Treatment as Prevention for Hepatitis C in Iceland

Hepatitis C Clinical Trial

— TraPHepC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02647879
• Other study ID #: LSH-15-003
• Status: Recruiting
• Start date: January 2016
• Est. completion date: May 2031

Study information

• Verified date: September 2020
• Source: Landspitali University Hospital
• Contact: Ragnheidur Fridriksdottir, B.Sc, MA
• Phone: + 354 543 6096
• Email: ragnhefr[@]landspitali.is
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 2031
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
Iceland	Landspitali	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
Landspitali University Hospital	National Center of Addiction Medicine (SAA)

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of transmission of HCV in Iceland		Measured annually for up to 15 years
Secondary	Incidence of cirrhosis and hepatocellular carcinoma in Iceland		Measured annually for up to 15 years
Secondary	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
Secondary	Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR		Measured for up to 36 months