Hepatitis C, Chronic, Drug Use
Conditions
Brief summary
Identify 300 PWUD with chronic, viremic HCV infection and engage them in a multidisciplinary, generalizable model of care and initiate HCV treatment
Interventions
DRUGEpclusa
HCV treatment
Sponsors
Vancouver Infectious Diseases Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of individuals enrolled in the study who initiate HCV treatment | 60 months |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of individuals enrolled in the study who achieve sustained virologic response | 72 months |
Countries
Canada
Outcome results
None listed