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Hepatitis C polymorphism testing : a review of the clinical evidence

Author: Canadian Agency for Drugs and Technologies in Health,
Publisher: Ottawa (ON) : Canadian Agency for Drugs and Technologies in Health, 24 February 2014.
Series: Rapid response report (Canadian Agency for Drugs and Technologies in Health)
Edition/Format:   eBook : Document : National government publication : English
Summary:
The hepatitis C virus (HCV) has six major genotypes, with genotype 1, and its subtypes 1a and 1b, being primarily found in North America. In the past, treatment of genotype 1 HCV with a combination of peginterferon alfa and ribavirin was suboptimal, with sustained virological response (SVR) rates of approximately 40%. Recent major advances in the treatment of hepatitis C, with the introduction of direct-acting  Read more...
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Genre/Form: Review
Material Type: Document, Government publication, National government publication, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Canadian Agency for Drugs and Technologies in Health,
OCLC Number: 910948343
Notes: Title from PDF caption.
Description: 1 online resource (1 PDF file (6 pages)).
Series Title: Rapid response report (Canadian Agency for Drugs and Technologies in Health)
Responsibility: prepared by Canadian Agency for Drugs and Technologies in Health.

Abstract:

The hepatitis C virus (HCV) has six major genotypes, with genotype 1, and its subtypes 1a and 1b, being primarily found in North America. In the past, treatment of genotype 1 HCV with a combination of peginterferon alfa and ribavirin was suboptimal, with sustained virological response (SVR) rates of approximately 40%. Recent major advances in the treatment of hepatitis C, with the introduction of direct-acting antivirals (DAAs) being used in triple combination therapy, have changed the treatment landscape. Simeprevir (brand name: Galexos), a NS3/4A protease inhibitor like the already available DAAs telaprevir and boceprevir, was recently approved by Health Canada for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-nav̐e or who have failed previous interferon therapy (peglyated or non-pegylated) with ribavirin. Phase 3 studies in patients with genotype 1 chronic hepatitis C, simeprevir in combination with peginterferon alfa and ribavirin has shown significantly higher SVR at week 12 of treatment (SVR12) rates as compared to placebo in combination with peginterferon alfa and ribavirin. Genetic polymorphisms, more specifically the Q80K mutation, have been found to affect SVR12 rates of simeprevir. Found primarily in HCV subtype 1a with prevalence up to 48% in North America, the Q80K mutation is a naturally occurring amino acid substitution in the viral NS3 region. In a pooled analysis of phase 3 studies of treatment-nav̐e genotype 1a HCV patients treated with simeprevir in combination with peginterferon and ribavirin, those with Q80K polymorphism at baseline had lower rates of SVR12 compared to those who did not have the polymorphism (58.3% vs. 83.6%, respectively). Given the impact of this polymorphism on simeprevir efficacy, the product manufacturer for simeprevir recommends that, when accessible, testing for Q80K polymorphism in patients with HCV genotype 1a be considered. This report will review the diagnostic accuracy of laboratory tests for the Q80K polymorphism.

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