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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05895448
• Other study ID #: 1364-2018
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: Center For Hepatitis C, Atlanta, GA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C
• Hepatitis C, Chronic
• People Who Inject Drugs

Intervention

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

Locations

Country	Name	City	State
United States	Wellstar Atlanta Medical Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Center For Hepatitis C, Atlanta, GA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response	Undetectable HCV RNA 12 weeks after completion of antiviral therapy	24 weeks after medication initiation
Secondary	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)
Secondary	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)
Secondary	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)