16th International AIDS Conference


Toronto, Canada - August 13 - 18, 2006

LONG-TERM CHANGES IN LIPIDS AND GLUCOSE/INSULIN LEVELS AMONG HIV-INFECTED ANTIRETROVIRAL NAÏVE PERSONS RANDOMIZED TO PI VS. NNRTI VS. PI + NNRTI-BASED ANTIRETROVIRAL REGIMENS: RESULTS OF THE CPCRA 061 METABOLIC STUDY

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. ThAb0101

Shlay J.1, Bartsch G.2, Peng G.2, Wang J.3, Gibert C.4, Visnegarwala F.5, Raghavan S.S.6, Xiang Y.2, Farrough M.7, Perry H.8, Kotler D.3, Grunfeld C.9, El-Sadr W.6
1 Denver Community Program for Clinical Research on AIDS, Denver Public Health, Denver, United States, 2 CPCRA Statistical and Data Management Center, University of Minnesota, Minneapolis, United States, 3 Body Composition Unit of St. Lukes-Roosevelt Hospital, Columbia University College of Physicians and Surgeons, New York, United States, 4 Wide-Ranging AIDS Program, Veterans Affairs Medical Center, Washington DC, United States, 5 Houston AIDS Research Team, Baylor College of Medicine, Houston, United States, 6 Harlem Hospital, Columbia University College of Physicians and Surgeons, New York, United States, 7 Wayne State University, Detroit, United States, 8 Southern New Jersey AIDS Clinical Trials, Camden, United States, 9 Veterans Affairs Medical Center, University of California, San Francisco, United States

BACKGROUND: Long-term comparative data on metabolic effects of initiating different antiretroviral treatment (ART) strategies are limited.

METHODS: Fasting triglycerides (TG), LDL-cholesterol (LDL-C), HDL-C, glucose, and insulin were measured at baseline, 1-month follow-up, and 4-month intervals among 422 antiretroviral-naïve patients randomized to 1 of 3 strategies: PI (N=141), NNRTI (N=141), or PI + NNRTI (N=140) containing regimens. The rates of change (mg/dL/month) were estimated using slopes of regression lines and overall mean changes from baseline were compared by strategy.

RESULTS: Median age was 38 years; 22% female; 60% African-American and 10% were Latino. The mean change at 1-month, rates of change after the first follow-up, and overall mean changes (median follow-up 5 years) were:
TG (mg/dL) HDL-C (mg/dL) LDL-C (mg/dL)
Strategy 1 mo Slope Mean 1 mo Slope Mean 1 mo Slope mean
PI 2.1 0.50* 15.2* 3.4* 0.01 5.6* 14.3* -.32* 8.5*
NNRTI 2.8 0.68* 24.9* 7.5* -0.04 10.3* 11.6* -.26* 7.9*
PI+NNRTI 48.9* -0.14 35.0* 5.1* 0.03 9.2* 25.5* -.42* 12.8*
Strategy
differences
NNRTI-PI NS NS NS <0.05 NS <0.05 NS NS NS
PI+NNRTI-PI <0.05 NS <0.05 NS NS NS <0.05 NS NS
PI+NNRTI-NNRTI <0.05 <0.05 NS NS NS NS <0.05 NS <0.05
*P<0.05. Significant increases were seen in overall mean insulin and glucose levels which did not differ by strategy (mean insulin change: PI: 3.86mu/ml, NNRTI: 2.95mu/ml, PI + NNRTI: 2.69mu/ml, p=0.98) (mean glucose change: PI: 2.92mg/dL, NNRTI: 4.88mg/dL, PI + NNRTI: 5.21mg/dL, p=0.36). PI + NNRTI strategy required more lipid-lowering treatment, while incidence of diabetes did not differ by strategy.

CONCLUSIONS: In this prospective trial, all ART strategies had impact on lipid and glucose metabolism. Highest increase in TG and LDL was noted in PI+NNRTI containing regimens. HDL increased the least on PI. Significant increases in insulin were seen with all strategies. These findings necessitate close monitoring of patients.

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2006-08-13
ThAb0101

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