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.
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.