Opportunstic Hepatitis C Virus Treatment

Study Overview
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Brief Summary
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The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.

Detailed Description
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The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure. We will use a stepped wedge design and include patients in 7 clusters Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.

Official Title
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Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients

Conditions
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Hepatitis C, Substance Use Disorders

Intervention / Treatment
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* Other: Opportunstic treatment
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Above 18 years of age HCV RNA positive Inpatient at participating ward Signed informed consent must be obtained and documented according to national and local regulations Exclusion criteria: Pregnancy or breastfeeding. In involuntarily health care. Ongoing treatment of hepatitis C. Current participation in another trial that might affect the current study. Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic clinical trial. Cluster randomised with stepped wedge design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge. | Other: Standard of care<br>* Referral at discharge<br>|
| Experimental: Opportunistic treatment<br>Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards | Other: Opportunstic treatment<br>* opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment completion | Proportion in each arm who have been dispensed the last 28 days package of HCV treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response | HCV RNA undetetctable 12 weeks after end of treatment | 24 weeks | 
| Reinfection | A HCV RNA strain not present at baseline is detected during or after treatment | Two years | 
| End of treatment response | Proportion in each arm who have undetectable HCV RNA at the end of treatment | 12 weeks |