
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine (Symtuza)
Other Names: DRV-COBI-TAF-FTCDrug Summary
Key Clinical Trials
A phase 3 trial in treatment-naïve individuals compared the fixed-dose single-tablet regimen darunavir-cobicistat-tenofovir alafenamide-emtricitabine with the regimen darunavir-cobicistat plus tenofovir DF-emtricitabine emtricitabine [AMBER]. In this trial, 725 treatment-naïve adults were randomized in 1:1 fashion to the two arms. At week 48, the proportion with HIV RNA level below 50 copies/mL was not statistically different (91.4% in the darunavir-cobicistat-tenofovir alafenamide-emtricitabine arm and 88.4% in the darunavir-cobicistat plus tenofovir DF-emtricitabine arm). Markers of bone mineral density and renal tubule wasting were better in the group who took the single-tablet, tenofovir alafenamide-containing regimen.
A phase 3 switch study enrolled individuals taking a boosted protease inhibitor plus tenofovir DF-emtricitabine and randomized participants to continue the regimen or switch to darunavir-cobicistat-tenofovir alafenamide-emtricitabine [EMERALD]. Overall, 1,141 enrollees were randomized in 2:1 fashion to the switch arm versus continue baseline therapy. All participants had a suppressed HIV RNA level and individuals were excluded if they had resistance mutations known to affect the activity of darunavir or tenofovir (past virologic failure on a non-darunavir-containing regimen was allowed). At 48 weeks, rates of virologic rebound were low and not statistically different between the two arms. Overall tolerability was similar between the two groups, though markers of bone mineral density loss and renal tubulopathy favored the tenofovir alafenamide-containing single tablet regimen. In this study, a retrospective analysis showed that 53 individuals had a history of lamivudine/emtricitabine resistance, but all had HIV RNA below 50 copies/mL at follow-up.