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Session 92 Poster Abstracts
Immune-Based Therapies
Wednesday, 1:30 - 3:30 pm
Hall A


516    
Interleukin-2 as Treatment for Immunological Discordant Patients with CD4 below 200 Cells/µL after at Least 1 Year of HAART
Juan Lopez*1, J Miro2, S Moreno3, R Rubio4, B Mahillo5, C Cifuentes6, V Navarro7, J Portilla8, J Terron9, A Jou10, C Minguez11, J Arribas12, P Viciana13, A Orti14, M Ruiz5, and Gesida 33/03 Study Group
1Hosp Univ Gregorio Marañon, Madrid, Spain; 2Hosp Clin, Barcelona, Spain; 3Hosp Ramon y Cajal, Madrid, Spain; 4Hosp 12 de Octubre, Madrid, Spain; 5AEC-GESIDA, Madrid, Spain; 6Hosp Son Llatzer, Mallorca, Spain; 7Hosp La Fe, Valencia, Spain; 8Hospital General. Alicante. Spain; 9Hosp de Jerez, Cadiz, Spain; 10Hosp Germans Trias i Pujol, Barcelona, Spain; 11Hosp Gen, Castellon, Spain; 12Hosp La Paz, Madrid, Spain; 13Hosp Virgen del Rocio, Seville, Spain; and 14Hosp Virgen de la Cinta, Tarragona, Spain

Background:  Of patients who begin antiretroviral therapy below 200 CD4 cells/µL, 9%will not increase the CD4 above this figure in spite of a good control of viral replication. These patients have a higher risk of developing AIDS-defining events. Our objective was to study the use of interleukin-2 (IL-2) in patients with immunological discordance receiving HAART in Spain.

Methods:  Patients were included if they had been receiving HAART for at least 12 months, had CD4 < 200 cells/µL without further increase for the last 12 months, and had good control of viral replication. Patients were treated with cycles of IL-2, 4,5 MIU subcutaneously every 12 hours for 5 days. Cycles were repeated every 8 weeks, and patients were evaluated after 3 cycles of IL-2.

Results:  Between May 2003 and October 2004, we enrolled 118 patients. Median age was 41 years, 82% were male, 53% were former intravenous drug users, 63% had had a previous AIDS-defining event, and 88% were taking prophylaxis for opportunistic infections. Median nadir CD4 was 24. At inclusion median CD4 cell counts were 129 (IQR 83 to 170) and 89% had an undetectable viral load. The amount of IL-2 administered per cycle was 43.6 MIU per patient in cycle 1, 44.6 MIU in cycle 2, and 43.5 MIU in cycle 3. At present, 72 patients have completed at least 3 cycles of IL-2, 34 patients are receiving their first 3 cycles, and 10 have discontinued IL-2 treatment due to adverse effects during the first 3 cycles. Although adverse effects caused by IL-2 therapy were frequent (78% in cycle 1, 68% in cycle 2, and 59% in cycle 3), grade 3 to 4 toxicity was small (11% in cycle 1, 9% cycle 2, and 5% cycle 3). The most frequent adverse effects were fever, malaise, and myalgia. For those patients who completed their first 3 cycles, the median CD4 cell counts increased from 128 (IQR 82 to 174) at baseline to 182 (IQR 109 to 267) after the third cycle (p < 0.0001), 37% of patients increase their CD4 above 200 cells/µL, and 87.5% remained with undetectable viral load. None of the patients reported new C events while being treated with IL-2.

Conclusions:  IL-2 may increase CD4 counts, even in HIV-infected patients with severe immunodepression. IL-2 should be considered a first option in the treatment of patients with immunovirological discordant response to HAART and CD4 counts < 200/µL.

Keywords: Interleukin-2; Immunotherapy; Inmunovirological discordance