Bioequivalence study of Odefsey as compared to Genvoya and Edurant

Trial Profile

Bioequivalence study of Odefsey as compared to Genvoya and Edurant

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Jun 2016

At a glance

  • Drugs Emtricitabine/rilpivirine/tenofovir alafenamide (Primary) ; Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide; Rilpivirine
  • Indications HIV-1 infections
  • Focus Adverse reactions
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 23 Jun 2016 According to a Gilead Sciences media release, the European Commission has granted marketing authorization for the once-daily single tablet regimen (STR) Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.
    • 29 Apr 2016 According to a Gilead Sciences media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted positive opinion on the MAA for Odefsey for the treatment of HIV-1 infection in adults and adolescents. The MAA was supported by data from this trial.
    • 07 Mar 2016 New trial record
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