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JAC Advance Access originally published online on May 25, 2005
Journal of Antimicrobial Chemotherapy 2005 56(1):190-195; 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

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 Torti1,*, Franco Maggiolo2, Andrea Patroni1,3, Fredy Suter2, Nicoletta Ladisa4, Giuseppe Paraninfo1, Piera Pierotti5, Anna Maria Orani6, Lorenzo Minoli7, Claudio Arici2, Laura Sighinolfi8, Carmine Tinelli3, Giampiero Carosi1 for the MASTER Cohort

1 Institute for Infectious and Tropical Diseases, University of Brescia, Italy; 2 Department of Infectious Diseases, Bergamo, Italy; 3 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

Received 15 January 2005; returned 7 March 2005; revised 11 April 2005; accepted 19 April 2005

* Correspondence address. Institute for Infectious and Tropical Diseases, P. le Spedali Civili, 1, 25123 Brescia, Italy. Tel: +39-030-3996624; Fax: +39-030-303061; E-mail: torti.carlo{at}libero.it

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: 0.33–0.89, 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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