16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

PROGRESSION OF HIV-RELATED DISEASE OR DEATH (POD) IN THE RANDOMISED SMART STUDY: WHY WAS THE RISK OF POD GREATER IN THE CD4-GUIDED ((RE)-INITIATE ART AT CD4 <250 CELLS/μL) DRUG CONSERVATION (DC) VS THE VIROLOGICAL SUPPRESSION (VS) ARM?

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. WeAb0203

Lundgren J.D., on behalf of the SMART Study Group
Hvidovre University Hospital/University of Copenhagen, Copenhagen HIV Programme (044), Hvidovre, Denmark

BACKGROUND: SMART(n=5472) demonstrated a 2.5-fold greater risk of POD in the DC- vs VS-arm. Factors associated with this finding are reported here.

METHODS: POD event (n=164) rates were calculated based on the proximal CD4 cell and HIV-RNA (VL) levels. Cox models assessed whether these levels affected the difference between arms in risk of POD and determined independent risk factors for POD in each arm.

RESULTS: The median (IQR) of the proximal CD4 cell count prior to diagnosis of PODs was 333 cells/μL (246 – 488) and 512 (328 – 651) in the DC- and VS-arms, respectively. The rate of POD was higher for lower strata of proximal CD4 counts and for higher strata of VL levels in both arms, but higher in DC- vs VS-arm for CD4>350 and VL<3.5.

Per design, in the DC-arm, more time was spent with lower CD4 and higher VL levels. Risk of POD in the DC-arm was associated with lower proximal CD4 counts and older age; higher proximal VL levels and older age predicted risk in VS-arm. The hazard ratio (DC/VS) for POD was reduced from 2.5 (p<0.001) to 1.4 (p=0.12) after adjustment for proximal CD4 and VL levels. Patients in DC-arm (re)-initiated ART at protocol-specified CD4 levels (232 cells/μL (192 – 299)), and achieved good CD4/VL responses (e.g. median time to VL <400 copies/mL = 3 months; 142 CD4-cell/μL increase after 8 months); POD rates were similar for three 4-month intervals following ART initiation: 5.1, 5.3, and 5.7/100 PY.

CONCLUSIONS: Intended differences in proximal CD4 and VL levels between the arms of the study explains a substantial part of the difference in the risk of POD between the DC and VS arms. Additional analyses on predictors of POD will be presented.

Download PDF of this abstract.

Download Power Point Presentation.

2006-08-13
WeAb0203

Copyright © 2006 - International AIDS Society (IAS). All information and content relating to the abstracts from the 16th International AIDS Conference, 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 a 501c(3) not-for-profit organization made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, GlaxoSmithKline, the National Library of Medicine, Roche / Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2006. 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, 2006. 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.