Is Velpatasvir safe while breastfeeding?

Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Velpatasvir. The text below is quoted from that source — it is not our own verdict.

Summary of use during breastfeeding

Limited information indicates that typical doses of velpatasvir produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants. If velpatasvir is used alone or in combination with sofosbuvir (Epclusa) or sofosbuvir and voxilaprevir (Vosevi), it is not a reason to discontinue breastfeeding.

Hepatitis C is not transmitted through breastmilk, and breastmilk has been shown to inactivate hepatitis C virus (HCV).[1-4] However, the Centers for Disease Control recommends that mothers with HCV infection should consider abstaining from breastfeeding if their nipples are cracked or bleeding. It is not clear if this warning would apply to mothers who are being treated for hepatitis C.

Infants born to mothers with HCV infection should be tested for HCV infection; because maternal antibody is present for the first 18 months of life and before the infant mounts an immunologic response, nucleic acid testing is recommended.[1,4]

Effects on the breastfed infant

Relevant published information was not found as of the revision date.

Effects on milk supply

Relevant published information was not found as of the revision date.

Levels in milk

Maternal Levels. Four mothers with hepatitis C infections began taking velpatasvir 100 mg in combination with sofosbuvir 400 mg orally once daily shortly after delivery. Paired samples of maternal serum and breastmilk were collected within the first 24 hours after commencing the drug regimen and at up to 6 days after initiation. Samples were collected from 1 to 25.6 hours after a dose. The median velpatasvir milk concentration was 26.8 mcg/L (range 6.6 to 59.7 mcg/L) with a median infant daily dosage of 4 mcg/kg and a relative infant dose of 0.14%.[5] Because of the random collection and the reporting method, the true values may vary somewhat from these numbers.

Infant Levels. Relevant published information was not found as of the revision date.

Alternatives LactMed lists

“No published information” means the studies do not exist yet — not that Velpatasvir is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.

Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Velpatasvir” (LM1255). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.