[13] PRELIMINARY RESULTS OF ESPRIT (EVALUATION OF SUBCUTANEOUS PROLEUKIN IN A RANDOMISED INTERNATIONAL TRIAL): BASELINE PREDICTORS OF CD4 T-CELL RESPONSE TO INTERLEUKIN-2

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] PRELIMINARY RESULTS OF ESPRIT (EVALUATION OF SUBCUTANEOUS PROLEUKIN IN A RANDOMISED INTERNATIONAL TRIAL): BASELINE PREDICTORS OF CD4 T-CELL RESPONSE TO INTERLEUKIN-2

[AUTHOR(S):] L Weiss¹, J Aboulhab², GA Babiker², JD Bebchuk³, J Darbyshire², D Newberry², C Capitant¹ and JP Aboulker¹ for the ESPRIT research group
¹Hospital European Georges Pompidou, Paris, France; ²Medical Research Council, London, UK; and ³University of Minnesota, Minneapolis, MN, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 13
Antiviral Therapy 2003; 8(Suppl. 1):S188

[ABSTRACT:] Background: ESPRIT is an international, randomized (1:1) trial to determine if subcutaneous (SC) IL-2 therapy in addition to combination antiretroviral therapy (ART), compared to ART alone reduces the risk of progression of disease (POD), (defined as AIDS or death) among patients (pts) with baseline CD4 ≥300 cells/mm³.

Methods: As of March 2003, among 3832 patients enrolled, 1394 of 1929 assigned IL-2 have completed at least 8 months follow up. Of these, the 1142 (82%) who completed 3 cycles of IL-2 are the focus of this report. The median age at baseline was 41 yrs. 18% were female, 23% had prior POD, 13% co-infected with HCV, 5% co-infected with HBV, median ART experience was 54 months, with 77% undetectable HIV viral load and median baseline CD4 and nadir CD4 of 472 (IQR: 380–600 cells/mm³) and 216 (IQR: 117–328 cells/mm³) respectively. The relationship between baseline characteristics and CD4 cell response after 3 cycles of IL-2 at 8 months of follow up are explored using logistic regression.

Results: Of the 1142 patients who completed 3 cycles of IL- 2 by month 8, 9.1% were classified as 'non-responders' because they had CD4 counts below their baseline values. There were 4.6% who had a small increase of less than 50 cells/mm³, and 22.4% who had an increase of between 51 and 200 cells/mm³. The remaining participants, 63.9%, were classified as 'responders' because they had an increase of at least 200 cells/mm³, (27.5% did not reach their CD4 goal, defined as twice the CD4 baseline or 1000 cells/mm³, and 36.4% did). The following were associated with CD4 response (>200 cell/mm³ increase or above CD4 goal at 8 months): higher nadir CD4 (P<0.001), higher baseline (P=0.02) CD4, and younger age (P=0.03). Odds of response increased by 28% and 11% respectively, for a 100 higher nadir and baseline CD4 count, and by 19% for 10 year younger age. There was no evidence of an association with viral load <500 copies/ml, hepatitis C or B status, time on ARTs, prior POD or gender.

Conclusions: CD4 cell count response after the first 3 cycles of IL-2 at Month 8 is associated with a higher nadir and baseline CD4 and younger age.

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