FDA approves Biktarvy(bictegravir, embitcitabine, tenofovir alafenamide)

What is the drug for?

BIKTARVY is a drug for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults. BIKTARVY is a combination of three antiviral drugs in a single tablet: bictegravir (new drug for HIV-1 treatment), emtricitabine, and tenofovir alafenamide (previously approved for HIV-1 treatment).

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

How is this drug used?

BIKTARVY is a tablet that is taken once daily with or without food.

What are the benefits of this drug?

In patients with HIV-1 infection, BIKTARVY decreases viral load (number of HIV-1 copies in the blood) and increases the number of immune cells in the blood (CD4 count).

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: BIKTARVY worked similarly in men and women.
• Race: BIKTARVY worked similarly in White and Black or African American patients. The number of patients in other races was small; therefore, differences in how the drug worked in other races could not be determined.
• Age: BIKTARVY worked similarly in patients below or above 50 years of age. The number of patients older than 65 years of age was small. Therefore, differences in how well the drug worked in patients above 65 years of age could not be determined.