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
Overview
- Phase
- Phase 4
- Intervention
- velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
- Conditions
- Chronic Hepatitis C
- Sponsor
- Center For Hepatitis C, Atlanta, GA
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Sustained Virologic Response
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility 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
Arms & Interventions
PWID (people who inject drugs)
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.
Intervention: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
Non-PWID
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.
Intervention: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
Outcomes
Primary Outcomes
Sustained Virologic Response
Time Frame: 24 weeks after medication initiation
Undetectable HCV RNA 12 weeks after completion of antiviral therapy
Secondary Outcomes
- Reinfection rate hepatitis C(in follow-up period (expected 2-3 years))
- Intravenous drug use(informed consent through end of follow-up (up to 3 years))
- Opioid Substitution Therapy (OST)(informed consent through end of follow-up (up to 3 years))