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>GI-5005 THERAPEUTIC VACCINE PLUS PEG-IFN/RIBAVIRIN SIGNIFICANTLY IMPROVES VIROLOGIC RESPONSE AND ALT NORMALIZATION AT END-OF-TREATMENT AND IMPROVES SVR24 COMPARED TO PEG-IFN/RIBAVIRIN IN GENOTYPE-1 CHRONIC HCV PATIENTS</B></h2> <p align='left'><b>I.M. Jacobson</b><sup>1</sup>*, J.G. McHutchison<sup>2</sup>, T.D. Boyer<sup>3</sup>, E.R. Schiff<sup>4</sup>, G.T. Everson<sup>5</sup>, P.J. Pockros<sup>6</sup>, R.M. Chasen<sup>7</sup>, J.M. Vierling<sup>8,9</sup>, E.J. Lawitz<sup>10</sup>, M. Kugelmas<sup>11,12</sup>, N.C. Tsai<sup>13</sup>, M.L. Shiffman<sup>14</sup>, R.J. Buynak<sup>15</sup>, A.M. Sheikh<sup>16</sup>, B. Armstrong<sup>17</sup>, T.C. Rodell<sup>18</sup>, D. Apelian<sup>18</sup><br> <em><sup>1</sup>Center for the Study of Hepatitis C, Weill Cornell Medical College, New York, NY, <sup>2</sup>Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, <sup>3</sup>Department of Medicine, University of Arizona College of Medicine, Tucson, AZ, <sup>4</sup>Center for Liver Diseases, University of Miami School of Medicine, Miami, FL, <sup>5</sup>Department of Medicine, University of Colorado Denver, Aurora, CO, <sup>6</sup>Scripps Clinic, La Jolla, CA, <sup>7</sup>Maryland Digestive Disease Research, Laurel, MD, <sup>8</sup>Department of Medicine and Surgery, Baylor College of Medicine, <sup>9</sup>St. Luke's Episcopal Hospital, Houston, <sup>10</sup>Alamo Medical Research, San Antonio, TX, <sup>11</sup>South Denver Gastroenterology, PC, <sup>12</sup>Center for Disease of the Liver and Pancreas, Swedish Medical Center, Englewood, CO, <sup>13</sup>University of Hawaii, Honolulu, HI, <sup>14</sup>Liver Institute of Virginia, Bon Secours Health System, Newport News, VA, <sup>15</sup>Northwest Indiana Center for Clinical Research, Valparaiso, IN, <sup>16</sup>Gastrointestinal Specialists of Georgia, Marietta, GA, <sup>17</sup>QST Consultations, LTD, Allendale, MI, <sup>18</sup>GlobeImmune, Inc., Louisville, CO, USA. *imj2001@med.cornell.edu</em></p><br> <p align='justify'><b><b>Background and aims: </b> </b>GI-5005 is a therapeutic vaccine expressing HCV NS3 and Core antigens. GI-5005 elicits antigen-specific T-cell responses with the goal of improving the rate of immune-mediated elimination of HCV-infected hepatocytes.<br><b><b>Methods: </b> </b>Naïve and non-responder (NR) chronic HCV genotype 1 patients were randomized1:1, and stratified by prior treatment status. Arm 1(N=68): GI-5005 monotherapy run-in consisting of five weekly followed by 2 monthly doses of GI-5005 over 12 weeks, followed by triple therapy consisting of monthly GI-5005 plus 48 weeks pegIFN ±-2a/ribavirin (SOC) in Naives or 72 weeks triple therapy in NRs. Arm 2(N=65): SOC alone (48 weeks in naives and 72 weeks in NRs).<br><b><b>Results: </b></b> All patients have completed GI-5005 triple therapy, and naïve patients have completed 24 weeks of post-treatment follow up. Triple therapy was well tolerated with no increase in discontinuations due to adverse events (10% in each group), related serious adverse events, or growth factor use for anemia or neutropenia. ETR*, SVR**, and ALT normalization*** are described below. <br><br><img hspace=5 vspace=5 src=pictures/p_248_00229.jpg ><br><i>[Table 1]</i><br><br><b><b>Conclusions: </b> </b>Triple therapy significantly improved ETR and ALT normalization compared to SOC alone. An improvement of 10% in SVR was observed in naïve patients 24 weeks after the completion of therapy. SVR in IL28 genotype TT patients was greater for triple therapy compared to SOC or historical controls, suggesting a potentially greater treatment effect in this high risk patient group. These data support further development of GI-5005 in combination with SOC and novel combination use with direct acting antiviral agents. <br></p> <img src='pictures/p_248_00229.jpg'> <br><a href='Session-PLB-13.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>