Integrated Treatment of Hepatitis C Virus Infection
Key facts
- Who runs it
- Haukeland University Hospital
- Where
- Norway2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 298 people enrolled
- Started
- 18 May 2017
- Ended
- 8 Mar 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Health care delivery
- Record updated
- 16 September 2025
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Receiving OST from included outpatient clinic
- Chronically infected with HCV (HCV RNA positive and also HCV RNA positive or anti-HCV at least 6 months before inclusion)
- Eligible for treatment according to national guidelines (criteria specified below)
- Obtaining informed consent; At the time of study initiation , eligibility for treatment according to national guidelines was defined as follows:
- Genotype 1 and 4 independent of degree of fibrosis
- Genotype 2 and 3, dependent on significant fibrosis; Significant fibrosis will be assessed with FibroScan indicating elastography of above 7 kPa. Where elastography cannot be obtained, significant fibrosis will be assessed with AST to platelet ratio index (APRI score) of > 0.7 (http://www.hepatitisc.uw.edu/page/clinical-calculators/apri), i.e; APRI = ASAT levels (in IU/L) / 40 (upper normal levels of ASAT in IU/L) / platelet count (109/L). An APRI score greater than 0.7 had a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis
Who cannot take part
- Currently receiving treatment for HCV
- Co-infection with HIV
- Decompensated liver failure assessed with Child-Pugh (CP) score (>6 points, class B and C)
- Severe extrahepatic HCV associated diseases (e.g. cerebral vasculitis, cryoglobulinemia/membranoprolifereative glomerulonephritis (MPGN), renal failure (eGFR <30), polyarthritis)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Integrated treatmentTreatment being tested
Patients randomised to receive integrated treatment will be counselled on treatment by physician working at MAR outpatient clinic where patient receive OST care, and will receive medication and follow-up at the same MAR outpatient clinic. Treatment medication will be given in line with national guidelines with a close and integrated follow-up.
Treatment: Health care delivery
- Standard treatmentExisting treatment, for comparison
Those randomised to receive standard treatment will be offered referral for standard HCV treatment at a medical ward hospital clinic. Treatment medication will be given in line with national guidelines.
Treatment: Health care delivery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Integrated Treatment of Hepatitis C Virus Infection Among Patients With Injecting Drug Abuse:a Randomised Controlled Trial (INTRO-HCV)
- Record updated
- 16 September 2025