Bictegravir/emtricitabine/tenofovir alafenamide

Drug Profile

Bictegravir/emtricitabine/tenofovir alafenamide

Alternative Names: B/F/TAF; BIC/FTC/TAF; Bictegravir/F/TAF; Emtricitabine/GS 9883/tenofovir alafenamide; F/GS 9883/TAF; GS 9883/F/TAF; GS 9883/tenofovir alafenamide/emtricitabine; GS-9883/emtricitabine/tenofovir alafenamide

Latest Information Update: 06 Oct 2017

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At a glance

  • Originator Gilead Sciences
  • Class Antiretrovirals; Antivirals; Deoxyribonucleosides; Purines; Pyrimidine nucleosides; Small molecules
  • Mechanism of Action HIV integrase inhibitors; Nucleoside reverse transcriptase inhibitors; Nucleotide reverse transcriptase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration HIV-1 infections

Most Recent Events

  • 04 Oct 2017 Safety and efficacy data from the phase III (Study 1878) trial in HIV-1 infections presented at the IDWeek 2017
  • 10 Aug 2017 FDA assigns PDUFA action date of 12/02/2018 for bictegravir/emtricitabine/tenofovir alafenamide for HIV-1 infections (Treatment-naive, Treatment-experienced)
  • 10 Aug 2017 Bictegravir/emtricitabine/tenofovir alafenamide receives priority review status for HIV-1 infections (Treatment-naive, Treatment-experienced) in USA
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