Sovaldi and Pregnancy
Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the benefits.
Although ribavirin has not been studied in pregnant women, it has been shown to cause birth defects in hamsters, rats, and rabbits. These birth defects include problems with the skull, eyes, jaw, limbs, and skeleton. Pregnancy Category X medicines should not be used during pregnancy.
Ribavirin should not be used in women who are pregnant or may become pregnant. Therefore, the combination of Sovaldi, ribavirin, and peginterferon alfa should also not be used in women who are pregnant or may become pregnant.
Pregnancy must be ruled out (typically, using a pregnancy test) immediately prior to the start of Sovaldi treatment and every month during treatment. In addition, women must use two forms of birth control while receiving Sovaldi, and for at least six months after stopping ribavirin. Hormonal forms of birth control may not work as well during Sovaldi treatment, so other forms of birth control are preferred.
At this time, it is unclear if Sovaldi use by a male partner will harm a developing fetus. However, it is recommended that the medicine not be used in males whose partner is pregnant.
Because Sovaldi is only approved for use in combination with peginterferon alfa and ribavirin, it should not be used during pregnancy. Using Sovaldi in combination with ribavirin and peginterferon alfa during pregnancy could cause birth defects. Therefore, if you are pregnant or thinking about becoming pregnant, let your healthcare provider know immediately.