EMERALD study for Symtuza for HIV shows high virologic suppression and low virologic failure.- Janssen Pharma.

The Janssen Pharmaceutical Companies of Johnson & Johnson unveils new 96-week data for Symtuza (darunavir 200 mg, cobicistat 150 mg, emtricitabine 200mg, and tenofovir alafenamide 10 mg; D/C/F/TAF), a single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-na�ve and certain virologically suppressed adults, in a presentation at IDWeek 2018 in San Francisco, CA.

Results from the pivotal Phase III EMERALD study demonstrate that in adults with HIV-1 who are virologically suppressed, switching to Symtuza resulted in maintained high virologic suppression (91%, 692/763) and low virologic failure (1%, 9/763) at week 96 (per FDA-Snapshot); low cumulative virologic rebound (3.1%, 24/763); and no resistance development, up to 96-weeks. This 96-week extension study, which follows on from the earlier 24- and 48-week results,reinforced the long-term efficacy, resistance and safety profile of Symtuza as a treatment for virologically suppressed adults with HIV-1. The patient population studied in EMERALD included patients who may have experienced prior virologic failure and/or who may have resistance to emtricitabine. Symtuza was well-tolerated with 2% (14/763) of people experiencing a study drug related grade 3 or 4 adverse event (AE) and 2% (17/763) AE-related discontinuations over 96 weeks.

The most common AEs (all grades, ?10% of adults) in the extension period were upper respiratory tract infection, viral upper respiratory tract infection, diarrhea, headache and back pain. After initial increases between baseline through to week 48, the lipid profile among D/C/F/TAF patients remained stable thereafter. Improvements in renal and bone parameters were maintained in the Symtuza group over 96 weeks and consistent with known tenofovir alafenamide and cobicistat profiles.

In a separate analysis, switching treatment to Symtuza from the multi-tablet control regimen after 52 weeks achieved comparable efficacy and safety to the 48-week results in the group that switched immediately. In this late-switch group, after 44 weeks of Symtuza exposure, the virologic suppression and virologic failure rates were 94% (330/352) and 2% (6/352) respectively at week 96 (per FDA-Snapshot), and the cumulative rebound rate was 2.3% (8/352) from switch at week-52 through week 96. Over 44 weeks, in this late-switch group, serious adverse events and adverse event-related discontinuations occurred in 6% (21/352) and 2% (7/352) of adults respectively while on Symtuza.