[117] ANTIVIRAL EFFICACY, METABOLIC CHANGES AND SAFETY OF ATAZANAVIR (ATV) VERSUS LOPINAVIR/RITONAVIR (LPV/RTV) IN COMBINATION WITH TWO NRTIs IN PATIENTS WHO HAVE EXPERIENCED VIROLOGICAL FAILURE WITH PRIOR PI-CONTAINING REGIMEN(S): 24-WEEK RESULTS FROM BMS AI424-043

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] ANTIVIRAL EFFICACY, METABOLIC CHANGES AND SAFETY OF ATAZANAVIR (ATV) VERSUS LOPINAVIR/RITONAVIR (LPV/RTV) IN COMBINATION WITH TWO NRTIs IN PATIENTS WHO HAVE EXPERIENCED VIROLOGICAL FAILURE WITH PRIOR PI-CONTAINING REGIMEN(S): 24-WEEK RESULTS FROM BMS AI424-043

[AUTHOR(S):] L Nieto-Cisneros¹, C Zala², WJ Fessel³, J Gonzalez-Garcia⁴, C Cohen⁵, R McGovern⁶, E Adler⁷ and C McLaren⁶
¹Hospital Regional No. 1 Gabriel Mancera, Del Valle, Mexico; ²Fundacion Huesped, Buenos Aires, Argentina; ³Kaiser Permanente Medical Center, San Francisco, CA; ⁴Hospital la Paz, Madrid, Spain; ⁵Community Research Initiative of New England, Boston, MA; ⁶Bristol-Myers Squibb Company, Wallingford, CT; and ⁷Bristol-Myers Squibb Company, Pennington, NJ, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 117
Antiviral Therapy 2003; 8(Suppl. 1):S212

[ABSTRACT:] Background: ATV is a potent once-daily azapeptide PI with a distinct resistance profile, demonstrated safety and efficacy in naïve and experienced patients, and a lipid profile superior to marketed PIs.

Objective: Compare efficacy, lipid profile and safety of non-boosted ATV with LPV/RTV regimens in ARV-experienced patients with virologic failure on a PI-containing regimen.

Methods: Multinational, open-label, controlled study in ARV-experienced patients randomized (1:1) to ATV 400 mg QD or LPV/RTV 400/100 mg BID with two NRTIs.

Results: Three hundred patients randomized, 290 treated. Week 24 results demonstrated significant virological responses for both regimens with a greater decrease in RNA for LPV/RTV vs ATV (mean changes from baseline (SE), HIV RNA (log₁₀ c/ml) –2.11 (0.09), –1.67 (0.08); CD4 (cells/mm³) 121 (14), 94 (13). A post-hoc analysis showed decrease in RNA was comparable between regimens in patients without nucleoside mutations at baseline. Mean lipid changes from baseline (LDL-C, total-C, HDL-C, triglycerides) were lower for ATV (–6%, –2%, +12%, –2%) vs LPV/RTV (+5%, +17%, +18%, +55%). Adverse events (AEs) were comparable between regimens and were consistent with known safety and tolerability profiles of the study drugs. Serious AEs were infrequent.

Conclusions: Significant reductions in HIV RNA and robust increases in CD4 cell counts were observed in this PI-failing, ARV-experienced population. While non-boosted ATV demonstrated less antiviral efficacy than the boosted LPV/RTV regimen, ATV had a more favourable lipid profile. ATV may be an option for some ARV-experienced patients, e.g., where lipid management is a priority.

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