Status:
COMPLETED
A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
Lead Sponsor:
Community Research Initiative of New England
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 regula...
Detailed Description
An estimated 3.2 million people in the United States are currently infected with hepatitis C virus (HCV). Since 1990, when the US introduced screening of the blood supply for HCV, injection drug use h...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- Age ≥ 18 years
- 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
- HCV genotype 1, 2, 3, 4, 5 or 6
- In stable remission from opiate use on buprenorphine/naloxone for at least 12 weeks
- Within the following laboratory parameters as assessed at the screening visit:
- HCV RNA quantifiable
- Screening rhythm strip without bradycardia (heart rate \> 60 or, if on beta blocker, \> 55 BPM)
- Alanine Aminotransferase (ALT) ≤ 10 x ULN (upper limit of normal)
- Aspartate Aminotransferase (AST) ≤ 10 x ULN
- Direct bilirubin ≤ 1.5 x ULN
- Platelets \> 60,000
- Hemoglobin A1C (HbA1c) ≤ 10%
- Creatinine clearance ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation
- Albumin ≥ 3g/dL
- International Normalized Ratio (INR) ≤ 1.5 x ULN or on an anticoagulant regimen affecting INR
- Female subject is eligible to enter if it is confirmed that she is:
- Not pregnant or nursing
- 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
- 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
- Male subjects must refrain from sperm donation from the date of screening until 90 days after the last dose of study drug
- Subject must be in generally good health, with the exception of HCV, in the opinion of the Sponsor-Investigator or Sub-Investigator(s)
- 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
- Presence of decompensated cirrhosis as defined by encephalopathy, ascites, or a history of a variceal bleed
- Prior treatment with direct acting antiviral hepatitis C medications
- Positive urine drug toxicity test at screening (except for cannabinoids and prescribed medications)
- Absence of buprenorphine in urine sample at screening
- Currently pregnant or breastfeeding female
- Detectable HIV RNA \> 50 copies/ml (co-infected subjects with suppressed viral load are eligible for participation)
- Use of any prohibited concomitant medication within 28 days prior to day 1
- Chronic use of systemically administered immunosuppressive agents
- Difficulty with blood collection or poor venous access
- History of solid organ transplantation
- Known significant allergy to sofosbuvir or velpatasvir
- Current chronic liver disease of a non-HCV etiology (including hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency)
- 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)
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03235154
Start Date
October 11 2017
End Date
September 26 2019
Last Update
May 13 2021
Active Locations (1)
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1
Cambridge Health Alliance Outpatient Addiction Services
Somerville, Massachusetts, United States, 02143