Nearly 1 in 150 Canadians are infected with Hepatitis C (HCV). British Columbia has an even higher average, affecting nearly 1 in every 50 residents. While antiviral drugs can lead to effective cures in more than 90% of patients, their efficacy is challenged by drug resistant strains of the virus leading to viral relapse after therapy.
Considering the extremely high cost of HCV drug treatments, (ranging between $30-50,000 per patient for a 12-week therapy), pre-screening for primary drug resistance is increasingly being recommended before initiating treatment. The US Food and Drug Administration currently recommends baseline HCV resistance screening before antiviral therapy and Health Canada is expected to follow the same guidelines.
To implement resistance screening for HCV in Canada, Drs. Richard Harrigan and Chanson Brumme at the BC Centre for Excellence in HIV/AIDS (BC-CfE) will develop and validate a genomics based HCV drug resistance test accredited by the College of American Pathologists and the BC Diagnostic Accreditation Program.
The team will use a pre-existing cohort to perform ‘deep’ sequence analysis of HCV variants to characterize the prevalence of drug resistance and the evolution of the virus within the body. This will provide a substantial leap forward in understanding the HCV genetic distribution, drug resistance and response, as well as rates of reinfection in people with high risk behaviors (‘core transmitters’) in BC. This information will be used to establish an international reference database of HCV genetic sequences and clinical outcomes, which can be used as a tool for the interpretation of antiviral resistance and clinical management for HCV infections.
“HCV drug development has been extremely rapid; however, the documentation of drug resistant strains has lagged behind.” said Dr. Richard Harrigan, Director of Research Laboratories at the BC-CfE. “Improved clarity surrounding drug resistance interpretation across drug classes and HCV genotypes is urgently required.”
Once implemented the province-wide accessible screen is expected to save up to $4 million annually by optimizing treatment strategies. Patients who show resistance will not be unnecessarily exposed to drugs, which may cause adverse reactions in some and limit future treatment options. In the longer term, the project will establish a leadership position for BC in the treatment of HCV infection and in the development of precision health strategies.
“Dr. Harrigan and his group have a proven track record and are uniquely positioned to provide a genomic approach to issues of HCV drug resistance,” said Dr. Catalina Lopez-Correa, Chief Scientific Officer and VP, Sectors at Genome BC. “The BC-CfE already provides highly successful drug resistance testing for HIV and recently completed the successful execution of a Genome BC-funded screening test for the HCV drug Simeprevir.”
This Investigator-Initiated Study is funded through Genome BC’s User Partnership Program and supported in part by Merck Canada Inc.
