Janssen says Phase 3 EMERALD study of darunavir-based regimen hit endpoint
Janssen Pharmaceutica, a Johnson & Johnson company, announced results from the pivotal Phase 3 EMERALD study which were published online in The Lancet HIV and will be presented at IDWeek 2017 in San Diego. The study met its primary endpoint, which focused on virologic rebound rate, and demonstrated that switching to the investigational single-tablet regimen containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg was non-inferior to continuing treatment with a boosted protease inhibitor plus emtricitabine and tenofovir disoproxil fumarate in human immunodeficiency virus type 1 positive, virologically suppressed adults. There were no observed resistance associated mutations to study drugs through 48 weeks. "If approved in the U.S., D/C/F/TAF would be the only complete regimen that may deliver the potential adherence benefit of a once-daily STR with the durability and high genetic barrier to resistance of darunavir and the demonstrated bone and renal safety profile of TAF," the company stated.