title: Atazanavir for treatment of HIV infection in clinical routine: efficacy, pharmacokinetics and safety.
abstract: BACKGROUND
  Atazanavir (ATV) is a novel protease inhibitor that has been recently introduced into therapy of HIV infection. Currently there is little data on ATV therapy from daily practice.
  
  
  METHODS
  In this retrospective study, we report on ATV efficacy and safety in clinical routine. Drug monitoring was performed consisting of unscheduled single measurements and a 4-hour-profile. Trough concentration of >80 ng/ml and peak concentration of 2000-6000 ng/ml were regarded as sufficient.
  
  
  RESULTS
  Between May 2003 and April 2004, ATV treatment was started in 42 patients, mean observation time was 32 weeks (6-53). Mean age was 45.6 years, 38% had prior AIDS, viral load was undetectable in 73%. Important side effects were minor or moderate diarrhea (27%) and fatigue (15%). ATV was discontinued in 10% due to side effects or malignant diseases. No significant influence on mean values of cholesterol, triglycerides, liver enzymes, CD4-cell-count, and HI-viral load was seen. Virologic failure occurred in 13% of patients, all of them were PI-experienced. Pharmacokinetic data are available for 32 patients, all patients had sufficient trough levels. 30% with unboosted ATV and 21% with boosted ATV had peak plasma concentrations below the level defined as sufficient. Mean trough levels, plasma profile and AUC did not differ significantly between groups with non-boosted versus boosted ATV regimes but showed a wide inter-patient variability.
  
  
  CONCLUSIONS
  ATV treatment of HIV-infected patients with or without a RTV booster was safe and effective in clinical routine. Drug levels were sufficient in the majority of cases. The variability of pharmacokinetic results in our sample supports therapeutic drug monitoring in patients treated with ATV.
authors.affiliation: Clinic for Gastroenterology, Hepatology, and Infectious Diseases, University Clinic of Düsseldorf, Moorenstr. 5, D-40225 Düsseldorf, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Feldt
authors.forename: Mark
authors.initials: M
authors.lastname: Oette
authors.forename: A
authors.initials: A
authors.lastname: Kroidl
authors.forename: K
authors.initials: K
authors.lastname: Göbels
authors.forename: R
authors.initials: R
authors.lastname: Leidel
authors.forename: A
authors.initials: A
authors.lastname: Sagir
authors.forename: D
authors.initials: D
authors.lastname: Kuschak
authors.forename: D
authors.initials: D
authors.lastname: Häussinger
mesh_terms: D019380:Anti-HIV Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D019963:Clinical Chemistry Tests; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy* / Q000473:pathology; D017320:HIV Protease Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006403:Hematologic Tests; D006801:Humans; D008875:Middle Aged; D009842:Oligopeptides / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011725:Pyridines / Q000493:pharmacokinetics / Q000627:therapeutic use*; D012189:Retrospective Studies; D019438:Ritonavir / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D009842:Oligopeptides; D011725:Pyridines; D000069446:Atazanavir Sulfate; D019438:Ritonavir