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Abstract
CD4-guided STI: four-years follow-up of a controlled, prospective trial
F. Maggiolo1, D. Ripamonti1, A. Callegaro2, G. Gregis1, G. Quinzan1, M. Airoldi1, E. Bombana1, C. Arici1, F. Suter1
Background: To compare continuous HAART with a CD4-driven STI strategy. The primary end-points were immunologic, virologic and clinical response.
Methods: The BASTA study is a randomized, controlled, prospective trial. CD4 counts >800 cells/mcl were set to stop HAART while therapy was resumed at a CD4 count of 400 cells/mcl. 114 patients were enrolled.
Results: Patients in the STI group performed 108 STI cycles, their were off-therapy for 70.46% of the FU time (mean). Patients who re-started restarted HAART always presented a sharp CD4 increment, however the STI strategy failed to constantly maintain a proportion of patients similar to that in the continuous HAART group with a CD4 count >400 cells/mcl. All patients responded virologically to the re-introduction of HAART and HIV-RNA declined invariably <400 copies/ml.
4/76 (5.2%) patients in the STI group and 1/38 (2.6%) in the control group failed virologically with resistance-conferring mutations (difference 2.7%; 95%CI from-4.6 to 9.8%). Being the 95%CI for the difference within ±10% the two strategies may be considered equivalent. Clinical progression or death was observed in 3 patients in the control group and in none in the STI group (P = 0.035). The nadir CD4 count was statistically associated (P<0.01) to the length of the first STI cycle, the proportion of follow-up off-therapy and to the cost of the strategy. A nadir CD4 count of 350 cells/mcL is a significant cut-off value.
Conclusions: CD4-guided pulse-therapy is as least as effective as continuous HAART from the immunologic, virologic and clinical standpoints and is generally safe if patients are properly monitored. A nadir CD4 cell count <350 cell/mcL is the main predictor of CD4 cell decline and of the possibility to stay off-therapy. These findings should be considered in designing STI programs, but also outline possible risks of a late start of HAART.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
WEAB0202
Suggested Citation
"F.Maggiolo, et al.
CD4-guided STI: four-years follow-up of a controlled, prospective trial.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
WEAB0202"
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