NCT05895448

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Center For Hepatitis C, Atlanta, GA · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C
• People Who Inject Drugs

Interventions

Type	Name	Description
DRUG	velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .	Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily

Timeline

• Start date: 2018-03-01
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study