title: 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, randomized clinical trial (SALT study).
abstract: 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.
  
  
  
  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%.
  
  
  
  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].
  
  
  
  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.
authors.affiliation: Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain jperezm@salud.madrid.org.
authors.forename: J A
authors.initials: JA
authors.lastname: Perez-Molina
authors.affiliation: HIV Unit, Hospital Universitario Doce de Octubre, i+12, Madrid, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Rubio
authors.affiliation: Infectious Diseases Unit, Hospital Universitario Reina Sofia/IMIBIC, Córdoba, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Rivero
authors.affiliation: Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Pasquau
authors.affiliation: Infectious Diseases Department, Hospital Infanta Elena, Huelva, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Suárez-Lozano
authors.affiliation: Infectious Diseases Department, Hospital Universitario Son Espases, Mallorca, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Riera
authors.affiliation: Infectious Diseases Department, Hospital Universitario La Paz, IDIPAZ, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Estébanez
authors.affiliation: Infectious Diseases Unit, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Palacios
authors.affiliation: Internal Medicine Department, Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Sanz-Moreno
authors.affiliation: Internal Medicine Department, Hospital Universitario Infanta Leonor, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Troya
authors.affiliation: HIV Unit, Hospital Arquitecto Marcide, Ferrol, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Mariño
authors.affiliation: Infectious Diseases Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Antela
authors.affiliation: Infectious Diseases Department, Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Navarro
authors.affiliation: Fundación SEIMC-GeSIDA, Madrid, Spain.
authors.forename: H
authors.initials: H
authors.lastname: Esteban
authors.affiliation: Infectious Diseases Department, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Moreno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents