[57] GENDER AND RACE SUBGROUP ANALYSES IN A PROSPECTIVE STUDY OF HYPERLIPIDAEMIA IN ART-NAIVE SUBJECTS TAKING TRIZIVIR (TZV), COMBIVIR (COM)/NELFINAVIR (NFV), OR STAVUDINE (D4T)/LAMIVUDINE (3TC)/NFV

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] GENDER AND RACE SUBGROUP ANALYSES IN A PROSPECTIVE STUDY OF HYPERLIPIDAEMIA IN ART-NAIVE SUBJECTS TAKING TRIZIVIR (TZV), COMBIVIR (COM)/NELFINAVIR (NFV), OR STAVUDINE (D4T)/LAMIVUDINE (3TC)/NFV

[AUTHOR(S):] K Tashima¹, P Kumar², A Rodriguez-French³, M Thompson⁴, P Wannamaker⁵, V Williams⁵ and K Pappa⁵
¹ Miriam Hospital, Providence, RI, USA; ² Georgetown University Medical Center, Washington, DC, USA; ³ San Fernando Hospital, Panama City, Panama; ⁴ ARCA, Atlanta, GA, USA; and ⁵ GlaxoSmithKline, RTP, NC, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 57
Antiviral Therapy 2003; 8(Suppl. 1):S197

[ABSTRACT:] Background: A gender and racially diverse population was enrolled in this study which offers a unique opportunity to compare complication and response rates in these groups.

Objective: To evaluate metabolic perturbations, assessments of lipid parameters, safety and efficacy in subjects treated with TZV vs COM/NFV vs d4T/3TC/NFV (groups 1, 2 and 3). Subgroup evaluations were assessed at 96 weeks.

Methods: 254 non-diabetic, ART-naïve subjects from the US, PR, Panama, DR and Guatemala with CD4 >50 cells/mm³ were randomized 1:1:1 to receive therapy. Evaluations consisted of fasting lipid profiles, HIV-1 RNA (vRNA) and CD4+ cell counts. Results were assessed in an analysis of covariance model. Statistical significance (ss) defined as P≤0.05.

Results: In this diverse population (50% female, 40% black, 37% hispanic), the groups were comparable at BL with overall mean vRNA and CD4+ of 4.43 log₁₀ c/ml and 355 cells/mm³, respectively. Mean LDL was significantly lower in group 1 compared to groups 2 and 3 for men (93, 117, 126 mg/dl, groups 1, 2, 3; P=0.012 vs group 2; P<0.001 vs group 3) and women (94, 121, 134 mg/dl, groups 1, 2, 3; P<0.001 vs groups 2 and 3). Similar responses were seen for blacks (104, 120, 142, groups 1, 2, 3; ss: 1 and 2 vs 3) and hispanics (89, 111, 111 mg/dl, groups 1, 2, 3; ss: 1 vs 2 and 3). Triglycerides were significantly higher in hispanics in group 3 (188, 211, 295 mg/dl, groups 1, 2, 3; ss: 1 and 2 vs 3). Total cholesterol was significantly higher in group 3 for females (173, 201, 226 mg/dl, groups 1, 2, 3; ss: 1 vs 2 and 3) and hispanics (162, 193, 201 mg/dl, groups 1, 2, 3; ss: 1 vs 2 and 3). Elevated lactate with d4T was seen in female and hispanic subgroups (female ss: 1 vs 3; hispanic ss: 1 vs 2 and 3). Virologic response (ITT Observed/ MEF) was similar across gender for proportions with vRNA <400 c/ml (81-100%/42-50%) and <50 c/ml (54-87%/31-44%). Response rate for TZV was consistently higher in hispanics (vRNA <400 c/ml, 65%, 45%, 44%; vRNA <50 c/ml, 61%, 39%, 31% for groups 1, 2, 3).

Conclusions: Virologic and metabolic responses to the different regimens appear to vary by gender and race and further study is justified.

030714
57