Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.
Identifieur interne : 000298 ( PubMed/Corpus ); précédent : 000297; suivant : 000299Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.
Auteurs : Michael Manns ; Henk Reesink ; Thomas Berg ; Geoffrey Dusheiko ; Robert Flisiak ; Patrick Marcellin ; Christophe Moreno ; Oliver Lenz ; Paul Meyvisch ; Monika Peeters ; Vanitha Sekar ; Kenneth Simmen ; Rene VerloesSource :
- Antiviral therapy ; 2011.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Bilirubin (analysis), Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Hepacivirus (drug effects), Hepatitis C (drug therapy), Hepatitis C (virology), Heterocyclic Compounds, 3-Ring (administration & dosage), Heterocyclic Compounds, 3-Ring (adverse effects), Heterocyclic Compounds, 3-Ring (therapeutic use), Humans, Interferon-alpha (administration & dosage), Interferon-alpha (therapeutic use), Male, Middle Aged, Polyethylene Glycols (administration & dosage), Polyethylene Glycols (therapeutic use), Protease Inhibitors (administration & dosage), Protease Inhibitors (adverse effects), Protease Inhibitors (therapeutic use), RNA, Viral (blood), Recombinant Proteins (administration & dosage), Recombinant Proteins (therapeutic use), Ribavirin (administration & dosage), Ribavirin (pharmacology), Ribavirin (therapeutic use), Simeprevir, Sulfonamides (administration & dosage), Sulfonamides (adverse effects), Sulfonamides (therapeutic use), Viral Load.
- MESH :
- chemical , administration & dosage : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Interferon-alpha, Polyethylene Glycols, Protease Inhibitors, Recombinant Proteins, Ribavirin, Sulfonamides.
- chemical , adverse effects : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Protease Inhibitors, Sulfonamides.
- chemical , analysis : Bilirubin.
- chemical , blood : RNA, Viral.
- chemical , pharmacology : Ribavirin.
- chemical , therapeutic use : Antiviral Agents, Heterocyclic Compounds, 3-Ring, Interferon-alpha, Polyethylene Glycols, Protease Inhibitors, Recombinant Proteins, Ribavirin, Sulfonamides.
- drug effects : Hepacivirus.
- drug therapy : Hepatitis C.
- virology : Hepatitis C.
- Adolescent, Adult, Aged, Double-Blind Method, Drug Therapy, Combination, Female, Genotype, Humans, Male, Middle Aged, Simeprevir, Viral Load.
Abstract
Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.
DOI: 10.3851/IMP1894
PubMed: 22024518
Links to Exploration step
pubmed:22024518Le document en format XML
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sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name></author><author><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name></author><author><name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name></author><author><name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name></author><author><name sortKey="Meyvisch, Paul" sort="Meyvisch, Paul" uniqKey="Meyvisch P" first="Paul" last="Meyvisch">Paul Meyvisch</name></author><author><name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name></author><author><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name></author><author><name sortKey="Simmen, 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effects" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Hepatitis C</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Genotype</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Simeprevir</term><term>Viral Load</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">22024518</PMID><DateCreated><Year>2011</Year><Month>10</Month><Day>25</Day></DateCreated><DateCompleted><Year>2012</Year><Month>04</Month><Day>20</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2040-2058</ISSN><JournalIssue CitedMedium="Internet"><Volume>16</Volume><Issue>7</Issue><PubDate><Year>2011</Year></PubDate></JournalIssue><Title>Antiviral therapy</Title><ISOAbbreviation>Antivir. Ther. (Lond.)</ISOAbbreviation></Journal><ArticleTitle>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial.</ArticleTitle><Pagination><MedlinePgn>1021-33</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3851/IMP1894</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Antiviral activity of TMC435, an oral, once-daily, HCV NS3/4A protease inhibitor, was evaluated with pegylated interferon-α2a/ribavirin (P/R) in HCV genotype-1 patients.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA-1; TMC435-C201; NCT00561353) is a Phase IIa, randomized, placebo-controlled study. Treatment-naive patients (n=74) received 25, 75 or 200 mg TMC435 once daily, or placebo for 7 days followed by 21 days of triple therapy with P/R, or triple therapy for 28 days. Treatment-experienced patients (n=37; 56.8% with cirrhosis) received 75, 150 or 200 mg TMC435 once daily, or placebo with P/R for 28 days. Patients continued P/R up to week 48.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Treatment-naive patients who received initial monotherapy had a rapid decline in HCV RNA by day 3. At day 7, HCV RNA reductions were greatest for the 75 and 200 mg doses (0.02, -2.63, -3.43 and -4.13 log(10) IU/ml for placebo, and TMC435 25, 75 and 200 mg, respectively). At day 28, all patients who received triple therapy with TMC435 75 or 200 mg had HCV RNA<25 IU/ml versus 4/9 for placebo. In total, 18/28 treatment-experienced patients (9/9 prior relapsers, 9/19 non-responders) who received TMC435 had HCV RNA<25 IU/ml at day 28 versus 0/9 for placebo; similar results were observed for the 150 and 200 mg doses. Most adverse events were grade 1/2. No relevant changes in laboratory parameters occurred, except mild and reversible bilirubin elevations, mostly at the 200 mg dose.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Manns</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. manns.michael@mh-hannover.de</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reesink</LastName><ForeName>Henk</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Berg</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Dusheiko</LastName><ForeName>Geoffrey</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Flisiak</LastName><ForeName>Robert</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Marcellin</LastName><ForeName>Patrick</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Moreno</LastName><ForeName>Christophe</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Lenz</LastName><ForeName>Oliver</ForeName><Initials>O</Initials></Author><Author ValidYN="Y"><LastName>Meyvisch</LastName><ForeName>Paul</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Peeters</LastName><ForeName>Monika</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Sekar</LastName><ForeName>Vanitha</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Simmen</LastName><ForeName>Kenneth</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Verloes</LastName><ForeName>Rene</ForeName><Initials>R</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00561353</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Antivir Ther</MedlineTA><NlmUniqueID>9815705</NlmUniqueID><ISSNLinking>1359-6535</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, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011994">Recombinant Proteins</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013449">Sulfonamides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C100416">peginterferon alfa-2a</NameOfSubstance></Chemical><Chemical><RegistryNumber>30IQX730WE</RegistryNumber><NameOfSubstance UI="D011092">Polyethylene Glycols</NameOfSubstance></Chemical><Chemical><RegistryNumber>49717AWG6K</RegistryNumber><NameOfSubstance UI="D012254">Ribavirin</NameOfSubstance></Chemical><Chemical><RegistryNumber>9WS5RD66HZ</RegistryNumber><NameOfSubstance UI="D000069616">Simeprevir</NameOfSubstance></Chemical><Chemical><RegistryNumber>RFM9X3LJ49</RegistryNumber><NameOfSubstance UI="D001663">Bilirubin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000293">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000998">Antiviral Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001663">Bilirubin</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000032">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004359">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005838">Genotype</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016174">Hepacivirus</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006526">Hepatitis C</DescriptorName><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" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016898">Interferon-alpha</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011092">Polyethylene Glycols</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011480">Protease Inhibitors</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012367">RNA, Viral</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000097">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011994">Recombinant Proteins</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012254">Ribavirin</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000494">pharmacology</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000069616">Simeprevir</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013449">Sulfonamides</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019562">Viral Load</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2011</Year><Month>10</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>10</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2012</Year><Month>4</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.3851/IMP1894</ArticleId><ArticleId IdType="pubmed">22024518</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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