Sofosbuvir has been assigned a Pregnancy Category B by the FDA (meaning that it there are no adequate and well-controlled studies in pregnant women but animal reproduction studies have not demonstrated a risk to the fetus and, or that adverse effects have been seen in animal studies, but adequate and well-controlled studies in pregnant women have not, in any trimester). However, ribavirin, a medication that is often given together with sofosbuvir to treat hepatitis C, is assigned a Pregnancy Category X (contraindicated in pregnancy) by the FDA. Pregnant women with hepatitis C who take ribavirin have shown some cases of birth defects and death in their fetus.[20] It is recommended that sofosbuvir/ribarivin combinations be avoided in pregnant females and their male sexual partners in order to reduce harmful fetal defects caused by ribavirin. Females who could potentially become pregnant should undergo a pregnancy test 2 months prior to starting the sofosbuvir/ribavirin/peginterferon combination treatment, monthly throughout the duration of the treatment, and 6 months post-treatment to reduce the risk of fetal harm in case of accidental pregnancy.
It is unknown whether sofosbuvir and ribavirin pass into breastmilk; therefore, it is recommended that the mother does not breastfeed during treatment with sofosbuvir alone or in combination with ribavirin.[
Application:
Sofosbuvir is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection.
