The Basics
What is Ledipasvir?
Used alone or in combination with ribavirin to treat certain types of chronic hepatitis C.
Brand names for Ledipasvir
Harvoni
How Ledipasvir is classified
Antiviral Agents, NS5A Inhibitors
Ledipasvir During Pregnancy
Ledipasvir pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Ledipasvir while pregnant
N/A
Taking Ledipasvir While Breastfeeding
What are recommendations for lactation if you're taking Ledipasvir?
Ledipasvir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99.8% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If ledipasvir alone or in combination with sofosbuvir (Harvoni) is required by the mother, it is not a reason to discontinue breastfeeding.[1] Some sources recommend against breastfeeding when ledipasvir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[2][3] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[4][5] 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.[2][3]
Maternal / infant drug levels
Ledipasvir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99.8% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If ledipasvir alone or in combination with sofosbuvir (Harvoni) is required by the mother, it is not a reason to discontinue breastfeeding.[1] Some sources recommend against breastfeeding when ledipasvir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[2][3] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[4][5] 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.[2][3]
Possible effects of Ledipasvir on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Ledipasvir
(Hepatitis C) Interferon Alfa, Interferon Alfacon-1, Peginterferon Alfa.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Spera AM, Eldin TK, Tosone G et al. Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women? World J Hepatol. 2016;8:557-65. PMID: 27134703
2. Cottrell EB, Chou R, Wasson N et al. Reducing risk for mother-to-infant transmission of hepatitis C virus: A systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;158:109-13. PMID: 23437438
3. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137. PMID: 26042815
4. Pfaender S, Heyden J, Friesland M et al. Inactivation of hepatitis C virus infectivity by human breast milk. J Infect Dis. 2013;208:1943-52. PMID: 24068703
5. Tovo PA, Calitri C, Scolfaro C et al. Vertically acquired hepatitis C virus infection: Correlates of transmission and disease progression. World J Gastroenterol. 2016;22:1382-92. PMID: 26819507
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
