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 2010 - Poster 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"><h1>Poster Presentations</h1> <P><b>Session Title:</b> Category 13. LATE-BREAKERS<br><b>Presentation Date:</b> Apr 15, 2010</P><h2 align='left'><B>Q2WEEK CONTROLLED-RELEASE-INTERFERON-ALPHA2B+RIBAVRIN REDUCES FLU-LIKE SYMPTOMS >50% AND PROVIDES EQUIVALENT EFFICACY IN COMPARISON TO WEEKLY PEGYLATED-INTERFERON-ALPHA2B+RIBAVIRIN IN TREATMENT-NAÏVE-GENOTYPE-1-CHRONIC-HEPATITIS-C: RESULTS FROM EMPOWER, A RANDOMIZED-OPEN-LABEL-12-WEEK-COMPARISON IN 133 PATIENTS</B></h2> <p align='left'><b>W.A. Long</b><sup>1</sup>*, D. Takov<sup>2</sup>, K. Tchernev<sup>3</sup>, I. Kotzev<sup>4</sup>, A. Rigney<sup>1</sup>, Z. Krastev<sup>5</sup>, S. Stoynov<sup>6</sup>, R. Balabanska<sup>7</sup>, E. Lawitz<sup>8</sup>, Z. Younossi<sup>9</sup>, R. Ghalib<sup>10</sup>, E. Zuckerman<sup>11</sup>, R. Safadi<sup>12</sup>, R. Tur-Kaspa<sup>13</sup>, N. Assy<sup>14</sup>, Y. Lurie<sup>15</sup><br> <em><sup>1</sup>Biolex Therapeutics, Pittsboro, NC, USA, <sup>2</sup>Military Medical Academy, <sup>3</sup>UMHAT  Alexandrovska , Sofia, <sup>4</sup>UMHAT  St. Marina , Varna, <sup>5</sup>UMHAT  St. Ivan Rilski , <sup>6</sup>UMHAT 'Queen Giovanna - ISUL' EAD, <sup>7</sup>Tokuda Hospital, Sofia, Bulgaria, <sup>8</sup>Alamo Medical Research, San Antonio, TX, <sup>9</sup>Inova Health Systems, Falls Church, VA, <sup>10</sup>The Liver Institute at Methodist Dallas, Dallas, TX, USA, <sup>11</sup>Carmel Medical Center,, Haifa, <sup>12</sup>Holy Family Hospital Nazareth, Nazareth, <sup>13</sup>Rabin Medical Center, Petah-Tikva, <sup>14</sup>Rebekah Ziv Medical Center, Zefat, <sup>15</sup>Sourasky Medical Center, Tel Aviv, Israel. *wlong@biolex.com</em></p><br> <p align='justify'><b>Background and <b>Aim: </b> </b>The aim of this study was to test the hypothesis that 480ug controlled-release-interferon-alpha2b (CR2b) dosed q2weeks reduces flu-like symptoms (FluSxs) but retains equal efficacy compared to pegylated interferon alpha2b (PEG2b) dosed weekly in treatment-naïve-genotype-1 (G1) chronic HCV patients treated with weight-based ribavirin.<br><b><b>Methods: </b> </b>EMPOWER is a 12-week, randomized, open-label Phase 2b trial designed with 85% power to detect a 50% reduction in flu-like symptoms in patients treated with 480ug CR2b [Locteron®, Biolex Therapeutics, Pittsboro, NC, USA] versus PEG2b [PegIntron®, Schering Plough, Kenilworth, NJ, USA], both in combination with weight-based ribavirin. Patients were enrolled in two contributing trials (SELECT-2 & 480STUDY) specifically designed to provide jointly the sample sizes required for the hypothesis test in EMPOWER. HCV RNA was measured weekly for three weeks and then every other week. Safety labs were measured weekly for three weeks and monthly thereafter. Adverse events including a pre-specified cluster of flu-like symptoms (FluSxs) were collected during weekly clinic visits for 12 weeks. FluSxs were also collected daily for 12 weeks by patient self-report using the internet (ePRO). Other measurements include serial measurements of BDI, HQLQ, SF-36, and days missed from work.<br><b><b>Results: </b> </b>Preliminary results from 101/133 enrolled patients are available (n=48 on q2week-480ug-CR2b, n=53 on PEG2b). Mean declines in Log10 HCV RNA from baseline were equivalent. FluSxs (arthralgia, chills, fever, headache, or myalgia reported at weekly clinic visits) counts during the first week were 50 versus 109 on q2week-480ug-CR2b vs. PEG2b, and total FluSxs counts during the 12 weeks were 109 versus 314 on q2week-480ug-CR2b vs. PEG2b. Total days missed from work were 82 versus 109 for q2week-480ug-CR2b versus PEG2b. Neutrophil counts < 750 occurred in 13% (6/48) and 8% (4/53) respectively for q2week-480ug-CR2b and PEG2b; no neutrophil counts < 500 were reported in the first 12 weeks. <br><b><b>Conclusions: </b> </b>In these 101 patients, q2week-480ug-CR2b over 12-weeks provided a) >50% reduction in FluSxs that preceded the possible impact of the q2week dosing interval, and b) equivalent antiviral efficacy. Days missed from work may also be reduced. Final 12-week results from all 133 patients (including ePRO) will be presented at the meeting.</p> <br><a href='Session-PLB-13.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>