Safety of antiviral drugs for hepatitis B during pregnancy

Most oral antiviral drugs (including tenofovir and entecavir) for chronic hepatitis B are classified by the Therapeutic Goods Administration (TGA) as pregnancy category B3.

Tenofovir is not associated with an increased risk for mothers or infants in pregnancy1, and is recommended for use in pregnancy when antiviral therapy is indicated.

Note: Tenofovir is recommended for use in pregnancy when antiviral therapy for hepatitis B is indicated.

Entecavir is not recommended in pregnancy because safety data are limited, and use should be avoided in females of childbearing potential who are planning pregnancy or are not using effective contraception. For female patients taking entecavir for management of chronic hepatitis B who become pregnant, switching to tenofovir is recommended.

Peginterferon should not be used in pregnancy because safety data are limited.

1 See the Antiretroviral Pregnancy Registry, available online.Return