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news.The FDA has approved a change in the label for GlaxoSmithKline and Vertex Pharmaceuticals' HIV protease inhibitor Lexiva.
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The change of label shows that simultaneous administration of Lexiva in combination with Nexium (esomeprazole) does not result in lowering of blood levels of Lexiva. Drug interactions that result in lower protease inhibitor blood levels may increase the risk for virologic failure in patients treated with HIV protease inhibitors.
This update is based on a study showing that blood levels of Lexiva remained unchanged when patients took Lexiva and 20 mg once-daily esomeprazole simultaneously. Lexiva is indicated for the treatment of HIV infection in adults in combination with other antiretroviral medications.
“With this update, patients know that they can take a proton pump inhibitor simultaneously with Lexiva without affecting blood levels of Lexiva,” said Mark Shaefer, acting vice president, HIV, Infectious Disease Medicine Development Center at GSK.