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sector_ico_Health_trans Human Health

Simeprevir screening assay for hepatitis C therapy

  • Project Leaders: Richard Harrigan, Huong Hew, Mel Krajden
  • Institutions: University of British Columbia (UBC)
  • Budget: $799600
  • Program/Competition: User Partnership Program
  • Genome Centre(s): Genome British Columbia
  • Fiscal Year: 2014
  • Status: Closed

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.

Simeprevir is a newly approved drug for treating HCV. It is 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 HCV infection before initiation of therapy. Until recently, this test was not available in Canada where an estimated 300,000 people are infected with HCV.

This project developed and validated two sequence-based HCV screening tests for Canada that identify the Q80K variant of HCV that will not respond to this treatment. Prevalence of this mutation in BC was 47% of HCV+ population. Approximately 2000 tests have been performed upon request of physicians across Canada and the tests have been widely disseminated. Janssen Inc., a pharmaceutical company of Johnson & Johnson, was able to generate revenue prior to the availability of new therapies because of the creation and implementation of this test.