Janssen-Cilag International has reported positive results from a Phase III clinical trial (EMERALD) of darunavir containing a single-tablet regimen (STR) in patients with human immunodeficiency virus type 1 (HIV-1).
STR includes 800mg of darunavir, 150mg of cobicistat, 200mg of emtricitabine and 10mg of tenofovir alafenamide (D/C/F/TAF).
The results showed that the regimen was effective and well tolerated, with a low cumulative virologic rebound rate and high virologic suppression rate at 24 weeks.
The non-inferiority, randomised, open-label, international, multi-centre, parallel-group Phase III trial assessed the efficacy and safety of D/C/F/TAF over 48 weeks and compared it to a boosted protease inhibitor (PI) and F/TDF regimen.
EMERALD evaluated 1,141 virologically suppressed adults who switched from a standard boosted (PI) regimen.
Janssen infectious disease therapeutics global therapeutic area head Lawrence Blatt said: “We remain dedicated to fulfilling our mission of delivering transformational innovations to meet the diverse needs of the HIV community and are excited to be bringing forward an evolved therapy with darunavir as its backbone.
“If approved, it has the potential to not only offer the benefits of darunavir but could also reduce the treatment burden faced by those taking lifelong HIV therapy, which may help to address the issues of both adherence and resistance.”
While cumulative virologic rebound during the trial was found to be 1.8%, virologic suppression was observed to be 96.3% with the STR.
Earlier this month, the D/C/F/TAF STR regimen obtained a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its marketing authorisation under the brand name Symtuza in the European Union (EU).