title: Effectiveness of a Treatment Switch to Nevirapine plus Tenofovir and Emtricitabine (or Lamivudine) in Adults with HIV-1 Suppressed Viremia.
abstract: BACKGROUND
  Switching subjects with persistently undetectable HIV-1 viremia under antiretroviral treatment (ART) to once-daily tenofovir/emtricitabine (or lamivudine) + nevirapine is a cost-effective and well-tolerated strategy. However, the effectiveness of this approach has not been established.
  
  
  METHODS
  We performed a retrospective study evaluating the rates of treatment failure, virological failure (VF), and variables associated, in all subjects initiating this switch combination in our clinic since 2001. Analyses were performed by a modified intention to treat, where switch due to toxicity equalled failure. The main endpoint was plasma HIV-RNA < 50 copies/mL.
  
  
  RESULTS
  341 patients were treated for a median of 176 (57; 308) weeks. At week 48, 306 (89.7%) subjects had HIV-1 RNA <50 copies/mL, 10 (2.9%) experienced VF, and 25 (7.4%) discontinued the treatment due to toxicity. During the whole follow-up 23 (6.7%) individuals (17 on lamivudine, 6 on emtricitabine; p = 0.034) developed VF and treatment modification due to toxicity occurred in 36 (10.7%). Factors independently associated with VF in a multivariate analysis were: intravenous drug use (HR 1.51; 95%CI 1.12, 2.04), time with undetectable viral load before the switch (HR 0.98; 0.97, 0.99), number of prior NRTIs (HR 1.49; 1.15, 1.93) or NNRTIs (HR 3.22; 1.64, 6.25), and previous NVP (HR 1.54; 1.10, 2.17) or efavirenz (HR 5.76; 1.11, 29.87) unscheduled interruptions. VF was associated with emergence of usual nevirapine mutations (Y181C/I/D, K103N and V106A/I), M184V (n = 16; 12 with lamivudine vs. 4 with emtricitabine, p = 0.04), and K65R (n = 7).
  
  
  CONCLUSIONS
  The rates of treatment failure at 48 weeks, or long-term toxicity or VF with this switch regimen are low and no unexpected mutations or patterns of mutations were selected in subjects with treatment failure.
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain.
authors.forename: Isabel
authors.initials: I
authors.lastname: Bravo
authors.affiliation: Department of Econometrics, Statistics and Economy, University of Barcelona, Barcelona, Spain.
authors.forename: Arelly
authors.initials: A
authors.lastname: Ornelas
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: José R
authors.initials: JR
authors.lastname: Santos
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Puig
authors.affiliation: Infectious Diseases Dept, Odense University Hospital, Odense, Denmark.
authors.forename: Raquel
authors.initials: R
authors.lastname: Martin-Iguacel
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain; Universitat de Vic (UVic). Vic, Catalonia, Spain.
authors.forename: Roger
authors.initials: R
authors.lastname: Paredes
authors.affiliation: HIV Unit and "Lluita contra la SIDA" Foundation, University Hospital Germans Trias i Pujol, Badalona, Spain; Universitat Autònoma de Barcelona, Barcelona, Spain; Universitat de Vic (UVic). Vic, Catalonia, Spain.
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage; D004338:Drug Combinations; D000068679:Emtricitabine / Q000008:administration & dosage*; D005260:Female; D015497:HIV-1 / Q000187:drug effects / Q000472:pathogenicity; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D000068698:Tenofovir / Q000008:administration & dosage*; D014766:Viremia / Q000188:drug therapy* / Q000473:pathology / Q000821:virology
chemical_list: D044966:Anti-Retroviral Agents; D004338:Drug Combinations; D012367:RNA, Viral; D019259:Lamivudine; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine