alexa Simplification to dual therapy (atazanavir ritonavir + lamivudine) versus standard triple therapy [atazanavir ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority,
Infectious Diseases

Infectious Diseases

Journal of AIDS & Clinical Research

Author(s): PerezMolina JA, Rubio R, Rivero A, Pasquau J, SurezLozano I,

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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. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: [email protected] This article was published in J Antimicrob Chemother and referenced in Journal of AIDS & Clinical Research

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