Bioequivalence study of Odefsey as compared to Genvoya and Edurant

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 27 Jun 2016

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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

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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