title: Open-label randomized multicenter selection study of once daily antiretroviral treatment regimen comparing ritonavir-boosted atazanavir to efavirenz with fixed-dose abacavir and lamivudine.
abstract: BACKGROUND
  The side-effects of anti-retroviral drugs are different between Japanese and Caucasian patients. Severe central nerve system (CNS) side-effects to efavirenz and low rate of hypersensitivity against abacavir characterize the Japanese.
  
  
  OBJECTIVE
  The objective of this study was to select a once daily regimen for further non-inferior study comparing the virological efficacy and safety of the first line once daily antiretroviral treatment regimens in the current HIV/AIDS guideline.
  
  
  METHODS
  The study design was a randomized, open label, multicenter, selection study. One arm was treated with efavirenz and the other with ritonavir-boosted atazanavir. A fixed-dose lamivudine plus abacavir were used in both arms. The primary endpoint was virologic success (viral load less than 50 copies/mL) rate at 48 weeks. Patients were followed-up to 96 weeks with safety as the secondary endpoint. Clinicaltrials.Gov (NCT00280969) and the University hospital Medical Information Network (UMIN000000243).
  
  
  RESULTS
  A total of 71 participants were enrolled. Virologic success rates in both arms were similar at week 48 [efavirenz arm 28/36 (77.8%); atazanavir arm 27/35 (77.1%)], but were decreased at week 96 to 55.6% in the efavirenz arm and 68.8% in the atazanavir arm (p=0.33). At the 96-week follow-up, 52.8% of the EFV arm and 34.3% of the ATV/r arm reached total cholesterol more than 220 mg/dL and required treatment. None of the patients developed cardiovascular complications in this study by week 96.
  
  
  CONCLUSIONS
  There was no significant difference in the efficacy of efavirenz and ritonavir-boosted atazanavir combined with lamivudine plus abacavir at 48 weeks. The evaluation of safety was extended to 96 weeks, which also showed no significant difference in both arms.
authors.affiliation: AIDS Clinical Center, National Center for Global Health and Medicine, Japan. honda-1@umin.ac.jp
authors.forename: Miwako
authors.initials: M
authors.lastname: Honda
authors.forename: Michiyo
authors.initials: M
authors.lastname: Ishisaka
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kimura
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy / Q000208:ethnology; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069446:Atazanavir Sulfate; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D001663:Bilirubin / Q000097:blood; D002784:Cholesterol / Q000097:blood; D003521:Cyclopropanes; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D007564:Japan; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D019438:Ritonavir / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D000410:Alanine Transaminase; D000480:Alkynes; D044966:Anti-Retroviral Agents; D000069446:Atazanavir Sulfate; D048588:Benzoxazines; D001663:Bilirubin; D002784:Cholesterol; D003521:Cyclopropanes; D015224:Dideoxynucleosides; D019259:Lamivudine; D009842:Oligopeptides; D011725:Pyridines; D019438:Ritonavir; D000099227:Abacavir; C098320:efavirenz