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

NCT ID: NCT05895448

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-01-01

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.

Conditions

Chronic Hepatitis C; People Who Inject Drugs

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .

Intervention Type: DRUG

Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily

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.

Group Type: ACTIVE_COMPARATOR

velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .

Intervention Type: DRUG

Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily

Interventions

velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .

Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center For Hepatitis C, Atlanta, GA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

brian pearlman, MD

Role: PRINCIPAL_INVESTIGATOR

Wellstar Internal Medicine Associates

Locations

Wellstar Atlanta Medical Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1364-2018

Identifier Type: -

Identifier Source: org_study_id