Summary of Use during Lactation

Daclatasvir has been removed from the US market. It has not been studied in nursing mothers being treated for hepatitis C infection. Because it is 99% bound to maternal plasma proteins, amounts in breastmilk are likely to be very low. If daclatasvir used alone or in combination with sofosbuvir is required by the mother, it is not a reason to discontinue breastfeeding.[1] Some sources recommend against breastfeeding when daclatasvir is used with ribavirin.

Hepatitis C is not transmitted through breastmilk and breastmilk has been shown to inactivate hepatitis C virus (HCV).[2-5] 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.[2,5]

Drug Levels

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.

Alternate Drugs to Consider

(Hepatitis C) Interferon Alfa, Interferon Alfacon-1, Peginterferon Alfa

References

1.

Spera AM, Eldin TK, Tosone G, Orlando R. Antiviral therapy for hepatitis C: Has anything changed for pregnant/lactating women? World J Hepatol 2016;8:557-65. [PMC free article: PMC4840161] [PubMed: 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. [PubMed: 23437438]

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. [PubMed: 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. [PMC free article: PMC4721973] [PubMed: 26819507]

5.

Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep 2021;70:1-187. [PMC free article: PMC8344968] [PubMed: 34292926]

Substance Name

Daclatasvir

CAS Registry Number

1009119-64-5

Drug Class

Breast Feeding

Lactation

Milk, Human

Antiviral Agents

NS5A Inhibitors