Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.

<h4>Background</h4>With the development of new specific inhibitors of hepatitis C virus (HCV) enzymes and functions that may yield different antiviral responses and resistance profiles according to the HCV subtype, correct HCV genotype 1 subtype identification is mandatory in clinical tr...

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Autores principales:	Stéphane Chevaliez, Magali Bouvier-Alias, Rozenn Brillet, Jean-Michel Pawlotsky
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2009
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/04f331e9dd264ae4bf0f3f292766a350
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spelling	oai:doaj.org-article:04f331e9dd264ae4bf0f3f292766a3502021-11-25T06:27:32ZHepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.1932-620310.1371/journal.pone.0008209https://doaj.org/article/04f331e9dd264ae4bf0f3f292766a3502009-12-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/19997618/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>With the development of new specific inhibitors of hepatitis C virus (HCV) enzymes and functions that may yield different antiviral responses and resistance profiles according to the HCV subtype, correct HCV genotype 1 subtype identification is mandatory in clinical trials for stratification and interpretation purposes and will likely become necessary in future clinical practice. The goal of this study was to identify the appropriate molecular tool(s) for accurate HCV genotype 1 subtype determination.<h4>Methodology/principal findings</h4>A large cohort of 500 treatment-naïve patients eligible for HCV drug trials and infected with either subtype 1a or 1b was studied. Methods based on the sole analysis of the 5' non-coding region (5'NCR) by sequence analysis or reverse hybridization failed to correctly identify HCV subtype 1a in 22.8%-29.5% of cases, and HCV subtype 1b in 9.5%-8.7% of cases. Natural polymorphisms at positions 107, 204 and/or 243 were responsible for mis-subtyping with these methods. A real-time PCR method using genotype- and subtype-specific primers and probes located in both the 5'NCR and the NS5B-coding region failed to correctly identify HCV genotype 1 subtype in approximately 10% of cases. The second-generation line probe assay, a reverse hybridization assay that uses probes targeting both the 5'NCR and core-coding region, correctly identified HCV subtypes 1a and 1b in more than 99% of cases.<h4>Conclusions/significance</h4>In the context of new HCV drug development, HCV genotyping methods based on the exclusive analysis of the 5'NCR should be avoided. The second-generation line probe assay is currently the best commercial assay for determination of HCV genotype 1 subtypes 1a and 1b in clinical trials and practice.Stéphane ChevaliezMagali Bouvier-AliasRozenn BrilletJean-Michel PawlotskyPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 4, Iss 12, p e8209 (2009)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Stéphane Chevaliez Magali Bouvier-Alias Rozenn Brillet Jean-Michel Pawlotsky Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
description	<h4>Background</h4>With the development of new specific inhibitors of hepatitis C virus (HCV) enzymes and functions that may yield different antiviral responses and resistance profiles according to the HCV subtype, correct HCV genotype 1 subtype identification is mandatory in clinical trials for stratification and interpretation purposes and will likely become necessary in future clinical practice. The goal of this study was to identify the appropriate molecular tool(s) for accurate HCV genotype 1 subtype determination.<h4>Methodology/principal findings</h4>A large cohort of 500 treatment-naïve patients eligible for HCV drug trials and infected with either subtype 1a or 1b was studied. Methods based on the sole analysis of the 5' non-coding region (5'NCR) by sequence analysis or reverse hybridization failed to correctly identify HCV subtype 1a in 22.8%-29.5% of cases, and HCV subtype 1b in 9.5%-8.7% of cases. Natural polymorphisms at positions 107, 204 and/or 243 were responsible for mis-subtyping with these methods. A real-time PCR method using genotype- and subtype-specific primers and probes located in both the 5'NCR and the NS5B-coding region failed to correctly identify HCV genotype 1 subtype in approximately 10% of cases. The second-generation line probe assay, a reverse hybridization assay that uses probes targeting both the 5'NCR and core-coding region, correctly identified HCV subtypes 1a and 1b in more than 99% of cases.<h4>Conclusions/significance</h4>In the context of new HCV drug development, HCV genotyping methods based on the exclusive analysis of the 5'NCR should be avoided. The second-generation line probe assay is currently the best commercial assay for determination of HCV genotype 1 subtypes 1a and 1b in clinical trials and practice.
format	article
author	Stéphane Chevaliez Magali Bouvier-Alias Rozenn Brillet Jean-Michel Pawlotsky
author_facet	Stéphane Chevaliez Magali Bouvier-Alias Rozenn Brillet Jean-Michel Pawlotsky
author_sort	Stéphane Chevaliez
title	Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
title_short	Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
title_full	Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
title_fullStr	Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
title_full_unstemmed	Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.
title_sort	hepatitis c virus (hcv) genotype 1 subtype identification in new hcv drug development and future clinical practice.
publisher	Public Library of Science (PLoS)
publishDate	2009
url	https://doaj.org/article/04f331e9dd264ae4bf0f3f292766a350
work_keys_str_mv	AT stephanechevaliez hepatitiscvirushcvgenotype1subtypeidentificationinnewhcvdrugdevelopmentandfutureclinicalpractice AT magalibouvieralias hepatitiscvirushcvgenotype1subtypeidentificationinnewhcvdrugdevelopmentandfutureclinicalpractice AT rozennbrillet hepatitiscvirushcvgenotype1subtypeidentificationinnewhcvdrugdevelopmentandfutureclinicalpractice AT jeanmichelpawlotsky hepatitiscvirushcvgenotype1subtypeidentificationinnewhcvdrugdevelopmentandfutureclinicalpractice
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Hepatitis C virus (HCV) genotype 1 subtype identification in new HCV drug development and future clinical practice.

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