Treatment of Chronic Hepatitis C Virus During Pregnancy
Official Title
Safety, Tolerability, and Outcomes of Velpatasvir/SofosbuviR in Treatment of Chronic Hepatitis C Virus during Pregnancy (STORC), pregnant womanPurpose
This study involves evaluating a medication for hepatitis C in pregnant women.
If you are a pregnant woman with chronic hepatitis C and you join the study, you are consenting to enroll yourself and your baby after he/she is born.
Maternal participants will have 7 visits over approximately 7 months. Infant participants have four visits over approximately the first year of life.
Could this study be right for you?
(This is not a complete list)
- Must be 18 - 45 years of age
- Chronic HCV infection of at least 6 months
- Singleton pregnancy at 20 + 0 to 30 + 0 weeks’ gestation
- Documented negative Hepatitis B testing for current infection (negative HBsAg test) prior to enrollment
- If living with HIV, must be on antiretroviral therapy
Exclusion Criteria (not a complete list)
- Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits
- History of cirrhosis
- Known fetal chromosomal abnormality prior to enrollment