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   By Maria Armental 
 

A two-drug, single-tablet regimen to treat the most prevalent type of the AIDS virus has been approved for sale in the U.S., the Food and Drug Administration said Monday.

Dovato (dolutegravir and lamivudine)--developed by GlaxoSmithKline PLC and Pfizer Inc.'s HIV venture ViiV Healthcare--is the first FDA two-drug, fixed-dose, complete regimen for adults infected with the human immunodeficiency virus type 1 who have never received treatment for HIV.

The current standard of care for such patients is a three-drug treatment, noted Dr. Debra Birnkrant, director of the FDA's division of antiviral products.

Dovato will carry a label warning patients with HIV and hepatitis B to have additional treatment for hepatitis B or use a different drug regimen.

Patients with HIV and hepatitis B who have taken products with lamivudine, one of the ingredients in Dovato, have developed hepatitis B variants associated with resistance to lamivudine and may have severe liver problems, including liver failure, when they stop taking drugs containing lamivudine, the FDA said.

The approval is part of the U.S. push to effectively end the HIV epidemic, reducing new infections by 75% in the next five years and by 90% in the next 10 years.

Write to Maria Armental at maria.armental@wsj.com

(END) Dow Jones Newswires

April 08, 2019 16:45 ET (20:45 GMT)

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