Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial
Identifieur interne : 000356 ( France/Extraction ); précédent : 000355; suivant : 000357Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial
Auteurs : Michael Manns [Allemagne] ; Henk Reesink [Pays-Bas] ; Thomas Berg [Allemagne] ; Geoffrey Dusheiko [Royaume-Uni] ; Robert Flisiak [Pologne] ; Patrick Marcellin [France] ; Christophe Moreno [Belgique] ; Oliver Lenz [Belgique] ; Paul Meyvisch [Belgique] ; Monika Peeters [Belgique] ; Vanitha Sekar [États-Unis] ; Kenneth Simmen [Irlande (pays)] ; Rene Verloes [Belgique]Source :
- Antiviral therapy : (London) [ 1359-6535 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
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. 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. 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 log10 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. Conclusions: Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.
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Pascal:11-0504707Le document en format XML
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<author><name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
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<author><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name>
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<country>États-Unis</country>
<placeName><region type="state">New Jersey</region>
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<author><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name>
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<s2>Cork</s2>
<s3>IRL</s3>
<sZ>12 aut.</sZ>
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<country>Irlande (pays)</country>
<wicri:noRegion>Cork</wicri:noRegion>
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<author><name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name>
<affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Tibotec</s1>
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<series><title level="j" type="main">Antiviral therapy : (London)</title>
<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
<imprint><date when="2011">2011</date>
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<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral</term>
<term>Cytokine</term>
<term>Drug combination</term>
<term>Genotype</term>
<term>Human</term>
<term>Interferon</term>
<term>Patient</term>
<term>Pegylated form</term>
<term>Randomization</term>
<term>Ribavirin</term>
<term>Single daily dose</term>
<term>Typing</term>
<term>Viral hepatitis C</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Dose journalière unique</term>
<term>Association médicamenteuse</term>
<term>Forme pégylée</term>
<term>Cytokine</term>
<term>Interféron</term>
<term>Ribavirine</term>
<term>Hépatite virale C</term>
<term>Génotype</term>
<term>Typage</term>
<term>Homme</term>
<term>Malade</term>
<term>Randomisation</term>
<term>Antiviral</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">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. 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=7<sub>4</sub>
) 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=3<sub>7</sub>
; 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. 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<sub>10</sub>
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. Conclusions: Once-daily TMC435 with P/R showed potent, dose-dependent antiviral activity over 28 days, and had a favourable tolerability profile.</div>
</front>
</TEI>
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<li>Belgique</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Basse-Saxe</li>
<li>District de Leipzig</li>
<li>Grand Londres</li>
<li>Hollande-Septentrionale</li>
<li>New Jersey</li>
<li>Région de Bruxelles-Capitale</li>
<li>Saxe (Land)</li>
</region>
<settlement><li>Amsterdam</li>
<li>Bruxelles</li>
<li>Hanovre</li>
<li>Leipzig</li>
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<orgName><li>Université libre de Bruxelles</li>
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<tree><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name>
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<name sortKey="Berg, Thomas" sort="Berg, Thomas" uniqKey="Berg T" first="Thomas" last="Berg">Thomas Berg</name>
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<country name="Pays-Bas"><region name="Hollande-Septentrionale"><name sortKey="Reesink, Henk" sort="Reesink, Henk" uniqKey="Reesink H" first="Henk" last="Reesink">Henk Reesink</name>
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<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name>
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<country name="Pologne"><noRegion><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
</noRegion>
</country>
<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
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<name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
<name sortKey="Meyvisch, Paul" sort="Meyvisch, Paul" uniqKey="Meyvisch P" first="Paul" last="Meyvisch">Paul Meyvisch</name>
<name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name>
<name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name>
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<country name="États-Unis"><region name="New Jersey"><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name>
</region>
</country>
<country name="Irlande (pays)"><noRegion><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>
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EXPLOR_STEP=$WICRI_ROOT/Wicri/Musique/explor/OperaV1/Data/France/Extraction
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