OperaV1, PascalFrancis, Corpus, bibRecord, 000145

Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial

Identifieur interne : 000145 ( PascalFrancis/Corpus ); précédent : 000144; suivant : 000146

Rapid 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 Verloes

Source :

Antiviral therapy : (London) [ 1359-6535 ] ; 2011.

RBID : Pascal:11-0504707

Descripteurs français

Pascal (Inist)
- Dose journalière unique, Association médicamenteuse, Forme pégylée, Cytokine, Interféron, Ribavirine, Hépatite virale C, Génotype, Typage, Homme, Malade, Randomisation, Antiviral.

English descriptors

KwdEn :
- Antiviral, Cytokine, Drug combination, Genotype, Human, Interferon, Patient, Pegylated form, Randomization, Ribavirin, Single daily dose, Typing, Viral hepatitis C.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A14	`01`			`@1 Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School @2 Hannover @3 DEU @Z 1 aut.`
A14	`02`			`@1 Academic Medical Center @2 Amsterdam @3 NLD @Z 2 aut.`
A14	`03`			`@1 Department of Hepatology, Clinic of Gastroenterology and Rheumatology, University Clinic Leipzig @2 Leipzig @3 DEU @Z 3 aut.`
A14	`04`			`@1 Royal Free Hospital @2 London @3 GBR @Z 4 aut.`
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C01	`01`		`ENG`	@0 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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Format Inist (serveur)

NO :	PASCAL 11-0504707 INIST
ET :	Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial
AU :	MANNS (Michael); REESINK (Henk); BERG (Thomas); DUSHEIKO (Geoffrey); FLISIAK (Robert); MARCELLIN (Patrick); MORENO (Christophe); LENZ (Oliver); MEYVISCH (Paul); PEETERS (Monika); SEKAR (Vanitha); SIMMEN (Kenneth); VERLOES (Rene)
AF :	Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School/Hannover/Allemagne (1 aut.); Academic Medical Center/Amsterdam/Pays-Bas (2 aut.); Department of Hepatology, Clinic of Gastroenterology and Rheumatology, University Clinic Leipzig/Leipzig/Allemagne (3 aut.); Royal Free Hospital/London/Royaume-Uni (4 aut.); Medical University of Biatystok/Białystok/Pologne (5 aut.); Hôpital Beaujon/Clichy/France (6 aut.); Erasme Hospital, Université Libre de Bruxelles/Brussels/Belgique (7 aut.); Tibotec/Beerse/Belgique (8 aut., 9 aut., 10 aut., 13 aut.); Tibotec Inc./Titusville, NJ/Etats-Unis (11 aut.); Tibotec Pharmaceuticals Ltd, Eastgate Village/Cork/Irlande (12 aut.)
DT :	Publication en série; Niveau analytique
SO :	Antiviral therapy : (London); ISSN 1359-6535; Royaume-Uni; Da. 2011; Vol. 16; No. 7; Pp. 1021-1033; Bibl. 24 ref.
LA :	Anglais
EA :	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.
CC :	002B02S05; 002B05C02G
FD :	Dose journalière unique; Association médicamenteuse; Forme pégylée; Cytokine; Interféron; Ribavirine; Hépatite virale C; Génotype; Typage; Homme; Malade; Randomisation; Antiviral
FG :	Virose; Infection; Analogue de nucléoside; Pathologie de l'appareil digestif; Pathologie du foie
ED :	Single daily dose; Drug combination; Pegylated form; Cytokine; Interferon; Ribavirin; Viral hepatitis C; Genotype; Typing; Human; Patient; Randomization; Antiviral
EG :	Viral disease; Infection; Nucleoside analog; Digestive diseases; Hepatic disease
SD :	Dosis diaria única; Asociación medicamentosa; Forma pegilada; Citoquina; Interferón; Ribavirina; Hepatítis virica C; Genotipo; Tipificación; Hombre; Enfermo; Aleatorización; Antiviral
LO :	INIST-27047.354000507873660110
ID :	11-0504707

