3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 23-26 October 2001, Athens, Greece

PROSPECTIVE STUDY OF HYPERLIPIDEMIA IN ANTIRETROVIRAL THERAPY-NAÏVE SUBJECTS TAKING ABACAVIR/COMBIVIR, COMBIVIR/NELFINAVIR, OR LAMIVUDINE/ STAVUDINE/NELFINAVIR (GSK PROTOCOL ESS40002)

Antiviral Therapy 2001; 6(Suppl. 4):19 (abstract no. 27)

P Kumar¹, A Rodriguez-French², M Thompson³, K Tashima⁴, V Williams⁵, P Wannamaker⁵, A Shachoy-Clark⁵ and K Pappa^5
1 Georgetown University Medical Center, Washington, DC, USA; ² San Fernando Hospital, Panama City, Panama; ³ ARCA, Atlanta, Ga., USA;⁴ The Miriam Hospital, Providence,RI,USA;and ⁵ GlaxoSmithKline, Research Triangle Park, NC, USA

BACKGROUND: Hyperlipidemia is commonly seen with highly active antiretroviral therapy (HAART). The effect that non-protease inhibitor (PI) containing regimens have on the development of hyperlipidemia and fat redistribution (FR) is not fully known.

OBJECTIVES: To evaluate changes in fasting metabolic parameters, clinical evaluations of FR, safety, and efficacy in subjects treated with abacavir/Combivir versus Combivir/nelfinavir versus lamivudine/stavudine/nelfinavir for 96 weeks. Female subjects, traditionally under represented, were targetted for enrollment to explore gender-related differences.

METHODS: Two-hundred-and-fifty-eight nondiabetic, HIV-1-positive, antiretroviral-naïve subjects with CD4>50 cells/mm³ were randomized 1:1:1 to the above regimens. Evaluations consisted of fasting lipid profiles and other clinical evaluations of FR at baseline through 96 weeks.

RESULTS: Preliminary results of a planned interim analysis at 24 weeks (50% female, 40% African American, 37% Hispanic) indicate increases in LDL and total cholesterol in both of the PI-containing arms. Median changes from baseline in metabolic parameters were as follows for the abacavir/Combivir (n=86), Combivir/nelfinavir (n=89), and lamivudine/tsavudine/nelfinavir (n=83) treatment groups, respectively; LDL: -1.0, 15.0 and 22.0 mg/dl; cholesterol: 5.0, 17.5 and 33 mg/dl; fasting triglycerides: 6.0, 1.0 and 20.0 mg/dl; insulin: 2.6,1.8 and 0.5 μIU/ml. Respective median LDL changes from baseline for male and female subjects were 0.0/-4.5, 16.0/8.0 and 33.0/19.0 mg/dl. Virological and immunological activity was similar across all groups: proportion of subjects with HIV-1 RNA <50 copies/ml (ITT -Obs/ITT-MEF) at 24 weeks were 73/59, 64/53 and 67/49%, and median CD4 counts change from baseline were 90.5, 132.5 and 137.5 cells/mm³ in the abacavir/Combivir, Combivir/nelfinavir and lamivudine/ stavudine/nelfinavir treatment groups, respectively. Hypersensitivity reaction to abaca vir has occurred in 2% of subjects.

CONCLUSIONS: These preliminary results indicate that therapy with abacavir/Combivir has similar virological and immunological efficacy with a more favorable lipid profile as compared with PI-containing regimens. Gender-related trends continue to be explored.

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