NCT05140941

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)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Catherine Anne Chappell · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 4, multicenter study, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Participants will be screened between 12+0 and 29+6 weeks of gestation confirmed by ultrasound. HCV RNA level to confirm the patient has active infection will be obtained. Laboratory evaluation of liver function will be obtained, to evaluate for renal insufficiency, decompensated cirrhosis and baseline elevations of lipase and creatine kinase. Hepatitis B virus (HBV) antigen will be performed to look for evidence of active HBV infection. Medical history and demographic information will also be collected at screening. If the inclusion and exclusion criteria are met, the patient will be enrolled into the study between 20+0 and 30+0 weeks' gestation and initiate a 12-week course of a fixed-dose combination tablet of sofosbuvir 400 mg and velpatasvir 100 mg. Maternal participants will take one SOF/VEL tablet once daily for 12 weeks (84 days). The study will be completed in 8 or 9 visits (6 maternal visits and 3 infant visits). The primary endpoints are 1) maternal HCV RNA PCR 12 weeks after completion of SOF/VEL treatment (HCV RNA PCR below the lower limit of quantification will be considered evidence of SVR12) and 2) preterm delivery (spontaneous and iatrogenic) prior to 37 weeks' gestation. The secondary endpoints are 1) Maternal safety defined as maternal adverse events and pregnancy and delivery outcomes (stillbirth or intrauterine fetal demise, intrapartum hemorrhage, postpartum hemorrhage, hypertensive disorders of pregnancy, gestational diabetes, intrauterine growth restriction, cholestasis of pregnancy, severe maternal morbidity (defined by CDC), maternal admission to the intensive care unit, maternal death), 2) composite neonatal/Infant safety endpoints defined as severe neonatal morbidity with admission to neonatal intensive care unit and stratified by perinatal preterm (\<37 weeks) (including fetal or neonatal death, severe bronchopulmonary dysplasia (grade 3) intraventricular hemorrhage grades III-IV, necrotizing enterocolitis (proven - Bell Stage 2A or greater), periventricular leukomalacia, retinopathy of prematurity stage III-V, or proven sepsis (early or late)) and perinatal term (\>= 37 weeks) (including fetal or neonatal death, respiratory support , Apgar score ≤ 3 at 5 minutes, hypoxic ischemic encephalopathy, seizure, infection (sepsis or pneumonia), birth trauma, meconium aspiration syndrome, intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support). Other secondary endpoints are admission to the neonatal intensive care unit, neonatal death, major malformations, defined as structural abnormalities with medical, surgical or cosmetic importance, weight, length, and head circumference at birth (by exam or chart review), 8 weeks, six months and 12 months, neurodevelopmental assessments at 6 months and 12 months by Ages \& Stages Questionnaires®, and infant HCV RNA PCR viral load at 8 weeks, 6 months and 12 months.

Conditions

• Hepatitis C, Chronic
• Pregnancy; Infection

Interventions

Type	Name	Description
DRUG	Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet	One Sofosbuvir/Velpatasvir 400 MG-100 MG Oral Tablet taken once daily for 84 days.

Timeline

• Start date: 2022-04-04
• Primary completion: 2026-08-01
• Completion: 2027-06-01
• First posted: 2021-12-02
• Last updated: 2026-04-15

Locations

9 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study