Can a pregnant female with 12-week gestation, hepatitis B (HBV) positive, high viral load, HBeAntigen (HBeAg) negative, and elevated liver enzymes, be started on Tenofovir (Tenofovir disoproxil fumarate) immediately or should treatment be delayed until 28 weeks?

From the Guidelines

Pregnant females with high viral load and elevated liver enzymes should not be started on Tenofovir immediately. According to the guidelines, antiviral prophylaxis with Tenofovir disoproxil fumarate should begin at 24–28 weeks of gestation and continue for up to 12 weeks after delivery in pregnant women with HBV DNA levels higher than 200,000 IU/ml or HBeAg-positive pregnant women 1.

Key Considerations

• HBV DNA levels: The patient has a high viral load, which increases the risk of mother-to-child transmission.
• HBeAg status: The patient is HBeAg negative, but this does not affect the recommendation for antiviral prophylaxis.
• Elevated liver enzymes: This indicates liver inflammation and damage, which may require antiviral treatment.
• Gestation age: The patient is at 12 weeks gestation, which is earlier than the recommended start time for antiviral prophylaxis.

Recommendations

• Delay treatment until 28 weeks: According to the guidelines, antiviral prophylaxis with Tenofovir disoproxil fumarate should begin at 24–28 weeks of gestation 1.
• Monitor liver function and HBV DNA levels: Regular monitoring of liver function and HBV DNA levels is essential to assess the need for antiviral treatment and to prevent mother-to-child transmission.
• Breastfeeding: Breastfeeding is not contraindicated in HBsAg-positive women treated with Tenofovir disoproxil fumarate 1.

Clinical Practice Guidelines

The guidelines from the European Association for the Study of the Liver (EASL) 1, Korean Association for the Study of the Liver (KASL) 1, American Association for the Study of Liver Diseases (AASLD) 1, and Asian-Pacific Association for the Study of the Liver (APASL) 1 all recommend delaying antiviral prophylaxis until 24–28 weeks of gestation in pregnant women with high HBV DNA levels.

From the FDA Drug Label

What is the most important information I should know about emtricitabine and tenofovir disoproxil fumarate tablets? Emtricitabine and tenofovir disoproxil fumarate tablets can cause serious side effects, including: Worsening of hepatitis B virus infection (HBV) Your healthcare provider will test you for HBV before start or when you start treatment with emtricitabine and tenofovir disoproxil fumarate tablets. If you have HBV infection and take emtricitabine and tenofovir disoproxil fumarate tablets, your HBV may get worse (flare-up) if you stop taking emtricitabine and tenofovir disoproxil fumarate tablets

The FDA drug label does not provide guidance on when to start Tenofovir in a pregnant female with HBV, high viral load, and elevated liver enzymes. However, it does mention that the healthcare provider will test for HBV before starting treatment and that HBV may get worse if treatment is stopped.

• Tenofovir can be used in pregnant women with HBV, but the decision to start treatment should be made by a healthcare provider, considering the risks and benefits.
• No specific guidance is provided on the optimal timing of starting Tenofovir in pregnant women with HBV, high viral load, and elevated liver enzymes.
• Healthcare providers should test for HBV before starting treatment and monitor the patient's condition closely. 2 2 2

From the Research

Treatment of Hepatitis B in Pregnancy

• The treatment of hepatitis B in pregnancy, especially in cases with high viral load, is crucial to prevent mother-to-child transmission (MTCT) of the virus 3, 4, 5, 6, 7.
• Tenofovir disoproxil fumarate (TDF) is a commonly used antiviral medication for the treatment of hepatitis B in pregnancy, and it has been shown to be effective in reducing MTCT of the virus 3, 4, 5, 6.
• The American Association for the Study of Liver Diseases and other guidelines recommend that antiviral therapy, including TDF, should be started in pregnant women with high viral load (HBV DNA levels greater than 200,000 IU/mL or 6 log copies/mL) around 28 to 32 weeks of gestation 7.
• However, the exact timing of when to start TDF in pregnant women with hepatitis B is not universally agreed upon, and some studies suggest that it may be beneficial to start treatment earlier in pregnancy, especially in cases with very high viral load or other risk factors for MTCT 4, 5, 6.
• In the case of a pregnant female with 12-week gestation, hepatitis B (HBV) positive, high viral load, HBeAntigen (HBeAg) negative, and elevated liver enzymes, the decision to start TDF immediately or delay treatment until 28 weeks should be made on a case-by-case basis, taking into account the individual patient's risk factors and medical history 3, 4, 5, 6, 7.

Safety and Efficacy of Tenofovir in Pregnancy

• TDF has been shown to be safe and effective in preventing MTCT of hepatitis B in pregnant women, with no significant increase in adverse maternal or fetal outcomes 4, 5, 6.
• However, TDF has been associated with a higher risk of drug-related adverse events and elevated creatine kinase levels compared to other antiviral medications 4.
• The benefits of TDF in preventing MTCT of hepatitis B in pregnant women with high viral load appear to outweigh the risks, and it is generally recommended as a first-line treatment option 3, 4, 5, 6, 7.

Management of Hepatitis B in Pregnancy

• All pregnant women should be screened for hepatitis B surface antigen (HBsAg) and antibody to HBsAg, and those with high-risk factors should be further evaluated and managed accordingly 7.
• Pregnant women with HBV DNA levels greater than 200,000 IU/mL or 6 log copies/mL should be treated with antiviral therapy, including TDF, around 28 to 32 weeks of gestation 7.
• The management of hepatitis B in pregnancy should be individualized, taking into account the patient's medical history, risk factors, and other relevant factors 3, 4, 5, 6, 7.