Overview

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

Status:
Active, not recruiting

Trial end date:
2024-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Center For Hepatitis C, Atlanta, GA

Treatments:

Sofosbuvir
Velpatasvir

Criteria

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