Exploratory analysis for the evaluation of lopinavir/ritonavir-versus efavirenz-based HAART regimens in antiretroviral-naive HIV-positive patients: results from the Italian MASTER Cohort

被引:33
作者
Torti, C [1 ]
Maggiolo, F
Patroni, A
Suter, F
Ladisa, N
Paraninfo, G
Pierotti, P
Orani, AM
Minoli, L
Arici, C
Sighinolfi, L
Tinelli, C
Carosi, G
机构
[1] Univ Brescia, Inst Infect & Trop Dis, Brescia, Italy
[2] Dept Infect Dis, Bergamo, Italy
[3] IRCCS, Policlin San Matteo, Biostat Unit, Pavia, Italy
[4] Univ Bari, Inst Infect Dis, Bari, Italy
[5] SM Annunziata Hosp, Dept Infect Dis, Florence, Italy
[6] A Manzoni Hosp, Dept Infect Dis, Lecce, Italy
[7] Univ Pavia, Inst Infect Dis, Pavia, Italy
[8] Dept Infect Dis, Ferrara, Italy
关键词
NNRTIs; boosted PIs; first line therapy;
D O I
10.1093/jac/dki172
中图分类号
R51 [传染病];
学科分类号
100401 ;
摘要
Objective: This retrospective longitudinal cohort study compared the virological and immunological responses to highly active antiretroviral therapy containing either efavirenz or lopinavir/ritonavir in previously antiretroviral-naive HIV-infected patients. Patients and methods: A total of 472 patients were selected (348 efavirenz and 124 lopinavir/ritonavir). The primary endpoint of this study was virological success (HIV RNA < 50 copies/mL). The immunological response was assessed on the basis of either CD4+ T cell count variations (absolute and percentage) with respect to baseline values or categorical endpoints (defined as either a CD4+ T cell increase of >= 1;50 cells/mm(3) at week 24 or of >= 1;75 cells/mm(3) at week 48). Results: At intention-to-treat (ITT) analysis, the adjusted odds ratio of virological success for patients who started lopinavir/ritonavir, compared with those who started efavirenz, was 0.54 (95% CI: 0.33-0.89, P = 0.016) at week 24 and 0.40 (95% CI: 0.33-0.89, P = 0.002) at week 48. However, patients receiving lopinavir/ritonavir had a more pronounced CD4+ T cell recovery, demonstrating both a mean absolute and percentage increase up to week 48 (MANOVA P < 0.0001). Conclusions: Although comparisons of drug efficacy in non-randomized studies should be viewed with caution, from a virological point of view efavirenz-containing regimens performed as well (on-treatment analysis) or better (ITT analysis) than those containing lopinavir/ritonavir. In contrast, immunological outcome appeared to favour lopinavir/ritonavir.
引用
收藏
页码:190 / 195
页数:6
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