NPI: Sasha Bernatsky
Co-PI: Marina Klein, Jordan Feld, and Louise Pilote
Duration: 1 year
We have been funded to answer a query related to the comparative effectiveness and safety of direct-acting antiviral agents (DAA) in combination or not with PEG + RBV (triple therapy). For the current project, aimed at enhancing drug safety and effectiveness research through the CanHepC network, we aim to harmonize existing data already collected around the country in varying clinical settings, as well as broadening the focus, to enroll on populations poorly represented in prior studies. In addition to merging existing data, we will collect new data in a prospective manner.
This project aims to enhance the clinical cohort on hepatitis C and the first generation of direct-acting antivirals (DAAs). This project has been focused on collecting high quality observational data on the use of novel therapeutics for HCV infection and to harmonizing datasets on HCV collected at centres across Canada. It also involves broadening the scope of the original cohort to enroll on populations poorly represented in prior studies. We are actively collecting data. We have over 1,000 patients with more than 2,5000 visits in the prospective database so far and we are expecting that to increase significantly very soon as we added five new sites.
Data collection is carried out using related but independent approaches:
- Retrospective Cohort: Existing clinical and research databases from Canadian academic sites and community-based clinics will be combined onto a single platform to allow for analysis of treatment outcomes that have already occurred.
- Prospective Cohort: A prospectively followed cohort, the Canadian Network Undertaking against Hepatitis C (CANUHC) will collect prospective data on all patients seen in HCV treatment clinics. The CANUHC database will be housed at the University of Calgary.
- Registry Linkage Cohort
The Canadian Network on Hepatitis C (CanHepC) is a national collaborative HCV research and training network funded by and modeled on the structure of the Canadian Institutes for Health Research (CIHR). The CanHepC network brings together researchers studying all aspects of HCV infection ranging from fundamental questions of virology and immunology to social sciences and health policy that influence HCV transmission. The network has 4 research cores: Basic Science Discovery, Clinical Research, Behavioural and Epidemiology Research and Health System and Policy Research, as well as a Training Core to facilitate research development for trainees and a Knowledge Translation core to ensure that the findings of the network are tangibly put into practice.
The main focus of the Clinical Research Core is to understand the real-world effectiveness of new HCV therapies with a particular focus on short and long-term outcomes in populations of high interest to Canada, many of which have not been well represented in registries in other regions.
The core will focus on the following areas of research:
- Clinical effectiveness of HCV therapy with a focus on short-term (SVR rate, adherence, treatment-related toxicity) and long-term (resistance, reinfection) outcomes with comparisons between different clinical populations and models of care
- Assessment of long-term clinical outcomes (HCC, liver transplantation, liver-related mortality, all-cause mortality, regression of fibrosis) in different clinical populations
- Access to care and treatment uptake in different HCV-infected populations
Approved Sub-Study Proposals
- Dan Smyth, et al. Real world outcomes with hepatitis C (HCV) direct-acting antivirals (DAAs) in Canada: overall summary analysis and key and neglected populations of interest.
- Dan Smyth, et al. Real world, prospective multicentre cohort study of HCV re-infection among patients enrolled in the Canadian Network Undertaking against Hepatitis C (CANUCH) prospective registry.
- Curtis Cooper, et al. HCV infected Canadian immigrant characteristics and treatment outcomes.
- Alnoor Ramji, et al.: Correlation of non-invasive fibrosis markers prior to HCV therapy and impact on SVR.
Presented to the European Association for the Study of the Liver (EASL) 2018:
- Ramji A, Tam E, Feld J, Cooper C, Wong A. Prevalence of baseline NS5A resistance associated substitutions in treatment naive patients with genotype 1a or 3. Journal of Hepatology. 68(1):S105–S364.
- Krassenburg L, Zanjir W.R, Georgie F, Munawar K, Cerocchi O, Stotland E, Lau J, Janssen H, Hansen B, Feld J. Comparison of event-free survival between DAA and IFN-based antiviral therapy for HCV, adjusted for disease severity. Journal of Hepatology. 68(1):S365–S604. S526.
- Mitchell R, Ou G, Leung A, Feizi J, Howe A, Cerocchi O, Kuriry H, Feld J, Ko H. H, Ramji A. Hepatitis C direct-acting antiviral failures: clinical characteristics and resistance testing from a realworld setting. Journal of Hepatology. 68(1):S105–S364. S291.
- Krassenburg L, Hansen B, Zanjir W.R, Georgie F, Cerocchi O, Lau J, Van der Meer A, Janssen H, Feld JJ The number needed to treat to prevent one clinical event at 2 years after antiviral treatment for HCV with DAAs compared to IFN-based therapy. Journal of Hepatology. 68(1):S365–S604. S527.
Accepted to the International Symposium on Hepatitis Care in Substance Users (INSHU) 2018:
- Materniak S, Smyth D, et al. HCV-infected youth characteristics and representation in the CanHepC Retrospective National Registry.
- Materniak S, Smyth D, et al. Differences in sustained virological response to direct-acting antiviral therapy for chronic Hepatitis C by sex: results from the CanHepC Retrospective National Registry.
Accepted to American Association for the Study of Liver Diseases 2018:
- Lau J, Krassenburg L, Zanjir W, Georgie G, Cerrochi O, Stotland E, Morales H, Janssen H, Hansen B, Feld JJ. Factors associated with a low risk of hepatocellular carcinoma (HCC) after sustained virological response (SVR).
For more information contact: Jessica (Lifang) Wang. Research Coordinator. [email protected] 514.934.1934 ext.44718