HCV Treatment in a Low-threshold Clinic (Prindsen)

Management of Hepatitis C Virus Infection Among People Who Inject Drugs in a Low-threshold Setting: Efficacy of Direct-acting Antiviral Treatment and the Risk of Reinfection

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis C; Substance Use Disorders
• Intervention / Treatment: Drug: Elbasvir / Grazoprevir Oral Tablet

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Norway
  • Select A State Or Province
    • Lørenskog, Select A State Or Province, Norway, 0278
      • Recruiting
      • AkershusUH
      • Contact: Olav Dalgard, MD PhD; Phone Number: 92616800; Email: odalgard@medisin.uio.no
      • Contact: Kjersti Ulstein, MD PhD; Phone Number: 0047 41226162; Email: kjersti.ulstein@vel.oslo.kommune.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ever injected drugs (100%) OAT (70%) Recent injecting drug use (70%)

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Investigators: Study Chair: Olav Dalgard, MD PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Substance-Related Disorders; Hepatitis; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Ledipasvir; Grazoprevir; Elbasvir-grazoprevir drug combination
• Other Study ID Numbers: 17_120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: depends on patient privacy decission

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.: No