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Abstract
A RANDOMISED TRIAL OF THYMIDINE ANALOGUE WITHDRAWAL IN LIPOATROPHIC HIV PATIENTS, VIROLOGICALLY CONTROLLED ON PROTEASE SPARING THERAPY - THE PIILR EXTENSION STUDY.
SMITH D, CARR A, LAW M, HUDSON J, HOY J, COOPER D
Background: Nucleoside analogue induced mitochondrial toxicity has been implicated in the loss of subcutaneous fat (lipoatrophy) in patients on HAART therapy. Both stavudine (d4T) and zidovudine (ZDV) are thought to induce this condition, although causation has been confounded by the metabolic effects of concurrent protease inhibitor (PI) therapies. We therefore studied the effect of thymidine analogue withdrawal in patients who were virologically well controlled on a PI sparing regimen, but had clinical lipoatrophy.
Methods: Patients with lipoatrophy, who replaced PI therapy for quadruple RT inhibitor therapy 6-12 months earlier (as part of the original PIILR study) were randomised to continue current therapy or to cease either stavudine or zidovudine, if their current viral load was <400 copies. Regional changes in body fat were assessed by DEXA scans at weeks 0, 12 and 24.
Results: Nineteen patients were enrolled, 10 to continue and 9 to cease d4T or ZDV. At baseline all 19 were on abacavir, nevirapine or efavirenz (18 / 1), d4T or AZT (17 / 2) and 3TC or ddI (18 / 1). 1 patient (cont arm) was lost to follow-up and excluded from the analysis. At 12 weeks significantly more limb fat had been lost in the continue group than the stop group (-0.2 Kg vs +0.19Kg, p=0.008). By 24 weeks the median change in total limb fat was –0.02 in the continue and +0.3 Kg in the stop group (p=0.06). Change in % limb fat was –0.3% vs +1.5% (p=0.034). Total body weight, central fat and lean body mass did not differ between groups.
There were no virological failures in the 10 continue patients, but 5 of the 9 stop patients had viral rebounds, 2 of whom resumed their d4T therapy, (at weeks 8 and 12).
Conclusions: withdrawal of thymidine analogue components of therapy in lipoatrophic patients on a PI-sparing regimen results in a significant improvement in peripheral fat stores, but is associated with loss of virological control in these treatment experienced patients.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
96
Suggested Citation
"SMITHD, et al.
A RANDOMISED TRIAL OF THYMIDINE ANALOGUE WITHDRAWAL IN LIPOATROPHIC HIV PATIENTS, VIROLOGICALLY CONTROLLED ON PROTEASE SPARING THERAPY - THE PIILR EXTENSION STUDY..
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
96"
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