[28] COMPARISON OF THE METABOLIC DISORDERS AND CLINICAL LIPODYSTROPHY 48 WEEKS AFTER SWITCHING FROM HIGHLY ACTIVE ANTIRETROVIRAL THERAPY TO TRIZIVIR VERSUS CPNTINUED HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (TRIZAL:AZL30002)

3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV

23-26 October 2001, Athens, Greece

COMPARISON OF THE METABOLIC DISORDERS AND CLINICAL LIPODYSTROPHY 48 WEEKS AFTER SWITCHING FROM HIGHLY ACTIVE ANTIRETROVIRAL THERAPY TO TRIZIVIR VERSUS CPNTINUED HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (TRIZAL:AZL30002)

Antiviral Therapy 2001; 6(Suppl. 4):20 (abstract no. 28)

A Lafeuillade¹ on behalf of the TRIZAL Study Team, J-P Marner² and A Cherer²
¹ Hôpital Chalucet,Toulon, France;and ² GlaxoSmithKline, Cedex,France

BACKGROUND: Use of highly active antiretroviral therapy (HAART) has been associated with lipid abnormalities and fat redistribution changes. Clinical manifestations of fat redistribution syndrome are heterogeneous and can range from peripheral fat depletion, lipoatrophy, central fat accumulation, lipo-hypertrophy or a combination of these symptoms.

OBJECTIVES: To compare metabolic and clinical lipodystrophy (LD) abnormalities after switching to Trizivir versus continued HAART at 48 weeks in HAART-experienced patients with viral load <400 copies/ml for the previous 6 months and <50 copies/ml at entry.

METHODS: Forty-eight-week, open-label, randomized study evaluating efficacy and tolerance of Trizivir versus continued HAART. Evaluations included morphological changes associated with LD, triglycerides and cholesterol. Comparisons between groups were performed by χ² test or Wilcoxon rank sum tests.

RESULTS: At baseline, 42/106 (40%) subjects receiving Trizivir and 51/103 (50%) receiving continued HAART reported at least one symptom of LD (P=0.150, NS) with similar median number of reported symptoms per subject in each group (Trizivir n=2 and continued HAART n=3; P=0.139 NS). By week 48, the number of subjects with ≥1 symptom of LD was significantly lower in the Trizivir group (27/97, 28%) than continued HAART (42/99, 42%; P=0.033). Moreover, the median number of LD symptoms per subject was significantly lower in Trizivir group (n=2) compared with continued HAART (n=4; P=0.016). Statistically significantly greater reductions in cholesterol and triglycerides occurred in Trizivir group: median change from baseline in cholesterol: -0.80 versus -0.44 mmol/l (P<0.001); triglycerides: -0.17 versus +0.01 mmol/l (P=0.006). Virological supression was maintained throughout 48 weeks in both groups.

CONCLUSIONS: Fully suppressed patients switching to Trizivir maintained virological suppression but had improvements in lipids and clinical manifestations of lipodystrophy at 48 weeks.

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Copyright © 2001 - International Medical Press Ltd. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Medical Editor, International Medical Press, 36 St Mary-at-Hill, London EC3R 8DU, United Kingdom.