Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018.[1] Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).[2]

Biktarvy®, a once-daily single tablet, developed by Gilead Sciences, is indicated for use in adult patients with HIV-1 infection without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences explained that if the product is approved it will be “the fifth TAF-based product for HIV in the European Union in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration we believe it could represent a meaningful advance in HIV treatment for appropriate patients in Europe.” [2]

For further information related to the first approval of bictegravir please visit Drugs[3], or to learn more about its overall development across all indications visit AdisInsight.[4]


Image credit: carlos-alberto-gomez-iniguez – Unsplash

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