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, 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, G. Cristini, S. Casari, F. Castelnuovo, M. A. Forleo, G. Lapadula, F. Moretti, P. NastaE. Quiros-Roldan, V. Tirelli, M. C. Uccelli, D. Ripamonti, F. Suter, G. Pastore, A. Antinori, G. Antonucci, S. Lo Caputo, F. Mazzotta, R. Maserati, S. Novati, F. Ghinelli, P. Mondello, G. Carnevale, D. Dionisio, A. Vivarelli, G. Rizzardini, P. Migliorino, L. Labate

Research output: Contribution to journalArticlepeer-review

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 3 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.

Original languageEnglish
Pages (from-to)190-195
Number of pages6
JournalJournal of Antimicrobial Chemotherapy
Volume56
Issue number1
DOIs
Publication statusPublished - Jul 2005

Keywords

  • Boosted PIs
  • First line therapy
  • NNRTIs

ASJC Scopus subject areas

  • Pharmacology
  • Microbiology

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