Symtuza found to improve viral response rate in HIV

Janssen Pharmaceutica announced that the pivotal Phase III AMBER study of Symtuza (darunavir + cobicistat + emtricitabine + tenofovir alafenamide) achieved its primary endpoint in HIV positive adults. The sudy focused on virologic response rate, and demonstrated that the investigational single-tablet regimen (STR) containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF) was non-inferior to darunavir/cobicistat (D/C) plus emtricitabine and tenofovir disoproxil fumarate (F/TDF) in previously untreated human immunodeficiency virus type 1 (HIV-1) positive adults.

Overall, the AMBER study met the primary endpoint, and D/C/F/TAF demonstrated non-inferiority versus the control group at 48 weeks (HIV RNA below 50 c/mL 91.4% vs 88.4% respectively) and also resulted in low virologic failure (VF) rates (VL of at least 50 c/mL; FDA Snapshot: 4.4% [16/362] versus 3.3% [12/363]). There were no observed resistance associated mutations (RAMs) to darunavir or TAF/TDF through 48 weeks.

D/C/F/TAF showed more favorable bone and renal safety parameters versus control. Statistically significant differences were observed in mean changes from baseline to Week 48 in bone mineral density (BMD) between D/C/F/TAF and control. Similar results were also demonstrated in safety versus control through 48 weeks in terms of rates of discontinuations due to adverse events, of Grade 3-4 AEs (5.2% vs 6.1%), and of serious AEs (4.7% vs. 5.8%). The results will be presented on October 27 at the 16th European AIDS Conference.