Janssen Pharmaceutica’s experimental combination therapy for HIV containing four medicines in a single pill has hit safety and efficacy targets in a late stage trial, results of which have been published in The Lancet HIV.
The pivotal Phase III EMERALD study met its primary endpoint, demonstrating that switching to the investigational single-tablet regimen (STR) containing darunavir 800mg, cobicistat 150mg, emtricitabine 200mg and tenofovir alafenamide 10mg (D/C/F/TAF) was non-inferior to continuing treatment with a boosted protease inhibitor (PI) plus emtricitabine and tenofovir disoproxil fumarate in HIV-1 positive, virologically suppressed adults.
Also, there were no observed resistance associated mutations (RAMs) to study drugs through 48 weeks, while D/C/F/TAF demonstrated similar safety versus the control group through 48 weeks. Rates of discontinuations due to adverse events (AEs) were 1.4 percent (D/C/F/TAF) versus 1.3 percent (control), while serious AEs were 4.6 percent versus 4.8 percent, respectively. There were no deaths in either arm of the study.
According to the press release, “if approved in the US, 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.”
Patients can find adherence to HIV treatment challenging for several reasons, but this increases the risk of drug resistance, “which can render their treatment – and even an entire class of treatments – ineffective,” adds Joseph Eron, Professor of Medicine and director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill.
“The findings from the EMERALD study bring us one step closer to being able to offer those who live with HIV and struggle with adherence an option that combines the efficacy and high genetic barrier to resistance of darunavir with the demonstrated safety profile of tenofovir alafenamide into a single tablet.”
