A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
Condition: Hepatitis C, Chronic; Hepatitis C; Opiate Dependence
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Opioid-Related Disorders
Intervention: sofosbuvir/velpatasvir
Intervention description: 12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Suboxone; Epclusa; psychiatrist

Summary:

      The main purpose of this pilot study is to investigate the safety, effectiveness and
      tolerability of the study medication in the treatment of people with chronic hepatitis C
      virus infection who regularly attend a psychiatrist-staffed clinic for opiate addiction
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent

          2. Age ≥ 18 years

          3. Confirmation of chronic HCV infection as documented by a positive HCV antibody test at
             least 6 months prior to the Baseline/Day 1 visit and positive HCV RNA test at
             screening

          4. HCV genotype 1, 2, 3, 4, 5 or 6

          5. In stable remission from opiate use on buprenorphine/naloxone for at least 12 weeks

          6. Within the following laboratory parameters as assessed at the screening visit:

               1. HCV RNA quantifiable

               2. Screening rhythm strip without bradycardia (heart rate > 60 or, if on beta
                  blocker, > 55 BPM)

               3. Alanine Aminotransferase (ALT) ≤ 10 x ULN (upper limit of normal)

               4. Aspartate Aminotransferase (AST) ≤ 10 x ULN

               5. Direct bilirubin ≤ 1.5 x ULN

               6. Platelets > 60,000

               7. Hemoglobin A1C (HbA1c) ≤ 10%

               8. Creatinine clearance ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation

               9. Albumin ≥ 3g/dL

              10. International Normalized Ratio (INR) ≤ 1.5 x ULN or on an anticoagulant regimen
                  affecting INR

          7. Female subject is eligible to enter if it is confirmed that she is:

               1. Not pregnant or nursing

               2. Not of childbearing potential (i.e. s/p hysterectomy, oophorectomy or has
                  medically documented ovarian failure, or are postmenopausal women > 50 years of
                  age with cessation of menses for 12 months or greater) OR Of childbearing
                  potential with a negative serum pregnancy test within 2 weeks of screening, a
                  negative urine pregnancy test on Day 1, and a commitment to either abstain from
                  intercourse or consistently use an acceptable method of birth control (Appendix
                  4) in addition to condom use by her male partner(s) from the date of screening
                  until 30 days after the last dose of study drug

          8. All male study participants must agree to consistently and correctly use condoms with
             their female partner(s) and their female partner(s) must agree to use an acceptable
             method of birth control (listed) from the date of screening until 90 days after the
             last dose of study drug

          9. Male subjects must refrain from sperm donation from the date of screening until 90
             days after the last dose of study drug

         10. Subject must be in generally good health, with the exception of HCV, in the opinion of
             the Sponsor-Investigator or Sub-Investigator(s)

         11. Subject must be able to comply with dosing instructions for study drug administration
             and able to complete the study visits, including all required post-treatment visits

        Exclusion Criteria:

          1. Presence of decompensated cirrhosis as defined by encephalopathy, ascites, or a
             history of a variceal bleed

          2. Prior treatment with direct acting antiviral hepatitis C medications

          3. Positive urine drug toxicity test at screening (except for cannabinoids and prescribed
             medications)

          4. Absence of buprenorphine in urine sample at screening

          5. Currently pregnant or breastfeeding female

          6. Detectable HIV RNA > 50 copies/ml (co-infected subjects with suppressed viral load are
             eligible for participation)

          7. Use of any prohibited concomitant medication within 28 days prior to day 1

          8. Chronic use of systemically administered immunosuppressive agents

          9. Difficulty with blood collection or poor venous access

         10. History of solid organ transplantation

         11. Known significant allergy to sofosbuvir or velpatasvir

         12. Current chronic liver disease of a non-HCV etiology (including hemochromatosis,
             Wilson's disease, alfa-1 antitrypsin deficiency)

         13. Active Hepatitis B virus (HBV) infection defined as either a positive HBV surface
             antigen test or a positive test for HBV DNA. (Subjects who are positive for HBV core
             antibody but negative for Hepatitis B surface antibody, surface antigen, and DNA ARE
             eligible)