To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Peg-Interferon Improves Event-Free Survival Compared With Colchicine in Patients With Cirrhosis and Portal Hypertension: Presented at EASL URL: http://www.pslgroup.com/dg/220162.htm Doctor's Guide April 25, 2008
By Emma Hitt, PhD MILAN, Italy -- April 25, 2008 -- Maintenance therapy with pegylated interferon alfa-2b (PEG-INF) is associated with improved event-free survival compared with colchicine in patients with portal hypertension, according to the findings of the long-term randomised Colchicine Versus Peg-Interferon Long-Term (COPILOT) trial. Nezam H. Afdhal, MD, Chief of Hepatology and Director, Liver Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, and colleagues reported their findings here at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). The COPILOT trial was conducted at approximately 40 sites in the United States and included 286 patients who received at least 1 dose of PEG-INF 0.5 mcg/kg weekly and 269 patients who received at least 1 dose of colchicine 0.6 mg twice daily. Primary endpoints were Child-Pugh-Turcotte score >2, death, transplant, variceal bleeding, and evidence of hepatocellular carcinoma (HCC). Both intention-to-treat (ITT; all treated patients including dropouts) and per protocol (excluding dropouts) analyses were conducted. Mean age of patients was 51 years, 87% were Caucasian, 78% had cirrhoses, and 45% had portal hypertension. The number of primary endpoints observed was comparable between groups in both the ITT and per protocol analyses. HCC was more common in the PEG-INF group, occurring in 26 patients in the PEG-INF group and in 12 patients in the colchicine group. Portal hypertension was more common in the colchicine group, occurring in 39 patients compared with 26 in the PEG-INF group, with the major difference being the incidence of variceal bleeding. In the ITT analysis, the 4-year event rate in patients with portal hypertension was 32% with colchicine versus 23% with PEG-INF (P = .057). In both the ITT and per protocol analyses, an event-free survival benefit was observed with PEG-INF in patients with portal hypertension at 2 and 4 years. The benefit was more significant in the per protocol analysis (logrank P = .038) than in the ITT analysis (logrank P = 0.057). In the overall study population, however, no difference between treatments was observed in either the ITT or per protocol analyses. In addition, there was no difference between the agents in their ability to prevent HCC. Of the overall patient group, 49% discontinued medication over the 4-year study period -- due to lack of adherence to treatment in 36% (96 patients with colchicine and 105 with PEG-INF) and due to adverse effects in 13% (26 patients with colchicine and 49 with PEG-INF). In the overall ITT analysis, Dr. Afdhal said, PEG-INF alfa-2b was not superior to colchicine as maintenance therapy, although the efficacy was superior in patients with portal hypertension, particularly in patients who stayed on treatment. "The mechanism of action may be mediated by the effect of PEG-INF on portal hypertension, and this effect appears to be more profound in the early phases of treatment," he added. The researchers concluded that PEG-INF alfa-2b should be considered for maintenance therapy in patients with portal hypertension who have failed eradication therapy. [Presentation title: Colchicine Versus Peg-Interferon Alfa 2b Long Term Therapy: Results of the 4 Year COPILOT Trial. Abstract 3] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.