From the Guidelines
The treatment of choice for hepatitis B in pregnancy is tenofovir disoproxil fumarate (TDF) at a dose of 300 mg once daily, as recommended by the most recent and highest quality study 1. This antiviral medication is preferred due to its high efficacy in reducing viral load, excellent safety profile during pregnancy, and minimal risk of fetal harm.
Key Considerations
- Treatment is typically recommended for pregnant women with high viral loads (HBV DNA >200,000 IU/mL) to reduce the risk of mother-to-child transmission.
- Treatment should begin at 28-32 weeks of gestation and continue through delivery.
- For women already on hepatitis B treatment when becoming pregnant, TDF should be continued throughout pregnancy.
- In addition to antiviral therapy, all infants born to HBsAg-positive mothers should receive 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 and better suppression of viral replication, which is crucial for preventing perinatal transmission and maternal hepatic flares during pregnancy, as supported by studies 1.
Additional Recommendations
- Cesarean delivery should not be performed solely to reduce the risk of mother-to-child transmission of hepatitis B, as it has not been shown to decrease this risk 1.
- Breastfeeding is not contraindicated in mothers with hepatitis B, as the risk of transmission through breast milk is low, and the benefits of breastfeeding outweigh the risks 1.
- Pregnant women with hepatitis B should be closely monitored for liver disease and other complications, and treatment should be adjusted as needed to prevent maternal and fetal morbidity, as recommended by recent guidelines 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 in pregnant women with chronic HBV infection.
- No increased risk of adverse pregnancy-related outcomes was observed with the use of tenofovir disoproxil fumarate during the third trimester of pregnancy.
- Tenofovir disoproxil fumarate was administered from 28 to 32 weeks gestation through 1 to 2 months postpartum in clinical trials.
- No new safety findings were observed in pregnant women compared to the known safety profile 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 telbivudine (LdT), to prevent mother-to-child transmission (MTCT) of the hepatitis B virus (HBV).
- TDF has been shown to be effective in reducing the rate of MTCT, with a study finding that the MTCT rate was 0% in the TDF-treated group compared to 6.3% in the untreated group 3.
- A meta-analysis of seven studies found that TDF significantly reduced the HBV MTCT rate compared to the control group (RR: 0.18,95% CI: 0.08-0.40) 4.
- TDF is recommended as the first-line therapy for pregnant women with HBV-DNA levels >200,000 IU/ml to prevent infant immunoprophylaxis failure 5.
- A clinical trial found that TDF therapy from 30 to 32 weeks of gestation until postpartum week 4 significantly reduced the rate of MTCT compared to the control group (5% vs. 18%, P=0.007) 6.
- A cohort study found that TDF and LdT treatments throughout pregnancy were equally effective in preventing MTCT and safe, with MTCT rates of 0% in both groups 7.
Safety of TDF in Pregnancy
- TDF has been shown to be well-tolerated in pregnant women, with no significant differences in neonatal congenital abnormalities, infant length and weight, Apgar score, rate of low birth weight, gestational age, or rate of cesarean section compared to the control group 3, 7.
- A study found that the maternal and infant safety profiles were similar in the TDF group and the control group, including birth-defect rates (2% vs. 1%, P=1.00) 6.
- However, more mothers in the TDF group had an increase in the creatine kinase level, and alanine aminotransferase elevations above the normal range occurred more frequently in mothers in the TDF group than in those in the control group after the discontinuation of TDF 6.