Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Inclusion Criteria:

1. Age 18 through 45 years (inclusive) at screening

2. Able and willing to provide written informed consent and take part in the studyprocedures

3. Able and willing to provide adequate locator information, defined as at least twoother alternate contacts

4. HCV antibody seropositivity with detectable HCV RNA viral load at screening

5. Chronic HCV infection of at least 6 months by laboratory report or participantreported medical history as determined by the site PI, or if duration of HCV cannotbe determined then the participant can be enrolled if there is no clinical evidenceof acute hepatitis C infection (defined by CDC as presence of jaundice or totalbilirubin >/= 3.0 mg/dL or ALT >200IU/L)

6. Singleton pregnancy at 20 + 0 to 30 + 0 weeks' gestation at enrollment withgestational dating confirmed by ultrasound

7. Having a comprehensive anatomy scan with no evidence of major structuralabnormalities as defined by the CDC birth surveillance toolkit (https://www.cdc.gov/ncbddd/birthdefects/surveillancemanual/chapters/chapter-4/chapter4-1.html) or an anomaly that would significantly impact delivery timing orneonatal outcomes as determined by the Protocol Safety Review Team (PSRT) prior toenrollment

8. Documented negative Hepatitis B testing for current infection (negative HBsAg test)prior to enrollment

9. If living with HIV, must be on antiretroviral therapy with HIV viral load <50copies/mL on the most recent HIV viral load test within 30 days before enrollmentand agree to continue antiretroviral therapy throughout study participation

10. If taking acid-suppressant medication(s), willing and able to either discontinueadministration during the 12-week period of study treatment or to follow specificdosing instructions for concomitant use with SOF/VEL

11. Per participant report at screening and enrollment, agrees not to participate inother research studies involving investigational medications or investigationalmedical devices for the duration of study participation (does not include durationof infant participation). Note: maternal participants can participate in researchstudies that include standard of care medications.

Exclusion Criteria:

1. Participant report of any of the following at screening or enrollment:

2. Previous DAA treatment for HCV (prior interferon-based treatment is acceptable)without documentation of SVR12 (HCV RNA below the lower limit of quantificationat least 24 weeks after DAA initiation)

3. Use of any medications contraindicated with concurrent use of velpatasvir orsofosbuvir according to the most current EPCLUSA® package insert30

4. Plans to relocate away from the study site area in the next 16 months andunable/unwilling to return for study visits

5. History of cirrhosis documented or reported by previous liver biopsy, imagingtests or on at least 2 noninvasive laboratory tests of fibrosis, includingcompensated cirrhosis

6. Reports participating in any other research study involving investigationalmedications or investigational medical devices within 60 days or less prior toenrollment (does not include research studies involving standard of caremedications)

7. Known fetal chromosomal abnormality prior to enrollment (confirmed by chorionicvillus sampling or amniocentesis)

8. Clinically significant and habitual non-therapeutic drug use, not includingmarijuana, as determined by site PI at screening and enrollment

9. At screening and enrollment, as determined by site PI, any significant,uncontrolled, active or chronic cardiovascular, renal, liver, hematologic,neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologicdisorder or infectious disease other than HCV (or HIV as outlined in eligibilitycriteria)

10. Any of the following laboratory abnormalities at screening:

11. Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10times the upper limit of normal

12. Hemoglobin less than 9 g/dL

13. Platelet count less than 90,000 per mm3

14. International normalized ratio (INR) > 1.5

15. Creatinine greater than 1.4

16. If living with HIV, CD4 count less than 200 cells/mm3 within 6 months of enrollment.

17. Any other condition that, in the opinion of the site PI/designee, would precludeappropriate informed consent, make study participation unsafe, complicateinterpretation of study outcome data, or otherwise interfere with achieving studyobjectives.