Opportunstic Hepatitis C Virus Treatment

Hepatitis C Clinical Trial

— Opportuni-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220645
• Other study ID #: 2019/128
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Opportunstic treatment
opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards
• Standard of care
Referral at discharge

Locations

Country	Name	City	State
Norway	AkershusUH	Lørenskog	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment completion	Proportion in each arm who have been dispensed the last 28 days package of HCV treatment	12 weeks
Secondary	Sustained virological response	HCV RNA undetetctable 12 weeks after end of treatment	24 weeks
Secondary	Reinfection	A HCV RNA strain not present at baseline is detected during or after treatment	Two years
Secondary	End of treatment response	Proportion in each arm who have undetectable HCV RNA at the end of treatment	12 weeks