
WASHINGTON, Nov. 18 (UPI) -- GlaxoSmithKline said Friday it has received approval for updated labeling for its HIV protease inhibitor Lexiva.
Glaxo and its partner Vertex Pharmaceuticals said the Food and Drug Administration has approved GSK's application to add to Lexiva's prescribing data that simultaneous administration of the HIV treatment in combination with esomeprazole, sold as Nexium, does not result in lowering of blood levels of Lexiva.
The company said the new information is based on a study showing that blood levels of Lexiva remained unchanged when patients took the Glaxo drug concurrently with 20 milligram once-daily esomeprazole.
Drug interactions that result in lower PI blood levels may increase the risk for virologic failure in patients treated with HIV protease inhibitors, GSK said.
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