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 12. IL28b POLYMORPHISM<br><b>Presentation Date:</b> Apr 17, 2010</P><h2 align='left'><B>PHARMACOGENOMIC ANALYSIS REVEALS IMPROVED VIROLOGIC RESPONSE IN ALL <I>IL-28</I>B GENOTYPES IN NAÏVE GENOTYPE 1 CHRONIC HCV PATIENTS TREATED WITH GI-5005 THERAPEUTIC VACCINE PLUS PEG-IFN/RIBAVIRIN </B></h2> <p align='left'><b>J.G. McHutchison</b><sup>1</sup>*, A.J. Thompson<sup>1</sup>, I.M. Jacobson<sup>2</sup>, T.D. Boyer<sup>3</sup>, E.R. Schiff<sup>4</sup>, G.T. Everson<sup>5</sup>, J.M. Vierling<sup>6,7</sup>, M.L. Shiffman<sup>8</sup>, R.S. Brown<sup>9</sup>, A.M. Di Bisceglie<sup>10</sup>, S.C. Gordon<sup>11</sup>, W.M. Lee<sup>12</sup>, Z. Guo<sup>13</sup>, T.H. King<sup>13</sup>, B. Armstrong<sup>14</sup>, T.C. Rodell<sup>13</sup>, D. Apelian<sup>13</sup><br> <em><sup>1</sup>Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, <sup>2</sup>Center for the Study of Hepatitis C, Weill Cornell Medical College, New York, NY, <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>Department of Medicine and Surgery, Baylor College of Medicine, <sup>7</sup>St. Luke's Episcopal Hospital, Houston, TX, <sup>8</sup>Liver Institute of Virginia, Bon Secours Health System, Newport News, VA, <sup>9</sup>Columbia University College of Physicians & Surgeons, New York, NY, <sup>10</sup>Saint Louis University, St. Louis, MO, <sup>11</sup>Henry Ford Hospital, Detroit, MI, <sup>12</sup>Department of Internal Medicine, University of Texas Southwestern Medical Center at Dallas, Dallas, TX, <sup>13</sup>GlobeImmune, Inc., Louisville, CO, <sup>14</sup>QST Consultations, LTD, Allendale, MI, USA. *mchut001@mc.duke.edu</em></p><br> <p align='justify'><b><b>Background and aims: </b> </b><i>IL-28</i>B genotypes (CC,CT,TT) predict sustained virologic response (SVR) to standard of care (SOC) PegIFN/ribavirin and spontaneous clearance of acute HCV. Since GI-5005 generates HCV-specific T-cells involved in spontaneous HCV clearance, we assessed the influence of <i>IL-28</i>B on end of treatment (ETR) and SVR responses to GI-5005 plus SOC in naïve genotype-1 chronic HCV. <br><b><b>Methods: </b> </b>Patients were randomized 1:1, and stratified by prior treatment status. Arm1-Triple(n=50):GI-5005 monotherapy for five weekly then 2 monthly doses, then monthly GI-5005 with 48 weeks pegIFN±-2a/ribavirin. Arm2-SOC(n=46):48 weeks SOC. The <i>IL-28</i>B locus was PCR amplified from patient genomic DNA and genotyped by bi-directional sequencing. <br><b><b>Results: </b></b> <i>IL-28</i>B genotypes were balanced in both arms. Results shown in Tables 1 and 2.<br><br><img hspace=5 vspace=5 src=pictures/p_248_00223.jpg ><br><i>[Table 1]</i><br><br><br><img hspace=5 vspace=5 src=pictures/p_248_00224.jpg ><br><i>[Table 2]</i><br><br><b><b>Conclusions: </b> </b>Pharmacogenomic analyses can provide valuable insights into therapeutic trial results. Triple therapy improved ETR regardless of <i>IL-28</i>B genotype; delivering more CC and CT RVRs and more CC and CT slow responders. The effect of GI-5005 on SVR is greatest in patients with the poorest prognosis genotype (TT). <i>IL-28</i>B genotyping suggests that the GI-5005 therapeutic vaccine augments response in those with unfavorable <i>IL-28</i>B types. <br></p> <img src='pictures/p_248_00223.jpg'> <img src='pictures/p_248_00224.jpg'> <br><a href='Session-P03-12.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>