5th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 8–11 July 2003, Le Meridien Montparnasse, Paris, France

ATAZANAVIR AND EFAVIRENZ, EACH COMBINED WITH FIXED-DOSE ZIDOVUDINE AND LAMIVUDINE, HAVE SIMILAR EFFECTS ON BODY FAT DISTRIBUTION IN ANTIRETROVIRAL-NAÏVE PATIENTS: 48-WEEK RESULTS FROM THE METABOLIC SUBSTUDY OF BMS AI424-034

Antiviral Therapy 2003; 8:L13 (abstract 14)

JG Jemsek¹, E Arathoon², M Arlotti³, C Perez⁴, N Sosa⁵, V Pokrovskiy⁶, M Giordano⁷, A Thiry⁷ and M Soccodato^7
1Jemsek Clinic PLLC, Huntersville, NC, USA; ²Hospital General San Juan de Dios, Guatemala, Guatemala; ³Ospedale degli Infermi, Rimini, Italy; ⁴Hospital Clínico de La Pontificia Universidad Católica, Santiago, Chile; ⁵Consultorio Royal Center, Panama City, Panama; ⁶Federal AIDS Center, Moscow, Russia; and ⁷Bristol-Myers Squibb Company, Wallingford, CT, USA

OBJECTIVES: To evaluate body fat redistribution in antiretroviral-naïve patients treated with atazanavir or efavirenz, each administered with fixed-dose zidovudine and lamivudine twice daily.

METHODS: Antiretroviral-naïve patients received atazanavir 400 mg once daily or efavirenz 600 mg once daily, each administered with fixed-dose zidovudine and lamivudine (300 mg/150 mg) twice daily in the double-blind, prospective trial BMS AI424-034. In the metabolic substudy, dual-energy x-ray absorptiometry and cross-section computerized tomography scans were performed at baseline and week 48.

RESULTS: Substudy results were based on 111 atazanavir- and 100 efavirenz-treated patients. Baseline characteristics, including age, HIV RNA level, CD4 count and body mass index, were consistent between the substudy participants and the overall study population (n=805). Increases from baseline (mean percent) at week 48 were observed for appendicular (3%, atazanavir; 3%, efavirenz), truncal (5%, atazanavir; 8%, efavirenz) and total body fat (5%, atazanavir; 5%, efavirenz) as well as for visceral (40%, atazanavir; 29%, efavirenz), subcutaneous (19%, atazanavir; 5%, efavirenz) and total adipose tissue (23%, atazanavir; 11%, efavirenz). The changes were significant on both regimens (P<0.05). The mean weight gain from baseline was 1.2 kg. No changes in the ratios of appendicular-to-total body fat, truncal-to-total body fat or visceral-to-total adipose tissue were observed on either regimen from baseline to week 48.

CONCLUSIONS: Atazanavir and efavirenz produced comparable and proportional effects on body fat distribution at 48 weeks when administered with fixed-dose zidovudine and lamivudine to antiretroviral-naïve patients. The pattern of fat increase observed on both regimens was consistent with weight gain and not with the patterns for central adiposity (disproportionate increase in truncal fat) or lipoatrophy (loss of appendicular fat) associated with the development of lipodystrophy.

Presenting author: JG Jemsek

2003-07-08
14

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