Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection

Inclusion criteria

• Age 18 or older
• Able and willing to provide written informed consent to be screened for and take part in the study procedures
• Able and willing to provide adequate contact information
• Chronic Hepatitis C Virus (HCV), genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV ribonucleic acid (RNA) viral load at screening
• Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
• Documented negative Hepatitis B testing within 3 months prior to enrollment
• Negative human immunodeficiency virus (HIV) testing within 3 months prior to enrollment
• Per participant report at screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
• Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC)

Exclusion criteria

• Participant report of any of the following at Screening or Enrollment:

• Previous treatment for Hepatitis C virus with a sofosbuvir based regimen
• Use of any medications contraindicated with concurrent use of sofosbuvir/velpatasvir according to the EPCLUSA package insert
• Plans to relocate away from the study site area in the next 18 months
• Current sexual partner is known to be infected with HIV or Hepatitis B virus
• History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic encephalopathy)
• Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
• Ongoing illicit drug use evidenced by positive urine drug screen with appropriate confirmatory testing for anything other than marijuana since the first prenatal visit that cannot be explained by a prescribed medication
• Breastfeeding or pumping and feeding infant breastmilk
• At screening or enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)
• Has any of the following laboratory abnormalities at Screening:

• Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limited of normal
• Hemoglobin less than 10 g/dL
• Platelet count less than 90,000 per mm3
• International normalized ratio (INR) > 1.5
• Glomerular filtration rate (GFR) < 40
• Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.