[O24A] PREDICTORS OF CURRENT CD4+ T-CELL RESPONSE AMONG PATIENTS RECEIVING SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 (RIL-2) IN ESPRIT (EVALUATION OF SUBCUTANEOUS PROLEUKIN® IN A RANDOMIZED INTERNATIONAL TRIAL)

11th Annual Conference Of The British HIV Association [BHIVA]

20–23 April 2005, Burlington Hotel·Dublin·Ireland

[TITLE:] PREDICTORS OF CURRENT CD4+ T-CELL RESPONSE AMONG PATIENTS RECEIVING SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 (RIL-2) IN ESPRIT (EVALUATION OF SUBCUTANEOUS PROLEUKIN® IN A RANDOMIZED INTERNATIONAL TRIAL)

[AUTHOR(S):] H Nuwagaba-Biribonwoha¹, BJ Angus^1,2, J Bebchuk³, A Babiker¹, B Cordwell¹, F van Hooff¹, L Hack¹, Y Moraes¹, B Gazzard⁴, J Darbyshire¹ on behalf of the ESPRIT Research Group
¹Medical Research Council Clinical Trials Unit, London, UK, ²Nuffield Department of Medicine, Oxford University, Oxford, UK, ³Division of Biostatistics/CCBR, School of Public Health, University of Minnesota, Minneapolis, USA, ⁴Chelsea and Westminster Hospital, London, UK

BHIVA Conf 2005 Apr 20-23;11:O24A

AIM: To examine predictors of current CD4+ response in patients on the rIL-2 arm of ESPRIT.

BACKGROUND: ESPRIT is an international, phase III, open-label, randomized trial comparing the effects of subcutaneous rIL-2 and no rIL-2 on disease progression and death in HIV-1 patients with absolute CD4+ counts ≥300/µl at baseline who are taking combination antiretroviral therapy (ART).

METHODS: Baseline and rIL-2 cycling characteristics of patients randomized to rIL-2 were analysed. Logistic regression determined the independent predictors of CD4+ increase >200/µl above baseline at 35 median months of follow-up.

RESULTS: Analysis was based on 1,977/1,998 (99%) of patients receiving rIL-2. At their most recent follow-up examination, 876 (44%) had CD4+ increase >200/µl while 1,101 (56%) had CD4+ increase ≤200/µl from a median baseline CD4+ of 470/µl and 460/µl respectively. More patients with CD4+ increase >200/µl had baseline viral load <50 copies/ml (83% versus 77%; OR=1.8, 95%CI 1.4–2.3, p<0.001); and had completed (4 cycles of rIL-2 (67% versus 48%; OR=2.2, 95%CI 1.8–2.7, p<0.001). Age, duration of ART, nadir CD4+, baseline CD4+, gender, and stage of HIV disease at baseline were not significantly associated with CD4+ increase >200/µl above baseline. The results were similar for the UK subset of patients.

CONCLUSIONS: More rIL-2 cycles and undetectable viral load at baseline were associated with a better CD4+ response.

PRESENTING AUTHOR: H Nuwagaba-Biribonwoha

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2005-04-20
O24A

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