Skip to main content

Sofosbuvir / velpatasvir / voxilaprevir Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jun 27, 2023.

Sofosbuvir / velpatasvir / voxilaprevir is also known as: Vosevi

Sofosbuvir / velpatasvir / voxilaprevir Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: As a precaution, use is not recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk summary: No adequate data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Sofosbuvir / velpatasvir / voxilaprevir Breastfeeding Warnings

Amounts of velpatasvir and voxilaprevir in breast milk are most likely very low as each component is highly bound to maternal plasma proteins.

LactMed: If the mother requires this drug, it is not a reason to discontinue breastfeeding; some experts recommend against breastfeeding when the active components are used with ribavirin.
-According to some authorities: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (GS-331007 [main circulating metabolite of sofosbuvir], velpatasvir, voxilaprevir)

-The 3 active components have not been studied in nursing mothers receiving treatment for hepatitis C virus infection.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir). Gilead Sciences. 2017.

References for breastfeeding information

  1. Cerner Multum, Inc. UK Summary of Product Characteristics.
  2. Cerner Multum, Inc. Australian Product Information.
  3. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  4. Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir). Gilead Sciences. 2017.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.