First-line antiretroviral therapy with efavirenz or lopinavir/ritonavir plus two nucleoside analogues: the SUSKA study, a non-randomized comparison from the VACH cohort.
BACKGROUND
Efavirenz and lopinavir/ritonavir are both recommended antiretroviral agents for combination first-line therapy, although information on direct comparisons between them is scarce. A retrospective longitudinal study from the VACH cohort comparing both regimens was performed.


METHODS
Efficacy was examined comparing time to virological failure, CD4 recovery and clinical progression. Tolerability was examined comparing time to treatment discontinuation for any reason and for toxicity. Survival analysis was conducted using the Kaplan-Meier method, and standard and weighted Cox regression models.


RESULTS
A total of 1550 antiretroviral-naive patients starting a two-nucleoside reverse transcriptase inhibitor regimen plus either efavirenz (n = 1159) or lopinavir/ritonavir (n = 391) were included in the study. At baseline, patients starting lopinavir/ritonavir had higher HIV-1 RNA and lower CD4+ cell counts. There was no difference in the adjusted hazards of virological failure [efavirenz versus lopinavir/ritonavir hazard ratio (HR) = 0.93, 95% confidence interval (CI): 0.77-1.12, P = 0.43], CD4 recovery (HR = 1.11, 95% CI: 0.95-1.30, P = 0.19) and clinical progression (HR = 0.71, 95% CI: 0.39-1.31, P = 0.27). There was an increased risk of discontinuation for any reason or for toxicity for lopinavir/ritonavir (HR = 2.10, 95% CI: 1.40-3.15, P = 0.0003). CD4 recovery with both drugs was also similar in the lowest CD4 strata. A higher risk of early hypertriglyceridaemia was associated with lopinavir/ritonavir-based regimens.


CONCLUSIONS
Our study suggests similar virological efficacy for efavirenz- or lopinavir/ritonavir-based first-line antiretroviral regimens, but an increased risk of discontinuation because of toxicity in case of lopinavir/ritonavir-based therapy. Immunological outcome appeared similar with both regimens.
Domingo
Pere
P
Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08025 Barcelona, Spain. pdomingo@santpau.es
Suárez-Lozano
Ignacio
I
Torres
Ferran
F
Teira
Ramón
R
Lopez-Aldeguer
José
J
Vidal
Francesc
F
Muñoz
Agustín
A
Viciana
Pompeyo
P
Lozano
Fernando
F
Vergara
Antonio
A
Roca
Bernadino
B
García Alcalde
Ma Luisa
ML
Cosín
Jaime
J
Terrón
Alberto
A
Galindo
Ma José
MJ
Geijo
Paloma
P
Ribera
Esteban
E
Gonzalez
Juan
J
Sanchez
Trinitario
T
Lacalle
Juan Ramón
JR
Garrido
Myriam
M
D000328:Adult; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D015228:Hypertriglyceridemia / Q000139:chemically induced; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D061466:Lopinavir; D008297:Male; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D028761:Withholding Treatment
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; C098320:efavirenz; D019438:Ritonavir