The Basics
What is Simeprevir?
Used along with ribavirin and peginterferon alfa to treat chronic hepatitis C.
Brand names for Simeprevir
Olysio
How Simeprevir is classified
Antiviral Agents, Protease Inhibitors
Simeprevir During Pregnancy
Simeprevir 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 Simeprevir while pregnant
N/A
Taking Simeprevir While Breastfeeding
What are recommendations for lactation if you're taking Simeprevir?
Simeprevir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is greater than 99.9% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. Some sources recommend against breastfeeding when simeprevir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[1][2] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[3][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][2]
Maternal / infant drug levels
Simeprevir has not been studied in nursing mothers being treated for hepatitis C infection. Because it is greater than 99.9% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. Some sources recommend against breastfeeding when simeprevir is used with ribavirin. Hepatitis C is not transmitted through breastmilk[1][2] and breastmilk has been shown to inactivate hepatitis C virus (HCV).[3][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][2]
Possible effects of Simeprevir on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Simeprevir
(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. 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
2. Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137. PMID: 26042815
3. 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
4. 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.
