514-M.
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Long-Term Efficacy of Subcutaneous IL-2 Therapy in HIV Infection. Final Analysis of the ANRS 079 Randomized Trial and Long-Term Follow-up
Y. Levy*1, C. Durier2, A. S. Lascaux1, C. Capitant2, C. Michon3, L. Weiss4, E. Oksenhendler5, J. A. Gastaut6, C. Goujard7, C. Rouzioux8, J. P. Aboulker2, J. F. Delfraissy7, and the ANRS 079 Study Group9
1Hosp. Henri Mondor, Créteil; 2INSERM, Villejuif; 3Hosp. Louis Mourier, Colombes; 4Hosp. Georges Pompidou, Paris; 5Hosp. Saint-Louis, Paris; 6Inst. Paoli-Calmettes, Marseille; 7Hosp. Bicêtre, Kremlin-Bicêtre; 8Hosp. Necker, Paris; and 9ANRS, Paris, France
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Background: Our goal was to assess the long term efficacy of SC IL-2.
Methods: 118 patients naïve to antiretrovirals or naïve to PI were randomized to start and receive over 74 weeks D4t+3TC+indinavir either alone (HAART, n=58) or combined with SC IL-2 cycles (n=58) (5 MIU, BID, 5 days) every 4 weeks (3 cycles), and then every 8 weeks (7 cycles). After week 74, 52 (HAART), and 50 (IL-2 arm) patients consented to an extended follow-up (EFU).
Results: Median follow-up was 35 (range 20-45) months. Patients from the IL-2 group received 446 and 10 cycles during the randomized phase and the EFU, respectively. 8 (HAART) patients received 15 cycles during the EFU. At baseline (BL) median CD4 cell counts/muL were 342 (HAART) and 353 (IL-2 arm). The median CD4 increase was +262 (HAART) and +835 (IL-2 arm) at week 74 (p<0.0001), and +365 and +604 at last assessment (LA), respectively (p=0.0002). At LA, 88 patients (90%) were on triple combination (48 and 40 pts in HAART and IL-2 groups, respectively, p=0.51), 6 patients were on NRTI combinations and 4 discontinued antivirals. Mean plasma HIV RNA log10 copies/mL, which was 4.16 (HAART) and 3.95 (IL-2 arm) at BL, decreased repectively in those 2 groups to 1.87 (SD 0.51) and 2.08 (0.83) at week 74 (p=0.16) and to 2.07 (0.92) and 2.04 (0.98) at LA (p=0.65). At LA, 78% (HAART) and 76% (IL-2 arm) of patients had HIV RNA below 50 copies/mL (p=0.81). At LA, 84% and 70% of patients respectively naïve to antiretrovirals or to PI at entry had HIV RNA <50 copies/mL, with no significant differences between groups.
Conclusions: IL-2 recipients experienced a faster and a higher immunological response, which was maintained over 35 months with rare IL-2 cycles after M18, compared to pts treated with HAART who progressively increased their CD4 counts over 3 years. At LA, the decrease of plasma HIV RNA and the proportion of patients with undetectable viral load was similar in both groups.
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