Opportunstic Hepatitis C Virus Treatment (Opportuni-C)

University Hospital, Akershus

Status: Completed

Conditions: Hepatitis C; Substance Use Disorders

Treatments: Other: Opportunstic treatment; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04220645

2019/128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Hospitalised patients with hep C are referred to the outpatient clinic at the medical department following discharge.

Treatment:

Other: Standard of care

Opportunistic treatment

Experimental group

Description:

Hospitalised patients with hep C are opportunistically and immediately treated when hospitalized for acute care in psychiatric, addiction treatment or somatic wards

Treatment:

Other: Opportunstic treatment