Opportunstic Hepatitis C Virus Treatment (Opportuni-C)

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Substance Use Disorders
• Intervention / Treatment: Other: Standard of care; Other: Opportunstic treatment

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Select A State Or Province
    • Lørenskog, Select A State Or Province, Norway, 0278
      • AkershusUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Akershus

Publications and helpful links

General Publications

• Midgard H, Finbraten AK, Malme KB, Berg-Pedersen RM, Tanum L, Olsen IC, Bjornestad R, Dalgard O. Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs. Trials. 2020 Jun 15;21(1):524. doi: 10.1186/s13063-020-04434-8.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Substance-Related Disorders; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 2019/128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No