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Opportunstic Hepatitis C Virus Treatment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04220645
Acronym
Opportuni-C
Enrollment
218
Registered
2020-01-07
Start date
2019-10-01
Completion date
2022-06-30
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Substance Use Disorders

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.

Interventions

OTHEROpportunstic treatment

opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards

OTHERStandard of care

Referral at discharge

Sponsors

University Hospital, Akershus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Pragmatic clinical trial. Cluster randomised with stepped wedge design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Treatment completion12 weeksProportion in each arm who have been dispensed the last 28 days package of HCV treatment

Secondary

MeasureTime frameDescription
Sustained virological response24 weeksHCV RNA undetetctable 12 weeks after end of treatment
ReinfectionTwo yearsA HCV RNA strain not present at baseline is detected during or after treatment
End of treatment response12 weeksProportion in each arm who have undetectable HCV RNA at the end of treatment

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026