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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 :

RBID : Pascal:11-0504707

Descripteurs français

English descriptors

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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A08 01  1  ENG  @1 Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial
A11 01  1    @1 MANNS (Michael)
A11 02  1    @1 REESINK (Henk)
A11 03  1    @1 BERG (Thomas)
A11 04  1    @1 DUSHEIKO (Geoffrey)
A11 05  1    @1 FLISIAK (Robert)
A11 06  1    @1 MARCELLIN (Patrick)
A11 07  1    @1 MORENO (Christophe)
A11 08  1    @1 LENZ (Oliver)
A11 09  1    @1 MEYVISCH (Paul)
A11 10  1    @1 PEETERS (Monika)
A11 11  1    @1 SEKAR (Vanitha)
A11 12  1    @1 SIMMEN (Kenneth)
A11 13  1    @1 VERLOES (Rene)
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.
A14 05      @1 Medical University of Biatystok @2 Białystok @3 POL @Z 5 aut.
A14 06      @1 Hôpital Beaujon @2 Clichy @3 FRA @Z 6 aut.
A14 07      @1 Erasme Hospital, Université Libre de Bruxelles @2 Brussels @3 BEL @Z 7 aut.
A14 08      @1 Tibotec @2 Beerse @3 BEL @Z 8 aut. @Z 9 aut. @Z 10 aut. @Z 13 aut.
A14 09      @1 Tibotec Inc. @2 Titusville, NJ @3 USA @Z 11 aut.
A14 10      @1 Tibotec Pharmaceuticals Ltd, Eastgate Village @2 Cork @3 IRL @Z 12 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

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Pascal:11-0504707

Le document en format XML

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<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
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<term>Interferon</term>
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<term>Pegylated form</term>
<term>Randomization</term>
<term>Ribavirin</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>
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<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>
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<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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