[WeOrB1262] Switching protease inhibitors to Nevirapine (NEV), Efavirenz (EFA) or Abacavir (ABA): A randomized, multicenter, open-label, simplification trial

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Switching protease inhibitors to Nevirapine (NEV), Efavirenz (EFA) or Abacavir (ABA): A randomized, multicenter, open-label, simplification trial

[AUTHOR(S):] E Martinez¹, D Podzamczer², E Ribera³, P Domingo⁴, H Knobel⁵, D Dalmau⁶, M Riera⁷, J M Gatell⁸

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. WeOrB1262

BACKGROUND: Responding patients on a protease inhibitor (PI)-containing highly active antiretroviral regimen (HAART) may have their therapy simplified by switching from PI to either NEV, EFA, or ABA. So far, head-to-head comparisons between these three drugs have not been reported.

METHODS: Adult patients on at least one PI plus two nucleoside analogue reverse transcriptase inhibitors (NRTI) with plasma HIV-1 RNA <200 copies/mL for ³6 months were randomly assigned to switch from the PI component to either NEV, EFA, or ABA. The primary end-point was the proportion of patients remaining <200 copies/mL after 12 months of follow-up.

RESULTS: A total of 460 patients were evaluable (NEV: 155, EFA: 156, ABA: 149). Baseline characteristics did not differ among groups. At 12 months, patients remaining below 200 copies/mL were 94% (NEV), 94% (EFA), and 87% (ABA) in the on-treatment analysis (p=0.06), and 78% (NEV), 74% (EFA), and 77% (ABA) in the intent-to-treat (ITT) analysis (p=0.7). Mean changes in CD4 cells per cubic millimeter were +41 (NEV), +51 (EFA), and +51 (ABA) (p=0.44). A significantly (p=0.009) lower proportion of patients discontinued the study medication due to adverse events in ABA (6%) than in NEV (16%) and EFA (17%) arms. 23 of 28 patients (82%) who developed a virological failure had received prior suboptimal therapy with one or two NRTI alone. Genotypic analysis revealed mutations to the study medication and to at least one of the NRTIs contained in the failing regimen in all cases. The % of patients with cholesterolemia above 240 mg/dL at the end of the study was significantly lower in the ABA arm (9%) as compared with the NEV (24%) or EFA (22%) arms (P=0.01).

CONCLUSIONS: The efficacy of switching from PI to either NEV, EFA, or ABA in responding patients on stable HAART was almost identical in the ITT analysis. Less adverse effects leading to discontinuation but a higher risk of virological failure were found with ABA as compared with NEV or EFA.

Presenting author: E Martinez

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1Hospital Clinic, Servei Farmacologia, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain

2Hospital de Bellvitge, L'Hospitalet, Spain

3Hospital Vall d'Hebron, Barcelona, Spain

4Hospital de Sant Pau, Barcelona, Spain

5Hospital del Mar, Barcelona, Spain

6Mutua de Terrassa, Terrassa, Spain

7Hospital Son Dureta, Palma de Mallorca, Spain

8Hospital Clinic, Servei Farmacologia, Hospital Clinic, Villarroel 170, 08036 Barcelona, Spain

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