Opportunstic Hepatitis C Virus Treatment

Not Applicable

Completed

• Conditions: Substance Use Disorders; Hepatitis C
• Interventions: Other: Standard of care; Other: Opportunstic treatment

• Registration Number: NCT04220645
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2020-01-06
• Study First Posted: 2020-01-07
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge.
Opportunistic treatment	Opportunstic treatment	Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Primary Outcome Measures

Name	Time	Method
Treatment completion	12 weeks	Proportion in each arm who have been dispensed the last 28 days package of HCV treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AkershusUH; 🇳🇴 Lørenskog, Select A State Or Province, Norway