title: Abacavir/lamivudine versus tenofovir/emtricitabine with atazanavir/ritonavir for treatment-naive Japanese patients with HIV-1 infection: a randomized multicenter trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of fixed-dose abacavir/lamivudine (ABC/3TC) and tenofovir/emtricitabine (TDF/FTC) with ritonavir-boosted atazanavir (ATV/r) in treatment-naïve Japanese patients with HIV-1 infection.
  
  
  METHODS
  A 96-week multicenter, randomized, open-label, parallel group pilot study was conducted. The endpoints were times to virologic failure, safety event and regimen modification.
  
  
  RESULTS
  109 patients were enrolled and randomly allocated (54 patients received ABC/3TC and 55 patients received TDF/FTC). All randomized subjects were analyzed. The time to virologic failure was not significantly different between the two arms by 96 weeks (HR, 2.09; 95% CI, 0.72-6.13; p=0.178). Both regimens showed favorable viral efficacy, as in the intention-to-treat population, 72.2% (ABC/3TC) and 78.2% (TDF/FTC) of the patients had an HIV-1 viral load <50 copies/mL at 96 weeks. The time to the first grade 3 or 4 adverse event and the time to the first regimen modification were not significantly different between the two arms (adverse event: HR 0.66; 95% CI, 0.25-1.75, p=0.407) (regimen modification: HR 1.03; 95% CI, 0.33-3.19, p=0.964). Both regimens were also well-tolerated, as only 11.1% (ABC/3TC) and 10.9% (TDF/FTC) of the patients discontinued the allocated regimen by 96 weeks. Clinically suspected abacavir-associated hypersensitivity reactions occurred in only one (1.9%) patient in the ABC/3TC arm.
  
  
  CONCLUSIONS
  Although insufficiently powered to show non-inferiority of viral efficacy of ABC/3TC relative to TDF/FTC, this pilot trial suggested that ABC/3TC with ATV/r is a safe and efficacious initial regimen for HLA-B*5701-negative patients, such as the Japanese population.
authors.affiliation: AIDS Clinical Center, National Center for Global Health and Medicine, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nishijima
authors.forename: Misao
authors.initials: M
authors.lastname: Takano
authors.forename: Michiyo
authors.initials: M
authors.lastname: Ishisaka
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Komatsu
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Gatanaga
authors.forename: Yoshimi
authors.initials: Y
authors.lastname: Kikuchi
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Endo
authors.forename: Masahide
authors.initials: M
authors.lastname: Horiba
authors.forename: Satoru
authors.initials: S
authors.lastname: Kaneda
authors.forename: Hideki
authors.initials: H
authors.lastname: Uchiumi
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Koibuchi
authors.forename: Toshio
authors.initials: T
authors.lastname: Naito
authors.forename: Masaki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Natsuo
authors.initials: N
authors.lastname: Tachikawa
authors.forename: Mikio
authors.initials: M
authors.lastname: Ueda
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Yokomaku
authors.forename: Teruhisa
authors.initials: T
authors.lastname: Fujii
authors.forename: Satoshi
authors.initials: S
authors.lastname: Higasa
authors.forename: Kiyonori
authors.initials: K
authors.lastname: Takada
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Shuzo
authors.initials: S
authors.lastname: Matsushita
authors.forename: Masao
authors.initials: M
authors.lastname: Tateyama
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Tanabe
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Mitsuya
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oka
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage; D044466:Asian People / Q000208:ethnology; D000069446:Atazanavir Sulfate; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015224:Dideoxynucleosides / Q000008:administration & dosage; D004338:Drug Combinations; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage*; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D008297:Male; D009842:Oligopeptides / Q000008:administration & dosage; D063065:Organophosphonates / Q000008:administration & dosage; D010865:Pilot Projects; D011725:Pyridines / Q000008:administration & dosage; D019438:Ritonavir / Q000008:administration & dosage; D000068698:Tenofovir; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D000225:Adenine; D019380:Anti-HIV Agents; D000998:Antiviral Agents; D000069446:Atazanavir Sulfate; D003841:Deoxycytidine; D015224:Dideoxynucleosides; D004338:Drug Combinations; D000068679:Emtricitabine; D017320:HIV Protease Inhibitors; D019259:Lamivudine; D009842:Oligopeptides; D063065:Organophosphonates; D011725:Pyridines; D019438:Ritonavir; D000068698:Tenofovir; D000099227:Abacavir; C492871:abacavir, lamivudine drug combination