Summary of use during lactation
Ombitasvir is no longer marketed in the United State. It has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99.9% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. Ritonavir used as a booster has been studied in several studies of breastfeeding mothers. It is excreted into milk in measurable concentrations and low levels can be found in the blood of some breastfed infants. No reports of adverse reactions in breastfed infants have been reported. For more information, refer to the LactMed record on ritonavir. 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]
Drug levels in milk and infant serum
Maternal Levels. Relevant published information was not found as of the revision date. Infant Levels. Relevant published information was not found as of the revision date.
Effects in breastfed infants
Relevant published information was not found as of the revision date.
Effects on lactation and breastmilk
Relevant published information was not found as of the revision date.
Alternative drugs to consider
(Hepatitis C) Interferon Alfa, Interferon Alfacon-1, Peginterferon Alfa, Sofosbuvir
Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.
Medical disclaimer: This page is for qualified healthcare professionals and is a decision-support aid only. It does not replace clinical judgement, local protocols or product information. Verify every dose and threshold before use. See the full Medical Disclaimer.