Janssen’s Symtuza has been approved US regulators as the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV in adults.
According to Janssen, single table regimens have the capacity to boost adherence and reduce the medicine burden
Symtuza darunavir (cobicistat/emtricitabine/tenofovir alafenamide) offers patients “the proven protective barrier to resistance of darunavir in a formulation designed for improved tolerability and the convenience,” it said.
"As clinicians, we may not always have the full picture of a patient's health or their risk for developing resistance when making treatment decisions,” said Joseph Eron, Professor of Medicine and director, Clinical Core, University of North Carolina Center for AIDS Research.
“In key Phase III clinical trials, Symtuza successfully treated those who were starting therapy, as well as those who were stably suppressed on antiretroviral (ARV) therapy – including patients with more complex treatment histories or previous virologic failure – demonstrating its potential as an important new treatment option for a wide variety of patients.”
The approval was based on data from two 48-week Phase III studies that assessed the safety and efficacy of Symtuza versus a control regimen in adults with no prior antiretroviral history (AMBER) and in virologically suppressed adults (EMERALD).
Results from both trials showed that Symtuza was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression.