Answer
Ledipasvir/Sofosbuvir Gilead is preferably avoided during pregnancy as a precaution because human data are absent or limited (fewer than 300 pregnancy outcomes); animal studies show no direct reproductive harm, but sofosbuvir exposure margins in rats relative to humans could not be fully estimated.
Sources for this answer
- Ledipasvir/Sofosbuvir Gilead 90 mg/400 mg film-coated tabletsGilead Sciences Ltd · emc · SmPC §4.6 Fertility, pregnancy and lactation · Version 6Document updated
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