The Usefulness of Defining Rapid Virological Response by a Very Sensitive Assay (TMA) during Treatment of HCV Genotype 2/3 Infection
The aim of this study was to determine in patients with HCV genotype 2 or 3 the performance at week 4 of two assays with different sensitivities for HCV RNA detection, for the prediction of SVR and stratification for treatment duration (14 and 24 weeks). Recruitment was from two trials comparing 14...
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| Veröffentlicht in: | PloS one 2015-08, Vol.10 (8), p.e0120866-e0120866 |
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| creator | Dalgard, Olav Martinot-Peignoux, Michelle Verbaan, Hans Bjøro, Kristian Ring-Larsen, Helmer Marcellin, Patrick |
| description | The aim of this study was to determine in patients with HCV genotype 2 or 3 the performance at week 4 of two assays with different sensitivities for HCV RNA detection, for the prediction of SVR and stratification for treatment duration (14 and 24 weeks). Recruitment was from two trials comparing 14 and 24 weeks treatment to patients with rapid virological response (RVR) (n = 550). RVR was originally defined as HCV RNA |
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Recruitment was from two trials comparing 14 and 24 weeks treatment to patients with rapid virological response (RVR) (n = 550). RVR was originally defined as HCV RNA <50 IU/ml at week 4. Patients with an available frozen plasma sample drawn at week 4 and with follow-up data week 24 post-treatment were included (n = 429). HCV-RNA was prospectively measured with COBAS Amplicor V2, Roche (CA) (lower detection limit 50 IU/ml) and retrospectively assessed with VERSANT HCV-RNA Qualitative Assay, Siemens (TMA) (lower limit detection 10 IU/ml). Genotype 3 was present in 80% and genotype 2 in 20%. A SVR was achieved in 82%. At week 4 HCV-RNA was undetectable in 74.8% and 63% of serum samples tested with CA and TMA, respectively. CA undetectable/TMA positive was observed in 61/341 (18%) of the samples. In genotype 3 patients a relapse was seen in 9% of the patients with both CA and TMA undetectable and in 25% of the patients who were CA undetectable/TMA positive (p = 0.006). In patients allocated to 14 weeks treatment a relapse was observed in 11% of TMA undetectable patients and 26% of TMA positive (p = 0.031). In genotype 2 patients treated for 14 weeks relapse was observed in 6% of the patients with both CA and TMA undetectable week 4. Assays with high sensitivity for HCV RNA identifies patients at week 4 with high risk of virological relapse. We recommend that patients with genotype 3 and detectable HCV RNA at levels below 50 IU/ml do not receive truncated therapy with pegIFN and ribavirin.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0120866</identifier><identifier>PMID: 26317978</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Antiviral Agents - administration & dosage ; Antiviral Agents - pharmacology ; Antiviral drugs ; Assaying ; Clinical Medicine ; Clinical trials ; Clinical Trials as Topic ; Drug Therapy, Combination ; Female ; Gastroenterologi ; Gastroenterology and Hepatology ; Genotype & phenotype ; Genotypes ; Hepacivirus - drug effects ; Hepacivirus - genetics ; Hepatitis ; Hepatitis C, Chronic - drug therapy ; Hepatitis C, Chronic - virology ; Hepatology ; Humans ; Infections ; Interferon ; Interferon-alpha - administration & dosage ; Interferon-alpha - pharmacology ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medicin och hälsovetenskap ; Middle Aged ; Patients ; Prospective Studies ; Recurrence ; Ribavirin ; Ribavirin - administration & dosage ; Ribavirin - pharmacology ; Ribonucleic acid ; RNA ; RNA, Viral - drug effects ; Sensitivity ; Sensitivity and Specificity ; Tempering ; Treatment Outcome ; Young Adult</subject><ispartof>PloS one, 2015-08, Vol.10 (8), p.e0120866-e0120866</ispartof><rights>2015 Dalgard et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Dalgard et al 2015 Dalgard et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c595t-8417eefb2ee610b65ec7e0cb279951c5cd235240d245540c25a4b47b31ae6eae3</citedby><cites>FETCH-LOGICAL-c595t-8417eefb2ee610b65ec7e0cb279951c5cd235240d245540c25a4b47b31ae6eae3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4552635/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4552635/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,723,776,780,860,881,2095,2914,23846,27903,27904,53769,53771,79346,79347</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26317978$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/8043811$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><contributor>Yu, Ming-Lung</contributor><creatorcontrib>Dalgard, Olav</creatorcontrib><creatorcontrib>Martinot-Peignoux, Michelle</creatorcontrib><creatorcontrib>Verbaan, Hans</creatorcontrib><creatorcontrib>Bjøro, Kristian</creatorcontrib><creatorcontrib>Ring-Larsen, Helmer</creatorcontrib><creatorcontrib>Marcellin, Patrick</creatorcontrib><title>The