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
Por:
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, de Lazzari, E, Gatell, JM
Publicada:
1 may 2009
Resumen:
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 (<= 200 copies/mL for >= 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 >= 1 PI-associated mutation (10% harboured :l 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 non-inferiorating). CD4(+) changes from baseline were similar in each arm (approximately 40 cells/mm(3)). 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].
Filiaciones:
Mallolas, J:
Univ Barcelona, Univ IDIBAPS, Hosp Clin, Infect Dis Serv, E-08036 Barcelona, Spain
Podzamczer, D:
Hosp Univ Bellvitge, Barcelona, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Clotet, B:
HIV, Fundacio IrsiCaixa, Barcelona, Spain
Ribera, E:
Hosp Valle De Hebron, Barcelona, Spain
Gutierrez, F:
Univ Elche, Gen Hosp, Elche, Spain
Knobel, H:
Hosp del Mar, Barcelona, Spain
Cosin, J:
Hosp Gen Gregorio Maranon, Madrid, Spain
Ferrer, E:
Hosp Univ Bellvitge, Barcelona, Spain
Arranz, JA:
Hosp Principe Asturias, Madrid, Spain
Roca, V:
Hosp Clin San Carlos, Madrid, Spain
Vidal, F:
Hosp Univ Tarragona Joan XXIII, Tarragona, Spain
Univ Rovira & Virgili, Tarragona, Spain
Murillas, J:
Hosp Son Dureta, Palma de Mallorca, Spain
Pich, J:
Hosp Clin Univ, Pharmacol UASP, Barcelona, Spain
Pedrol, E:
Hosp Granollers, Granollers, Spain
Llibre, JM:
Hosp Calella, Calella, Spain
Dalmau, D:
Hosp Mutua Terrasa, Terrassa, Spain
Garcia, I:
Hosp Llobregat, Hosp Hosp, Lhospitalet De Llobregat, Spain
Aranda, M:
Consorci Sanitari Terrasa, Terrassa, Spain
Cruceta, A:
Hosp Clin Univ, Pharmacol UASP, Barcelona, Spain
Open Access
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