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Abstract
STI VS. CONTINUOUS HAART DURING CHRONIC HIV INFECTION
LORI F, FOLI A, TOMASONI L, MAGGIOLO F, HURWITZ S, LISZIEWICZ J, MASERATI R
Background. Viral load (VL) set-point can be lowered by structured treatment interruptions (STI) during acute infection, but uncontrolled studies suggest that such results may not apply to chronic infection. We present the first prospective, randomized, controlled trial comparing continuous HAART to STI.
Methods. 60 drug-naïve patients with chronic HIV infection (CD4 >250, VL >5,000) were randomized to receive ddI-d4T-IDV or ddI-d4T-HU. After 12 weeks therapy, they were further randomized to receive 24 weeks of fixed-schedule STI (3weeks on/3weeks off therapy, 4 cycles), or continuous HAART. VL and CD4 changes in the first 30 patients during 36 weeks follow up (interim analysis) were analyzed with Wilcoxon signed rank, rank-sum exact statistical tests.
Results. Regardless of the drug regimen (HU or IDV) VL rebounded in the STI group at each therapy interruption, in most cases to values similar to baseline, and the rate of VL rebound did not change significantly during subsequent interruptions. Restarting therapy, however, suppressed VL to values similar to the continuous HAART group. At week 36, VL was 182 [108, 341] and 70 [<50, 1101] copies/ml in the STI and continuous HAART groups, respectively. CD4 count (cells/mm3) transiently decreased during interruptions. Nonetheless, at week 36 the median [Q1, Q3] increase in the STI/IDV group was 154 [95, 285] (P=0.036 from baseline), similar to the continuous HAART/IDV group (167 [116, 219]). In the continuous HAART/HU group a CD4 decrease of -27 [-68, 15] was observed at week 36. Unexpectedly, the CD4 count increase in the STI/HU group was 134 [103, 145] (P=0.031 from baseline), comparable to the STI/IDV group.
Conclusions. Encouraging (VL decrease and CD4 increase similar to continuous therapy, or improved) and tempering (transient CD4 loss and VL rebound without set-point reduction) results must be weighed to assess whether STI is a valuable alternative for long-term control of HIV.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
56
Suggested Citation
"LORIF, et al.
STI VS. CONTINUOUS HAART DURING CHRONIC HIV INFECTION.
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
56"
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