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Abstract
Effects of tipranavir/r (500/200 or 500/100 mg BID) in comparison with lopinavir/r (400/100 mg BID) on changes in body composition and metabolic parameters in ARV-naïve patients over 48 weeks
Carr A.1, Zajdenverg R.2, Workman C.3, Gatell J.4, Cahn P.5, Ritzhaupt A.6, Zhang W.7, Chaves R.6
Objectives: Protease inhibitor (PI)-based antiretroviral therapy is associated with progressive lipoatrophy, relative central fat accumulation and insulin resistance.
Methods: We evaluated changes in body composition and metabolism in 140 ARV-naive patients randomised to tenofovir-lamivudine with tipranavir/ritonavir (500/200 [TPV/r200] or 500/100 mg [TPV/r100] BID) or lopinavir/ritonavir (400/100 mg [LPV/r] BID) in a metabolic sub-study. Body composition (DEXA for total and regional fat; L4-5 abdominal CT for subcutaneous and visceral adipose tissue [SAT; VAT]) and metabolic parameters (including lipids, glucose, insulin, adiponectin, leptin) were assessed at baseline and Week 48. The primary analysis was the change in limb fat in TPV/r100 vs. LPV/r and TPV/r200 vs. LPV/r (Wilcoxon rank-sum test p=0.025 two-sided).
Results: Baseline limb fat was higher in both TPV/r groups versus LPV/r, although medians were comparable (Kruskal-Wallis test, p=0.907). At Week 48, limb fat increased more for LPV/r, but this was not significantly different from TPV/r groups (p>0.07). VAT and trunk fat decreased in all groups. Adiponectin, but not leptin, increased substantially, but significantly more with TPV/r100 and TPV/r200 (p<0.002). No glucose sensitivity changes were observed.
| Parameter | TPV/r100 | TPV/r200 | LPV/r | p value | | | Wk 0 | Median change Wk 48 | Wk 0 | Median change Wk 48 | Wk 0 | Median change Wk 48 | TPV/r100 vs LPV | TPV/r200 vs LPV | | Limb fat (kg) | 5.9 | 0.41 | 6.2 | 0.83 | 5.0 | 1.17 | 0.072 | 0.163 | | VAT (cm2) | 72.1 | -5.7 | 63.2 | -8.6 | 70.8 | -3.0 | 0.402 | 0.036 | | Adiponectin (ng/mL) | 5962 | 4497 | 5347 | 6010 | 5920 | 1360 | 0.002 | <0.0001 | | Leptin (pg/mL) | 3037 | -39 | 3855 | 608 | 2271 | 1168 | 0.015 | 0.324 | | Glucose (mg/dL) | 88.6 | 0.0 | 89.0 | 0.9 | 84.0 | 3.8 | 0.320 | 0.355 | | Insulin (µU/mL) | 5.6 | -0.8 | 6.1 | 0.6 | 4.5 | -0.2 | 0.149 | 0.317 | | HOMA-IR | 1.3 | -0.1 | 1.4 | 0.2 | 0.9 | -0.1 | 0.150 | 0.684 |
Conclusions: After 48 weeks, subcutaneous fat increased with both TPV/r and LPV/r. TPV/r treatment was not associated with increased insulin resistance or VAT, in contrast to previous studies with other PIs.
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention
Abstract no.
TUPEB072
Suggested Citation
"CarrA., et al.
Effects of tipranavir/r (500/200 or 500/100 mg BID) in comparison with lopinavir/r (400/100 mg BID) on changes in body composition and metabolic parameters in ARV-naïve patients over 48 weeks.
Poster exhibition:
4th IAS Conference on HIV Pathogenesis, Treatment and Prevention:
Abstract no.
TUPEB072"
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