ÿþ<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"> <html> <head> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <title>EASL 2011 - Oral Presentations</title> <link rel="stylesheet" type="text/css" href="style.css"> </head> <body> <table width="750" align="center" border="0" cellspacing="0" cellpadding="0" class="MainTable"> <tr> <td><img src="http://www2.kenes.com/liver-congress/PublishingImages/top_ei.jpg" width="760" height="129" /></td> </tr> <tr> <td class="content"><p><b>Abstracts on line are sponsored by</b><br /> <img src="../logo_janssen.jpg" /></p><h1>Oral Presentations</h1> <P><b>Session Title:</b> OPENING AND GENERAL SESSION 1<br><b>Presentation Date:</b> 31 MAR, 2011</P><h2 align='left'><B>REALIZE TRIAL FINAL RESULTS: TELAPREVIR-BASED REGIMEN FOR GENOTYPE 1 HEPATITIS C VIRUS INFECTION IN PATIENTS WITH PRIOR NULL RESPONSE, PARTIAL RESPONSE OR RELAPSE TO PEGINTERFERON/RIBAVIRIN</B></h2> <p align='left'><b>S. Zeuzem</b><sup>1</sup>*, P. Andreone<sup>2</sup>, S. Pol<sup>3</sup>, E.J. Lawitz<sup>4</sup>, M. Diago<sup>5</sup>, S. Roberts<sup>6</sup>, R. Focaccia<sup>7</sup>, Z.M. Younossi<sup>8</sup>, G.R. Foster<sup>9</sup>, A. Horban<sup>10</sup>, P.J. Pockros<sup>11</sup>, R. Van Heeswijk<sup>12</sup>, S. de Meyer<sup>12</sup>, D. Luo<sup>13</sup>, G. Picchio<sup>13</sup>, M. Beumont<sup>12</sup><br> <em><sup>1</sup>Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany, <sup>2</sup>Università di Bologna, Bologna, Italy, <sup>3</sup>Université Paris Descartes, INSERM Unité 567, and Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Paris, France, <sup>4</sup>Alamo Medical Resarch, San Antonio, TX, USA, <sup>5</sup>Hospital General de Valencia, Valencia, Spain, <sup>6</sup>Department of Gasteroenterology, Alfred Hospital, Melbourne, VIC, Australia, <sup>7</sup>Emilio Ribas Infectious Diseases Institute, São Paulo, Brazil, <sup>8</sup>Center for Liver Disease, Inova Fairfax Hospital, Falls Church, VA, USA, <sup>9</sup>Institute of Cell and Molecular Science, Queen Mary University of London, London, UK, <sup>10</sup>Medical University of Warsaw, Warsaw, Poland, <sup>11</sup>Scripps Clinic and The Scripps Research Institute, La Jolla, CA, USA, <sup>12</sup>Tibotec BVBA, Beerse, Belgium, <sup>13</sup>Tibotec Inc., Titusville, NJ, USA. *zeuzem@em.uni-frankfurt.de</em></p><br> <p align='justify'><b><b>Background: </b></b> The Phase 3 study REALIZE evaluated telaprevir (T) in combination with pegylated-IFN alfa-2a (P) and ribavirin (R) in well-characterised prior PR treatment-failure patients.<br><b><b>Methods: </b></b> REALIZE was a randomised, international, multicentre, double-blind, placebo-controlled trial to evaluate the efficacy, safety and tolerability of T (750 mg q8h) plus P (180 µg/w) and R (1000-1200 mg/d) compared with PR alone in G1 HCV-infected patients with prior PR treatment failure including non-responders (null- and partial-responders) and relapsers. The treatment arms (randomised 2:2:1, stratified by viral load and type of prior response) were: 1) T/PR for 12 weeks, followed by PR for 36 weeks (T12/PR48); 2) PR for 4 weeks followed by T/PR for 12 weeks, then PR for 32 weeks (Lead-in T12/PR48); 3) PR for 48 weeks (Pbo/PR48). The primary objective was to evaluate the superior efficacy of the T/PR arms for non-responders and relapsers. Secondary objectives included the evaluation of a lead-in and efficacy in prior null- and partial-responders separately. HCV RNA was quantified with the COBAS TaqMan® v2.0 assay (LLOQ=25IU/mL). ESAs were not allowed for anaemia management. <br><b><b>Results: </b></b> 833 patients were screened, 663 randomised, and 662 treated. 70% of patients were male, 93% were Caucasian, 26% had cirrhosis, and 89% had baseline HCV RNA e"800,000IU/mL.<br><br><br><table border=1> <tr><td width='11%' align='center'> </td> <td width='11%' align='center' colspan='3'><span style='font-weight:normal; font-style:normal'>Relapsers</span></td> <td width='11%' align='center' colspan='3'><span style='font-weight:normal; font-style:normal'>Non-responders</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Partial-responders</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Null-responders</span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>n/N (%)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>SVR24<sup>a</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Virological failure/stopping rule</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Relapse<sup>b</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>SVR24<sup>a</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Virological failure/stopping rule</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>Relapse<sup>b</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>SVR24<sup>a</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>SVR24<sup>a</sup></span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>T12/PR48</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>121/145 (83) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>2/145 (1)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>10/135 (7)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>50/121 (41) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>50/121 (41)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>16/69 (23)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>29/49 (59) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>21/72 (29) p<0.0001<sup>c</sup></span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>Lead-in T12/PR48</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>124/141 (88) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>1/141 (1)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>9/138 (7)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>51/123 (41) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>44/123 (36)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>18/72 (25)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>26/48 (54) p<0.0001<sup>c</sup></span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>25/75 (33) p<0.0001<sup>c</sup></span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>Pbo/PR48</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>16/68 (24)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>18/68 (26)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>30/46 (65)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>6/64 (9)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>50/64 (78)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>3/9 (33)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>4/27 (15)</span></td> <td width='11%' align='center'><span style='font-weight:normal; font-style:normal'>2/37 (5)</span></td> </tr><tr><td width='11%' align='left' colspan='9'><span style='font-weight:normal; font-style:normal'><sup>a</sup>Assessed 24 weeks after planned treatment completion; <sup>b</sup>at week 72 in patients with undetectable HCV RNA at end of assigned treatment; <sup>c</sup>comparison with Pbo/PR48.</span></td> </tr></table><i>[Table 1]</i><br /><br>Adverse events reported most frequently with telaprevir were fatigue, pruritus, rash, nausea, influenza-like illness, anaemia, and diarrhoea. The most common reasons for premature telaprevir discontinuation due to adverse events were rash (4%) and anaemia (3%). <br><b><b>Conclusions: </b></b> T/PR demonstrated superior efficacy compared with PR in all prior treatment-failure populations studied including null- and partial-responders. A lead-in did not have a significant impact on SVR rates. The safety profile of T/PR in prior treatment-failure patients was consistent with that observed in treatment naïve patients.</p> <br><a href="javascript://;" onclick="history.back()">Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>