AEGiS-Glasgow [PL2.3] Induction-maintenance antiretroviral therapy with Trizivir plus either efavirenz or lopinavir/r: results of a multicentre randomized clinical trial at 72 weeks

Eighth International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 12-16 November 2006

[PL2.3] Induction-maintenance antiretroviral therapy with Trizivir plus either efavirenz or lopinavir/r: results of a multicentre randomized clinical trial at 72 weeks

Int Cong Drug Therapy HIV 2006 Nov 12-16;8:Abstract No. PL2.3

J Mallolas, M Penaranda, P Domingo, H Knobel, E Pedrol, F Gutierrez, P Barrufet, J Peraire, D Dalmau, E Ribera, A Ocampo, MA Muniain, C Alonso, V Estrada, JR Blanco, J Cucurull, J Pich, E De Lazzari, A Leon
JM Gatell Hospital Clinic, Barcelona, Spain

PURPOSE OF THE STUDY: Induction-maintenance strategies in antiretroviral therapy were associated with low response. With newer drugs available, the study aims to compare virologic response with 2 different induction regimens: Trizivir (TZV) + either efavirenz (EFV) or lopinavir/r (LPV/r).

METHODS: 209 ARV-naïve HIV-patients were randomized to TZV + EFV or LPV/r for 24-weeks. Those with undetectable viral load (UVL) after induction entered 48-week maintenance on TZV only. Primary endpoint was proportion of patients with UVL at 72 weeks.

SUMMARY OF RESULTS: 104 and 105 patients were randomized in EFV and LPV/r arms. 114 (55%) entered maintenance (EFV: 54; LPV/r: 60). Baseline characteristics were comparable. At W72, 12 vs 13 patients were lost to follow-up, 3 vs 1 withdrew consent, 3 vs 3 died and 2 vs 2 progressed to AIDS in EFV and LPV/r arms. Virologic failure (VF) occurred in 27 cases: 6 during induction (EFV:3; LPV/r:3; p=1.0) and 21 during maintenance (EFV: 14; LPV/r:7; p=0.057). 34 patients in EFV arm switched treatment due to adverse events vs 25 in LPV/r arm (p=0.17). Primary endpoint proportions were: 63% and 75% (on-treatment analysis, p=0.172), 43% and 53% (intent-to-treat (ITT), p=0.199) and 31% and 43% (ITT switches=failure, p=0.076) in EFV and LPV/r arms. Median CD4 changes at W48 and W72 were: +169/+252 (p=0.034) and +247/+274 (p=0.7) cells/L in EFV and LPV/r arms.

CONCLUSIONS: ARV-naïve patients undergoing induction with TZV + EFV or LPV/r followed by maintenance with TZV achieved adequate immunological and virological response at W72. The study shows a trend to an increased VF in EFV arm.

Plenary Session: Open Papers

2006-11-12
PL2.3

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