title: Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study.
abstract: BACKGROUND
  Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naïve patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking.
  
  
  METHODS
  HIV-1-infected patients with suppressed viral load (VL) during a PI-containing regimen (>12 months) and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water) (ETR group, n = 22) or to continue with the same regimen (control group, n = 21). Percentage of patients with VL ≤ 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.
  
  
  RESULTS
  We included 43 patients [72.9% male, 46.3 (42.2; 50.6) years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation) and another in the control group (simplification) discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL); treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure) (p = 0.58). CD4+ T-cell counts did not significantly vary [+49 cells/µL in the ETR group (p = 0.25) and -4 cells/µL in the control group (p = 0.71)]. The ETR group showed significant reductions in cholesterol (p<0.001), triglycerides (p = <0.001), and glycemia (p = 0.03) and higher satisfaction (0-10 scale) (p = 0.04). Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.
  
  
  CONCLUSIONS
  Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01034917.
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: Patricia
authors: P
authors: Echeverría
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: Anna
authors: A
authors: Bonjoch
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: Jordi
authors: J
authors: Puig
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: José
authors: J
authors: Moltó
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain ; IrsiCaixa AIDS Research Institute-HIVACAT, Barcelona, Spain.
authors: Roger
authors: R
authors: Paredes
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: Guillem
authors: G
authors: Sirera
authors: Department of Econometrics, Statistics and Spanish Economy; University of Barcelona, Barcelona, Spain.
authors: Arelly
authors: A
authors: Ornelas
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain ; Statistics and Operations Research Department, Universitat Politècnica de Catalunya, Barcelona, Spain.
authors: Nuria
authors: N
authors: Pérez-Álvarez
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain ; IrsiCaixa AIDS Research Institute-HIVACAT, Barcelona, Spain.
authors: Bonaventura
authors: B
authors: Clotet
authors: Department of HIV, Lluita contra la Sida Foundation, Germans Trias i Pujol University Hospital, Autonomous University of Barcelona, Barcelona, Spain.
authors: Eugènia
authors: E
authors: Negredo
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D017060:Patient Satisfaction; D011724:Pyridazines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D011743:Pyrimidines; D016896:Treatment Outcome
chemical_list: D017320:HIV Protease Inhibitors; D008055:Lipids; D009570:Nitriles; D011724:Pyridazines; D011743:Pyrimidines; C451734:etravirine