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Session 67 Poster Session Disease Progression/Effects of Treatment Session Time: 4:30-6:30 pm Room 4E-F

476-M. Changes in both CD4 Cell Counts and HIV-1 RNA Levels Predict Subsequent Disease Progression among HIV-1-Infected Persons Initiating Antiretroviral Therapy R. Hogg*, B. Yip, K. Chan, E. Wood, P. R. Harrigan, K. Craib, M. V. O'Shaughnessy, and J. S. G. Montaner BC Ctr. for Excellence in HIV/AIDS and the Univ. of British Columbia, Vancouver, Canada; Background: Our objective was to describe the impact of changes in CD4 cell count and HIV-1 RNA levels on disease progression among HIV-1 infected persons initiating antiretroviral therapy. Methods: A population-based analysis of antiretroviral therapy-naïve HIV-positive men and women 18 years or older in British Columbia, Canada. Eligible patients were antiretroviral therapy naïve and initiated triple combination therapy between August 1, 1996 and September 30, 1999. Cumulative mortality rates were estimated using Kaplan-Meier methods. Rates of progression from the initiation of therapy to death were determined using various CD4 and plasma HIV-1 RNA thresholds. Cox-proportional hazard regression was used to model the simultaneous effect of prognostic variables on survival. CD4, HIV-1 RNA levels, a diagnosis of AIDS, and treatment class (PI versus NNRTI) were treated time-dependent co-variates. An intent-to-treat principle was used in all analyses. Results: A total of 1219 men and women were eligible. As of September 30, 2000, 82 patients had died of AIDS-related causes, for a crude mortality rate of 6.7%. Cumulative mortality at 12 months was 2.9% + 0.5. In univariate analyses, a prior AIDS diagnosis, CD4 cell count, the use of protease inhibitors, and HIV-1 RNA levels at baseline were found to be associated with mortality. Only CD4 cell count and HIV-1 RNA level remain statistically significant in the time-dependent analysis. Those with CD4 cell counts of <50 cells/ mm3 were 15.74 (95% CI: 8.83, 28.04; p < 0.001) times more likely to die and those with counts of 50 to 199 cells/ mm3 were 2.27 (95% CI: 1.20, 4.29; p < 0.001) times more likely to die than those with CD4 cell counts *200 cells/ mm3. In comparison, those with HIV-1 RNA levels > 100,000 copies/mL were 2.17 (95% CI: 1.33, 3.54; p < 0.001) were likely to die than those with HIV-1 RNA levels < 100,000 copies/mL. Conclusion: Our data demonstrated a continued clustering of deaths among persons initiating therapy with CD4 cell counts <200 cells/ mm3. In this time-dependent analysis we show that changes in CD4 count and in HIV-1 RNA levels are markers of disease progression independent of treatment class and AIDS diagnosis.

©2002 9th Conference on Retroviruses and Opportunistic Infections