Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of
chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second
or third trimester in approximately 100 pregnant people. Maternal participants will take one
SOF/VEL tablet once daily for 12 weeks (84 days) and followed until 12 weeks after treatment
completion (postpartum). Infants will be followed from birth until one year of age. The
primary objectives are to evaluate the sustained virologic response 12 weeks after completion
of SOF/VEL treatment (SVR12) in participants treated during pregnancy and to evaluate impact
of antenatal treatment with SOF/VEL on the gestational age at delivery.