FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD


August 01, 2018

In This Article

HIV-1 Infection: Biktarvy (bictegravir/emtricitabine/tenofovir AF)

Indication: Indicated as a complete regimen for HIV-1 infection in adults who are antiretroviral therapy (ART)-naive or to replace current ART regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components.


Bictegravir: A new HIV-1 integrase strand transfer inhibitor (INSTI).

Emtricitabine: Nucleoside reverse transcriptase inhibitor (NRTI).

Tenofovir AF: NRTI prodrug of tenofovir.


1 tablet PO once daily with or without food.

Fixed dose tablet contains bictegravir 50mg, emtricitabine 200mg, and tenofovir AF 25mg.

Approval was based on 2 randomized controlled trials that found bictegravir/emtricitabine/tenofovir AF was noninferior to both dolutegravir/abacavir/lamivudine and dolutegravir/emtricitabine/tenofovir AF as initial treatment for patients with HIV-1 infection.


  • Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. https://www.ncbi.nlm.nih.gov/pubmed/28867497

  • Sax PE, Pozniak A, Montes ML, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. https://www.ncbi.nlm.nih.gov/pubmed/28867499


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