Links to Exploration step

Pascal:11-0504707

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</title>
<author><name sortKey="Manns, Michael" sort="Manns, Michael" uniqKey="Manns M" first="Michael" last="Manns">Michael Manns</name>
<affiliation><inist:fA14 i1="01"><s1>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School</s1>
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<author><name sortKey="Reesink, Henk" sort="Reesink, Henk" uniqKey="Reesink H" first="Henk" last="Reesink">Henk Reesink</name>
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<author><name sortKey="Dusheiko, Geoffrey" sort="Dusheiko, Geoffrey" uniqKey="Dusheiko G" first="Geoffrey" last="Dusheiko">Geoffrey Dusheiko</name>
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<author><name sortKey="Flisiak, Robert" sort="Flisiak, Robert" uniqKey="Flisiak R" first="Robert" last="Flisiak">Robert Flisiak</name>
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<author><name sortKey="Marcellin, Patrick" sort="Marcellin, Patrick" uniqKey="Marcellin P" first="Patrick" last="Marcellin">Patrick Marcellin</name>
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</affiliation>
</author>
<author><name sortKey="Moreno, Christophe" sort="Moreno, Christophe" uniqKey="Moreno C" first="Christophe" last="Moreno">Christophe Moreno</name>
<affiliation><inist:fA14 i1="07"><s1>Erasme Hospital, Université Libre de Bruxelles</s1>
<s2>Brussels</s2>
<s3>BEL</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
<affiliation><inist:fA14 i1="08"><s1>Tibotec</s1>
<s2>Beerse</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Meyvisch, Paul" sort="Meyvisch, Paul" uniqKey="Meyvisch P" first="Paul" last="Meyvisch">Paul Meyvisch</name>
<affiliation><inist:fA14 i1="08"><s1>Tibotec</s1>
<s2>Beerse</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Peeters, Monika" sort="Peeters, Monika" uniqKey="Peeters M" first="Monika" last="Peeters">Monika Peeters</name>
<affiliation><inist:fA14 i1="08"><s1>Tibotec</s1>
<s2>Beerse</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Sekar, Vanitha" sort="Sekar, Vanitha" uniqKey="Sekar V" first="Vanitha" last="Sekar">Vanitha Sekar</name>
<affiliation><inist:fA14 i1="09"><s1>Tibotec Inc.</s1>
<s2>Titusville, NJ</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name>
<affiliation><inist:fA14 i1="10"><s1>Tibotec Pharmaceuticals Ltd, Eastgate Village</s1>
<s2>Cork</s2>
<s3>IRL</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name>
<affiliation><inist:fA14 i1="08"><s1>Tibotec</s1>
<s2>Beerse</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<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>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Antiviral therapy : (London)</title>
<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>
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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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<fA08 i1="01" i2="1" l="ENG"><s1>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>MANNS (Michael)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>REESINK (Henk)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>BERG (Thomas)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>DUSHEIKO (Geoffrey)</s1>
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<fA11 i1="05" i2="1"><s1>FLISIAK (Robert)</s1>
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<fA11 i1="06" i2="1"><s1>MARCELLIN (Patrick)</s1>
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<fA11 i1="07" i2="1"><s1>MORENO (Christophe)</s1>
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<fA11 i1="08" i2="1"><s1>LENZ (Oliver)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>MEYVISCH (Paul)</s1>
</fA11>
<fA11 i1="10" i2="1"><s1>PEETERS (Monika)</s1>
</fA11>
<fA11 i1="11" i2="1"><s1>SEKAR (Vanitha)</s1>
</fA11>
<fA11 i1="12" i2="1"><s1>SIMMEN (Kenneth)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>VERLOES (Rene)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School</s1>
<s2>Hannover</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Academic Medical Center</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Hepatology, Clinic of Gastroenterology and Rheumatology, University Clinic Leipzig</s1>
<s2>Leipzig</s2>
<s3>DEU</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Royal Free Hospital</s1>
<s2>London</s2>
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<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Medical University of Biatystok</s1>
