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New Drugs Approved in February

Biktarvy
Biktarvy

Biktarvy, which received FDA approval on February 7, 2018, is a once-daily three-drug, single tablet regimen for the treatment of HIV-1 infection.

Developed by Gilead Sciences, Inc. (GILD) Biktarvy is a combination of three drugs bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF and is the smallest INSTI-based triple-therapy STR available.

Descovy, a combination of Emtricitabine and Tenofovir Alafenamide as a single tablet, is already approved by the FDA. DESCOVY is used together with other HIV-1 medicines to treat HIV-1 in people who weigh at least 77 lbs (35kg).

Additional clinical trials of Biktarvy are ongoing, including a dedicated study in women, as well as a study in adolescents and children living with HIV.

Biktarvy has a Boxed Warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B.

Gilead launched Biktarvy with a wholesale acquisition cost of $2,945.65 for a 30-tablet bottle.

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