A pharmacokinetic and treatment study of ledipasvir/sofosbuvir in pregnant women with hepatitis C virus

CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020

“…Safety data during pregnancy are preliminary and larger studies are required. A small study of seven pregnant women treated with ledipasvir/sofosbuvir identified no safety concerns (42). Until DAAs become available for use during pregnancy, testing women during pregnancy for HCV infection still has benefits to both the mother and the infant.…”

HCV in Women and Pregnancy

“…All achieved SVR12 and delivered at term without serious (grade 3 or 4) adverse events in mothers or infants; pharmacokinetic analysis and long-term pediatric follow-up is ongoing. (61) Furthermore, there are limited retrospective data out of Egypt showing that sofusbuvir and daclatasavir may be safe in pregnancy and effective in preventing vertical transmission without congenital abnormalities or significant harm to mothers. This is based on observations of women with accidental pregnancy while receiving this DAA therapy.…”

Toward Elimination of Hepatitis C Infection: How Best to Address Gaps in the Cascade of Care?

“…In this report by Kim et al, 60% of individuals with a pregnancy history with detectable HCV RNA received treatment. A preliminary report suggested that it is feasible to treat pregnant women with direct‐acting antiviral (DAA) therapy, although this strategy will require further study to determine whether it is more advantageous (and safe) to treat during pregnancy or to provide therapy postpartum . Regardless, if HCV infection is identified during pregnancy, there should be an established pathway for linkage to therapy, as many HCV‐infected individuals will be maximally engaged in the health care system during this period (Fig.…”