title: A simplification trial switching from nucleoside reverse transcriptase inhibitors to once-daily fixed-dose abacavir/lamivudine or tenofovir/emtricitabine in HIV-1-infected patients with virological suppression.
abstract: BACKGROUND
  Data comparing abacavir/lamivudine versus tenofovir/emtricitabine in antiretroviral-naive patients are controversial. We compared 48-week efficacy and safety of these combinations as substitutes of nucleosides in patients with virological suppression.
  
  
  METHODS
  We randomly assigned 333 HIV-1-infected patients on lamivudine-containing triple regimens with <200 copies per milliliter for at least 6 months to switch their nucleosides to either abacavir/lamivudine (n = 167) or tenofovir/emtricitabine (n = 166). The primary outcome was treatment failure ["switching = failure" intention to treat (ITT) analysis, noninferiority margin 12.5%]. Secondary outcomes were time to treatment failure, virological failure, adverse events, and changes in CD4 count, fasting plasma lipids, lipodystrophy, body fat, bone mineral density, and renal function.
  
  
  RESULTS
  Treatment failure occurred in 32 patients (19%) on abacavir/lamivudine and 22 patients (13%) on tenofovir/emtricitabine [difference 5.9%; (95% confidence interval -2.1% to 14.0%), P = 0.06]. Four patients in the abacavir/lamivudine group versus none in the tenofovir/emtricitabine group developed virological failure [difference 2.4; (95% confidence interval 0.05 to 6.0), P = 0.04]. Twenty-three patients (14%) assigned to abacavir/lamivudine and 10 (6%) to tenofovir/lamivudine experienced grade 3 or 4 adverse effects (P = 0.03). CD4 counts and plasma lipids showed higher increments in the abacavir/lamivudine group than in the tenofovir/emtricitabine group.
  
  
  CONCLUSIONS
  In HIV-1-infected patients with virological suppression, abacavir/lamivudine did not meet the noninferiority outcome for treatment efficacy compared with tenofovir/emtricitabine.
authors.affiliation: Hospital Clínic-Institut d'Investigaciones Biomédiques August Pi i Sunyer, University of Barcelona, 08036 Barcelona, Spain. esteban@fundsoriano.es
authors.forename: Esteban
authors.initials: E
authors.lastname: Martínez
authors.forename: José A
authors.initials: JA
authors.lastname: Arranz
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Montserrat
authors.initials: M
authors.lastname: Loncá
authors.forename: José
authors.initials: J
authors.lastname: Sanz
authors.forename: Patricia
authors.initials: P
authors.lastname: Barragán
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.forename: Victor
authors.initials: V
authors.lastname: Roca
authors.forename: Félix
authors.initials: F
authors.lastname: Gutiérrez
authors.forename: José L
authors.initials: JL
authors.lastname: Blanco
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: David
authors.initials: D
authors.lastname: Dalmau
authors.forename: Ferran
authors.initials: F
authors.lastname: Segura
authors.forename: José R
authors.initials: JR
authors.lastname: Arribas
authors.forename: Jaime
authors.initials: J
authors.lastname: Cosín
authors.forename: Pilar
authors.initials: P
authors.lastname: Barrufet
authors.forename: Esperanza
authors.initials: E
authors.lastname: Casas
authors.forename: Elena
authors.initials: E
authors.lastname: Ferrer
authors.forename: Adrià
authors.initials: A
authors.lastname: Curran
authors.forename: Alicia
authors.initials: A
authors.lastname: González
authors.forename: Judit
authors.initials: J
authors.lastname: Pich
authors.forename: Ana
authors.initials: A
authors.lastname: Cruceta
authors.forename: Joan A
authors.initials: JA
authors.lastname: Arnaiz
authors.forename: José M
authors.initials: JM
authors.lastname: Miró
authors.forename: José M
authors.initials: JM
authors.lastname: Gatell
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015224:Dideoxynucleosides / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D013030:Spain; D000068698:Tenofovir; D017211:Treatment Failure; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D000225:Adenine; D019380:Anti-HIV Agents; D003841:Deoxycytidine; D015224:Dideoxynucleosides; D000068679:Emtricitabine; D019259:Lamivudine; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D000068698:Tenofovir; D000099227:Abacavir