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Abstract
DEXA outcomes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz or both plus dual nucleosides: long-term results from A5005s, a substudy of ACTG 384
M. Dubé1, L. Komarow2, K. Mulligan3, S. Grinspoon4, R. Parker2, G. Robbins5, P. Tebas6, AIDS Clinical Trials Group A5005s and 384 Study Teams
Background: Long-term regional body fat outcomes have not been well-described in randomized antiretroviral drug trials. We previously reported changes in limb fat over 64 weeks that favored ZDV+3TC over ddI+d4T, and efavirenz over nelfinavir.
Methods: DEXA scans were performed every 16 weeks on a subset of 157 antiretroviral-naive subjects who were randomized to receive nelfinavir, efavirenz, or both, combined with ZDV+3TC or ddI+d4T in a multicenter trial. Subjects with any available data after baseline up to week 144 contributed to this as-treated analysis. Data were censored 28 days after a regimen change.
Results: Median limb fat increased similarly in all treatment arms during the first 32 weeks. 65 subjects had week 144 DEXA, including 32 continuing their original regimen. Among 13 subjects who continued to receive ddI+d4T at week 144, the median change from baseline in limb fat was -32.5% (p=0.04 from baseline) and among 19 subjects on ZDV+3TC , the median change was +1.4% (p=1.0 from baseline). After week 32, limb fat changed by -1.7%/year for ZDV+3TC and -19.0%/year for ddI+d4T (MMANOVA p<0.0001). Among 7 subjects receiving nelfinavir without efavirenz at week 144, the median change from baseline limb fat was -23.8%; among 14 receiving both nelfinavir+efavirenz -21.4% (p=0.05 from baseline for pooled data from all nelfinavir recipients), and among 11 subjects on efavirenz without nelfinavir, the median change was +2.4% (p=0.90 from baseline). Focusing only on subjects receiving ZDV+3TC , the most tolerable nucleoside combination from ACTG 384, after week 32 limb fat changed by +2.7%/year with efavirenz and -7.9%/year for the combined nelfinavir and nelfinavir+efavirenz group (MMANOVA p=0.03).
Conclusions: Over 144 weeks, ZDV+3TC continued to be superior to ddI+d4T with regards to limb fat loss. In particular, the combination of ZDV+3TC +efavirenz showed no overall pattern suggesting limb fat loss over time and was significantly superior to the pooled ZDV+3TC +nelfinavir (with and without efavirenz) arms.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
WEPE0167
Suggested Citation
"M.Dubé, et al.
DEXA outcomes in antiretroviral-naive subjects randomized to nelfinavir or efavirenz or both plus dual nucleosides: long-term results from A5005s, a substudy of ACTG 384.
:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
WEPE0167"
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