title: Efficacy and safety of "unboosting" atazanavir in a randomized controlled trial among HIV-infected patients receiving tenofovir DF.
abstract: To assess safety and efficacy of a switch to unboosted atazanavir (ATV) among HIV-infected adults receiving ATV/ritonavir (r) and tenofovir disoproxil fumarate (TDF).
  
  
  
  HIV-infected adults with viral load (VL) <40 copies/mL at screening and <150 copies/mL consistently for ≥3 months while receiving a regimen including ATV/r and TDF were randomized to continue ATV/r 300/100 mg daily (control) or change to ATV 400 mg daily (switch), while maintaining their TDF backbone. The primary outcome was proportion of subjects without treatment failure (regimen switch or VL > 200 copies/mL twice consecutively) at 48 weeks.
  
  
  
  Fifty participants (46 male, median age 47 years) were randomized, 25 to each arm. At week 48, treatment success occurred in 76% in the control arm and 92% in the switch arm (ITT, p = 0.25). ATV trough levels at week 9 were higher in controls (median 438 ng/mL) than in the switch arm (median 124 ng/mL) (p = 0.003), as was total bilirubin at week 48 (median 38 μmol/L and 28 μmol/L, respectively; p = 0.02). Estimated glomerular filtration rate (eGFR) decreased in the control arm (p = 0.007), but did not change in the switch arm. At week 48, eGFR was higher in the switch arm (median 96 mL/min) than in the control arm (median 85 mL/min) (p = 0.035), but the arms were similar with respect to fasting glucose, C-reactive protein, and lipid parameters.
  
  
  
  Switching from ATV/r to unboosted ATV appears to be safe and effective in selected virologically suppressed patients receiving TDF-containing regimens, and may have favorable effects on bilirubin and renal function.
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.|b Faculty of Medicine, Department of Family Practice , University of British Columbia , Vancouver , Canada.|c Faculty of Medicine, Division of AIDS, Department of Medicine , University of British Columbia , Vancouver , Canada.
authors.forename: Marianne
authors.initials: M
authors.lastname: Harris
authors.affiliation: d AIDS Research Program , St. Paul's Hospital , Vancouver , Canada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Ganase
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.
authors.forename: Birgit
authors.initials: B
authors.lastname: Watson
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.|c Faculty of Medicine, Division of AIDS, Department of Medicine , University of British Columbia , Vancouver , Canada.
authors.forename: Mark W
authors.initials: MW
authors.lastname: Hull
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.|b Faculty of Medicine, Department of Family Practice , University of British Columbia , Vancouver , Canada.|c Faculty of Medicine, Division of AIDS, Department of Medicine , University of British Columbia , Vancouver , Canada.
authors.forename: Silvia A
authors.initials: SA
authors.lastname: Guillemi
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.
authors.forename: Wendy
authors.initials: W
authors.lastname: Zhang
authors.affiliation: e Faculty of Medicine, Department of Pathology & Laboratory Medicine , University of British Columbia , Vancouver , Canada.
authors.forename: Ramesh
authors.initials: R
authors.lastname: Saeedi
authors.affiliation: a British Columbia Centre for Excellence in HIV/AIDS , Vancouver , Canada.|c Faculty of Medicine, Division of AIDS, Department of Medicine , University of British Columbia , Vancouver , Canada.
authors.forename: P Richard
authors.initials: PR
authors.lastname: Harrigan
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D000069446:Atazanavir Sulfate / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015415:Biomarkers; D018791:CD4 Lymphocyte Count; D057915:Drug Substitution; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D000068698:Tenofovir / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D015415:Biomarkers; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D000069446:Atazanavir Sulfate; D000068698:Tenofovir
keywords: Atazanavir; HIV; Nephrotoxicity; Ritonavir; Tenofovir; Unboosting; eGFR