Novel Diagnostic Marker for Prediction of Clearance of Hepatitis C Virus Infection
Posted Feb 20 2013 7:00pm
Description of Invention: One of the unfortunate aspects of hepatitis C virus (HCV) infection is that the majority of infected individuals will develop a chronic HCV infection. The current treatment for HCV infection involves direct acting antiviral drugs, such as HCV protease inhibitors, with or without pegylated IFN-alpha/ribavirin. Not all patients respond to treatments and the treatments themselves can cause severe adverse effects. The subject invention (IFNL4-deltaG) is a novel genetic polymorphism in the newly discovered Interferon Lambda 4 (IFNL4) gene, which is located near the IFNL3 (former IL28B) gene. The IFNL4-deltaG polymorphism can predict the likelihood of whether or not a patient will respond to treatment of HCV and, possibly, of other diseases treated with IFN-alpha (or other interferons). In particular, IFNL4-deltaG was found to be a better predictor of clinical outcome for IFN-alpha based treatment in people of African descent than the currently available diagnostic test (‘IL28B’ genotype, defined by rs12979860 located within first intron of IFNL4). The predictive value of the IFNL4-deltaG polymorphism for response to IFN-alpha based treatment in HCV-infected Caucasians and Asians is comparable to current diagnostics. In addition, IFNL4-deltaG can predict the likelihood of a whether a person who is acutely infected with HCV infection will spontaneously clear the infection or develop chronic infection. As with treatment outcome, among individuals of African ancestry, genotype for IFNL4-deltaG is a better predictive marker for spontaneous clearance of HCV than ‘IL28B’ genotype, while providing similar predictive value in individuals of European or Asian descent.
Applications:
Diagnostic for prediction of patient response to HCV treatment
Diagnostic for prediction of patient response to treatment with IFN-alpha (or other interferons)
Diagnostic tool for prediction of spontaneous clearance of HCV infection
Advantages:
Better than current ‘IL28B’ based diagnostics for predicting response to IFN-alpha based HCV treatments for people of African descent.
Comparable predictive capabilities to current ‘IL28B’ based diagnostics for response to IFN-alpha based HCV treatments in Caucasians and Asians.
Collaborative Research Opportunity: The NCI Division of Cancer Epidemiology & Genetics, Laboratory of Translational Genomics, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize development of a gene-based test to be used in the clinic. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov .
For Licensing Information Please Contact: Kevin Chang Ph.D. NIH Office of Technology Transfer 6011 Executive Blvd. Suite 325, Rockville, MD 20852 United States Email: changke@mail.nih.gov Phone: 301-435-5018 Fax: 301-402-0220
Description of Invention:
One of the unfortunate aspects of hepatitis C virus (HCV) infection is that the majority of infected individuals will develop a chronic HCV infection. The current treatment for HCV infection involves direct acting antiviral drugs, such as HCV protease inhibitors, with or without pegylated IFN-alpha/ribavirin. Not all patients respond to treatments and the treatments themselves can cause severe adverse effects. The subject invention (IFNL4-deltaG) is a novel genetic polymorphism in the newly discovered Interferon Lambda 4 (IFNL4) gene, which is located near the IFNL3 (former IL28B) gene. The IFNL4-deltaG polymorphism can predict the likelihood of whether or not a patient will respond to treatment of HCV and, possibly, of other diseases treated with IFN-alpha (or other interferons). In particular, IFNL4-deltaG was found to be a better predictor of clinical outcome for IFN-alpha based treatment in people of African descent than the currently available diagnostic test (‘IL28B’ genotype, defined by rs12979860 located within first intron of IFNL4). The predictive value of the IFNL4-deltaG polymorphism for response to IFN-alpha based treatment in HCV-infected Caucasians and Asians is comparable to current diagnostics. In addition, IFNL4-deltaG can predict the likelihood of a whether a person who is acutely infected with HCV infection will spontaneously clear the infection or develop chronic infection. As with treatment outcome, among individuals of African ancestry, genotype for IFNL4-deltaG is a better predictive marker for spontaneous clearance of HCV than ‘IL28B’ genotype, while providing similar predictive value in individuals of European or Asian descent.
Applications:
Advantages:
Development Status:
Inventors:
Liudmila Prokunina (NCI)
Thomas R O'Brien (NCI)
Brian P Muchmore (NCI)
Raymond P Donnelly (FDA)
Patent Status:
HHS, Reference No. E-217-2011/0
PCT, Application No. PCT/US2012/59048 filed 05 Oct 2012
Related Technologies:
US, Application No. 61/616,664 filed 28 Mar 2012, Reference No. E-217-2011/1
Relevant Publication:
Collaborative Research Opportunity:
The NCI Division of Cancer Epidemiology & Genetics, Laboratory of Translational Genomics, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize development of a gene-based test to be used in the clinic. For collaboration opportunities, please contact John Hewes, Ph.D. at hewesj@mail.nih.gov .
For Licensing Information Please Contact:
Kevin Chang Ph.D.
NIH Office of Technology Transfer
6011 Executive Blvd. Suite 325,
Rockville, MD 20852
United States
Email: changke@mail.nih.gov
Phone: 301-435-5018
Fax: 301-402-0220
Ref No: 2538
Updated: 02/2013