From the Guidelines
The treatment of choice for hepatitis B in pregnancy is tenofovir disoproxil fumarate (TDF), typically dosed at 300 mg once daily, due to its high efficacy in reducing viral load, excellent safety profile during pregnancy, and low risk of resistance, as recommended by the most recent guidelines 1.
Key Considerations
- Treatment is generally recommended for pregnant women with high viral loads (typically HBV DNA >200,000 IU/mL or >1 million copies/mL) to reduce the risk of mother-to-child transmission.
- Treatment should begin at 28-32 weeks of gestation and continue through delivery.
- For the newborn, prevention includes administration of hepatitis B immune globulin (HBIG) and the first dose of hepatitis B vaccine within 12 hours of birth, followed by completion of the vaccine series.
- Tenofovir is preferred over other antivirals like lamivudine or telbivudine because it has a higher barrier to resistance.
- The medication crosses the placenta and has shown no significant adverse effects on fetal development.
- Regular monitoring of liver function tests and viral load during treatment is essential.
- After delivery, the decision to continue treatment depends on the mother's hepatitis B status independent of pregnancy considerations.
Breastfeeding Considerations
- Breastfeeding is not contraindicated for mothers taking TDF, as the medication is minimally excreted in breast milk and is unlikely to cause significant toxicity to the infant 1.
- However, the unknown risk of low-level exposure to the infant should be discussed with mothers.
Resistance and Safety
- TDF has a high genetic barrier to resistance, making it a preferred choice for treatment during pregnancy.
- The safety of TDF during pregnancy has been established, with no significant adverse effects on fetal development or maternal outcomes.
- The risk of maternal HBV flare after TDF discontinuation is low, and regular monitoring of liver function tests and viral load during treatment is essential to minimize this risk 1.
From the FDA Drug Label
If coadministration is necessary, monitor for adverse reactions associated with TDF. Published studies in HBV-infected subjects do not report an increased risk of adverse pregnancy-related outcomes with the use of tenofovir disoproxil fumarate during the third trimester of pregnancy 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
The treatment of choice for hepatitis B in pregnancy is tenofovir disoproxil fumarate.
- Key points:
- Tenofovir disoproxil fumarate can be used during the third trimester of pregnancy.
- No increased risk of adverse pregnancy-related outcomes was observed with the use of tenofovir disoproxil fumarate.
- Tenofovir disoproxil fumarate was administered to 327 pregnant women with chronic HBV infection from 28 to 32 weeks gestation through 1 to 2 months postpartum.
- No new safety findings were observed in pregnant women compared to the known safety profile of tenofovir disoproxil fumarate in HBV-infected adults 2
From the Research
Treatment of Hepatitis B in Pregnancy
The treatment of choice for hepatitis B in pregnancy is antiviral therapy, specifically tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide fumarate (TAF), to prevent mother-to-child transmission.
- TDF has been shown to be safe and effective in reducing the risk of mother-to-child transmission of hepatitis B 3, 4, 5.
- A meta-analysis of seven studies found that TDF significantly reduced the risk of mother-to-child transmission of hepatitis B compared to no treatment 5.
- TDF has also been shown to be effective in reducing the viral load and preventing perinatal transmission of hepatitis B 4, 6.
- TAF has also been found to be effective in preventing mother-to-child transmission of hepatitis B and may have a better safety profile than TDF, particularly with regard to renal safety and breastfeeding 7.
Key Findings
- TDF and TAF have been shown to be effective in reducing the risk of mother-to-child transmission of hepatitis B.
- TDF has been found to be safe and well-tolerated in pregnant women and their infants.
- TAF may have a better safety profile than TDF, particularly with regard to renal safety and breastfeeding.
- Antiviral therapy with TDF or TAF should be considered for pregnant women with high viral loads to prevent mother-to-child transmission of hepatitis B 3, 4, 5, 6, 7.