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

Autor: Carmine Tinelli, Franco Maggiolo, A. Manzoni, Carlo Torti, Fredy Suter, Anna Orani, Giampiero Carosi, Giuseppe Paraninfo, Andrea Patroni, Policlinico S. Matteo, Lorenzo Minoli, Claudio Arici, Piera Pierotti, Nicoletta Ladisa, Laura Sighinolfi
Rok vydání: 2005
Předmět:
Zdroj: The Journal of antimicrobial chemotherapy. 56(1)
ISSN: 0305-7453
Popis: 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.A total of 472 patients were selected (348 efavirenz and 124 lopinavir/ritonavir). The primary endpoint of this study was virological success (HIV RNA50 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 ofor =1;50 cells/mm(3) at week 24 or ofor =1;75 cells/mm(3) at week 48).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 P0.0001).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.
Databáze: OpenAIRE