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- Title
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.
- Authors
Carlo Torti; Franco Maggiolo; Andrea Patroni; Fredy Suter; Nicoletta Ladisa; Giuseppe Paraninfo; Piera Pierotti; Anna Maria Orani; Lorenzo Minoli; Claudio Arici; Laura Sighinolfi; Carmine Tinelli; Giampiero Carosi
- Abstract
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/mm3 at week 24 or of =1;75 cells/mm3 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: 0.330.89, P = 0.016) at week 24 and 0.40 (95% CI: 0.330.89, 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.
- Subjects
HIV-positive persons; CELLS; IMMUNITY; PHYSIOLOGY
- Publication
Journal of Antimicrobial Chemotherapy (JAC), 2005, Vol 56, Issue 1, p190
- ISSN
0305-7453
- Publication type
Article
- DOI
10.1093/jac/dki172