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Registry Data Show Hepatitis B Medications Appear Safe during Pregnancy

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An analysis of data from the Antiretroviral Pregnancy Registry found no evidence that pregnant women's use of drugs to treat chronic hepatitis B -- including lamivudine (Epivir) and tenofovir (Viread) -- is associated with birth defects, according to a report in the November 2012 Journal of Hepatology.

Hepatitis B virus (HBV) can be transmitted from mother-to-child during pregnancy or delivery. Treatment with antiviral medications can reduce HBV viral load -- and thereby lower the risk of transmission -- but caution is warranted when using drugs during pregnancy because some can cause problems including congenital abnormalities.

Robert Brown from Columbia University Medical Center and colleagues analyzed neonatal safety data from the Antiretroviral Pregnancy Registry, the largest pregnancy safety database of antiviral drugs used to treat hepatitis B and HIV. Lamivudine, the related drug emtricitabine (Emtriva), and tenofovir are effective against both viruses and are commonly used together.

The study authors extracted data from pregnant women prospectively enrolled in registry between 1989 and 2011. The main outcome of interest was rates of major birth defects associated with exposure to all antiviral agents, individual drug classes, and specific drugs, compared with rates for the general population.

Results

  • Among HBV drugs, only lamivudine and tenofovir had enough individual data for review (at least 200 cases).
  • Out of 13,711 cases analyzed, the overall birth defect prevalence rate among babies born to pregnant women taking hepatitis B drugs was comparable to Centers for Disease Control and Prevention population data (2.8% vs 2.7%, respectively).
  • These rates were also similar to those seen in 2 prospective cohorts of newborns exposed to antiretroviral drugs during pregnancy (2.8% and 1.5%).
  • The birth defect prevalence for babies exposed to these drugs during the first trimester -- when major organ systems form -- was similar to that of infants exposed during the second and third trimesters (3.0% vs 2.7%, respectively).
  • No increased risk of major birth defects was observed with lamivudine or tenofovir exposure compared to population-based controls.
  • No specific pattern of major birth defects was observed either overall or for specific individual antiviral drugs.

Based on these findings, the authors concluded, "No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to chronic hepatitis B treatment overall or to [lamivudine] or [tenofovir] compared to population-based controls."

However, they added, "Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy."

10/30/12

Reference

RS Brown, EC Verna, MR Pereira, et al. Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: Findings from the Antiretroviral Pregnancy Registry. Journal of Hepatology 57(5):953-959. November 2012.