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.
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.


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 > or =1;50 cells/mm(3) at week 24 or of > or =1;75 cells/mm(3) 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.
Torti
Carlo
C
Institute for Infectious and Tropical Diseases, University of Brescia, Italy. torti.carlo@libero.it
Maggiolo
Franco
F
Patroni
Andrea
A
Suter
Fredy
F
Ladisa
Nicoletta
N
Paraninfo
Giuseppe
G
Pierotti
Piera
P
Orani
Anna Maria
AM
Minoli
Lorenzo
L
Arici
Claudio
C
Sighinolfi
Laura
L
Tinelli
Carmine
C
Carosi
Giampiero
G
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D048588:Benzoxazines; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D003521:Cyclopropanes; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006679:HIV Seropositivity / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008137:Longitudinal Studies; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D010078:Oxazines / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000008:administration & dosage*; D012189:Retrospective Studies; D019438:Ritonavir / Q000008:administration & dosage*
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D010078:Oxazines; D011744:Pyrimidinones; D061466:Lopinavir; C098320:efavirenz; D019438:Ritonavir