title: Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, antiretroviral-naïve patients treated with ritonavir-boosted atazanavir plus fixed-dose tenofovir DF/emtricitabine given once daily.
abstract: OBJECTIVE
  Evaluate efficacy, safety, tolerability, pharmacokinetics, adherence, and treatment satisfaction of atazanavir/ritonavir (ATV/r) 300 mg/100mg and tenofovir DF/emtricitabine (TDF/FTC) 300 mg/200mg once daily in antiretroviral-naïve HIV-infected patients.
  
  
  METHODS
  Single-arm, open-label, multicenter 48-week study.
  
  
  RESULTS
  100 patients were evaluated; 17 patients discontinued early including 6 for adverse events. There were 2 deaths (multi-organ failure, lactic acidosis). At 48 weeks, 81% achieved HIV-1 RNA <50 copies/mL (ITT, M=F). No K65R or ATV/r associated mutations emerged; M184V developed in one patient. Median CD4 increase was 217 cells/mm3. The most common adverse events (> or = 10%) were diarrhea, nausea, scleral icterus, fatigue, upper respiratory tract infection, headache, and vomiting. Grade 4 hyperbilirubinemia occurred in 5%. Median increases at 48 weeks in total cholesterol, HDL, LDL, and triglycerides were 11, 3, 2, and 5 mg/dL, respectively. Two patients had confirmed graded increases in serum creatinine (one grade 1, one grade 2). Median (IQR) creatinine clearance change from baseline at 48 weeks was -7 (-19, 2) mL/min. Geometric mean (95% CI) ATV trough concentrations exceeded suggested therapeutic range. At 48 weeks, 92% of patients reported complete adherence by 1-week recall and 90% reported being "very satisfied" with the regimen.
  
  
  CONCLUSIONS
  ATV/r+TDF/FTC was safe, well tolerated, and convenient for patients. Larger comparative trials are ongoing.
authors.affiliation: Whitman Walker Clinic, Washington, DC 20009, USA. drrelion@aol.com
authors.forename: Richard
authors.initials: R
authors.lastname: Elion
authors.forename: Calvin
authors.initials: C
authors.lastname: Cohen
authors.forename: Douglas
authors.initials: D
authors.lastname: Ward
authors.forename: Peter
authors.initials: P
authors.lastname: Ruane
authors.forename: Roberto
authors.initials: R
authors.lastname: Ortiz
authors.forename: Y Sunila
authors.initials: YS
authors.lastname: Reddy
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Damian
authors.initials: D
authors.lastname: McColl
authors.forename: Brian
authors.initials: B
authors.lastname: Kearney
authors.forename: Alvan
authors.initials: A
authors.lastname: Fisher
authors.forename: John
authors.initials: J
authors.lastname: Flaherty