3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

SAFETY OF ABACAVIR (ABC)+LAMIVUDINE (3TC)-BASED HAART IN ART-NAÏVE HIV-INFECTED SUBJECTS WITH AND WITHOUT HEPATITIS B (HBV) AND/OR HEPATITIS C (HCV) CO-INFECTION

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe1.1C16

Zhao H., Hernandez J., Cutrell A., Givens N., Wakeford J., Scott T.
GlaxoSmithKline R&D, Research Triangle Park, North Carolina, United States of America

INTRODUCTION: HIV infection has been associated with increases in HBV-related morbidity and mortality and accelerated HCV-related liver damage. Conversely, HBV and/or HCV co-infection may increase the risk of liver toxicity from antiretroviral therapy (ART).

METHODS: Data from ART-naïve, HIV-infected subjects participating in 4 large, randomized clinical trials using ABC+3TC once daily (QD) or twice daily (BID) in combination with EFV or protease inhibitors (PI) were used for this analysis. Safety data over >48 weeks of ART for patients with HBV (baseline positive HBV-SAg) and/or HCV (baseline positive anti-HCV) co-infection were compared to those of subjects without co-infection. Descriptive statistics were summarized for subjects with and without HBV and/or HCV co-infection.

RESULTS: The percentage of subjects with HBV and/or HCV co-infection was 15 to 25% in these 4 large clinical trials using ABC+3TC. Of 1985 subjects participating, 389 (20%) were HBV and/or HCV co-infected. Baseline demographics and disease characteristics were comparable between subjects with and without (1596 subjects) HBV/HCV co-infection. The overall incidence of Adverse Events (AEs) was not different between the two groups. The percentages of subjects reporting grade 2-4 AEs through 48 weeks were 71% (275/389) of subjects with vs. 71% (1135/1596) of subjects without co-infection (p=0.9 by two sided Fisher's exact test). Similarly, the percentages of subjects reporting treatment emergent AEs were also comparable: 70% (272/389) of subjects with vs. 71% (1135/1596, p=0.6, two-sided Fischer's exact test) without co-infection.

CONCLUSIONS: In subjects treated with ABC+3TC based HAART, there was no significant difference in the incidence and/or type of AEs, grade 2-4 AEs or treatment emergent AEs, regardless of whether subjects were HBV and/or HCV co-infected or not. In addition, the incidence of specific adverse events in co-infected subjects did not differ between subjects taking ABC QD and those taking ABC BID.

Download PDF of this abstract.

050724
Clinical | TuPe1.1C16 | Trevor Scott
Hepatitis viruses

Copyright © 2005 - International AIDS Society (IAS). All information and content relating to the abstracts from the 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment, such as text, graphics, logos, button icons, images, audio clips, and software is protected by copyright. Permission is hereby granted for the non-commercial use or reproduction of the information on this web site, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.

AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. Permission is hereby granted for the non-commercial use or reproduction of the information herein, provided that the use of such information is accompanied by an acknowledgement that IAS is the source of the information and the name of the author of the article.