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Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study.

Author(s): Mallolas J, Podzamczer D, Milinkovic A, Domingo P, Clotet B, Ribera E, Gutierrez F, Knobel H, Cosin J, Ferrer E, Arranz JA, Roca V, Vidal F, Murillas J, Pich J, Pedrol E, Llibre JM, Dalmau D, Garcia I, Aranda M, Cruceta A, Martinez E, Blanco JL, Lazzari E, Gatell JM, ATAZIP Study Group

Affiliation(s): Hospital Clinic Universitari-IDIBAPS, University of Barcelona, Barcelona, Spain. mallolas@clinic.ub.es

Publication date & source: 2009-05-01, J Acquir Immune Defic Syndr., 51(1):29-36.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVES: To evaluate the efficacy and safety of switching from boosted lopinavir (LPV/r) to boosted atazanavir (ATV/r) in virologically suppressed HIV-1-infected patients versus continuing LPV/r. METHODS: Forty-eight weeks analysis of a randomized, open-label, noninferiority trial including patients with virological suppression (< or = 200 copies/mL for > or = 6 months) on LPV/r-containing triple highly active antiretroviral therapy. Patients (n = 248) were randomized 1:1 either to continue LPV/r twice a day (n = 127) or to switch to ATV/r every day (ATV/r; n = 121), with no change in nucleoside reverse transcriptase inhibitor backbone. Those known to have >4 protease inhibitor (PI)-associated mutations and/or who had failed >2 PI-containing regimens were excluded. RESULTS: Baseline characteristics were balanced. 30% harboured > or = 1 PI-associated mutation (10% harboured > or = 1 major mutation). Treatment failure at 48 weeks (primary end point) occurred in 20% (25 of 127) of the LPV/r arm and in 17% (21 of 121) of the ATV/r arm (difference -2.3%; 95% confidence interval: -12.0 to 8.0; P = 0.0018). Virological failure occurred in 7% (9 of 127) of the LPV/r arm and in 5% (6 of 121) of the ATV/r arm (difference -2.1%; 95% confidence interval: -8.7% to 4.2%, P < 0.0001 for noninferiorating). CD4 changes from baseline were similar in each arm (approximately 40 cells/mm). Adverse event rate leading to study drug discontinuation was 5% in both arms. Median fasting triglycerides and total cholesterol decreased significantly in the ATV/r arm (-53 and -19 mg/dL, respectively versus -4 and -4 mg/dL in the LPV/r arm; P < 0.001 in both comparisons). Alanine aminotransferase/aspartate aminotransferase hepatic abnormalities were similar in the 2 arms. CONCLUSIONS: Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].

Page last updated: 2009-10-20

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