Integrated Treatment of Hepatitis C Virus Infection

Summary

INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST) compared to standard treatment. The trial will recruit approximately 250 HCV infected in Bergen and Stavanger and about 1000 in a linked observational study.

Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and treatment evaluation and treatment delivery.

Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger (intervention arm) with standard treatment provided after referral to infectious disease clinics among patients who receive OST having HCV Secondary objectives: Compare treatment adherence between the intervention and control arms, and assess changes in quality of life, fatigue and psychological well-being before and after HCV treatment, as well as changes in drug use, infection related risk behavior, and risk of reinfection among those with sustained virological response.

Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study population: The target group will be patients receiving care with MAR from involved outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and eligible for treatment according to national guidelines.

Study duration: Participants will be included and followed up at least annually for the total study duration between 2017 and 2021.

Expected outcome: This study will inform on the relative advantages and disadvantages of an integrated treatment program for HCV into MAR compared to standard care aiming to increase access to treatment and improved treatment adherence. If the integrated treatment structure is found to be safe and efficacious, it can be considered for further scale-up.

Conditions

• Hepatitis C, Chronic
• Opioid Dependence, on Agonist Therapy

Interventions

OTHER

Health care delivery

Integrated HCV treatment within the OST clinics will compared to standard treatment. Those who are eligible to receiving treatment in line with national guidelines, have no exclusion criteria and consent to study participation, will be randomised to either standard or integrated treatment. For the integrated treatment, treatment initiation, follow-up and delivery of medication will be given at a MAR outpatient clinic where they already receive care including OST. Those randomised to standard treatment will be referred to a medical ward clinic for assessment of treatment initiation and follow-up. Assessment of outcomes will be done 12 weeks after completed treatment and adherence will be assessed at 4, 8 and 12 weeks after initiation of treatment.

Sponsors & Collaborators

• Helse Stavanger HF

  collaborator OTHER_GOV

• Forskningsrådet

  collaborator UNKNOWN

• Helse Vest

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Folkehelseinstituttet

  collaborator UNKNOWN

• Bergen kommune

  collaborator UNKNOWN

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Lars T Fadnes, MD, PhD · Department of Addiction Medicine, Haukeland University Hospital

• Else-Marie Løberg, MA, PhD · Department of Addiction Medicine, Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-18

Primary Completion

2020-03-15

Completion

2025-03-08

Countries

• Norway

Study Locations