Simplification to dual therapy (atazanavir/ritonavir plus lamivudine) versus standard triple therapy [atazanavir/ritonavir plus two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)
Por:
Perez-Molina, JA, Rubio, R, Rivero, A, Pasquau, J, Suarez-Lozano, I, Riera, M, Estebanez, M, Palacios, R, Sanz-Moreno, J, Troya, J, Marino, A, Antela, A, Navarro, J, Esteban, H, Moreno, S, Domingo Pedro, P., Gutierrez, M., Mateo, G., Warncke, F.
Publicada:
1 ene 2017
Resumen:
Objectives: We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r+3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r+2NUCs) at 96 weeks of follow-up.
Methods: SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA,50 copies/mL for >= 6 months were randomized (1: 1) to ATV/r+3TC or ATV/r+2NUCs. The primary endpoint was HIV-1-RNA,50 copies/mL in the PP population. Non-inferiority was demonstrated if the lower bound of the 95% CI for the difference was not below -12%.
Results: Some 286 patients were analysed. At week 96, 74.4% had HIV-1-RNA,50 copies/mL in the ATV/r+3TC arm versus 73.9% in the ATV/r+2NUCs arm (95% CI for the difference, 29.9%-11.0%). In both groups, similar values were observed for patients with confirmed virological failure in ATV/r+3TC versus ATV/r+2NUCs (9 versus 5), death (1 versus 0), discontinuation due to ART-related toxicity (7 versus 11), withdrawal from the study (7 versus 9) and loss to follow-up (6 versus 6). One patient taking ATV/r+2NUCs developed resistance mutations (M184V and L63P). Similar values were obtained for change in mean CD4 count [ 19 versus 18 cells/mm(3) (95% CI for the difference, 249.3-50.7), grade 3-4 adverse events (70.7% versus 70.2%) and changes in the global deficit score, -0.3 (95% CI, -0.5 to -0.1) for ATV/r+3TC, versus -0.2 (95% CI, -0.4 to -0.1) for ATV/r+2NUCs].
Conclusions: The long-term results of switching to ATV/r+3TC show that this strategy is effective, safe and non-inferior to ATV+2NUCs in virologically suppressed HIV-infected patients.
Filiaciones:
Perez-Molina, JA:
Hosp Univ Ramon y Cajal, Infect Dis Dept, IRYCIS, Madrid, Spain
Rubio, R:
Hosp Univ Doce de Octubre, HIV Unit, I 12, Madrid, Spain
Rivero, A:
Hosp Univ Reina Sofia, IMIBIC, Infect Dis Unit, Cordoba, Spain
Pasquau, J:
Hosp Univ Virgen Nieves, Infect Dis Unit, Granada, Spain
Suarez-Lozano, I:
Hosp Infanta Elena, Infect Dis Dept, Huelva, Spain
Riera, M:
Hosp Univ Son Espases, Dept Infect Dis, Mallorca, Spain
Estebanez, M:
Hosp Univ La Paz, Dept Infect Dis, IDIPAZ, Madrid, Spain
Palacios, R:
Hosp Univ Virgen Victoria, Infect Dis Unit, Malaga, Spain
Sanz-Moreno, J:
Hosp Univ Principe Asturias, Dept Internal Med, Alcala De Henares, Spain
Troya, J:
Hosp Univ Infanta Leonor, Dept Internal Med, Madrid, Spain
Marino, A:
Hosp Arquitecto Marcide, HIV Unit, Ferrol, Spain
Antela, A:
Hosp Clin Univ Santiago, Dept Infect Dis, Santiago De Compostela, Spain
Navarro, J:
Hosp Univ Vall dHebro, Infect Dis Dept, Barcelona, Spain
Esteban, H:
Fdn SEIMC GESIDA, Madrid, Spain
Moreno, S:
Hosp Univ Ramon y Cajal, Infect Dis Dept, IRYCIS, Madrid, Spain
Domingo Pedro, P.:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Gutierrez, M.:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Mateo, G.:
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Warncke, F. :
Hospital Xeral Cíes de Vigo, Pontevedra, Spain
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