) in the third trimester if the mother's HBV DNA level is greater than 200,000 IU/mL
• Consideration of earlier initiation of antiviral treatment for HBV-DNA levels of 7-log IU/mL or greater
• Breastfeeding is generally considered safe for mothers with chronic hepatitis B, provided the infant receives proper immunoprophylaxis 1. It is also important to note that cesarean delivery has not been shown to reduce the risk of MTCT and should be used for obstetrical indications only 1. Overall, the goal of these interventions is to prevent MTCT and reduce the risk of chronic infection, cirrhosis, and hepatocellular carcinoma in the infant.

From the FDA Drug Label

In published data from three controlled clinical trials, a total of 327 pregnant women with chronic HBV infection were administered tenofovir disoproxil fumarate from 28 to 32 weeks gestation through 1 to 2 months postpartum and followed for up to 12 months after delivery There were no new safety findings in pregnant women compared with the known safety profile of tenofovir disoproxil fumarate in HBV-infected adults An increased risk of adverse pregnancy-related outcomes was not observed; 2 stillbirths were identified, and there was 1 major birth defect (talipes) and 1 occurrence of multiple congenital abnormalities (not further specified) in tenofovir disoproxil fumarate -exposed infants Infants were followed for up to 12 months after delivery; there were no clinically relevant drug-related safety findings in infants exposed to tenofovir disoproxil fumarate during late gestation

The recommended intervention for a pregnant woman with chronic HBV infection is to administer tenofovir disoproxil fumarate from 28 to 32 weeks gestation through 1 to 2 months postpartum, as it has been shown to be safe and effective in preventing mother-to-child transmission of HBV 2.

• Key points:
  • Tenofovir disoproxil fumarate has been shown to be safe in pregnant women with chronic HBV infection
  • It should be administered from 28 to 32 weeks gestation through 1 to 2 months postpartum
  • Infants exposed to tenofovir disoproxil fumarate during late gestation had no clinically relevant drug-related safety findings up to 12 months after delivery
• Important consideration: The decision to administer tenofovir disoproxil fumarate should be made on a case-by-case basis, taking into account the individual patient's situation and the potential benefits and risks of treatment.

From the Research

Intervention for Pregnant Women with Chronic Hepatitis B (HBV) Infection

The following interventions are recommended for pregnant women with chronic HBV infection:

• Antiviral therapy with tenofovir disoproxil fumarate (TDF) is recommended for pregnant women with high viral loads (>200,000 IU/mL) during the third trimester to prevent vertical transmission 3, 4, 5
• Administration of hepatitis B vaccine and hepatitis B immunoglobulin within 12 hours of birth to all newborns of HBsAg-positive mothers or those with unknown or undocumented HBsAg status, regardless of whether maternal antiviral therapy has been given during the pregnancy 3, 6, 5
• HBV viral load testing in the third trimester is suggested for pregnant women with HBV infection 6
• Maternal antiviral therapy should be considered for pregnant women with HBV infection and viral load >6-8 log 10 copies/mL to decrease the risk of intrauterine fetal infection 6
• Tenofovir is suggested as a first-line agent for maternal antiviral therapy in pregnant women with HBV infection 6
• Women with HBV infection can breastfeed as long as the infant receives immunoprophylaxis at birth (HBV vaccination and hepatitis B immunoglobulin) 3, 6, 5
• Cesarean delivery is not recommended for the sole indication of reducing perinatal HBV transmission 3, 6, 5

Safety and Efficacy of Antiviral Therapy

The safety and efficacy of antiviral therapy in pregnant women with chronic HBV infection have been evaluated in several studies:

• TDF has been shown to be well tolerated in pregnant women and can safely reduce the rate of mother-to-child transmission (MTCT) of HBV 4
• Antiviral therapy with lamivudine or telbivudine has been shown to improve maternal HBV DNA suppression at delivery and during postpartum follow-up 7
• No significant differences were found in congenital malformation rate, prematurity rate, and Apgar scores between pregnant women with HBV infection who received antiviral therapy and those who did not 7, 4