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)

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.