FDA approves Gilead's four-drug HIV treatment

(Reuters) - U.S. health regulators on Monday approved Gilead Sciences Inc's four-drug combination pill treatment for HIV, the virus that causes AIDS.

The four drugs in one pill, which was formerly called the Quad and widely considered one of Gilead's more important future growth drivers, will be sold under the brand name Stribild, the U.S. Food and Drug Administration said.

Stribild, a once-daily treatment, contains two previously approved HIV medicines and two new drugs.

The older medicines, emtricitabine and tenofovir, are currently sold by Gilead in its combination pill Truvada, which was approved in 2004. The newer drugs are elvitegravir and cobicistat.

'Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,' Edward Cox, director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said in a statement. 'New combination HIV drugs like Stribild help simplify treatment regimens.'

As a condition of approval, Gilead will be required to conduct additional studies to help further characterize the drug's safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs, the FDA said.

(Reporting by Bill Berkrot; Editing by Bernard Orr)



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