AMBER Study: Phase 3 Symtuza Results

At the 16th European AIDS Conference in Milan, Italy, on October 25, 2017, Janssen Pharmaceutica, NV announced the results of its Phase 3 AMBER study. In short, the study demonstrated that its new single-tablet regimen (STR) Symtuza (containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg) (D/C/F/TAF) was effective in achieving a suppressed viral load (viral load of less than 50 copies per mL at forty-eight weeks, per FDA Snapshot analysis) in adults with previously untreated HIV-1 infection. “The 48-week AMBER study results further build on the growing clinical data set that demonstrates the safety and efficacy of darunavir in a once-daily, single-pill dosing regimen,” said Joseph Eron, MD, Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, NC.

The AMBER study—a Phase 3 randomized, double-blind, active-controlled, international, multi-center study—was designed to assess the safety and efficacy of the single-tablet D/C/F/TAF versus the control in patients whose HIV-1 had not previously been treated. The control consisted two medications, D/C plus F/TDF, and patients were randomly assigned to the two groups (362 D/C/F/TAF; 363 control). The goal of the study was to assess the effectiveness of the STR versus the control in achieving viral suppression. D/C/F/TAF demonstrated non-inferiority versus the control group at forty-eight weeks (HIV RNA Non-adherence to a daily regiment of HIV medications can lead to drug resistance and nullify treatment. As of September 25, 2017, Symtuza has been approved by the European Commission for treating HIV-1 infection in adults and adolescents aged twelve years and older who weigh at least 40 kg and can now be marketed in all member states of the European Union and the European Economic Area. Janssen has filed a new drug application with the U.S. Food and Drug Administration (FDA) and is awaiting approval. If approved, Symtuza will be the only complete, simplified regimen for patients with adherence problems.

“The 48-week AMBER results demonstrated that if approved in the U.S., the investigational darunavir-based STR—combining the durability and high genetic barrier to resistance of darunavir with the safety profile of TAF—could provide a complete and simplified regimen for treatment-naïve patients who may struggle with adherence, and in turn face the risk of developing drug resistance,” said Rick Nettles, MD, Vice President, Medical Affairs, Janssen Infectious Diseases.

Reporting by Hank Trout