<s2>Białystok</s2>
<s3>POL</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Hôpital Beaujon</s1>
<s2>Clichy</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Erasme Hospital, Université Libre de Bruxelles</s1>
<s2>Brussels</s2>
<s3>BEL</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Tibotec</s1>
<s2>Beerse</s2>
<s3>BEL</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Tibotec Inc.</s1>
<s2>Titusville, NJ</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Tibotec Pharmaceuticals Ltd, Eastgate Village</s1>
<s2>Cork</s2>
<s3>IRL</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA20><s1>1021-1033</s1>
</fA20>
<fA21><s1>2011</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>27047</s2>
<s5>354000507873660110</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2011 INIST-CNRS. All rights reserved.</s1>
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<fA45><s0>24 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>11-0504707</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Antiviral therapy : (London)</s0>
</fA64>
<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02S05</s0>
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<fC02 i1="02" i2="X"><s0>002B05C02G</s0>
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<s5>03</s5>
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<s5>04</s5>
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<s5>05</s5>
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<s5>05</s5>
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<s5>05</s5>
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<s5>07</s5>
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<s5>07</s5>
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<s5>10</s5>
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<s5>10</s5>
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<s5>10</s5>
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<s5>11</s5>
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<s5>11</s5>
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<s5>11</s5>
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<s5>12</s5>
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</fN21>
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</standard>
<server><NO>PASCAL 11-0504707 INIST</NO>
<ET>Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial</ET>
<AU>MANNS (Michael); REESINK (Henk); BERG (Thomas); DUSHEIKO (Geoffrey); FLISIAK (Robert); MARCELLIN (Patrick); MORENO (Christophe); LENZ (Oliver); MEYVISCH (Paul); PEETERS (Monika); SEKAR (Vanitha); SIMMEN (Kenneth); VERLOES (Rene)</AU>
<AF>Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School/Hannover/Allemagne (1 aut.); Academic Medical Center/Amsterdam/Pays-Bas (2 aut.); Department of Hepatology, Clinic of Gastroenterology and Rheumatology, University Clinic Leipzig/Leipzig/Allemagne (3 aut.); Royal Free Hospital/London/Royaume-Uni (4 aut.); Medical University of Biatystok/Białystok/Pologne (5 aut.); Hôpital Beaujon/Clichy/France (6 aut.); Erasme Hospital, Université Libre de Bruxelles/Brussels/Belgique (7 aut.); Tibotec/Beerse/Belgique (8 aut., 9 aut., 10 aut., 13 aut.); Tibotec Inc./Titusville, NJ/Etats-Unis (11 aut.); Tibotec Pharmaceuticals Ltd, Eastgate Village/Cork/Irlande (12 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Antiviral therapy : (London); ISSN 1359-6535; Royaume-Uni; Da. 2011; Vol. 16; No. 7; Pp. 1021-1033; Bibl. 24 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B02S05; 002B05C02G</CC>
<FD>Dose journalière unique; Association médicamenteuse; Forme pégylée; Cytokine; Interféron; Ribavirine; Hépatite virale C; Génotype; Typage; Homme; Malade; Randomisation; Antiviral</FD>
<FG>Virose; Infection; Analogue de nucléoside; Pathologie de l'appareil digestif; Pathologie du foie</FG>
<ED>Single daily dose; Drug combination; Pegylated form; Cytokine; Interferon; Ribavirin; Viral hepatitis C; Genotype; Typing; Human; Patient; Randomization; Antiviral</ED>
<EG>Viral disease; Infection; Nucleoside analog; Digestive diseases; Hepatic disease</EG>
<SD>Dosis diaria única; Asociación medicamentosa; Forma pegilada; Citoquina; Interferón; Ribavirina; Hepatítis virica C; Genotipo; Tipificación; Hombre; Enfermo; Aleatorización; Antiviral</SD>
<LO>INIST-27047.354000507873660110</LO>
<ID>11-0504707</ID>
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Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial

Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial

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