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 5f. VIRAL HEPATITIS: f. HEPATITIS C - CLINICAL (EXCEPT THERAPY)<br><b>Presentation Date:</b> Apr 17, 2010</P><h2 align='left'><B>INDEPENDENT VALIDATION OF THE SAFE BIOPSY ALGORITHM: ANALYSIS OF THE ACHIEVE COHORTS</B></h2> <p align='left'><b>A. Thompson</b><sup>1</sup>*, P. Clark<sup>2</sup>, H. Tillmann<sup>2</sup>, M. Torbenson<sup>3</sup>, E. Pulkstenis<sup>4</sup>, G.M. Subramanian<sup>4</sup>, J. McHutchison<sup>1</sup>, K. Patel<sup>2</sup><br> <em><sup>1</sup>Duke Clinical Research Institute, Duke University Medical Centre, <sup>2</sup>GI / Hepatology Research Program, Duke Clinical Research Insitiute, Duke University, Durham, NC, <sup>3</sup>Pathology Department, Johns Hopkins University School of Medicine, Baltimore, <sup>4</sup>Human Genome Sciences, Inc., Rockville, MD, USA. *alexander.thompson@duke.edu</em></p><br> <p align='justify'><b><b>Background: </b> </b>The SAFE biopsy algorithm, that uses sequential APRI and FibroTest, has recently been proposed as a non-invasive screening tool for significant fibrosis in HCV carriers (HEPATOLOGY 2009;49:1821). We independently investigated the performance of the SAFE biopsy in chronic HCV patients enrolled in the ACHIEVE-1 and ACHIEVE-2/3 trials. <br><b><b>Methods: </b> </b>2255 treatment-naïve patients with chronic HCV-1 or HCV-2/3 were enrolled in two separate phase 3, active-controlled studies of albinterferon alfa-2b plus ribavirin for 48 or 24 weeks, respectively. Clinical evaluation included age, gender, race, body mass index (BMI), HCV genotype, HCV viral load, ALT, AST, platelet count, insulin resistance (HOMA-IR), FibroTest/FibroSure and baseline liver biopsy evaluated for steatosis, METAVIR grade and fibrosis by a single pathologist. Standard APRI and FibroTest cut-offs were applied for stage F2-4 and F4. Statistical analysis was performed using SAS 9.1.<br><b><b>Results: </b> </b>Baseline fibrosis prevalence in the ACHIEVE cohort was: F0 (794, 35.8%), F1 (1005, 45.3%), F2 (182, 8.2%), F3 (116, 5.2%) and F4 (124, 5.6%). The prevalence of significant fibrosis (METAVIR F2-4) was therefore lower than in the published SAFE cohort was (19.9% vs 46.7%, P-value < 0.001). The SAFE biopsy identified F2-4 with 83% accuracy (Table 1). 626/2161 (29%) patients avoided having a liver biopsy. However, of these 626 patients, 357 (57%) were misclassified as F2-4. The SAFE biopsy identified cirrhosis (F4) with 92% accuracy, and biopsy was avoided in 96% of patients (Table 1).<br><b><b>Conclusion: </b> </b>In this independent validation, the performance characteristics of the SAFE biopsy were good for identifying the presence of cirrhosis, and most patients would have avoided liver biopsy. However, in this cohort, the SAFE biopsy was less accurate for diagnosing F2-4 fibrosis, most patients would still have required a liver biopsy, and the misclassification rate of patients not undergoing liver biopsy was high. <br><br><table border=1> <tr><td width='11%' align='left'> </td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>Accuracy</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>Sensitivity</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>Specificity</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>PPV</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>NPV</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>LR+</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>LR-</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>N (liver biopsy)</span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>F2-4</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>83%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>100%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>80%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>52%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>100%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>4.95</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>0</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>1138 (71%)</span></td> </tr><tr><td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>F4</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>92%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>52%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>92%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>34%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>97%</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>8.9</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>0.5</span></td> <td width='11%' align='left'><span style='font-weight:normal; font-style:normal'>94 (4%)</span></td> </tr></table><i>[Table 1]</i><br /><br></p> <br><a href='Session-P03-5f.htm'>Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>