First Darunavir-Based Single-Tablet Treatment Regimen for HIV Wins FDA Approval

Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg) is the first and only complete darunavir-based single tablet regimen (STR) for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults.

Officials with the FDA have approved Janssen’s Symtuza for the treatment of HIV-1 infection, according to a press release.

Symtuza (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg) is the first and only complete darunavir-based single tablet regimen (STR) for the treatment of HIV-1 in treatment-naïve and certain virologically suppressed adults.

Cobicistat, emtricitabine, and tenofovir alafenamide are from Gilead Sciences, Inc.

The approval is based on data from two phase 3 studies, AMBER and EMERALD, which evaluated the safety and efficacy of Symtuza compared with a control regimen in adults with no prior antiretroviral (ARV) history and in virologically suppressed adults.

The AMBER trial compared treatment with Symtuza to darunavir/cobicistat (D/C) plus emtricitabine/tenofovir disoproxil fumarate (F/TDF). According to the data, similar viral suppression rates were demonstrated between darunavir-based STR versus the control and low virologic rates at 48 weeks. Additionally, Symtuza showed less bone loss and a significant improvement in markers of renal function versus the control. Overall, the treatment was well-tolerated in participants.

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