Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy.
Identifieur interne : 000269 ( PubMed/Checkpoint ); précédent : 000268; suivant : 000270Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy.
Auteurs : Oliver Lenz [Belgique] ; Joep De Bruijne ; Leen Vijgen ; Thierry Verbinnen ; Christine Weegink ; Herwig Van Marck ; Ina Vandenbroucke ; Monika Peeters ; Kenneth Simmen ; Greg Fanning ; Rene Verloes ; Gaston Picchio ; Hendrik ReesinkSource :
- Gastroenterology ; 2012.
English descriptors
- KwdEn :
- Antiviral Agents (therapeutic use), Drug Resistance, Viral, Drug Therapy, Combination, Genotype, Hepacivirus (genetics), Hepatitis C (blood), Hepatitis C (drug therapy), Hepatitis C (virology), Heterocyclic Compounds, 3-Ring (therapeutic use), Humans, Interferon-alpha (therapeutic use), Male, Mutation, Polyethylene Glycols (therapeutic use), Protease Inhibitors (therapeutic use), RNA, Viral (blood), RNA, Viral (drug effects), Recombinant Proteins (therapeutic use), Ribavirin (therapeutic use), Simeprevir, Sulfonamides (therapeutic use), Viral Load.
- MESH :
- chemical , blood : RNA, Viral.
- chemical , drug effects : RNA, Viral.
- chemical , therapeutic use : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Interferon-alpha, Polyethylene Glycols, Protease Inhibitors, Recombinant Proteins, Ribavirin, Sulfonamides.
- blood : Hepatitis C.
- drug therapy : Hepatitis C.
- genetics : Hepacivirus.
- virology : Hepatitis C.
- Drug Resistance, Viral, Drug Therapy, Combination, Genotype, Humans, Male, Mutation, Simeprevir, Viral Load.
Abstract
In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment.
DOI: 10.1053/j.gastro.2012.07.117
PubMed: 22885330
Affiliations:
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first="Thierry" last="Verbinnen">Thierry Verbinnen</name></author><author><name sortKey="Weegink, Christine" sort="Weegink, Christine" uniqKey="Weegink C" first="Christine" last="Weegink">Christine Weegink</name></author><author><name sortKey="Van Marck, Herwig" sort="Van Marck, Herwig" uniqKey="Van Marck H" first="Herwig" last="Van Marck">Herwig Van Marck</name></author><author><name sortKey="Vandenbroucke, Ina" sort="Vandenbroucke, Ina" uniqKey="Vandenbroucke I" first="Ina" last="Vandenbroucke">Ina Vandenbroucke</name></author><author><name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name></author><author><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name></author><author><name sortKey="Fanning, Greg" sort="Fanning, Greg" uniqKey="Fanning G" first="Greg" last="Fanning">Greg Fanning</name></author><author><name sortKey="Verloes, Rene" 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sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name><affiliation wicri:level="1"><nlm:affiliation>Janssen Infectious Diseases, Beerse, Belgium. olenz@its.jnj.com</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Janssen Infectious Diseases, Beerse</wicri:regionArea><wicri:noRegion>Beerse</wicri:noRegion></affiliation></author><author><name sortKey="De Bruijne, Joep" sort="De Bruijne, Joep" uniqKey="De Bruijne J" first="Joep" last="De Bruijne">Joep De Bruijne</name></author><author><name sortKey="Vijgen, Leen" sort="Vijgen, Leen" uniqKey="Vijgen L" first="Leen" last="Vijgen">Leen Vijgen</name></author><author><name sortKey="Verbinnen, Thierry" sort="Verbinnen, Thierry" uniqKey="Verbinnen T" first="Thierry" last="Verbinnen">Thierry Verbinnen</name></author><author><name sortKey="Weegink, Christine" sort="Weegink, Christine" uniqKey="Weegink C" first="Christine" last="Weegink">Christine Weegink</name></author><author><name sortKey="Van Marck, Herwig" sort="Van Marck, Herwig" uniqKey="Van Marck H" first="Herwig" last="Van Marck">Herwig Van Marck</name></author><author><name sortKey="Vandenbroucke, Ina" sort="Vandenbroucke, Ina" uniqKey="Vandenbroucke I" first="Ina" last="Vandenbroucke">Ina Vandenbroucke</name></author><author><name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name></author><author><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name></author><author><name sortKey="Fanning, Greg" sort="Fanning, Greg" uniqKey="Fanning G" first="Greg" last="Fanning">Greg Fanning</name></author><author><name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name></author><author><name sortKey="Picchio, Gaston" sort="Picchio, Gaston" uniqKey="Picchio G" first="Gaston" last="Picchio">Gaston Picchio</name></author><author><name sortKey="Reesink, Hendrik" sort="Reesink, Hendrik" uniqKey="Reesink H" first="Hendrik" last="Reesink">Hendrik Reesink</name></author></analytic><series><title level="j">Gastroenterology</title><idno type="e-ISSN">1528-0012</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (therapeutic use)</term><term>Drug Resistance, Viral</term><term>Drug Therapy, Combination</term><term>Genotype</term><term>Hepacivirus (genetics)</term><term>Hepatitis C (blood)</term><term>Hepatitis C (drug therapy)</term><term>Hepatitis C (virology)</term><term>Heterocyclic Compounds, 3-Ring (therapeutic use)</term><term>Humans</term><term>Interferon-alpha (therapeutic use)</term><term>Male</term><term>Mutation</term><term>Polyethylene Glycols (therapeutic use)</term><term>Protease Inhibitors (therapeutic use)</term><term>RNA, Viral (blood)</term><term>RNA, Viral (drug effects)</term><term>Recombinant Proteins (therapeutic use)</term><term>Ribavirin (therapeutic use)</term><term>Simeprevir</term><term>Sulfonamides (therapeutic use)</term><term>Viral Load</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="drug effects" xml:lang="en"><term>RNA, Viral</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Heterocyclic Compounds, 3-Ring</term><term>Interferon-alpha</term><term>Polyethylene Glycols</term><term>Protease Inhibitors</term><term>Recombinant Proteins</term><term>Ribavirin</term><term>Sulfonamides</term></keywords><keywords scheme="MESH" qualifier="blood" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Drug Resistance, Viral</term><term>Drug Therapy, Combination</term><term>Genotype</term><term>Humans</term><term>Male</term><term>Mutation</term><term>Simeprevir</term><term>Viral Load</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">22885330</PMID><DateCreated><Year>2012</Year><Month>10</Month><Day>24</Day></DateCreated><DateCompleted><Year>2013</Year><Month>01</Month><Day>14</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1528-0012</ISSN><JournalIssue CitedMedium="Internet"><Volume>143</Volume><Issue>5</Issue><PubDate><Year>2012</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Gastroenterology</Title><ISOAbbreviation>Gastroenterology</ISOAbbreviation></Journal><ArticleTitle>Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy.