Clinical trial NCT02647879: Treatment as Prevention for Hepatitis C in Iceland
Official title: Treatment as Prevention for Hepatitis C in Iceland. A Nationwide Campaign for Reducing Disease Burden Using Combination Antiviral Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Lead sponsor: Landspitali University Hospital
Sponsor class: OTHER
Collaborators: name: National Center of Addiction Medicine (SAA)
First posted: 2016-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with chronic HCV infection in Iceland

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of transmission of HCV in Iceland
timeFrame: Measured annually for up to 15 years
Secondary outcomes:
measure: Incidence of cirrhosis and hepatocellular carcinoma in Iceland
timeFrame: Measured annually for up to 15 years
measure: Sustained virological response rate (SVR) to treatment with antiviral agents as measured by negative HCV RNA 12 weeks post treatment
timeFrame: Measured for up to 36 months
measure: Reinfection rate as measured by new infections diagnosed in patients who were previously treated and achieved SVR
timeFrame: Measured for up to 36 months
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Landspitali
Study officials:
affiliation: Landspitali University Hospital
name: Sigurdur Olafsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johannesson JM, Fridriksdottir RH, Love TJ, Runarsdottir V, Hansdottir I, Love A, Thordardottir M, Hernandez UB, Olafsson S, Gottfredsson M; Treatment as Prevention for Hepatitis C (TraP Hep C) group. High Rate of Hepatitis C Virus Reinfection Among Recently Injecting Drug Users: Results From the TraP Hep C Program-A Prospective Nationwide, Population-Based Study. Clin Infect Dis. 2022 Nov 14;75(10):1732-1739. doi: 10.1093/cid/ciac272.
citation: Olafsson S, Fridriksdottir RH, Love TJ, Tyrfingsson T, Runarsdottir V, Hansdottir I, Bergmann OM, Bjornsson ES, Johannsson B, Sigurdardottir B, Love A, Baldvinsdottir GE, Hernandez UB, Gudnason T, Heimisdottir M, Hellard M, Gottfredsson M. Cascade of care during the first 36 months of the treatment as prevention for hepatitis C (TraP HepC) programme in Iceland: a population-based study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):628-637. doi: 10.1016/S2468-1253(21)00137-0. Epub 2021 Jun 23.
citation: Olafsson S, Tyrfingsson T, Runarsdottir V, Bergmann OM, Hansdottir I, Bjornsson ES, Johannsson B, Sigurdardottir B, Fridriksdottir RH, Love A, Hellard M, Love TJ, Gudnason T, Heimisdottir M, Gottfredsson M. Treatment as Prevention for Hepatitis C (TraP Hep C) - a nationwide elimination programme in Iceland using direct-acting antiviral agents. J Intern Med. 2018 May;283(5):500-507. doi: 10.1111/joim.12740. Epub 2018 Mar 7.