SYMTUZA® (darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide)

SYMTUZA - Pivotal Clinical Trial Publications

AMBER:

Eron JJ, Orkin C, Gallant J, et al. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018;32(11):1431-1442.

Orkin C, Eron JJ, Rockstroh J, et al. Week 96 results of a phase 3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve HIV-1 patients. AIDS. 2020;34(5):707-718.

Rashbaum B, Spinner CD, McDonald C, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naïve patients with HIV-1: subgroup analyses of the phase 3 AMBER study. HIV Res Clin Pract. 2019;20(1):24-33.

EMERALD:

Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5(1):e23-e34.

Eron JJ, Orkin C, Cunningham D, et al. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1. Antiviral Res. 2019;170:104543.

Huhn GD, Eron JJ, Girard PM, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. AIDS Res Ther. 2019a;16(1):23.

AMBER and EMERALD:

Ackaert O, McDougall D, Pérez-Ruixo C, et al. Population pharmacokinetic analysis of darunavir and tenofovir alafenamide in HIV-1-infected patients on the darunavir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen (AMBER and EMERALD studies). AAPS J. 2021;23(4):82.

Lathouwers E, Wong EY, Brown K, et al. Week 48 resistance analyses of the once-daily, single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase III randomized AMBER and EMERALD trials. AIDS Res Hum Retroviruses. 2020;36(1):48-57.

Lathouwers E, Weinsteiger S, Baugh B, et al. Week 96 resistance analyses of the once-daily, single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the phase 3 randomized AMBER and EMERALD trials. J Med Virol. 2021;93(6):3985-3990.

Huhn GD, Wilkin A, Mussini C, et al. Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once dailydarunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen inantiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1. HIV Res Clin Pract. 2020;21(6):151-167.

DIAMOND:

Huhn GD, Crofoot G, Ramgopal M, et al. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in a rapid-initiation model of care for HIV-1 infection: primary analysis of the DIAMOND study. Clin Infect Dis. 2020;71(12):3110-3117.

Dunn K, Rogers R, Simonson R, et al. Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis. HIV Res Clin Pract. 2021;22(2):55-61.

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