[42] INDUCTION OF ANTIRETROVIRAL-NAÏVE HIV-INFECTED SUBJECTS WITH TRIZIVIR (TZV) AND SUSTIVA (EFV) FOR 48 WEEKS (ESS40013)

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] INDUCTION OF ANTIRETROVIRAL-NAÏVE HIV-INFECTED SUBJECTS WITH TRIZIVIR (TZV) AND SUSTIVA (EFV) FOR 48 WEEKS (ESS40013)

[AUTHOR(S):] M Markowitz¹, J Lang², E DeJesus³, C Hill-Zabala⁴, ER Lanier⁴, Q Liao⁴, K Pappa⁴ and M Shaefer⁴
¹ Aaron Diamond AIDS Research Center, New York, NY, USA; ² ID Consultants, Charlotte, NC, USA; ³ IDC Research Initiative, Altamonte Springs, FL, USA; and ⁴ GlaxoSmithKline, RTP, NC, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 42
Antiviral Therapy 2003; 8(Suppl. 1):S195

[ABSTRACT:] Purpose: ESS40013 was designed to test a 4-drug induction 3-drug maintenance approach to ART. Subjects received TZV and EFV during 48-wk induction (I) and were randomized to TZV with or without EFV for 48-wk maintenance (M).

Methods: 448 ART-naïve HIV-1 infected subjects with HIV-1 RNA (vRNA) >5,000 c/ml received TZV+EFV during 48-wk I. After I, subjects with vRNA <50 c/ml were randomized to M with TZV+EFV for an additional 48 wks. Genotypes were done at time of virologic failure (VF) and baseline (BL). Planned interim analysis for completed 48-wk I is presented.

Results: BL mean vRNA was 5.04 log₁₀ c/ml (56% >100,000 c/ml) and mean CD4 cell count was 245 cells/mm³ (48% <200 cells). At wk 48, proportion of subjs with vRNA <50 c/ml was 61% (ITT: M=F) and 90% (ITT: Obs). Proportion of subjects with vRNA <50 c/ml (ITT: Obs) stratified by entry vRNA (EvRNA) was similar: 95, 86 and 90% for EvRNA <100,000, 100,000–749,999 and >750,000 respectively. Time to median vRNA <50 c/ml was: 16, 17 and 35 wks for EvRNA <100,000, 100,000–749,999 and >750,000 respectively. Mean change from BL in vRNA and CD4 cell count was –3.25 log₁₀ c/ml and 205 cells/mm³ respectively. 31 subjects (6.9%) had hypersensitivity to abacavir. Other drug-related adverse events with >10% incidence were nausea, fatigue, dreams, dizziness, rashes, sleep disorders, vomiting, and headaches. 51 subjects (11%) discontinued for AEs, 33 (7%) for consent withdrawn, 28 (6%) for LTFU and 28 (6%) for VF. Genotype was available at BL and VF for 22 subjects. Most common treatment-emergent reverse transcriptase mutations were M184V (46%) and K103N (41%).

Conclusions: TZV+EFV is a compact potent 4-drug regimen that can effectively reduce vRNA in patients with broad ranges of vRNA and CD4 cell counts. Full data from M will be presented in the future.

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