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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Hepatitis C; People Who Inject Drugs
• Intervention / Treatment: Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .

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.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Wellstar Atlanta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: 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.	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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Center For Hepatitis C, Atlanta, GA
• Investigators: Principal Investigator: brian pearlman, MD, Wellstar Internal Medicine Associates

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Velpatasvir
• Other Study ID Numbers: 1364-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No