To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Outcome Data Disputed in Abacavir/Lamivudine Comparison Trial: Presented at AIDS 2008 URL: http://www.pslgroup.com/dg/22799E.htm Doctor's Guide August 10, 2008
By Ed Susman MEXICO CITY -- August 10, 2008 -- A pooled analysis of 6 clinical trials did not uncover any evidence that the fixed-dose combination of abacavir/lamivudine is inferior to other dual drugs used in treating patients with human immunodeficiency virus (HIV) infection, according to researchers from GlaxoSmithKline, reporting here at the 17th International AIDS Conference (AIDS 2008). Keith Pappa, PharmD, GlaxoSmithKline, Research Triangle Park, North Carolina, and colleagues performed their analysis following reports from the AIDS Clinical Trial Group that its A5205 trial results found abacavir/lamivudine less beneficial to patients than the comparator fixed-dose combination of tenofovir/emtricitabine. "The recent A5205 findings are unique and differ from clinical experience," said Dr. Pappa speaking here on August 7, following an oral presentation of the A5205 data. He noted that, when the data from the GlaxoSmithKline-sponsored clinical trials were analysed -- using the same endpoints as in A5205 -- there was no difference in outcome between the abacavir/lamivudine data and any comparator drug. The 6 trials, including the company-sponsored Head-to-Head Epzicom and Truvada (HEAT) trial presented earlier this year, all showed a probability of virological failure at week 48 of no more than 13% regardless of viral load, said Dr. Pappa. He added that the HEAT trial demonstrated comparable numbers of patients in each arm reaching a viral load of less than 50 copies/mL throughout the course of the study. HEAT was the first large, prospective, long-term, head-to-head trial to evaluate the safety and efficacy of abacavir/lamivudine and tenofovir/emtricitabine when both were combined with lopinavir/ritonavir, a boosted protease inhibitor administered once daily in adults with no previous exposure to HIV drugs. The study involved 688 HIV therapy-naïve patients: 343 were randomised to treatment with abacavir/lamivudine and 345 were randomised to treatment with tenofovir/emtricitabine. Virologic failure occurred in 14% of patients for both groups. The 96-week HEAT study confirmed that the abacavir combination was not inferior to the tenofovir/emtricitabine pill, Dr. Pappa said. Dr. Paul Sax, MD, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, and presenter of the A5205 data at AIDS 2008, noted that the HEAT trial had only 296 patients with viral loads above 100,000 copies/mL compared with about 800 patients in A5205. He added that HEAT combined the fixed-dose medications with lopinavir/ritonavir, while in A5205 the patients were dosed with efavirenz or atazanavir. Those variations, Dr. Sax stated, might account for the different findings. [Presentation title: Abacavir/Lamivudine (ABC/3TC) Shows Robust Virologic Responses in ART-Naïve Patients for Baseline (BL) Viral Loads (VL) of ³100,000c/mL and <100,000c/mL by Endpoint Used in ACTG5202. Abstract: THAB0304] --------------------------------------------------------------------------------------------- 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.