Genome British Columbia: Personalized Treatments Will Improve Outcomes for Hepatitis C Patients & Save Healthcare Dollars

VANCOUVER, BRITISH COLUMBIA--(Marketwired - July 29, 2014) - A group of BC scientists has implemented a sophisticated screening process to ensure an effective, but expensive, Hepatitis C virus (HCV) treatment will be given to only those patients who can derive benefit from it.

A newly approved drug for treating HCV is simeprevir, an effective treatment which can potentially eliminate HCV infection. When used in combination with two other agents (interferon and ribavirin), however, almost a quarter of the patient population in the US was found to have HCV variants - Genotype 1a - that responded less well to this combination. These HCV variants have a polymorphism called "Q80K". Leading scientists believe similar figures may apply in Canada.

The US FDA has strongly recommended a Q80K screening test for patients with Genotype 1a infection before initiation of therapy. And up until recently, this test was not available in Canada where an estimated 300,000 people are infected with HCV.

With funding from Genome British Columbia, the BC Centre for Excellence in HIV/AIDS (BC-CfE), in partnership with simeprevir manufacturer Janssen Inc., has undertaken a significant project to develop an HCV screening test for Canada. Population-based DNA sequencing was used to develop and validate the simeprevir screening test, to determine baseline prevalence of the variant Q80K polymorphism.

Dr. Richard Harrigan, director of the Laboratory Program at the BC-CfE and associate professor in the UBC Faculty of Medicine, will continue to lead the next phase in the project which includes analysis of past HCV populations to determine mutation over time. By determining a baseline of HCV infected individuals residing in BC, as well as characterize the stability of the relevant polymorphis within an individual over time: this data will inform healthcare and budgetary decision-making.

"By applying a similar approach that has been very successful in managing HIV and AIDS, specifically tailoring treatments to match individuals, we have the best chance of eliminating the HCV virus," says Dr. Harrigan. "These newer therapies are completely changing the landscape of Hepatitis C treatment."

"The health of HCV-positive British Columbians will be dramatically improved as a result of this project," says Dr. Alan Winter, President and CEO of Genome BC. "Our primary concern, the patient, stands to be in a much better position through personalized treatments and fewer side effects from non-effective drugs. In addition, the genomic screening test will result in significant cost savings or cost avoidance to the public healthcare system - approximately $36,000 for each twelve-week course of treatment not given to patients who will not benefit from it."

This project, valued at close to $800,000 was funded through Genome BC's User Partnership Program (UPP). UPP is designed to form partnerships with users to find research solutions that address the needs of the key sectors of the BC economy and directly connect receptors in BC economic sectors to new products, services, and practices that arise from genomics-related research. The UPP represents an initial investment of $9M for new research projects, with $3M from Genome BC. The remaining funds are to be provided by user partners and other co-funders.

About the British Columbia Centre for Excellence in HIV/AIDS

The BC Centre for Excellence in HIV/AIDS (BC-CfE) is Canada's largest HIV/AIDS research, treatment and education facility and is internationally recognized as an innovative world leader in combating HIV/AIDS and related diseases. BC-CfE is based at St. Paul's Hospital, Providence Health Care, a teaching hospital of the University of British Columbia. The BC-CfE works in close collaboration with key provincial stakeholders, including health authorities, health care providers, academics from other institutions, and the community to decrease the health burden of HIV and AIDS. By developing, monitoring and disseminating comprehensive research and treatment programs for HIV and related illnesses, the BC-CfE helps improve the health of British Columbians living with HIV.

About Genome British Columbia

Genome British Columbia is a catalyst for the life sciences cluster on Canada's West Coast, and manages a cumulative portfolio of over $660M in 211 research projects and science and technology platforms. Working with governments, academia and industry across sectors such as forestry, fisheries, agriculture, environment, bioenergy, mining and human health, the goal of the organization is to generate social and economic benefits for British Columbia and Canada. Genome BC is supported by the Province of British Columbia, the Government of Canada through Genome Canada and Western Economic Diversification Canada and more than 300 international public and private co-funding partners. www.genomebc.ca
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BACKGROUNDER

Chronic hepatitis C, caused by HCV, is a blood-borne infectious disease that attacks the liver. In some patients, left untreated, it can cause significant damage, including liver failure, cirrhosis and cancer.

Approximately a quarter of a million Canadians are infected with hepatitis C virus (HCV), with 1 in 5 individuals being unaware of their HCV status. A further 5,000 new infections are estimated to occur annually.

HCV causes chronic infection in 50%-85% of patients and progresses to cirrhosis in 2%-20% of cases after 20-30 years. A small proportion of these patients experience liver failure, or liver cancer. Although many infected individuals are asymptomatic, they remain infectious and may transmit HCV to new hosts.

The majority of HCV diagnoses in Canada occur in Ontario (42%), British Columbia (21%) and Quebec (14%).

The financial burden of HCV infection in Canada was projected to be $1billion in 2010.

HCV is classified into 6 (or more) distinct genotypes (1-6) with multiple subtypes. HCV genotype 1 predominates in Canada accounting for approximately 60% of cases.

Simeprevir (Janssen Inc.) is a newly approved HCV NS3 inhibitor used for the treatment for HCV genotype 1 in combination with interferon and ribavirin. It is the first once-daily treatment to become available and has an improved efficacy, tolerability and safety profile compared to other NS3 agents.

Patients whose HCV harbours the Q80K mutation have a reduced susceptibility in vitro and response in vivo to simeprevir. The overall prevalence of a baseline Q80K mutation varies widely, reported to be about 16% in Europe and 48% in the US. Thus there is a need to screen for Q80K prior to initiating simeprevir therapy.

Patients interested to learn more about HCV, available treatments, and whether Q80K testing is appropriate for them or not should discuss with their healthcare provider.