Integrated Treatment of Hepatitis C Virus Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 30 October 2023
• Main ID: NCT03155906
• Date of registration: 04/05/2017
• Prospective Registration: Yes
• Primary sponsor: Haukeland University Hospital
• Public title: Integrated Treatment of Hepatitis C Virus Infection INTRO-HCV
• Scientific title: Integrated Treatment of Hepatitis C Virus Infection Among Patients With Injecting Drug Abuse:a Randomised Controlled Trial (INTRO-HCV)
• Date of first enrolment: May 18, 2017
• Target sample size: 240
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03155906
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Lars T Fadnes, MD, PhD
• Affiliation: Department of Addiction Medicine, Haukeland University Hospital

• Name: Else-Marie Løberg, MA, PhD
• Affiliation: Department of Addiction Medicine, Haukeland University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis C, Chronic

Opioid Dependence, on Agonist Therapy

Intervention(s)

Other: Health care delivery

Primary Outcome(s)

Treatment initiation [Time Frame: 6 months after diagnosing HCV in need of treatment]

Sustained virological response of HCV at 12 [Time Frame: At 12 (10 - 14) weeks after completed treatment]

Secondary Outcome(s)

Changes in drug infection related risk behaviour [Time Frame: At 12 weeks after treatment compared to before treatment]

Changes in drug use [Time Frame: At 12 weeks after treatment compared to before treatment]

Changes in fatigue [Time Frame: At 12 weeks after treatment compared to before treatment]

Changes in psychological well-being [Time Frame: At 12 weeks after treatment compared to before treatment]

Changes in quality of life [Time Frame: At 12 weeks after treatment compared to before treatment]

Changes in incidence of HCV [Time Frame: Assessed annually at follow-up assessments, up to 3 years]

Treatment adherence [Time Frame: At 4, 8 (and 12 for treatment recommended beyond 8 weeks) weeks after treatment initiation]

Secondary ID(s)

2017/51/REK vest

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forskningsrådet

Folkehelseinstituttet

Helse Stavanger HF

University of Bergen

Bergen kommune

Helse Vest