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

NCT05895448 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1364-2018
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C; People Who Inject Drugs

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response

  Undetectable HCV RNA 12 weeks after completion of antiviral therapy

  24 weeks after medication initiation

Secondary Outcomes (3)

• 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)

Study Arms (2)

PWID (people who inject drugs)

EXPERIMENTAL

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) .

Non-PWID

ACTIVE COMPARATOR

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) .

Interventions

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

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

Non-PWID; PWID (people who inject drugs)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Center For Hepatitis C, Atlanta, GA: lead

Study Sites (1)

Wellstar Atlanta Medical Center

Atlanta, Georgia, 30312, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

velpatasvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• brian pearlman, MD

  Wellstar Internal Medicine Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PWID arm and non-PWID arm prospective, parallel observational cohorts

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 8, 2023
• Study Start: March 1, 2018
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)