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 - Oral 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-congress2010/PublishingImages/top_ei.jpg" width="760" height="129" /></td> </tr> <tr> <td class="content"><h1>Oral Presentations</h1> <P><b>Session Title:</b> GENERAL SESSION 3 & AWARDS 2<br><b>Presentation Date:</b> Apr 17, 2010</P><h2 align='left'><B>EXTENDED (2 YEARS) TREATMENT WITH PEGINTERFERON ALFA-2A [40KD] IMPROVES SUSTAINED RESPONSE RATES IN GENOTYPE D PATIENTS WITH HBEAG NEGATIVE CHRONIC HEPATITIS B</B></h2> <p align='left'><b>P. Lampertico</b><sup>1</sup>, M. Vigano<sup>1</sup>, G. Di Costanzo<sup>2</sup>, E. Sagnelli<sup>3</sup>, M. Fasano<sup>4</sup>, V. Di Marco<sup>5</sup>, S. Boninsegna<sup>6</sup>, P. Farci<sup>7</sup>, S. Fargion<sup>1</sup>, T. Giuberti<sup>8</sup>, C. Iannacone<sup>1</sup>, B. Massetto<sup>9</sup>, P. Fedeli<sup>1</sup>, M. Colombo<sup>1</sup>, Peg.B.e.Liver Study Group<br> <em><sup>1</sup>First Division Gastroenterology, IRCCS Fondazione Policlinico, Milan, <sup>2</sup>Liver Unit, Cardarelli Hospital, Naples, <sup>3</sup>Infectious Disease Unit, SS Anna and Sebastiano Hospital, Caserta, <sup>4</sup>Clinic of Infectious Disease, Universita di Bari, Bari, <sup>5</sup>Gastroenterology and Hepatology Unit, Universita di Palermo, Palermo, <sup>6</sup>Department of Surgical and Gastroenterological Sciences, Universita di Padova, Padova, <sup>7</sup>Medical Science Department, Universita di Cagliari, Cagliari, <sup>8</sup>Department of Internal Medicine, IRCCS Fondazione Policlinico, Universita di Studi di Milano, Milan, <sup>9</sup>Unit of Infectious Diseases and Hepatology, Azienda Ospedaliera di Parma, Parma, <sup>10</sup>Biostatistics Unit of Quintiles, Milan, <sup>11</sup>Roche, Monza, Italy. *pietro.lampertico@unimi.it</em></p><br> <p align='justify'><b><b>Background and aims: </b></b> Treatment for 1 year with peginterferon alfa-2a (PEG-IFN±-2a) provides a long-term virological response in a proportion of HBeAg-negative patients with chronic hepatitis B (CHB); genotype D-infected patients are likely to be less responsive. Since extended therapy with conventional interferon was shown to increase the response rates among these difficult-to-treat patients, we assessed the long-term response of 1 versus 2 years of PEG-IFN±-2a treatment in genotype D patients. <b><br><b>Methods: </b> </b>127 Italian patients were randomized to receive either 48 weeks of weekly PEG-IFN±-2a 180 µg (Group A; N=51), 48 weeks PEG-IFN±-2a 180 µg followed by 48 weeks at 135 µg (Group B; N=52), or PEG-IFN±-2a 180 µg plus lamivudine 100 mg/day for 48 weeks followed by 48 weeks PEG-IFN±-2a 135 µg (Group C; N=24). Efficacy endpoints were virological response (HBV DNA d"2,000 IU/mL), ALT normalization and HBsAg clearance at 1-year post-treatment. Preliminary results for Group A and B patients are presented.<br><b><b>Results: </b> </b>Baseline features such as age (45 years), ALT (95 IU/mL), HBV DNA (6 log<sub>10</sub> IU/mL), genotype D (94%), cirrhosis (12%) were similar in Groups A and B; there were more women in Group A (35%). The rates of virological response were similar in the two groups both at the end of therapy (59% versus 67%) and 6 months post treatment (24% versus 29%). In contrast, a significantly higher rate of 1-year post-treatment virological response occurred in Group B compared with Group A (31% vs 10%; p= 0.01). ALT normalization rates were 41% in Group A and 37% in Group B 1 year post-treatment. In the first post-treatment year, HBsAg was cleared in 3 patients (9%) and reduced d"10 IU/ml in 2 additional patients (6%) in Group B. Drop-out rates were similar in Groups A and B (20% vs 23%), due to side effects in half of the cases.<br><b><b>Conclusions: </b> </b>In HBeAg-negative genotype D patients with CHB, 2-year treatment with PEG-IFN±-2a was safe and improved significantly the rates of post-treatment virological and serological response.</p> <br><a href="javascript://;" onclick="history.back()">Back</a><br> <p>&nbsp;</p> <p>&nbsp;</p></td> </tr> </table> </body> </html>