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Treatment as Prevention for Hepatitis C in Iceland

Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02647879
Acronym
TraPHepC
Enrollment
1000
Registered
2016-01-06
Start date
2016-01-31
Completion date
2031-05-31
Last updated
2020-09-25

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

Conditions

Hepatitis C

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.

Interventions

None listed

Sponsors

National Center of Addiction Medicine (SAA)
CollaboratorOTHER
Landspitali University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of transmission of HCV in IcelandMeasured annually for up to 15 years

Secondary

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

Countries

Iceland

Contacts

Primary ContactRagnheidur Fridriksdottir, B.Sc, MA
ragnhefr@landspitali.is+ 354 543 6096
Backup ContactHalla Arnardottir, B Sc
hallarn@landspitali.is+354 5435711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026