9th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 19-21 July 2007, Sydney, Australia

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

Antiviral Therapy 2007; 12(Suppl. 2):L32 (abstract no. P-19)

A Carr¹, R Zajdenverg², C Workman³, J Gatell⁴, P Cahn⁵, A Ritzhaupt⁶, W Zhang⁷ and R Chaves^6
1St Vincent‘s Hospital, Sydney, Australia; ²Projeto Praça Onze – UFRJ Hospital Escola São Francisco de Assis, Rio de Janeiro, Brazil; ³AIDS Research Initiative, Darlinghurst, Australia; ⁴Hospital Clinic de Barcelona, Barcelona, Spain; ⁵Fundacion Huesped, Buenos Aires, Argentina; ⁶Boehringer Ingelheim GmbH, Biberach an der Riss, Germany; ⁷Boehringer Pharmaceuticals Inc. Ridgefield, CT, USA

This poster abstract is also presented as oral abstract O-07.

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-naïve patients randomized to tenofovir-lamivudine with tipranavir/ritonavir (500/200 [TPV/r200] or 500/100 mg [TPV/r100] twice daily) or lopinavir/ritonavir (400/100 mg [LPV/r] twice daily) 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 fasting metabolic parameters (including lipids, glucose, insulin, adiponectin and leptin) were assessed at baseline and week 48. The primary analysis was the change in limb fat in TPV/r100 versus LPV/r and TPV/r200 versus LPV/r (Wilcoxon rank-sum test P=0.025 two-sided).

RESULTS: Baseline mean limb fat mass 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 by 1.17 kg with LPV/r as compared with 0.83 kg with TPV/r200 (P=0.163) and 0.41 kg with TPV/r100 (P=0.072). VAT decreased in all groups: -3 cm² with LPV/r as compared with -9 cm² with TPV/r200 (P=0.036) and -6 cm² with TPV/r100 (P=0.402). No significant between-group change in glucose sensitivity was observed as measured by fasting glucose, insulin or HOMA-IR. Of interest, plasma adiponectin levels increased, but significantly less with LPV/r (+1,360 ng/ml) than with TPV/r200 (6,010 ng/ml; P<0.0001) or TPV/r100 (+4,497 ng/ml; P=0.002). In contrast, there was much less change in plasma leptin levels.

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 increased VAT, in contrast to previous studies with other PIs.

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2007-07-24
P-19

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