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

被引:69
作者
Mallolas, Josep [1 ]
Podzamczer, Daniel [2 ]
Milinkovic, Ana
Domingo, Pere [3 ]
Clotet, Bonaventura [4 ]
Ribera, Esteve [5 ]
Gutierrez, Felix [6 ]
Knobel, Hernando [7 ]
Cosin, Jaime [8 ]
Ferrer, Elena [2 ]
Alberto Arranz, Jose [9 ]
Roca, Victor [10 ]
Vidal, Francesc [11 ,12 ]
Murillas, Javier [13 ]
Pich, Judit [14 ]
Pedrol, Enric [15 ]
Llibre, Josep M. [16 ]
Dalmau, David [17 ]
Garcia, Isabel [18 ]
Aranda, Miquel [19 ]
Cruceta, Ana [14 ]
Martinez, Esteban
Blanco, Jose L.
de Lazzari, Elisa
Gatell, Jose M.
机构
[1] Univ Barcelona, Univ IDIBAPS, Hosp Clin, Infect Dis Serv, E-08036 Barcelona, Spain
[2] Hosp Univ Bellvitge, Barcelona, Spain
[3] Hosp Santa Creu & Sant Pau, Barcelona, Spain
[4] HIV, Fundacio IrsiCaixa, Barcelona, Spain
[5] Hosp Valle De Hebron, Barcelona, Spain
[6] Univ Elche, Gen Hosp, Elche, Spain
[7] Hosp del Mar, Barcelona, Spain
[8] Hosp Gen Gregorio Maranon, Madrid, Spain
[9] Hosp Principe Asturias, Madrid, Spain
[10] Hosp Clin San Carlos, Madrid, Spain
[11] Hosp Univ Tarragona Joan XXIII, Tarragona, Spain
[12] Univ Rovira & Virgili, Tarragona, Spain
[13] Hosp Son Dureta, Palma de Mallorca, Spain
[14] Hosp Clin Univ, Pharmacol UASP, Barcelona, Spain
[15] Hosp Granollers, Granollers, Spain
[16] Hosp Calella, Calella, Spain
[17] Hosp Mutua Terrasa, Terrassa, Spain
[18] Hosp Llobregat, Hosp Hosp, Lhospitalet De Llobregat, Spain
[19] Consorci Sanitari Terrasa, Terrassa, Spain
关键词
atazanavir; HIV; HAART; lopinavir; protease inhibitor; ACTIVE ANTIRETROVIRAL THERAPY; TWICE-DAILY LOPINAVIR/RITONAVIR; ONCE-DAILY ATAZANAVIR/RITONAVIR; EXPERIENCED PATIENTS; PROTEASE INHIBITORS; HIV-INFECTION; COMBINATION; LAMIVUDINE; ADHERENCE; REGIMENS;
D O I
10.1097/QAI.0b013e31819a226f
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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].
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页码:29 / 36
页数:8
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