February 7, 2018 / 9:46 PM / 7 months ago

CORRECTED-U.S. FDA approves Gilead's three-drug HIV regimen

(Corrects to remove reference to “bictegravir” as a previously approved drug)

Feb 7 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences Inc’s three-drug regimen to treat HIV-1 infection.

The treatment, Biktarvy, is a once-daily tablet that combines two previously approved drugs - emtricitabine, tenofovir alafenamide and a new integrase inhibitor bictegravir, the company said.

It is available to patients who have been on a stable regimen for at least three months.

Biktarvy has a boxed warning about the risk of post-treatment acute increase of hepatitis B.

The approval puts GlaxoSmithKline’s HIV businesses under threat as the company has been facing slowing demand and new competition.

Gilead’s shares were up 3.45 percent at $83.16 in afternoon trading on Wednesday. (Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Sriraj Kalluvila)

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