Long-term safety and efficacy data from Phase 3 EMERALD study presented at IDWeek 20181
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-naïve and certain virologically suppressed adults, in a presentation at IDWeek 2018 in San Francisco, CA.
Results from the pivotal Phase 3 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.1
‘The 96-week results from the EMERALD study demonstrate that SYMTUZA™ can offer clinically appropriate people living with HIV a single-tablet option that may help them maintain high rates of virologic suppression over time,’ said Joseph Eron, M.D., Professor of Medicine and Director, Clinical Core, University of North Carolina Center for AIDS Research, Chapel Hill, NC.
This 96-week extension study, which follows on from the earlier 24 – and 48-week results,2,3,4 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.1 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.1
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.1 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™.
‘These new data are extremely important, as they further demonstrate that through 96-weeks SYMTUZA™ offers sustained efficacy, a long-term safety profile and the protective barrier to resistance of darunavir in a single-tablet option for clinically appropriate adults. These are all important factors for people who require long-term HIV-1 therapy,’ said Richard Nettles M.D., Vice President, US Medical Affairs, Janssen Scientific Affairs, LLC.
On September 25, 2017, SYMTUZA™ was approved for the treatment of HIV-1 infection by the European Commission based on results from a bioequivalence study that compared SYMTUZA™ with the combined administration of the separate agents darunavir [D] 800mg, cobicistat [C] 150mg, and emtricitabine/tenofovir alafenamide [FTC/TAF] 200mg/10mg fixed-dose combination.5,6FDA approval was granted on July 17, 2018 based on the results from the two pivotal Phase 3 studies, EMERALD and AMBER.5,7
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