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INTERSTART : PATIENTS AND DESIGN

Interleukin-2 (IL-2) therapy to prevent CD4 T-cell loss and defer HAART in antiretroviral naïve HIV-infected patients (ANRS 119 – Interstart trial).

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INTERSTART : PATIENTS AND DESIGN

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  1. Interleukin-2 (IL-2) therapy to prevent CD4 T-cell loss and defer HAART in antiretroviral naïve HIV-infected patients (ANRS 119 – Interstart trial) Molina JM, Levy Y, Fournier I, Boulet T, Bentata M, Beck-Wirth G, Sereni D, Jeanblanc F, Goujeon ML, Venet A, Madelaine I, Simon F, Aboulker JP for the ANRS 119 - Interstart study team. XVII International AIDS Conference Mexico city, 3-8 August 2008

  2. INTERSTART : PATIENTS AND DESIGN • Phase II/III randomised, controlled trial with primary analysis at Week 96 and extended follow-up to 3 years • Asymptomatic HIV-infection • Treatment-naive or ≤ 3 months HAART • 500 ≥ CD4 ≥ 300 CD4/mm3 • Any plasma HIV RNA level IL-2 : 4.5 MIU/bid 5 days No treatment • Patients in the IL-2 arm received : • 4 cycles of IL-2 at weeks 0, 8, 16 and 24 • 1 or 2 additional cycles per year after week 48 if CD4 count < 1.2 times baseline • Primary endpoint : treatment failure defined as • confirmed CD4 count < 300 • AIDS defining event or death • initiation of HAART for any other reason XVII International AIDS Conference Mexico city, 3-8 August 2008

  3. 1.0 1.0 1.0 0.9 0.9 0.9 0.8 0.8 0.8 0.7 0.7 0.7 0.6 0.6 0.6 0.5 0.5 0.5 0.4 0.4 0.4 0.3 0.3 0.3 0.2 0.2 0.2 0.1 0.1 0.1 0.0 0.0 0.0 INTERSTART : TIME TO TREATMENT FAILURE Probability of non progression IL­2 Control 48 Wks Log Rank P-Value <0.0001 0 0 0 25 25 25 50 50 50 75 75 75 100 100 100 125 125 125 150 150 150 175 175 175 200 200 200 Control 63 50 38 31 22 11 4 IL-2 65 61 54 50 38 32 14 3 XVII International AIDS Conference Mexico city, 3-8 August 2008

  4. < 4.5 log10 IL-2 < 4.5 log10 Control 0.64 [0.47-0.77] 0.10 [0.02-0.26] 43 43 40 36 31 28 13 2 34 28 23 17 10 4 2 TIME TO TREATMENT FAILURE BY BASELINE PLASMA HIV-RNA LEVELS (post-hoc analysis) Probability of non progression 1.0 1.0 1.0 1.0 1.0 1.0 ≥ 4.5 log10 IL-2 ≥ 4.5 log10 Control 0.9 0.9 0.9 0.9 0.9 0.9 0.8 0.8 0.8 0.8 0.8 0.8 80 Wks 0.7 0.7 0.7 0.7 0.7 0.7 0.6 0.6 0.6 0.6 0.6 0.6 0.5 0.5 0.5 0.5 0.5 0.5 0.4 0.4 0.4 0.4 0.4 0.4 W150 Estimates 0.3 0.3 0.3 0.3 0.3 0.3 0.10 [0.02-0.26] 0.2 0.2 0.2 0.2 0.2 0.2 0.1 0.1 0.1 0.1 0.1 0.1 0.11 [0.03-0.28] 0.0 0.0 0.0 0.0 0.0 0.0 0 0 0 0 0 0 25 25 25 25 25 25 50 50 50 50 50 50 75 75 75 75 75 75 100 100 100 100 100 100 125 125 125 125 125 125 150 150 150 150 150 150 175 175 175 175 175 175 200 200 200 200 200 200 Patients at risk Weeks 21 17 13 13 7 4 1 1 29 22 15 14 12 7 2 XVII International AIDS Conference Mexico city, 3-8 August 2008

  5. INTERSTART : CONCLUSIONS • IL-2 therapy, by its effect on CD4 T-cells, was able to slow the progression to the primary endpoint in asymptomatic HIV-infected patients • IL-2 benefit extended well beyond week 48, with no or very little additional IL-2 cycles. • Patients with low levels of plasma HIV-1 RNA at baseline benefited most from this intervention. • A strategy of IL-2 therapy that could prevent CD4 loss and immune deficiency, and defer thereby the need for HAART for years, deserves further investigation. XVII International AIDS Conference Mexico city, 3-8 August 2008

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