Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

Study Overview
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Brief Summary
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Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded. Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.

Detailed Description
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Chronically HCV-infected participants were recruited and treated at two liver referral clinics in Georgia, but had been referred from opioid substitution therapy clinics, primary care and GI clinics, neighboring hospitals, and correctional centers. Once consented, a nurse navigator was assigned to each participant was responsible for all subjects' appointments, and med supplies. Drug testing was mandated at specified intervals. Patients with recent injection drug use (within 6 months) were assigned to the PWID (people who inject drugs) arm, and those who hadn't injected within 6 months, but agreed to be in the study and signed consents, were assigned to the non-PWID arm. Both groups were treated with velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic). Adherence was assessed by pill counts. Mandatory treatment visits were scheduled for baseline, 4 and 12 weeks (+/- 2 weeks) and follow-up (FU) week 12 (+ 4 months). Long-term FU was flexible and could be virtual, but was mandated once yearly with HCV RNA testing.

Official Title
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Treatment of Recent Injection Drug Use With Chronic HCV Infection in U.S. Liver Referral Clinics: A Prospective, Observational Cohort Study And Contemporaneous Therapy Cohort Without Injection Drug Use

Conditions
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Chronic Hepatitis C, People Who Inject Drugs

Intervention / Treatment
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* Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HCV infection and PWID arm: use of intravenous drug use at least once in preceding six months. In Non-PWID arm: no use of intravenous drug use at least once in preceding six months. Exclusion Criteria: Co-infection with chronic hepatitis B; Decompensated cirrhosis current or by history; inability to sign informed consent; unwilling to take therapy or unable to obtain therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PWID arm and non-PWID arm prospective, parallel observational cohorts
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PWID (people who inject drugs)<br>velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had used intravenous drugs at least once in preceding six months. | Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .<br>* Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily<br>|
| Active Comparator: Non-PWID<br>velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had NOT used intravenous drugs at least once in preceding six months, but were treated concurrently in the same hepatology referral clinics. | Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .<br>* Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response | Undetectable HCV RNA 12 weeks after completion of antiviral therapy | 24 weeks after medication initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reinfection rate hepatitis C | Detection of HCV RNA in follow-up period after SVR has been obtained | in follow-up period (expected 2-3 years) | 
| Intravenous drug use | rate of IV drug use compared between baseline and end of follow-up | informed consent through end of follow-up (up to 3 years) | 
| Opioid Substitution Therapy (OST) | rate of OST compared between baseline and end of follow-up | informed consent through end of follow-up (up to 3 years) |