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Pregnancy
Sofosbuvir alone has been assigned a Pregnancy Category B by the FDA. Animal studies in pregnant rats and rabbits showed no effects on the development of the fetus and there have been no similar studies for Sofosbuvir in pregnant women.

Sofosbuvir used in combination with Ribavirin or Peginterferon and Ribavirin has been assigned a Pregnancy Category X by the FDA. Ribavirin has been shown to cause fetal birth defects and possibly death and should be avoided in both the pregnant female and her sexual partner. Since Sofosbuvir is commonly used together with Ribavirin and/or Peginterferon, it is recommended that Sofosbuvir used in combination should be avoided in pregnant females and their male sexual partners in order to reduce harmful fetal defects caused by Ribavirin. Pregnant females 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. Positive pregnancy results should be reported to the patient's health care provider immediately. Both the patient and the health care provider are encouraged to contact the Ribavirin Pregnancy Registry which is a public health program that documents outcomes for females and their sexual partners who were exposed to Ribavarin during pregnancy.

Breastfeeding
It is unknown whether Sofosbuvir and Copegus (Ribavirin) passes into breastmilk; therefore, it is recommended that the mother does not breastfeed during treatment with Sofosbuvir alone or in combination with Ribavirin.