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Blood, 1 May 2004, Vol. 103, No. 9, pp. 3282-3286.
Prepublished online as a Blood First Edition Paper on January 15, 2004; DOI 10.1182/blood-2003-09-3283.


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Submitted September 29, 2003
Accepted December 31, 2003

Induction and Maintenance Therapy with Intermittent Interleukin-2 in HIV-1 Infection

Claire E Farel, Doreen G Chaitt, Barbara K Hahn, Jorge A Tavel, Joseph A Kovacs, Michael A Polis, Henry Masur, Dean A Follmann, H C Lane, and Richard T Davey*

Laboratory of Immunoregulation, NIAID/NIH, Bethesda, MD, USA
Critical Care Medicine Department, NIH Clinical Center, Bethesda, MD, USA

* Corresponding author; email: rdavey{at}niaid.nih.gov.

Studies establishing that intermittent sc interleukin-2 (IL-2) therapy can lead to substantial CD4 cell increases in many HIV-infected patients have generally been of limited duration. We studied 77 patients participating in active longitudinal studies of sc IL-2 therapy at our center in order to determine the long-term feasibility of this approach. Following initial induction, patients in each trial were eligible to receive intermittent 5-day cycles of sc IL-2 treatment at individualized doses and frequencies capable of maintaining CD4 counts at post-induction levels. The mean duration of study participation to date is 5.9 (range: 1.0 - 9.3) years. Mean baseline CD4 cell count and CD4% values of 521 cells/microLiter and 27% have risen to 1005 cells/µl and 38%, respectively, at 90 months. The mean number of sc IL-2 cycles required to achieve and maintain these increases was 10 (range: 3 - 29) cycles, and the current mean interval of cycling required to maintain these elevations is 39 (median = 35, range: 2 - 91) months. We conclude that sc IL-2 therapy is capable of maintaining CD4 cell increases for an extended period using a remarkably low frequency of intermittent cycling. These observations may contribute to patients' acceptance of sc IL-2 as a favorable long-term treatment strategy.


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