To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Low Risk of Hepatotoxicity With Once-Daily Nevirapine: Presented at CROI URL: http://www.pslgroup.com/dg/21C952.htm Doctor's Guide February 6, 2008
By Maria Bishop BOSTON, MA -- February 6, 2008 -- Switching to a once-daily nevirapine regimen is associated with low rates of hepatotoxicity in patients who have already been on standard nevirapine-containing regimens for at least 12 to 18 weeks, according to results of a study presented here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). Traditionally, a great proportion of patients with HIV who develop nevirapine-related hepatotoxicity present with these effects as part of a hypersensitivity reaction in the first 12 to 18 weeks of treatment, according to the study's lead author Daniel Podzamczer, MD, Coordinator, AIDS Unit and Member, Infectious Diseases Service, Hospital Universitario de Bellvitge, Barcelona, Spain. In an open, randomized, multicenter study, Dr. Podzamczer and colleagues studied 302 stable patients who tolerated a standard twice-daily regimen containing nevirapine. Patients were switched to a once-daily dose (n = 150) or continued on the twice-daily dose (n = 152). Patients were stratified by CD4 count (< or > 200 cells/mcL) and according to hepatitis C virus (HCV) status. Among the 143 patients who completed the study after switching to the once-daily regimen, 114 (80%) continued without hepatotoxicity, compared with 133 (91%) of 146 patients in the twice-daily group. Overall, 3.5% of patients in the once-daily group experienced liver toxicity versus 0.7% in the twice-daily group. In the once-daily group, 2 patients considered to have liver toxicity presented with hepatitis A and C viruses. If these patients are removed the percentage of events changes to 2.1%. Hepatitis C virus and alanine aminotransferase (ALT) levels at baseline were independently associated with risk of hepatotoxicity, Dr. Podzamczer noted. The primary outcome in the study -- time to liver toxicity (represented by an ALT and/or aspartate aminotransferase level of grade 3 or more) -- was demonstrated at the following times in the 6 observed patients: week 48, week 8, week 10, week 12, week 24, week 48. The authors concluded that switching to once-daily nevirapine is associated with a low frequency of hepatotoxicity while viral suppression is maintained. [Presentation title: Low Hepatoxicity in Patients Randomized to Switching to Nevirapine Once Daily vs Continuing With Nevirapine Twice Daily. Abstract 960] --------------------------------------------------------------------------------------------- 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.