Usefulness of Defining Rapid Virological Response by a Very Sensitive Assay (TMA) during Treatment of HCV Genotype 2/3 Infection</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>The aim of this study was to determine in patients with HCV genotype 2 or 3 the performance at week 4 of two assays with different sensitivities for HCV RNA detection, for the prediction of SVR and stratification for treatment duration (14 and 24 weeks). Recruitment was from two trials comparing 14 and 24 weeks treatment to patients with rapid virological response (RVR) (n = 550). RVR was originally defined as HCV RNA <50 IU/ml at week 4. Patients with an available frozen plasma sample drawn at week 4 and with follow-up data week 24 post-treatment were included (n = 429). HCV-RNA was prospectively measured with COBAS Amplicor V2, Roche (CA) (lower detection limit 50 IU/ml) and retrospectively assessed with VERSANT HCV-RNA Qualitative Assay, Siemens (TMA) (lower limit detection 10 IU/ml). Genotype 3 was present in 80% and genotype 2 in 20%. A SVR was achieved in 82%. At week 4 HCV-RNA was undetectable in 74.8% and 63% of serum samples tested with CA and TMA, respectively. CA undetectable/TMA positive was observed in 61/341 (18%) of the samples. In genotype 3 patients a relapse was seen in 9% of the patients with both CA and TMA undetectable and in 25% of the patients who were CA undetectable/TMA positive (p = 0.006). In patients allocated to 14 weeks treatment a relapse was observed in 11% of TMA undetectable patients and 26% of TMA positive (p = 0.031). In genotype 2 patients treated for 14 weeks relapse was observed in 6% of the patients with both CA and TMA undetectable week 4. Assays with high sensitivity for HCV RNA identifies patients at week 4 with high risk of virological relapse. We recommend that patients with genotype 3 and detectable HCV RNA at levels below 50 IU/ml do not receive truncated therapy with pegIFN and ribavirin.</description><subject>Adult</subject><subject>Antiviral Agents - administration & dosage</subject><subject>Antiviral Agents - pharmacology</subject><subject>Antiviral drugs</subject><subject>Assaying</subject><subject>Clinical Medicine</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Gastroenterologi</subject><subject>Gastroenterology and Hepatology</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Hepacivirus - drug effects</subject><subject>Hepacivirus - genetics</subject><subject>Hepatitis</subject><subject>Hepatitis C, Chronic - drug therapy</subject><subject>Hepatitis C, Chronic - virology</subject><subject>Hepatology</subject><subject>Humans</subject><subject>Infections</subject><subject>Interferon</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - pharmacology</subject><subject>Klinisk medicin</subject><subject>Male</subject><subject>Medical and Health Sciences</subject><subject>Medicin och hälsovetenskap</subject><subject>Middle Aged</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Recurrence</subject><subject>Ribavirin</subject><subject>Ribavirin - administration & dosage</subject><subject>Ribavirin - pharmacology</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - drug effects</subject><subject>Sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>Tempering</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>D8T</sourceid><sourceid>DOA</sourceid><recordid>eNptkk1vEzEQhlcIREvhHyCwxKUckvpzvXtBigK0kYKQSpqr5fXOpo429mLvFuXOD8dL0qpFHCxb9jvPzLyeLHtL8JQwSS62fghOt9POO5hiQnGR58-yU1IyOskpZs8fnU-yVzFuMRYsiV5mJzRnRJayOM1-r24B3URohtZBjMg36DM01lm3Qde6szVa2-Bbv7FGt-gaYkoXAVV7pNEawh79ABdtb-8AzWLUe3S--jb7iOohjIRVAN3vwPUj92q-RpfgfL_vANELhhauAdNb715nLxrdRnhz3M-ym69fVvOryfL75WI-W06MKEU_KTiRAE1FAXKCq1yAkYBNRWVZCmKEqSkTlOOaciE4NlRoXnFZMaIhBw3sLHt_4Hatj-poYFREkpLmRZmLpFgcFLXXW9UFu9Nhr7y26u-FDxulQ29NC4ozUqccRosGOKmlpjQv67LEgpYCWJFYywMr_oJuqJ7Q2qFLq0pLRVAARmAJUumm5oqTRqr0c0SBKLAGWgMpeMJ9OhY_VDuoTXI16PYJ9emLs7dq4-9UMiP999jb-REQ_M8BYq92NhpoW-3AD6MNuChKwQuWpB_-kf7fLH5QmeBjDNA8FEOwGmf0PkqNM6qOM5rC3j1u5CHofijZHyZm5IU</recordid><startdate>20150828</startdate><enddate>20150828</enddate><creator>Dalgard, Olav</creator><creator>Martinot-Peignoux, Michelle</creator><creator>Verbaan, Hans</creator><creator>Bjøro, Kristian</creator><creator>Ring-Larsen, Helmer</creator><creator>Marcellin, Patrick</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AGCHP</scope><scope>AOWAS</scope><scope>D8T</scope><scope>D95</scope><scope>ZZAVC</scope><scope>DOA</scope></search><sort><creationdate>20150828</creationdate><title>The