Single-Tablet Regimen Symtuza Approved to Treat HIV-1 Infection

Symtuza combines darunavir, cobicistat, emtricitabine and tenofovir alafenamide
Symtuza combines darunavir, cobicistat, emtricitabine and tenofovir alafenamide

Janssen announced that the Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection in treatment-naive and in virologically suppressed adults (<50 copies/mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.

Symtuza is the first complete darunavir-based single-tablet regimen to be approved. The drug combines darunavir, an HIV-1 protease inhibitor; cobicistat, a CYP3A inhibitor; and emtricitabine and tenofovir alafenamide, both HIV-1 nucleoside analog reverse transcriptase inhibitors. 

The approval was supported by data from two, 48-week, non-inferiority, Phase 3 studies that evaluated Symtuza vs a control regimen, in adults who were treatment-naive (AMBER) and in virologically suppressed adults (EMERALD). In AMBER (N=725), Symtuza was compared to darunavir/cobicistat + emtricitabine/tenofovir disoproxil fumarate. The data showed similar viral suppression rates between the 2 arms (91.4% vs 88.4%, respectively) as well as low virologic failure rates (4.4% vs 3.3%) at week 48. Also, less bone loss and significantly improved markers of renal function were observed with Symtuza vs control. 

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In EMERALD (N=1141), Symtuza was compared with continued boosted protease inhibitor + emtricitabine/tenofovir disoproxil fumarate. The data showed low virologic failure rates (0.8% vs 0.5%) and high virologic suppression rates (94.9% vs 93.7%) at week 48. Also, an improvement in bone mineral density and significantly improved markers of renal function were observed with Symtuza vs control. 

Symtuza carries a Boxed Warning describing the risk of post-treatment acute exacerbation of hepatitis B. Treatment is not recommended in patients with CrCl <30mL/min or in those with severe hepatic impairment. The product will be supplied as 800mg/150mg/200mg/10mg strength tablets in 30-count bottles.

For more information call (800) 526-7736 or visit Janssen.com.