Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
Condition: Hepatitis C, Chronic; Opioid-use Disorder
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Opioid-Related Disorders; Substance-Related Disorders
Intervention: Sofosbuvir/Velpatasvir
Intervention description: Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Intervention model description: Single arm, open-label, prospective cohort study
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Incorporating Hepatitis C Virus (HCV) treatment into opioid maintenance treatment program
      clinical protocols is an innovative health care delivery model that has been associated with
      improved HCV treatment uptake in non-pregnant, drug-using populations. This "medical home"
      approach would combine HCV and opioid maintenance treatment into one treatment regimen and
      incorporate the expertise of obstetricians, hepatologists, substance abuse treatment
      providers and pediatricians into one comprehensive clinical care model. The purpose of this
      study is to evaluate the feasibility/acceptability of a combined, peripartum HCV and opioid
      maintenance treatment program on adherence to HCV treatment regimens and evaluate the rate of
      intravenous drug use (IVDU) recidivism, HCV reinfection and health related Quality of Life
      (QOL) in women with opioid use disorder (OUD) during the first postpartum year.

      The protocol involves three separate study phases. All 3 study phases will occur with support
      from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment
      and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood
      and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will
      undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum.
      Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8
      and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months
      after treatment completion. Treatment effectiveness and sustained virologic response (SVR)
      will be evaluated at 3 months and rates of IVDU recidivism, HCV reinfection and patient
      centered outcomes such as health related quality of life (QOL) will be assessed at 6, 9 and
      12 months following treatment completion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 or older

          2. Able and willing to provide written informed consent to be screened for and take part
             in the study procedures

          3. Able and willing to provide adequate contact information

          4. 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

          5. Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating
             confirmed by ultrasound

          6. Documented negative Hepatitis B testing within 3 months prior to enrollment

          7. Negative human immunodeficiency virus (HIV) testing within 3 months prior to
             enrollment

          8. 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

          9. Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center
             (UPMC)

        Exclusion Criteria:

          1. Participant report of any of the following at Screening or Enrollment:

               1. Previous treatment for Hepatitis C virus with a sofosbuvir based regimen

               2. Use of any medications contraindicated with concurrent use of
                  sofosbuvir/velpatasvir according to the EPCLUSA package insert

               3. Plans to relocate away from the study site area in the next 18 months

               4. Current sexual partner is known to be infected with HIV or Hepatitis B virus

               5. History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic
                  encephalopathy)

          2. Reports participating in any other research study involving drugs or medical devices
             within 60 days or less prior to enrollment

          3. 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

          4. Breastfeeding or pumping and feeding infant breastmilk

          5. 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)

          6. Has any of the following laboratory abnormalities at Screening:

               1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10
                  times the upper limited of normal

               2. Hemoglobin less than 10 g/dL

               3. Platelet count less than 90,000 per mm3

               4. International normalized ratio (INR) > 1.5

               5. Glomerular filtration rate (GFR) < 40

          7. 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.