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JAC Advance Access published online on May 25, 2005
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dki172
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© The Author 2005. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oupjournals.org
Received January 15, 2005
Revised April 11, 2005
Accepted April 19, 2005

Original article

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

Carlo Torti 1*, Franco Maggiolo 2, Andrea Patroni 3, Fredy Suter 2, Nicoletta Ladisa 4, Giuseppe Paraninfo 1, Piera Pierotti 5, Anna Maria Orani 6, Lorenzo Minoli 7, Claudio Arici 2, Laura Sighinolfi 8, Carmine Tinelli 9, Giampiero Carosi 1, and for the MASTER Cohort

1 Institute for Infectious and Tropical Diseases, University of Brescia, Italy
2 Department of Infectious Diseases, Bergamo, Italy
3 Institute for Infectious and Tropical Diseases, University of Brescia, Italy; Biostatistics Unit, IRCCS Policlinico S. Matteo, Pavia, Italy
4 Institute of Infectious Diseases, University of Bari, Bari, Italy
5 Department of Infectious Diseases, S.M. Annunziata Hospital, Florence, Italy
6 Department of Infectious Diseases, ‘A. Manzoni’ Hospital, Lecco, Italy
7 Institute of Infectious Diseases, University of Pavia, Pavia, Italy
8 Department of Infectious Diseases, Ferrara, Italy
9 Biostatistics Unit, IRCCS Policlinico S. Matteo, Pavia, Italy

* To whom correspondence should be addressed.
Carlo Torti, E-mail: torti.carlo{at}libero.it


  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 ≥50 cells/mm3 at week 24 or of ≥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: 0.33-0.89, 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.

Keywords: NNRTIs; boosted PIs; first line therapy.
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