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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概要

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• 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. Conclusion 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.

著者

• Endo Tomoyuki

  Department Of Emergency And Critical Care Medicine Tohoku University Graduate School Of Medicine

• Yokomaku Yoshiyuki

  Clinical Res. Center National Hospital Organization Nagoya Medical Center

• Takano Misao

  AIDS Clinical Center, National Center for Global Health and Medicine, Japan

• Oka Shinichi

  Aids Clinical Center International Medical Center Of Japan

• Uchiumi Hideki

  Department Of Applied Chemistry Nagoya Institute Of Technology

• Naito Toshio

  Department Of Chemistry Graduate School Of Science Hokkaido University

• Komatsu Hirokazu

  Department Of Applied Chemistry Keio University

• Kikuchi Yoshimi

  Aids Clinical Center International Medical Center Of Japan

• Tanabe Yoshinari

  Division Of Clinical Infection Control And Prevention Niigata University Graduate School Of Medical

• Gatanaga Hiroyuki

  Aids Clinical Center International Medical Center Of Japan

• Mitsuya Hiroaki

  Department Of Hematology And Infectious Diseases Kumamoto University Graduate School Of Medical Scie

• TACHIKAWA Natsuo

  Departments of Infectious Deseases, Institute of Medical Science, University of Tokyo

• FUJII Teruhisa

  Division of Blood Transfusion Services, Hiroshima University Medical Hospital

• Yoshida Masaki

  Department Of 2nd Internal Medicine Jikei University School Of Medicine

• Matsushita Shuzo

  Center For Aids Research Kumamoto University

• Koibuchi Tomohiko

  Department Of Infectious Disease And Applied Immunology University Of Tokyo

• Yamamoto Masahiro

  Internal Medicine 1 Jusei Hospital

• Tateyama Masao

  Department of Infections, Respiratory, and Digestive Medicine, Control and Prevention of Infectious Diseases, Faculty of Medicine, University of the Ryukyus, Japan

• Mitsuya Hiroaki

  Departments of Infectious Diseases and Hematology, Kumamoto University Graduate School of Medical Sciences, Japan

• Nishijima Takeshi

  AIDS Clinical Center, National Center for Global Health and Medicine, Japan

• Ishisaka Michiyo

  AIDS Clinical Center, National Center for Global Health and Medicine, Japan

• Horiba Masahide

  Division of Respiratory Medicine, Higashisaitama National Hospital, Japan

• Kaneda Satoru

  Department of Gastroenterology, National Hospital Organization Chiba Medical Center, Japan

• Ueda Mikio

  Immunology and Infectious Disease, Ishikawa Prefectural Central 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

• Tateyama Masao

  Department of Infectious, Respiratory, and Digestive Medicine Control and Prevention of Infectious Diseases Faculty of Medicine, University of the Ryukyus, Japan

• Komatsu Hirokazu

  Department of Community Care, Saku Central Hospital, Japan

• Tachikawa Natsuo

  Department of Infectious Diseases, Yokohama Municipal Citizen's Hospital, Japan

• Tanabe Yoshinari

  Division of Infection Control and Prevention, Niigata University Medical and Dental Hospital, Japan

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