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Grant: Foundation Grant

Research Institute of the McGill University Health Centre

$4,835,202.00

Tracking a revolution: Evaluating the impact of modern HCV therapy on HIV-HCV coinfection

FY 2014-15

Summary
RESEARCH PROGRAM New, highly effective therapies that directly target HCV (DAAs) will completely alter the landscape for HCV infected patients. But we are faced with a fundamental paradox. DAAs are the most expensive anti-infectives ever to be developed and HCV disproportionately affects the poorest and most disenfranchised populations in Canada and globally. My goal in the next 7 years is to develop the tools and amass evidence to effect clinical and policy changes that increase access to HCV treatment and improve health outcomes for vulnerable populations. I will build on the only national clinical research network focused on HCV, the Canadian Coinfection Cohort which has followed 1321 HIV-HCV coinfected participants over 10 years. The introduction of DAAs into this well characterized prospective cohort provides a unique opportunity to evaluate their full impact on coinfected Canadians and inform the wider response to the HCV epidemic by demonstrating how to increase access to and optimally use these new therapies. We will: 1) perform qualitative and quantitative surveys to identify patient, provider and systemic barriers and facilitators to DAA treatment access; 2) determine the best models to deliver DAA care; 3) develop novel methodologic approaches for conducting observational research in vulnerable populations; 4) apply them to evaluate the real world efficacy and safety of DAAs and; 5) measure the downstream impacts of DAAs on liver and non-liver related health outcomes and costs and determine at which disease stage patients most benefit from receiving therapy. ANTICIPATED RESULTS Our collaborative research agenda, inclusive of communities affected, is a model for evaluating health interventions in vulnerable populations. By gathering evidence on the real-world impact of DAAs our work will be essential for determining how best to treat coinfected persons. We will use our results to engage policy makers to bring about equitable access to HCV treatment, maximize successful outcomes and reduce the enormous health and economic burdens of chronic liver disease. Our high quality observational data, methods and linked biobank will serve a broad range of Canadian and international research efforts. The program is tied to the larger research agenda for HCV nationally and internationally and thus will have wide impact beyond coinfection to HCV monoinfection and other complex medical conditions in vulnerable and marginalized people. EXPERTISE I am an internationally recognized expert in HIV and HCV, Epidemiology and clinical trials. I have a track record of leading large research groups and am widely engaged in national and international collaborative research networks. I have assembled a strong and unique multidisciplinary research team that brings together expertise in HIV, infectious diseases, hepatology, immunology, public health, epidemiology and biostatistics. Program experts include internationally recognized methodologists (E Moodie, J Young, E Strumpf), young investigators, Aboriginal researchers and community partners. MENTORSHIP My program provides for comprehensive cross-disciplinary collaborative training of an array of health researchers. My goals are to train highly qualified clinical epidemiologists capable of applying modern biostatistical approaches, support the early career development of clinician scientists and expand capacity for observational and clinical research focused on vulnerable populations across the Canada.
Program
Foundation Grant
Location
Quebec, Canada
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
313381
Name
Klein Marina B
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Infection and Immunity
Theme2
Clinical
Prcname2
Foundation Grant
Projecttitle
Tracking a revolution: Evaluating the impact of modern HCV therapy on HIV-HCV coinfection
Programtype2
Operating Grants
Orgnameinp2
Research Institute of the McGill University Health Centre
Cihramount2
$4,835,202
Cihrequipment2
$0
Programname2
Foundation Grant
Keyworddelim
Antiviral Treatments; Clinical Trials; Cohort Study; Health Economics; Health Outcomes; Hepatitis C Virus (Hcv); Hiv; Methods; Models Of Care; Vulnerable Populations
Abstract
<html> <body> <p> <strong>RESEARCH PROGRAM</strong> </p> <p>New, highly effective therapies that directly target HCV (DAAs) will completely alter the landscape for HCV infected patients. But we are faced with a fundamental paradox. DAAs are the most expensive anti-infectives ever to be developed and HCV disproportionately affects the poorest and most disenfranchised populations in Canada and globally.</p> <p>My goal in the next 7 years is to develop the tools and amass evidence to effect clinical and policy changes that increase access to HCV treatment and improve health outcomes for vulnerable populations. I will build on the only national clinical research network focused on HCV, the Canadian Coinfection Cohort which has followed 1321 HIV-HCV coinfected participants over 10 years. The introduction of DAAs into this well characterized prospective cohort provides a unique opportunity to evaluate their full impact on coinfected Canadians and inform the wider response to the HCV epidemic by demonstrating how to increase access to and optimally use these new therapies.</p> <p>We will: 1) perform qualitative and quantitative surveys to identify patient, provider and systemic barriers and facilitators to DAA treatment access; 2) determine the best models to deliver DAA care; 3) develop novel methodologic approaches for conducting observational research in vulnerable populations; 4) apply them to evaluate the real world efficacy and safety of DAAs and; 5) measure the downstream impacts of DAAs on liver and non-liver related health outcomes and costs and determine at which disease stage patients most benefit from receiving therapy.</p> <p> <strong>ANTICIPATED RESULTS</strong> </p> <p>Our collaborative research agenda, inclusive of communities affected, is a model for evaluating health interventions in vulnerable populations. By gathering evidence on the real-world impact of DAAs our work will be essential for determining how best to treat coinfected persons. We will use our results to engage policy makers to bring about equitable access to HCV treatment, maximize successful outcomes and reduce the enormous health and economic burdens of chronic liver disease. Our high quality observational data, methods and linked biobank will serve a broad range of Canadian and international research efforts. The program is tied to the larger research agenda for HCV nationally and internationally and thus will have wide impact beyond coinfection to HCV monoinfection and other complex medical conditions in vulnerable and marginalized people.</p> <p> <strong>EXPERTISE</strong> </p> <p>I am an internationally recognized expert in HIV and HCV, Epidemiology and clinical trials. I have a track record of leading large research groups and am widely engaged in national and international collaborative research networks. I have assembled a strong and unique multidisciplinary research team that brings together expertise in HIV, infectious diseases, hepatology, immunology, public health, epidemiology and biostatistics. Program experts include internationally recognized methodologists (E Moodie, J Young, E Strumpf), young investigators, Aboriginal researchers and community partners.</p> <p> <strong>MENTORSHIP</strong> </p> <p>My program provides for comprehensive cross-disciplinary collaborative training of an array of health researchers. My goals are to train highly qualified clinical epidemiologists capable of applying modern biostatistical approaches, support the early career development of clinician scientists and expand capacity for observational and clinical research focused on vulnerable populations across the Canada.</p> </body> </html>
Competitiondate
201409
Approvedterm2
7 yrs 0 mth
Pinamesdelim
Klein, Marina B
Approvedterm
7 ans 0 mois
Cihrcontribution2
~ $4,835,202~ $0~