• Takeshi Nishijima, Misao Takano, Michiyo Ishisaka, Hirokazu Komatsu, Hiroyuki Gatanaga, Yoshimi Kikuchi, Tomoyuki Endo, Masahide Horiba, Satoru Kaneda, Hideki Uchiumi, Tomohiko Koibuchi, Toshio Naito, Masaki Yoshida, Natsuo Tachikawa, Mikio Ueda, Yoshiyuki Yokomaku, Teruhisa Fujii, Satoshi Higasa, Kiyonori Takada, Masahiro Yamamoto, Shuzo Matsushita, Masao Tateyama, Yoshinari Tanabe, Hiroaki Mitsuya, Shinichi Oka, and Epzicom-Truvada study team.
• AIDS Clinical Center, National Center for Global Health and Medicine, Japan.
• Intern. Med. 2013 Jan 1; 52 (7): 735744735-44.

ObjectiveTo 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.MethodsA 96-week multicenter, randomized, open-label, parallel group pilot study was conducted. The endpoints were times to virologic failure, safety event and regimen modification.Results109 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.ConclusionAlthough 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.

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