4th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 22-25 September 2002, San Diego, CA, USA

PROSPECTIVE EVALUATION OF INSULIN RESISTANCE IN HIGHLY ACTIVE ANTIRETROVIRAL THERAPY ASSOCIATED METABOLIC SYNDROME

Antiviral Therapy 2002; 7:L26 (abstract 37)

F Visnegarwala, J DarCourt, Q Hasan, P Sajja, O Ong, M Maldonado
Baylor College of Medicine, Houston, Tex., USA

BACKGROUND: Increase in insulin resistance (IR) and diabetes mellitus (DM) has been associated with the use of protease inhibitors (PI) containing highly active antiretroviral therapy (HAART)-containing regimens. However prospective data in patients newly starting these regimens are limited.

OBJECTIVE: To compare metabolic changes in antiretroviral (ARV)-naïve patients started on PIs versus non-PIs containing regimens in a clinical setting.

METHODS: All ARV-naïve patients seen at Thomas Street Clinic (TSC) between November 2000 and June 2001 were eligible if they did not have any major organ failure, active opportunistic infection or diabetes. Baseline demographics, anthropometrics, fasting lipids, glucose and insulin values were collected. Three and six and nine month measurements were repeated in patients started on HAART. The predominant PI used was nelfinavir and the non-PI used was efavirenz.

RESULTS: One hundred and thirty-four patients were enrolled in the study and 79 of the study participants were started on HAART, 38 on a non-PI containing regimen and 41 on PI regimens. Median age was 38 years, 35% women, 68% African Americans, 54% had at least one cardiovascular risk factor. Median CD4 140 cells/mm³ and median VL 59K. Baseline, waist/hip ratio (WHR), fasting cholesterol, triglycerides, insulin, and fasting blood sugar were not significantly different between the two groups. However, patients on non-PIs had a higher body mass index (BMI) 25.2 (±5.5) versus 22.7 (±4.0) in patients on PIs (P<0.05). The 3-9 month follow up data on metabolic parameters on 40 patients on HAART is available. The mean change in BMI (kg/m²), WHR (cm), fasting glucose (mg/dl), fasting plasma insulin (mU/l), HOMA and fasting triglycerides for non-PI (n=21) versus PI (n=19) were: -1.9/+0.34; +0.003/+0.012; -0.6/+3.3, +1.2, +10.38 (P=0.11); +0.7, 0.4; -28.8, +39.4* (*P<0.05).

CONCLUSIONS: An early significant increase in triglycerides in patients started on PI-containing regimens was seen. There was an increase in WHR and fasting insulin levels in patients on PIs, despite a significantly lower baseline BMI compared with those not on PIs. Larger sample size and longer follow-up may be needed to reach statistical significance.

Presenting author: F Visnegarwala

2002-09-22
37

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