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Session 100 Poster Abstracts
Dyslipidemias and Body Fat Abnormalities: Incidence, Risk Factors, Response to Therapy
Monday, 1:30 - 3:30 pm
Poster Hall


718
Fat Redistribution and Metabolic Study (FRAMS) in Patients Receiving a Nucleoside Reverse Transcriptase Inhibitor, non-NRTI, or Protease Inhibitor-based Regimen over 4 Years: FRAMS II Substudy of the Atlantic Study
R Murphy*1, C Katlama2, G-J Weverling3, F Hoff1, R Roubenoff4, B Berzins1, J Gatell5, A Horban6, A van Eeden7, F Antunes8, E Bijleveld3, B Clotet9, S Staszewski10, R van Leeuwen3, J Lange3, and Atlantic Study Team
1Northwestern Univ., Chicago, IL, USA; 2Hosp. Pitie-Salpetriere, Paris, France; 3Intl. Antiviral Therapy Evaluation Ctr., Amsterdam, The Netherlands; 4Tufts Univ., Boston, MA, USA; 5Hosp. Clin., Barcelona, Spain; 6Wojewodzki Szpital Zakazny, Warsaw, Poland; 7Jan van Goyenkliniek, Amsterdam, The Netherlands; 8Hosp. Santa Maria, Lisbon, Portugal; 9Hosp. Univ. Germans Trias I Pujol, Barcelona, Spain; and 10Klinikum der Johann Wolfgang Goethe Univ., Frankfurt, Germany

Background:  FRAMS II studied fat distribution and metabolic changes in patients treated with NRTI-, non-NRTI-, or PI-based regimens over 204 weeks.

Methods:  The Atlantic Study was a prospective, randomized, open-label international trial of d4T + ddI combined with indinavir (IDV), nevirapine (NVP), or 3TC in treatment naïve patients (n = 298) for 204 weeks. After a median of 144 weeks on treatment (range 72 to 204), 81 patients (IDV 24, NVP 24, 3TC 33) were enrolled in the FRAMS II substudy. Every 24 weeks clinicians completed a questionnaire about clinical lipodystrophy and FRAMS II patients had an abdominal CT scan, whole body DEXA, and laboratory tests including fasting lipid profiles, serum cortisol, insulin, lipoprotein a, C-peptide, testosterone, estradiol, DHEA, and urine cortisol levels.  

Results:  Fat accumulation was reported in 15% of patients (10/69) at week 96 and decreased to 8% by week 192 (p = 0.02); no difference between groups was noted however the 3TC group decrease over time was significant (p = 0.02). Fat atrophy was reported in 25% (17/69) at week 96 and increased to 39% by week 192 (p = 0.03); there were no differences between groups. The first abdominal CT scan done at a median of 144 weeks (n = 53 patients) showed visceral adipose tissue of 178 cm2 for IDV compared with 83 for NVP (p = 0.002) and 94 for 3TC (p = 0.006). Visceral adipose tissue increased significantly over time for NVP (p = 0.02) and 3TC (p = 0.01) but not for IDV. There was no difference in subcutaneous adipose tissue between groups or in changes over time. The mean fat percentage and fat weight of extremities by DEXA scan (n = 63 pts) did not differ between arms at median wk 144 (p=0.47, p=0.55).  Total fat % was 16.9, 15.5, and 15.2, and limb fat percentage was 14.5, 14.0, and 12.4 for IDV, NVP, and 3TC, respectively. There were no differences in any of the laboratory parameters between groups. At week 144, HDL cholesterol was 39.3, 50.1, and 38.5 mg/dL for IDV, NVP, and 3TC, respectively. Over time, HDL cholesterol increased more in the NVP group compared to the IDV and 3TC groups (p <0.0001). 

Conclusions:  In patients treated with an NRTI backbone of ddI+d4T, peripheral fat atrophy was common and increased significantly over 4 years, while fat accumulation became less common. IDV-based therapy was associated with higher visceral adipose tissue and NVP-based therapy was associated with significant increases in HDL cholesterol.   

 

Keywords: Metabolic Complications; Lipodystrophy; Antiretroviral Therapy