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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 : 000C18 ( Main/Exploration ); précédent : 000C17; suivant : 000C19

Rapid 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 :

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.


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<name sortKey="Simmen, Kenneth" sort="Simmen, Kenneth" uniqKey="Simmen K" first="Kenneth" last="Simmen">Kenneth Simmen</name>
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<name sortKey="Verloes, Rene" sort="Verloes, Rene" uniqKey="Verloes R" first="Rene" last="Verloes">Rene Verloes</name>
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<series>
<title level="j" type="main">Antiviral therapy : (London)</title>
<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
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<title level="j" type="main">Antiviral therapy : (London)</title>
<title level="j" type="abbreviated">Antivir. ther. : (Lond.)</title>
<idno type="ISSN">1359-6535</idno>
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<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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<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>
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<li>Belgique</li>
<li>France</li>
<li>Irlande (pays)</li>
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<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>
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<name sortKey="Lenz, Oliver" sort="Lenz, Oliver" uniqKey="Lenz O" first="Oliver" last="Lenz">Oliver Lenz</name>
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