9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland

Background: Randomised clinical trials to establish the usefullness of genotypic resistance-guided treatment decisions (GRT) are short term.

Methods: We analysed the virological, immunological and clinical outcomes for 36 months of patients Argenta: for the initial 6 months patients were randomized to GRT or SOC, afterwards both arms received GRT. Predictors of virologic outcomes were analysed by logistic regression; predictors of clinical progession (new AIDS events/death) by Cox's models. All analyses were intent-to-treat.

Results: 174 patients were initially randomized (85 GRT, 89 SOC). Baseline characteristics were homogeneous (except IDU in SOC 42%, in GRT 22%). Median antiretroviral exposure was 24 months, 25% had failed >3 HAART regimens. At 36 months drop-outs were 23.6%. HIV RNA<500 at 3 months was higher in GRT (27% vs 12% p=.01). 36-month mean change from baseline VL and CD4 were -1.21 log and +86 cells/ml. Clinical progression occurred in 24 (6.4/100 PY). Independent predictors of 36-month VL<500 were daily doses of initial salvage therapy (OR 0.64, 95%CI 0.42-0.97) and 3-month VL change (1 log more OR 1.52, 1.08-2.16). Predictors of clinical progression were CDC class C at entry (HR 2.78; 1.12-7.03), higher baseline VL (each log HR 2.15; 1.04-4.46) and 3-month VL reduction (1 log less HR 1.73;1.04-2.89). In a model using baseline virologic co-variates, K20M (HR 3.17;1.15-8.84) and I84V (HR 3.38;1.13-10.2) independently predicted clinical progression.

Conclusion: GRT conferred a sustained virologic and immunological benefit independently from the number of failed regimens and immediate or deferred use. Initial VL response predicted long term clinical outcomes.

Presenting Author: DR DE LUCA ANDREA, Catholic University, Rome, Italy, Largo Francesco Vito 1, 00168, Rome, Italy, Phone: +390630154945

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