J A Perez-Molina1, R Rubio2, A Rivero3, J Pasquau4, I Suárez-Lozano5, M Riera6, M Estébanez7, R Palacios8, J Sanz-Moreno9, J Troya10, A Mariño11, A Antela12, J Navarro13, H Esteban14, S Moreno15. 1. Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain jperezm@salud.madrid.org. 2. HIV Unit, Hospital Universitario Doce de Octubre, i+12, Madrid, Spain. 3. Infectious Diseases Unit, Hospital Universitario Reina Sofia/IMIBIC, Córdoba, Spain. 4. Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain. 5. Infectious Diseases Department, Hospital Infanta Elena, Huelva, Spain. 6. Infectious Diseases Department, Hospital Universitario Son Espases, Mallorca, Spain. 7. Infectious Diseases Department, Hospital Universitario La Paz, IDIPAZ, Madrid, Spain. 8. Infectious Diseases Unit, Hospital Universitario Virgen de la Victoria, Málaga, Spain. 9. Internal Medicine Department, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain. 10. Internal Medicine Department, Hospital Universitario Infanta Leonor, Madrid, Spain. 11. HIV Unit, Hospital Arquitecto Marcide, Ferrol, Spain. 12. Infectious Diseases Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain. 13. Infectious Diseases Department, Hospital Universitario Vall d'Hebrón, Barcelona, Spain. 14. Fundación SEIMC-GeSIDA, Madrid, Spain. 15. Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
Abstract
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, -9.9%-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/mm3 (95% CI for the difference, -49.3-50.7), 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.
RCT Entities:
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, -9.9%-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/mm3 (95% CI for the difference, -49.3-50.7), 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-infectedpatients.
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