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>PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF NITAZOXANIDE PLUS PEGINTERFERON AND RIBAVIRIN IN HCV GENOTYPE 1 NAïVE PATIENTS: WEEK 12 SUSTAINED VIROLOGIC RESPONSE RATE</B></h2> <p align='left'><b>B.R. Bacon</b><sup>1</sup>*, M.L. Shiffman<sup>2</sup>, J.K. Lim<sup>3</sup>, A. Berman<sup>4</sup>, V.K. Rustgi<sup>5</sup>, E.B. Keeffe<sup>6,7</sup><br> <em><sup>1</sup>Division of Gastroenterology and Hepatology, St Louis University Medical Center, St Louis, MO, <sup>2</sup>Liver Institute of Virginia, Bon Secours Health System, Newport News, VA, <sup>3</sup>Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT, <sup>4</sup>Florida Center for Gastroenterology, Largo, FL, <sup>5</sup>Georgetown University Medical Center, Washington, DC, <sup>6</sup>The Romark Institute for Medical Research, Romark Laboratories, L.C., Sausalito, <sup>7</sup>Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, CA, USA. *baconbr@slu.edu</em></p><br> <p align='justify'><b>Background and Aims</b>: Treatment of chronic hepatitis C (CHC) with nitazoxanide (NTZ) and peginterferon (PegIFN) +/- ribavirin (RBV) improves sustained virologic response (SVR) rates in naïve genotype 4 patients (Rossignol JF, et al. <i>Gastroenterology.</i> 2009;136:856). The aim of this study was to determine the efficacy of NTZ plus PegIFN and RBV in naïve patients with CHC genotype 1; SVR12 rates are reported.<br><b>Methods</b>: 112 treatment-naïve patients with CHC genotype 1 underwent 2:1 randomization in 13 U.S. centers in this double-blind, placebo-controlled study of NTZ (n=75) versus placebo (PBO) (n=37) twice daily over a 4-week lead-in followed by continued NTZ or PBO plus PegIFN alfa-2a 180 ug weekly and weight-based RBV (1000 to 1200 mg/d) for 48 weeks. Serum HCV RNA was measured using the Roche Cobas Taqman assay (LOQ = 50 IU/mL). <br><b>Results</b>: Mean ages (±SD) in the NTZ and PBO groups were 50 ± 7 and 51 ± 8 years, respectively, and 65% of patients were men in both groups. Mean baseline HCV RNA was 6.3 ± 0.7 log<sub>10</sub> IU/mL in the NTZ group and 6.4 ± 0.7 log<sub>10</sub> IU/mL in the PBO group. Analysis was by intention-to-treat for patients who received any dose of peginterferon. Results are shown in Table 1: <br><br><br><table border=1> <tr><td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>Treatment Group</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>RVR</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>cEVR</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>ETR</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>SVR12</span></td> </tr><tr><td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>NTZ + PegIFN + RBV (n=73)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>9 (12%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>45 (62%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>46 (63%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>32 (44%)</span></td> </tr><tr><td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>PBO + PegIFN + RBV (n=37)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>7 (19%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>18 (49%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>17 (46%)</span></td> <td width='20%' align='left'><span style='font-weight:normal; font-style:normal'>12 (32%)</span></td> </tr></table><i>[Table 1]</i><br /><br>In patients with HCV RNA levels >800,000 IU/mL, SVR12 rates were also higher in the NTZ (n=62) vs. PBO (n=31) group (42% vs. 29%). In sites with customary standard of care response rates, SVR12 rates were higher in the NTZ group: 57% (n=49) vs. 42% (n=24), and 55% vs. 35% in patients with high viral load. There were no significant differences in SAEs between the two treatment groups.<br><b><b>Conclusions: </b> </b>Consistent with previously reported results in naïve genotype 4 patients, the addition of NTZ increased the SVR12 rate in genotype 1 naïve patients by more than one-third. A NTZ 675 mg tablets will be used in phase 3 studies with the goal of further improving SVR rates.</p> <br><a href='Session-PLB-13.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>