1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 26–28 June 1999 - San Diego, CA, USA

INCIDENCE OF LIPODYSTROPHY IN START (SELECTION OF THYMIDINE ANALOG REGIMEN THERAPY) STUDIES

Antiviral Therapy 1999; 4(Suppl. 2):49(abstract no. 30)

E Dale¹, J Mauney¹, K Uffelman¹, M Stevens² and R Grosso^2
1Pharma Research Corporation, Morrisville, North Carolina; and ²Bristol-Myers Squibb, Plainsboro, New Jersey, USA

BACKGROUND: Recent reports suggest that patients receiving NRTI plus PI therapy have developed partial or generalized lipodystrophy. The START studies randomized antiretroviral-naïve patients with CD4 counts >200 cells/mm³ and HIV RNA >5-10000 copies/ml (bDNA) to stavudine/ lamivudine/indinavir, stavudine/didanosine/indinavir or zidovudine/lamivudine/indinavir.

OBJECTIVES: To compare the incidence of lipodystrophy-associated findings across treatment arms.

DESIGN: The stavudine/lamivudine/indinavir (n=100) and stavudine/didanosine/indinavir (n=102) groups were combined and compared with zidovudine/ lamivudine/indinavir (n=205), for lipodystrophy-related adverse events by examining investigator text and coded terms for all events reported on study or within 30 days of permanent study drug discontinuation. Changes from baseline body mass index, weight, non-fasting serum glucose and non-fasting triglycerides were also evaluated.

RESULTS: Reported lipodystrophy-related adverse events were minimal (6% in stavudine arms and 7% in zidovudine arms). Grade 3 or 4 elevations in non-fasting glucose occurred in 7/202 stavudine-treated patients (3.5%) and 9/205 zidovudine-treated patients (4.4%) (P=0.632). Grade 3 or 4 hypertriglyceridaemia (non-fasting) occurred in eight stavudine-treated patients (4.0%) and six zidovudine-treated patients (2.9%) (P=0.568). Triglyceride levels on all regimens increased from baseline as the trials progressed. Statistically significant differences were seen intermittently with higher levels in the stavudine group [greatest mean difference (stavudine-zidovudine) 48.4 mg/dl at week 48 (P=0.001)]. These modest differences in non-fasting triglycerides, while statistically significant, are not clinically relevant. No significant changes in weight or body mass index were observed.

CONCLUSION: Based on this ad hoc analysis, there do not appear to be clinically significant differences in the incidence of lipodystrophy among stavudine and zidovudine treatment groups.

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