Clinical trial NCT04220645: Opportunstic Hepatitis C Virus Treatment
Official title: Opportunistic Treatment of Hepatitis C Virus Infection (OPPORTUNI-C): A Pragmatic Clinical Trial of Immediate Versus Outpatient Treatment Initiation Among Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Substance Use Disorders
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic clinical trial. Cluster randomised with stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Treatment completion
timeFrame: 12 weeks
Secondary outcomes:
measure: Sustained virological response
timeFrame: 24 weeks
measure: Reinfection
timeFrame: Two years
measure: End of treatment response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: AkershusUH
state: Select A State Or Province
Study officials:
References:
citation: 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.