</ArticleTitle><Pagination><MedlinePgn>1176-8.e1-6</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1053/j.gastro.2012.07.117</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S0016-5085(12)01160-2</ELocationID><Abstract><AbstractText>In the TMC435-C101 study, 6 patients infected with hepatitis C virus genotype 1 were treated with the protease inhibitor TMC435 (200 mg once daily) as monotherapy for 5 days. Approximately 1.5 years later, 5 of these patients were re-treated with TMC435 (200 mg once daily) plus pegylated interferon alfa-2a and ribavirin (PegIFNα-2a and RBV) for 4 weeks, followed by PegIFNα-2a and RBV until week 48 (in the Optimal Protease inhibitor Enhancement of Response to therApy [OPERA-1] study). TMC435-resistant variants, which emerged in all 5 patients during the TMC435-C101 study, were no longer detected at the beginning of the OPERA-1 study based on virus population sequencing. During the OPERA-1 study, 3 patients had a sustained virologic response; deep sequencing indicated low-level persistence of resistant variants in the remaining 2 patients, which might have affected their response to re-treatment.</AbstractText><CopyrightInformation>Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Lenz</LastName><ForeName>Oliver</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Janssen Infectious Diseases, Beerse, Belgium. olenz@its.jnj.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Bruijne</LastName><ForeName>Joep</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Vijgen</LastName><ForeName>Leen</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Verbinnen</LastName><ForeName>Thierry</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Weegink</LastName><ForeName>Christine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Van Marck</LastName><ForeName>Herwig</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Vandenbroucke</LastName><ForeName>Ina</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Peeters</LastName><ForeName>Monika</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Simmen</LastName><ForeName>Kenneth</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Fanning</LastName><ForeName>Greg</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Verloes</LastName><ForeName>Rene</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Picchio</LastName><ForeName>Gaston</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Reesink</LastName><ForeName>Hendrik</ForeName><Initials>H</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00561353</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>08</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Gastroenterology</MedlineTA><NlmUniqueID>0374630</NlmUniqueID><ISSNLinking>0016-5085</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D006575">Heterocyclic Compounds, 3-Ring</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D016898">Interferon-alpha</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011480">Protease Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012367">RNA, 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UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D024882">Drug Resistance, Viral</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004359">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005838">Genotype</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016174">Hepacivirus</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000235">genetics</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006526">Hepatitis C</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000097">blood</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000821">virology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006575">Heterocyclic Compounds, 3-Ring</DescriptorName><QualifierName MajorTopicYN="Y" 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IdType="pubmed">22885330</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Belgique</li></country></list><tree><noCountry><name sortKey="De Bruijne, Joep" sort="De Bruijne, Joep" uniqKey="De Bruijne J" first="Joep" last="De Bruijne">Joep De Bruijne</name><name sortKey="Fanning, Greg" sort="Fanning, Greg" uniqKey="Fanning G" first="Greg" last="Fanning">Greg Fanning</name><name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name><name sortKey="Picchio, Gaston" sort="Picchio, Gaston" uniqKey="Picchio G" first="Gaston" last="Picchio">Gaston Picchio</name><name sortKey="Reesink, Hendrik" sort="Reesink, Hendrik" uniqKey="Reesink H" first="Hendrik" last="Reesink">Hendrik Reesink</name><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name><name sortKey="Van Marck, Herwig" sort="Van Marck, Herwig" uniqKey="Van Marck H" first="Herwig" last="Van Marck">Herwig Van Marck</name><name sortKey="Vandenbroucke, Ina" sort="Vandenbroucke, Ina" uniqKey="Vandenbroucke I" first="Ina" last="Vandenbroucke">Ina Vandenbroucke</name><name sortKey="Verbinnen, Thierry" sort="Verbinnen, Thierry" uniqKey="Verbinnen T" first="Thierry" last="Verbinnen">Thierry Verbinnen</name><name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name><name sortKey="Vijgen, Leen" sort="Vijgen, Leen" uniqKey="Vijgen L" first="Leen" last="Vijgen">Leen Vijgen</name><name sortKey="Weegink, Christine" sort="Weegink, Christine" uniqKey="Weegink C" first="Christine" last="Weegink">Christine Weegink</name></noCountry><country name="Belgique"><noRegion><name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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