HCV Treatment in a Low-threshold Clinic

• Conditions: Substance Use Disorders; Hepatitis C

• Registration Number: NCT04063839
• Lead Sponsor: University Hospital, Akershus

Brief Summary

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Detailed Description

This is a cohort of people who inject drugs with chronic HCV infection. Patients are seen at a low-threshold clinic. All patients are offered treatment for HCV and subsequently followed for to years

Inclusion Consenting patients older than 18 years attending the low threshold HCV clinic in Oslo

The primary aims are to assess the efficacy (SVR rate) of DAA treatment among PWID treated in a low-threshold primary care setting (Work Package 1) and to estimate the incidence HCV reinfection f

The secondary aims are to:

* Evaluate adherence to DAA treatment (Work Package 1)

* Identify factors associated with SVR and adherence (Work Package 1)

* Characterize reinfection using next generation sequencing (Work Package 2)

* Identify factors associated with reinfection (Work Package 2)

* Evaluate changes in recent injecting risk behaviours longitudinally (Work Package 2)

* Identify factors associated with changes in risk behaviours (Work Package 2)

The hypothesis is that high SVR rates and good treatment adherence will be achieved in PWID treated for HCV infection in a low-threshold primary health care setting. Further,it is anticipated that the incidence of reinfection will be 5-10/100 PY and associated with younger age, low education level and ongoing injecting risk behaviours.

The study will include 300 patients and are close to achieving that aim the summer of 2019

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2019-06-27
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-21
• Last Update Posted: 2019-08-21
• Primary Completion: 2019-10-31
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• HCV RNA positive Attending the low-threshold HCV clinic in Oslo

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sustained virological response	12 weeks	HCV RNA undetectable 12 weeks post treatment
Reinfection	2 years	HCV RNA detectable after SVR 12 in a patient who injected drugs post SVR 12

Trial Locations

Locations (1)

AkershusUH; 🇳🇴 Lørenskog, Select A State Or Province, Norway