FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD

August 01, 2018

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.

Mechanism:

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

Emtricitabine: Nucleoside reverse transcriptase inhibitor (NRTI).

Tenofovir AF: NRTI prodrug of tenofovir.

Dosage:

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.

References:

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

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Next Section

Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.

Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.

Comments

Commenting is limited to medical professionals. To comment please Log-in.

Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.