AEGiS-14IAC: Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. WeOrB1306)

Murphy RL, Katlama C, Weverling GJ, Hoff F, Berzins B, Gatell J, Horban A, van Eeden A, Antunes F, Staszewski S, Clotet B, Bijleveld E
Northwestern University Medical School, Chicago, United States

BACKGROUND: FRAMS aims to assess whether differences in metabolic parameters and body habitus can be detected in patients (pts) treated with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI or protease inhibitor-based regimen.

METHODS: The Atlantic Study is an ongoing prospective, randomized, international trial of d4T+ ddI combined with 3TC, nevirapine (NVP), or indinavir (IDV) in treatment naïve pts (N=298). 69 pts (N=3TC 26, NVP 22, IDV 21) were enrolled in the FRAMS substudy at a median of 120 weeks on treatment. At entry and every 24 weeks questionnaires are completed by clinicians on body appearance of pts. Loss of fat in the arms, legs, face, or buttocks (atrophy, ATR) and/or fat gain in the abdomen, neck, or breasts (accumulation, ACC) is scored. Pts undergo abdominal CT scans, whole body DEXA, BIA, and resting energy expenditure (REE) evaluations. Laboratory evaluations include urine cortisol levels, serum cortisol, proinsulin, lipoprotein a, C-peptide, testosterone, estradiol, estrogens, DHEA and lipid profiles.

RESULTS: At the FRAMS entry visit, ACC was reported by questionnaire in 23% (3TC), 9% (NVP), and 5%(IDV) of pts (p=.15). ATR was reported in 27%, 27%, and 19%(p=.78). CT scans (n=38) showed no significant differences between arms in the VAT/TAT and SAT/TAT ratios. The mean VAT/TAT ratio in pts with reported ACC was 0.52 and without ACC was 0.55 (p= 0.59). The mean SAT/TAT ratio with reported ATR was 0.41 and without ATR was 0.52 (p=.15). DEXA results showed no significant difference between treatments. Completed BIA and REE numbers are too small to draw conclusions. Lab evaluations are under analysis.

CONCLUSIONS: There was no significant difference in fat distribution between the NRTI, non-NRTI, or PI-based treatment arms, suggesting that in the first 2-3 years of therapy in pts on the same NRTI backbone, no significant differences between treatment approaches occurs.

Keywords: AEGIS, Reverse Transcriptase Inhibitors, Lamivudine, Stavudine, Nevirapine, Protease Inhibitors, Didanosine, HIV Protease Inhibitors, Indinavir, Human

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