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 9. ELASTOGRAPHY / LIVER STIFFNESS<br><b>Presentation Date:</b> Apr 15, 2010</P><h2 align='left'><B>LONGITUDINAL PROSPECTIVE COMPARISON OF FIBROSURE AND TRANSIENT ELASTOGRAPHY IN RELATION TO VIROLOGIC RESPONSE: A SUBSTUDY OF THE PHASE 3 ALBINTERFERON ALFA-2B TRIALS</B></h2> <p align='left'><b>K. Patel</b><sup>1</sup>*, M. Friedrich-Rust<sup>2</sup>, M. Torbenson<sup>3</sup>, Y. Zhu<sup>4</sup>, E. Pulkstenis<sup>4</sup>, G. Subramanian,<sup>4</sup>, J. McHutchison<sup>1</sup>, D. Nelson<sup>5</sup>, M. Sulkowski<sup>3</sup>, Y. Benhamou<sup>6</sup>, S. Zeuzem<sup>2</sup>, for the ACHIEVE Study Group<br> <em><sup>1</sup>Duke Clinical Research Institute, Durham, NC, USA, <sup>2</sup>J.W.Goethe University Hospital, Frankfurt/Main, Germany, <sup>3</sup>Johns Hopkins University School of Medicine, Baltimore, <sup>4</sup>Human Genome Sciences, Inc., Rockville, MD, <sup>5</sup>University of Florida, Gainesville, FL, USA, <sup>6</sup>Hôpital Pitié-Salpêtrière, Paris, France. *keyur.patel@duke.edu</em></p><br> <p align='justify'><b><b>Background and aims: </b></b> Noninvasive alternatives to biopsy that can follow fibrosis changes would be useful to assess histologic therapeutic endpoints. This substudy compared the changes in the validated serum marker panel FibroSURE (FS) and transient elastography (TE) with virologic responses in two phase 3 trials of albinterferon alfa-2b (albIFN) in chronic hepatitis C (CHC) patients.<br><b><b>Methods: </b></b> CHC patients were randomized equally to 3 treatment groups: peginterferon alfa-2a qwk, and albIFN 900 and 1200µg q2wk, all with ribavirin for 24wk (800mg/d; genotypes 2/3) or 48wk (1000-1200mg/d; genotype 1). FS was determined at baseline and wk12 post-treatment follow-up; baseline biopsy evaluation for METAVIR score was done by a single pathologist; and TE was obtained before/after therapy from non-US centers with available TE. Data from both trials were pooled for analysis.<br><b><b>Results: </b></b> At baseline, 2055 CHC patients were classified by biopsy (mean length 17.0mm) as F0-1 (n=1678) or F2-4 (n=377). For F2-4, FS had a sensitivity and specificity of 0.87 and 0.61, respectively, with area under the receiver operating curve of 0.82; the corresponding numbers with TE (n=214) were 0.77, 0.88, and 0.88. By combining FS and TE, accuracy for F2-4=0.86. Agreement between TE-determined F2-4 and FS was 0.71 (k=0.41). FS and TE scores were available in 2082 and 217 patients, respectively, with virologic response. At wk12 post-therapy follow-up, there was a significant reduction in FS fibrosis scores from baseline for sustained virologic responders (SVR; n=1197, ”=0.06) compared with nonresponders (n=534; ”=0.0; <i>P</i>< .001). Changes in FS inflammatory activity scores at follow-up were also lower for SVR vs nonresponders (difference=-0.32; <i>P</i>< .001). Although TE scores were lower at baseline in SVR vs nonresponders (6.4vs7.9; <i>P</i>=.003), further small declines in TE score for both groups did not differ appreciably at follow-up (median difference=-0.3).<br><b><b>Conclusions: </b></b> The combination of imaging and serum tests may reliably differentiate mild from moderate-advanced-stage disease. FS fibrosis and TE scores were lower at baseline and follow-up in SVR. Overall TE scores were lower post-therapy, but these declines were not related to virologic response and may reflect differences in inflammatory activity detection between TE and serum biomarkers in relation to response. <br></p> <br><a href='Session-P01-9.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>