Expressions of Intent for IPY 2007-2008 Activities

Expression of Interest Details

PROPOSAL INFORMATION

Hepatitis B in Aboriginal Populations in the Arctic: Alaska Natives, Canadian Inuit and First Nations Peoples, Greenland Inuits and Russian Native Populations  (Hepatitis B in Aboriginal Populations in the Arctic)

Outline
Although liver disease is the 12th leading cause of death in Americans, it is the 6th leading causing of death in American Indians and Alaska Natives. Similarly in Canada, deaths from liver disease are also the fifth leading cause of deaths in the 45-65 year age group. Chronic viral hepatitis due to hepatitis B and C are believed to be major contributors to liver disease in these populations. Greenland has one of the highest rates of HBV infection in the world and HBV and HCV are felt to be a major health problem in Russia, especially in remote populations. We propose to study the epidemiology of HBV in Aboriginal populations in the Arctic, the factors associated with disease progression, including demographic, environmental and viral factors and the impact of antiviral therapy in persons deemed suitable for treatment by established practice guidelines. The goals of this proposal are: 1. To determine the epidemiology of chronic HBV in Aboriginal Populations in the Arctic. 2. To monitor cohorts of HBV infected patients in these regions to determine the proportion who develop active liver disease by monitoring liver aminotransferase and HBV DNA levels on a regular basis and reviewing results of liver biopsies performed for clinical purposes. 3. To examine demographic factors associated with disease outcome. 4. To examine environmental factors associated with disease outcome including contaminants in the environment and food sources. 5. To examine the role of cofactors that might contribute to liver disease such as alcohol intake, obesity and the metabolic syndrome. 6. To examine viral characteristics in indigenous populations in the Arctic comparing HBV genotype distribution, viral loads and viral mutations that could be related to disease outcomes 7. By identifying potential treatment candidates and examining barriers to treatment and outcome of treatment including the role of factors such as demographic, viral genotype and environmental factors in response to treatment.

What significant advance(s) in relation to the IPY themes and targets can be anticipated from this project?
The Arctic is one of the areas of the world where the highest rates of hepatitis B virus (HBV) infection are found. This proposal examines the impact of HBV on indigenous Human Societies in Alaska, Canada, Greenland and Russia, including the impact of HBV on the development of liver disease and liver cancer. It fits very well into the theme of Human Societies in the polar region. The data collected will include disease incidence and prevalence as well as molecular analysis and comparison of the characteristics of different HBV strains thus fulfilling the Target of Natural Science Research.

What international collaboration is involved in this project?
Collaboration will occur between researchers in Alaska, Canada, Greenland, Denmark and Russian. Epidemiologists from each country and molecular biology laboratories in three countries, Alaska, Canada and Russia will participate. Comparison of the disease impact of HBV on populations in these countries will help to understand how HBV effects Arctic Peoples.

FIELD ACTIVITY DETAILS

Geographical location(s) for the proposed field activities:
Field work will be conducted in Villages in Western Alaska, Yukon Territories and Nunavut in Canada, communities in Eastern and Western Greenland and the Barents Sea and several areas in Siberia, Russia with laboratory, epidemiological and support from statisticians coming from Anchorage, Winnipeg, Copenhagen and Moscow.

Approximate timeframe(s) for proposed field activities:
Arctic: 01/07 – 12/08            
Antarctic: n/a

Significant facilities will be required for this project:
Molecular biology and serology labs are available in Anchorage at the Alaska Native Medical Center and at AIP/CDC, in Winnipeg Canada at the University of Manatoba, in Copenhagen at the Staten Serum Institute and in Moscow at Central Research Institute of Epidemiology. These facilities can be shared with other researchers.

Will the project leave a legacy of infrastructure?
This project will link epidemiology programs in the Arctic with state of the art laboratories in the area, thus allowing future collaboration and scientific pursuit. In addition, the epidemiologic programs from the Arctic will be strengthened and linked together in areas collaboration allowing for future scientific work.

How is it envisaged that the required logistic support will be secured?
Consortium
Other sources of support

Epidemiology programs and laboratories in Alaska, Winnipeg, Copenhagen, Moscow and Arkhangelsk Russia have already shown willingness to participate. A meeting is planned in Novosibirsk in June 2006 to plan the project and participants from other areas of Siberia have been invited to this meeting.

Has the project been "endorsed" at a national or international level?
This project will be part of the Arctic Council, Arctic Human Health Initiative (AHHI) IPY proposal number 167. The project has been endorsed by the CDC. The WHO is providing funding to support a meeting to plan the project to be held in conjunction with the 13th ICCH.

PROJECT MANAGEMENT AND STRUCTURE

Is the project a short-term expansion (over the IPY 2007-2008 timeframe) of an existing plan, programme or initiative or is it a new autonomous proposal?
Yes
This project will be a new and autonomous project. Many of the elements of this project have been successfully implemented in Alaska but not in any of the other regions of the Arctic.

How will the project be organised and managed?
A project coordinator will work under the direction of the investigators below. A planning meeting will be held at ICCH 13. The project investigators listed will organize the specific epidemiologic field work in each country. Serum specimens will be sent to the four participating laboratories for analysis. Each laboratory will analyze its own specimens. In order to compare genomic differences in viral strains, detailed molecular analysis on selected specimens will be conducted from participating countries from which personal identifiers have been removed. Monthly conference calls and yearly face to face meetings will be held to plan and review project components.

What are the initial plans of the project for addressing the education, outreach and communication issues outlined in the Framework document?
Investigational Review and Indigenous Native Boards approval will be sought in each Country. Project presentation and approval will be sought from participating communities. Educational Materials and on site project updates will be provided to communities, Native Groups and participants. Manuscripts will be submitted to IJCH and other peer review journals.

What are the initial plans of the project to address data management issues (as outlined in the Framework document)?
Each country will be responsible for its own data entry. Statistical analysis will be performed on data which has been stripped of all identifiers for confidentiality by established departments of biostatistics in Anchorage (CDC) and Copenhagen (Staten Institute) using statisticians experienced in analysing data from the Arctic Region.

How is it proposed to fund the project?
Assuming that each country will allocate funds specifically for Arctic research in IPY, the investigators listed below from each country will apply for funds to its own country’s funding board.

Is there additional information you wish to provide?
Persons infected with chronic HBV have a 20% to 40% risk without intervention of dying from liver cancer or cirrhosis in their lifetime. New effective drugs to suppress HBV are available. Not all infected persons need treatment. The extent of serious complications in the Arctic, other than in Alaska Natives, is unknown. This project will hopefully lead to the identification of viral and other factors that place infected persons at risk for complications. This project could provide data to plan treatment programs in each country and identify persons that could be treated by local providers and the outcome of treatment.

PROPOSER DETAILS

Brian McMahon
Liver Disease and Hepatitis Program, Alaska Native Tribal Health Consortium and Arctic Investigations Program Centers for Disease Control and Prevention
4315 Diplomacy Drive
Anchorage Alaska
99508
USA

Tel: 907-729-3419
Mobile:
Fax: 907-729-3429
Email:

Other project members and their affiliation

Other Information