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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Primary objective: 1. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old Secondary objectives: Rate of sobriety maintenance for 1 year after enrollment Re-infection rate with HCV over 1 year after enrollment Re-admission rates for detox Cravings

Official Title
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Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care

Conditions
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Hepatitis C, Addict Heroin

Intervention / Treatment
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* Drug: Glecaprevir-pibrentasvir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label Treatment Arm<br>Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients | Drug: Glecaprevir-pibrentasvir<br>* Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate of Hepatitis C Infection | Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years | 12 weeks after treatment completion viral load measure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sobriety from Drug Use | Rate of sobriety maintenance for 1 year after enrollment | 1 year | 
| Hepatitis C Reinfection Rate | Re-infection rate with HCV over 1 year after enrollment | 1 year |