Sovaldi and Pregnancy
Even though it is classified as a pregnancy Category B medicine, Sovaldi (sofosbuvir) should not be taken during pregnancy. Why is this so? Sovaldi is always used in combination with another drug called ribavirin, which is a pregnancy Category X medicine. Pregnancy Category X medications should be avoided during pregnancy.
Sovaldi™ (sofosbuvir) is a prescription medication approved to treat chronic hepatitis C infections in combination with ribavirin (Copegus®, Rebetol®, RibaPak®, Ribasphere®) and sometimes peginterferon alfa (Pegasys®, PEG-Intron®).
Sovaldi is a pregnancy Category B medication, which usually means a drug is fairly safe for use during pregnancy. However, this product is always used in combination with ribavirin, which is a pregnancy Category X medication. Therefore, Sovaldi should not be used in pregnant women, or in men whose partner is pregnant.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Sovaldi is classified as a pregnancy Category B medication.
Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Sovaldi has not been adequately studied in pregnant humans. However, in animal studies, it did not cause birth defects or other problems when given to pregnant rats and rabbits. However, because Sovaldi is always given in combination with ribavirin, which is a pregnancy Category X medicine, it should not be used in pregnant women.