The Janssen Pharmaceutical Companies of Johnson & Johnson has announced new 96-week data from the pivotal Phase 3 AMBER study of Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide), a single-tablet regimen (STR) for treatment-naïve and certain virologically suppressed adults living with human immunodeficiency virus type 1 (HIV-1).
The 96-week data, which is the continuation of the 48-week results, reinforce the long-term safety, efficacy and tolerability profile of Symtuza as a treatment for people new to HIV antiretroviral treatment.
According to Janssen, the results, presented at HIV Glasgow, further build on the growing clinical data set, which includes the EMERALD, AMBER, and DIAMOND studies, demonstrating that Symtuza, the first and only complete darunavir-based STR, gives healthcare providers a new treatment option to bring clinically appropriate patients the protective barrier to resistance of darunavir in a formulation designed for tolerability and the convenience of an STR.
Based on the U.S. 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. The International Antiviral Society (IAS)-USA guidelines also recommend darunavir-based regimens in rapid initiation scenarios.
The 96-week data were presented at HIV Glasgow on Tuesday, October 30.