Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

• Status: Unknown status
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

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

Details

• Lead Sponsor: Id Care
• Collaborator: AbbVie

Criteria

Inclusion Criteria:

• Age 18 - 30

• Successfully detoxed at PHBH from opioids

• Agree to participate in a closely monitored program

• Positive HCV VL > 5,000 on two tests

• Minimum one follow-up visit after discharge from PHBH to be enrolled

• Any genotype

• APRI less than 1 and Fibrosure less than 0.45

• Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret

• Treatment naïve for HCV

• Signed informed consent

Exclusion Criteria:

• Cirrhosis

• Co-infection with HIV or HBV

• Inability to comply with treatment or follow up

• Renal failure with GFR less than 50 mL/min5*

• Any prior treatment for HCV

• Diabetes with HgA1c more than 8.0

• Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:

• ALT/AST > 10x normal value,

• WBC with ANC < 1500 cell/ul,

• Hemoglobin < LLN,

• Treatment for cancer or lymphoma in the past 5 years,

• Hemoglobin A 1C > 8%.

• Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.

• Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres