Integrated Treatment of Hepatitis C Virus Infection

NCT03155906 | Completed

• 1 other identifier: 2017/51/REK vest
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Chronic hepatitis C; Opiate Substitution Treatment; Integrated Delivery of Health Care; Substance Abuse Treatment Centers

Outcome Measures

Primary Outcomes (2)

• Sustained virological response of HCV at 12

  Sustained virological response of HCV will be assessed by HCV RNA at 12 (range 10 - 14) weeks after completed treatment

  At 12 (10 - 14) weeks after completed treatment

• Treatment initiation

  Treatment initiation within 6 months after diagnosing HCV in need of treatment (in line with national guidelines). This will be assessed through observation in intervention and in reported obtainment from pharmacies of the prescribed drugs

  6 months after diagnosing HCV in need of treatment

Secondary Outcomes (7)

• Treatment adherence

  At 4, 8 (and 12 for treatment recommended beyond 8 weeks) weeks after treatment initiation

• Changes in quality of life

  At 12 weeks after treatment compared to before treatment

• Changes in fatigue

  At 12 weeks after treatment compared to before treatment

• Changes in psychological well-being

  At 12 weeks after treatment compared to before treatment

• Changes in drug use

  At 12 weeks after treatment compared to before treatment

Study Arms (2)

Integrated treatment

EXPERIMENTAL

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.

Other: Health care delivery

Standard treatment

ACTIVE COMPARATOR

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.

Other: Health care delivery

Interventions

Health care delivery OTHER

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.

Also known as: Integrated health care

Integrated treatment; Standard treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving OST from included outpatient clinic
• 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.

You may not qualify if:

• Co-infection with HIV
• Severe extrahepatic HCV associated diseases (e.g. cerebral vasculitis, cryoglobulinemia/membranoprolifereative glomerulonephritis (MPGN), renal failure (eGFR \<30), polyarthritis)
• Decompensated liver failure assessed with Child-Pugh (CP) score (\>6 points, class B and C)
• Currently receiving treatment for HCV

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helse Stavanger HF: collaborator
• Forskningsrådet: collaborator
• Helse Vest: collaborator
• University of Bergen: collaborator
• Folkehelseinstituttet: collaborator
• Bergen kommune: collaborator

Study Sites (2)

Department of Addiction Medicine, Haukeland University Hospital

Bergen, Hordaland, 5020, Norway

Location

LAR Helse Stavanger HF

Stavanger, Rogaland, 4010, Norway

Location

Related Publications (24)

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  PMID: 37095561 DERIVED

• Fadnes LT, Aas CF, Vold JH, Leiva RA, Ohldieck C, Chalabianloo F, Skurtveit S, Lygren OJ, Dalgard O, Vickerman P, Midgard H, Loberg EM, Johansson KA; INTRO-HCV Study Group. Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). PLoS Med. 2021 Jun 1;18(6):e1003653. doi: 10.1371/journal.pmed.1003653. eCollection 2021 Jun.

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  PMID: 31703669 DERIVED

Related Links

• Project web page (in Norwegian)

MeSH Terms

Conditions

Hepatitis C, Chronic; Opioid-Related Disorders

Interventions

Delivery of Health Care; Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lars T Fadnes, MD, PhD

  Department of Addiction Medicine, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Else-Marie Løberg, MA, PhD

  Department of Addiction Medicine, Haukeland University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Even though complete blinding is regarded as difficult, there will be some degree of blinding/masking. Randomisation will be disclosed to physician and other health care staff providing OST treatment, but not to research nurses conducting data collection for outcomes. Patients will be informed of the follow-up they will receive, but not on other follow-up alternatives that are used or the exact hypotheses for the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicentre, randomised controlled clinical trial.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 16, 2017
• Study Start: May 18, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 8, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)