Usefulness of Defining Rapid Virological Response by a Very Sensitive Assay (TMA) during Treatment of HCV Genotype 2/3 Infection</title><author>Dalgard, Olav ; Martinot-Peignoux, Michelle ; Verbaan, Hans ; Bjøro, Kristian ; Ring-Larsen, Helmer ; Marcellin, Patrick</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c595t-8417eefb2ee610b65ec7e0cb279951c5cd235240d245540c25a4b47b31ae6eae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antiviral Agents - 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Recruitment was from two trials comparing 14 and 24 weeks treatment to patients with rapid virological response (RVR) (n = 550). RVR was originally defined as HCV RNA <50 IU/ml at week 4. Patients with an available frozen plasma sample drawn at week 4 and with follow-up data week 24 post-treatment were included (n = 429). HCV-RNA was prospectively measured with COBAS Amplicor V2, Roche (CA) (lower detection limit 50 IU/ml) and retrospectively assessed with VERSANT HCV-RNA Qualitative Assay, Siemens (TMA) (lower limit detection 10 IU/ml). Genotype 3 was present in 80% and genotype 2 in 20%. A SVR was achieved in 82%. At week 4 HCV-RNA was undetectable in 74.8% and 63% of serum samples tested with CA and TMA, respectively. CA undetectable/TMA positive was observed in 61/341 (18%) of the samples. In genotype 3 patients a relapse was seen in 9% of the patients with both CA and TMA undetectable and in 25% of the patients who were CA undetectable/TMA positive (p = 0.006). In patients allocated to 14 weeks treatment a relapse was observed in 11% of TMA undetectable patients and 26% of TMA positive (p = 0.031). In genotype 2 patients treated for 14 weeks relapse was observed in 6% of the patients with both CA and TMA undetectable week 4. Assays with high sensitivity for HCV RNA identifies patients at week 4 with high risk of virological relapse. We recommend that patients with genotype 3 and detectable HCV RNA at levels below 50 IU/ml do not receive truncated therapy with pegIFN and ribavirin.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>26317978</pmid><doi>10.1371/journal.pone.0120866</doi><oa>free_for_read</oa></addata></record> |
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| issn | 1932-6203 1932-6203 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; SWEPUB Freely available online; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adult Antiviral Agents - administration & dosage Antiviral Agents - pharmacology Antiviral drugs Assaying Clinical Medicine Clinical trials Clinical Trials as Topic Drug Therapy, Combination Female Gastroenterologi Gastroenterology and Hepatology Genotype & phenotype Genotypes Hepacivirus - drug effects Hepacivirus - genetics Hepatitis Hepatitis C, Chronic - drug therapy Hepatitis C, Chronic - virology Hepatology Humans Infections Interferon Interferon-alpha - administration & dosage Interferon-alpha - pharmacology Klinisk medicin Male Medical and Health Sciences Medicin och hälsovetenskap Middle Aged Patients Prospective Studies Recurrence Ribavirin Ribavirin - administration & dosage Ribavirin - pharmacology Ribonucleic acid RNA RNA, Viral - drug effects Sensitivity Sensitivity and Specificity Tempering Treatment Outcome Young Adult |
| title | The Usefulness of Defining Rapid Virological Response by a Very Sensitive Assay (TMA) during Treatment of HCV Genotype 2/3 Infection |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-26T10%3A25%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=The%20Usefulness%20of%20Defining%20Rapid%20Virological%20Response%20by%20a%20Very%20Sensitive%20Assay%20(TMA)%20during%20Treatment%20of%20HCV%20Genotype%202/3%20Infection&rft.jtitle=PloS%20one&rft.au=Dalgard,%20Olav&rft.date=2015-08-28&rft.volume=10&rft.issue=8&rft.spage=e0120866&rft.epage=e0120866&rft.pages=e0120866-e0120866&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0120866&rft_dat=%3Cproquest_plos_%3E3827974361%3C/proquest_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1719268965&rft_id=info:pmid/26317978&rft_doaj_id=oai_doaj_org_article_431d0c2ca5fe41d7a2269d9905295e38&rfr_iscdi=true |