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US FDA approves ViiV Healthcare's treatment regimen for certain HIV patients

The U.S. Food and Drug Administration approved GlaxoSmithKline plc's majority-owned unit ViiV Healthcare's Juluca, making it the first complete two-drug regimen to treat certain adults with HIV-1.

The current standard HIV treatment regimen mainly consists of three or more drugs.

Juluca, which is a fixed-dose tablet containing dolutegravir and rilpivirine, will treat adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Pill fatigue, under which patients do not adhere to the prescription plan, has been a problem with patients taking complicated regimens, which can contribute to resistance.

The approval is based on two phase 3 studies that showed that Juluca was effective in keeping the HIV virus suppressed and comparable to those who continued their current anti-HIV therapy with three to four drugs.

Meanwhile, ViiV Healthcare, which counts Pfizer Inc. and Shionogi & Co. Ltd. as its shareholders, is also developing a single-dose regimen, Tivicay, to treat HIV-1 patients.

Rival Gilead Sciences Inc. is also developing its own single-tablet competitor and could report phase 3 data for the drug later this year.