Treatment as Prevention for Hepatitis C in Iceland

Recruiting

• Conditions: Hepatitis C

• Registration Number: NCT02647879
• Lead Sponsor: Landspitali University Hospital

Brief Summary

The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.

Detailed Description

In Iceland, a nationwide effort is planned where all patients with HCV infection will be offered treatment using direct acting antiviral agents. The aim of the initiative, besides offering cure to patients, is to substantially reduce domestic transmission of HCV and thereby lower the incidence. Ultimately, with these intense efforts the long-term complications of chronic HCV infection could potentially be nearly eliminated. In Iceland, there is mandatory reporting of all new cases of hepatitis C to the State Epidemiologist.

In the study, short term and long term outcomes of this initiative will be investigated. In an initial treatment phase which will last for up to three years, all patients diagnosed with hepatitis C in Iceland will be offered treatment with direct acting antiviral agents. Virological response rate and compliance will be monitored. Long term, the incidence of HCV infection acquired in Iceland will be monitored for up to 15 years, and the incidence rates of cirrhosis and hepatocellular carcinoma due to HCV will be monitored for up to 15 years.

Study Timeline

• Study First Submitted: 2015-12-30
• Study Start: 2016-01
• Study First Submitted QC: 2016-01-05
• Study First Posted: 2016-01-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-25
• Primary Completion: 2021-12
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.

Exclusion Criteria

• Age under 18 years
• Inability to sign informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of transmission of HCV in Iceland	Measured annually for up to 15 years

Secondary Outcome Measures

Name	Time	Method
Incidence of cirrhosis and hepatocellular carcinoma in Iceland	Measured annually for up to 15 years
Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR	Measured for up to 36 months
Sustained virological response rate (SVR) to treatment with antiviral agents as measured by negative HCV RNA 12 weeks post treatment	Measured for up to 36 months

Trial Locations

Locations (1)

Landspitali; 🇮🇸 Reykjavik, Iceland