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Abstract
PRELIMINARY RESULTS OF A RANDOMIZED TRIAL COMPARING D4T/DDI/ABACAVIR/EFAVIRENZ TO THE SAME COMBINATION PLUS HYDROXYUREA WITH OR WITHOUT IL-2 AS SALVAGE REGIMENS (THE HYDILE STUDY)
LAFEUILLADE A, CHADAPAUD S, HITTINGER G, MIARA A, BACONNET A, POGGI C
Background: Our objective was to evaluate the efficacy of a RTI regimen, with or without Hydroxyurea (HU) and Interleukin-2 (IL-2), in HIV-infected pts failing PI-containing regimens.
Methods: Randomized study comparing d4T + ddI + abacavir + efavirenz (Group 1) to the same regimen + HU at 500 mg bid (Group 2), to the same regimen + HU and IL-2 at 4.5 MUI bid for 5 consecutive days, 3 courses (Group 3) in pts failing PI-containing regimens but naive of nNRTI and abacavir. Efficacy was assessed by intent-to-treat (ITT) (missing = failure) and on-treatment (OT) analysis.
Results: In 02/01, 62 pts have been included (Group 1: 24, Group 2: 21, Group 3: 17). The median number of previously received drugs was 4 for RTIs and 2 for PIs. Baseline mean CD4 was 386 cells/µL, mean viral load (VL) was 4.01 log (median: 3.92); 71% of pts had = 3 ZDV resistance mutations and 42% had a M184V mutation on plasma sequencing. All pts were ZDV experienced and 87% were d4T experienced. In an ITT analysis at 24 weeks (W), 33.3% (Group 1), 76.1% (Group 2) and 58.8% (Group 3) had VL <200 c/ml (p = 0.01), while in an OT analysis 47.0% (Group 1) vs. 81.2% (Group 2+3) had VL <200 c/ml (p = 0.01). In an ITT analysis at W48, 20.8% (Group 1), 52.3% (Group 2) and 41.1% (Group 3) had VL <200 c/ml (p = 0.04), while in an OT analysis 50.0% (Group 1) vs. 62.1% (Group 2+3) had VL <200 c/ml (p = 0.09). In an ITT analysis at W48, 16.6% (Group 1) and 42.1% (Group 2+3) had VL <50 c/ml (p = 0.03), while in an OT analysis 40% (Group 1), 58.8% (Group 2) and 50% (Group 3) had VL <50 c/ml (p = 0.07). At W48, a mean gain of 104 CD4 was observed in Group 1, a mean decrease of 29 in Group 2 and a mean gain of 77 in Group 3.
Conclusions: These preliminary results suggest that this quadruple regimen keeps activity in multiply RTI experienced pts and is enhanced by addition of HU. Although the use of IL-2 did not increase the antiviral effect, it can attenuate the cytotoxic effects of HU.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
113
Suggested Citation
"LAFEUILLADEA, et al.
PRELIMINARY RESULTS OF A RANDOMIZED TRIAL COMPARING D4T/DDI/ABACAVIR/EFAVIRENZ TO THE SAME COMBINATION PLUS HYDROXYUREA WITH OR WITHOUT IL-2 AS SALVAGE REGIMENS (THE HYDILE STUDY).
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
113"
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