Eliminating HCV Infection Among PWUD

Micro-elimination of HCV Infection Among People Who Use Drug (PWUD) in British.Columbia: A Comprehensive, Multidisciplinary, Scalable Programmatic Approach

Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C, Chronic; Drug Use
• Intervention / Treatment: Drug: Epclusa

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Recruiting
      • Vancouver Infectious Diseases Centre
      • Contact: Rossitta Yung; Phone Number: 303 604-642-6429; Email: rossitta.yung@vidc.ca
      • Principal Investigator: Brian Conway, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HCV-infected current drug users

Description

Inclusion Criteria:

1. Ability to review, sign and date the IRB/IEC approved informed consent form
2. Age ≥19 years
3. Documented HCV RNA positive for 6 months or more, with any HCV genotype
4. Active PWUD (ongoing drug use or documented use within the previous 6 months) OR active enrolment in an opiate substitution program

Exclusion Criteria:

1. Previous DAA-based HCV treatment
2. Pregnant or breast-feeding
3. Indications of decompensated liver disease
4. Diagnosis of active hepatocellular carcinoma
5. Positive test at the time of screening for hepatitis B surface antigen (HBsAg)
6. Frequent injecting drug use that is judged by the treating physician to compromise subsequent HCV treatment safety
7. Inability or unwillingness to provide informed consent or to actively engage in care leading to the initiation of HCV treatment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of individuals enrolled in the study who initiate HCV treatment	60 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of individuals enrolled in the study who achieve sustained virologic response	72 months

Collaborators and Investigators

• Sponsor: Vancouver Infectious Diseases Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir-velpatasvir drug combination
• Other Study ID Numbers: IN-CA-987-5437

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.: Yes