Vosevi Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir, voxilaprevir or Vosevi in pregnant women.
Sofosbuvir: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
It has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Velpatasvir: Animal studies have shown a possible link to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Voxilaprevir: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure, Vosevi use is not recommended during pregnancy.
Breast-feeding: It is unknown whether sofosbuvir, metabolites of sofosbuvir, velpatasvir or voxilaprevir are excreted in human milk.
Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk. When administered to lactating rats, voxilaprevir was detected in the plasma of nursing pups.
A risk to the newborns/infants cannot be excluded. Therefore, Vosevi should not be used during breast-feeding.
Fertility: No human data on the effect of Vosevi on fertility are available. Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.