Abacavir/Lamivudine versus Tenofovir/Emtricitabine with Atazanavir/Ritonavir for Treatment-naive Japanese Patients with HIV-1 Infection: A Randomized Multicenter Trial

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Author(s)

    • Nishijima Takeshi
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan|Center for AIDS Research, Kumamoto University Graduate School of Medical Sciences, Japan
    • Uchiumi Hideki
    • Department of Medicine and Clinical Science, Gunma University Graduate School of Medicine, Japan
    • Koibuchi Tomohiko
    • Department of Infectious Diseases and Applied Immunology, Research Hospital of the Institute of Medical Science, The University of Tokyo, Japan
    • Naito Toshio
    • Department of General Medicine, Juntendo University School of Medicine, Japan
    • Yoshida Masaki
    • Department of Infectious Diseases and Infection Control, The Jikei University School of Medicine, Japan
    • Tachikawa Natsuo
    • Department of Infectious Diseases, Yokohama Municipal Citizen's Hospital, Japan
    • Ueda Mikio
    • Immunology and Infectious Disease, Ishikawa Prefectural Central Hospital, Japan
    • Yokomaku Yoshiyuki
    • Clinical Research Center, National Hospital Organization Nagoya Medical Center, Japan
    • Fujii Teruhisa
    • Division of Blood Transfusion, Hiroshima University Hospital, Japan
    • Higasa Satoshi
    • Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Japan
    • Takada Kiyonori
    • Postgraduate Clinical Training Center, Ehime University Hospital, Japan
    • Takano Misao
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan
    • Yamamoto Masahiro
    • Internal Medicine, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan
    • Matsushita Shuzo
    • Center for AIDS Research, Kumamoto University Graduate School of Medical Sciences, Japan
    • Tateyama Masao
    • Department of Infectious, Respiratory, and Digestive Medicine Control and Prevention of Infectious Diseases Faculty of Medicine, University of the Ryukyus, Japan
    • Tanabe Yoshinari
    • Division of Infection Control and Prevention, Niigata University Medical and Dental Hospital, Japan
    • Mitsuya Hiroaki
    • Departments of Infectious Diseases and Hematology, Kumamoto University Graduate School of Medical Sciences, Japan|Experimental Retrovirology Section, HIV and AIDS Malignancy Branch, National Cancer Institute, National Institutes of Health, USA
    • Oka Shinichi
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan|Center for AIDS Research, Kumamoto University Graduate School of Medical Sciences, Japan
    • Ishisaka Michiyo
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan
    • Gatanaga Hiroyuki
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan|Center for AIDS Research, Kumamoto University Graduate School of Medical Sciences, Japan
    • Kikuchi Yoshimi
    • AIDS Clinical Center, National Center for Global Health and Medicine, Japan
    • Endo Tomoyuki
    • Department of Hematology, Hokkaido University Hospital, Japan
    • Horiba Masahide
    • Division of Respiratory Medicine, Higashisaitama National Hospital, Japan
    • Kaneda Satoru
    • Department of Gastroenterology, National Hospital Organization Chiba Medical Center, Japan

Abstract

<b>Objective</b> 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.<br> <b>Methods</b> 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.<br> <b>Results</b> 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.<br> <b>Conclusion</b> 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.<br>

Journal

  • Internal Medicine

    Internal Medicine 52(7), 735-744, 2013

    The Japanese Society of Internal Medicine

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