Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus During Pregnancy (STORC)
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet
One Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet taken once daily for 84 days.