Janssen Pharmaceutical Companies of Johnson & Johnson has reported new 96-week data from the Phase III AMBER clinical trial that evaluated the safety and efficacy of symtuza against a control for the treatment of antiretroviral treatment (ART) naïve adults with human immunodeficiency virus type 1 (HIV-1).
The control included two separate medications of darunavir / cobicistat and emtricitabine / tenofovir disoproxil fumarate.
The double-blind, active-controlled, non-inferiority international study randomly assigned 362 and 363 patients to receive symtuza and the control respectively.
New long-term results showed that 85% of ART-naïve adults with HIV-1 achieved virologic suppression at 96 weeks when treated with symtuza.
Only one patient treated with symtuza developed a nucleoside reverse transcriptase inhibitor resistance-associated mutation to emtricitabine (M184V), while a low virologic failure rate of 6% was also reported.
Efficacy and safety outcomes were similar to the previous 48-week results in the symtuza group.
Among other data, the newly released results demonstrated consistency in bone, renal and lipid safety data with known profiles of tenofovir alafenamide and cobicistat.
University of North Carolina Centre for AIDS Research Clinical Core director and Janssen consultant Joseph Eron said: “The 96-week AMBER data further demonstrate the importance of symtuza as a treatment option for adults new to HIV therapy who may benefit from a single-tablet regimen that offers the protective barrier to resistance of darunavir along with the tolerability profile of TAF.
“Based on the US Department of Health and Human Services (DHHS) guidelines, darunavir-based regimens are a recommended option in situations where clinicians may not have all genotypic resistance test results, when patients may be at risk for sub-optimal adherence or in rapid initiation scenarios.”