A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic

• Status: Completed
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Community Research Initiative of New England
• Collaborator: Gilead Sciences
• Treatments: Sofosbuvir; Velpatasvir

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)