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Long-term effects of intermittent interleukin-2 therapy in chronic HIV-infected patients (ANRS 048–079 Trials)*

Durier, Christinea; Capitant, Catherinea; Lascaux, Anne-Sophieb; Goujard, Cécilec; Oksenhendler, Ericd; Poizot-Martin, Isabellee; Viard, Jean-Paulf; Weiss, Laurenceg; Netzer, Emmanuellea; Delfraissy, Jean-Françoisc,h; Aboulker, Jean-Pierrea; Lévy, Yvesb

doi: 10.1097/QAD.0b013e3282703825
Clinical Science

Objective: Interleukin (IL)-2 therapy leads to significant CD4 cell increases in HIV-infected patients. Since phase III trials are ongoing, studies supporting the long-term feasibility of this strategy are needed.

Methods: We studied the long-term outcomes of 131 patients treated with IL-2 in two studies initiated either before (ANRS 048) or following (ANRS 079) the advent of HAART.

Results: At the last assessment (median follow-up 3.4 years), these patients experienced a gain of 428 cells/μl and a decrease in plasma HIV RNA to 1.70 log10 copies/ml. In both studies, high CD4 cell counts were maintained with a median of ten 5-day cycles of subcutaneous IL-2. Median time since the last cycle was 2 years. At last assessment, 59% of 048 patients maintained a non-HAART regimen. Detailed analysis at week 170 showed that median CD4 cell counts were 856 (048) and 964 (079) cells/μl. This corresponded to a gain from baseline of 515 (048) and 627 (079) cells/μl. The median viral load decreases from baseline and corresponded to 1.70 (048) and 1.88 (079) log10 copies/ml. Comparisons across the studies showed that CD4 gains and viral load changes were similar whether HAART or non-HAART was used. The frequency of cycling, but not CD4 cell counts, viral loads or antiviral regimen at baseline, was predictive of long-term CD4 gain (P = 0.03).

Conclusion: Altogether, these observations support IL-2 as a long-term therapeutic strategy in HIV infection.

From the aINSERM SC10, Villejuif

bHôpital Henri Mondor, Université Paris 12, INSERM U 841, Créteil, Paris

cHôpital Bicêtre, Kremlin-Bicêtre, Paris

dHôpital Saint-Louis, Paris

eHôpital Sainte-Marguerite, Marseille, Paris

fHôpital Necker, Paris, France

gHôpital Européen Georges-Pompidou, Paris, France

hANRS, Paris, France.

Received 21 December, 2006

Revised 2 May, 2007

Accepted 10 May, 2007

Correspondence to Yves Lévy, Unité d'Immunologie Clinique, Hôpital Henri Mondor, 51, avenue du Maréchal de Lattre de Tassigny 94010 CRETEIL Cedex, France. E-mail:

*Acknowledgements for ANRS 048 and ANRS 079 Study members, ANRS, Paris, France.

© 2007 Lippincott Williams & Wilkins, Inc.