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Lexiva (Fosamprenavir) Approved

October 31, 2003

On October 20 the U.S. Food and Drug Administration approved the protease inhibitor LexivaTM (generic name fosamprenavir, also called 908). Lexiva is converted into amprenavir (Agenerase), a previously approved protease inhibitor, in the body. Lexiva is easier to take than amprenavir because of the smaller pill burden (usually 4 pills a day including the ritonavir, vs. 16 pills a day for Agenerase), and lack of food restrictions. It was developed by GlaxoSmithKline and Vertex Pharmaceuticals Incorporated.

Persons taking Lexiva should review the safety and other patient information, including dangerous interactions with certain other drugs. Information for patients (and prescribing information for physicians) is at www.lexiva.com.

For More Information

For a brief review by the FDA of the pivotal clinical trials, see: www.thebody.com/fda/lexiva.html (or search for Lexiva on http://search.thebody.com).

For Glaxo's review, see: www.gsk.com/press_archive/press2003/press_10212003a.htm.

For an extensive review by the AIDS treatment activist organization TAG (Treatment Action Group), supporting approval -- but only when Lexiva is "boosted" with a low dose of ritonavir to increase blood levels of Lexiva -- see: www.aidsinfonyc.org/tag/tx/fosamprenavir.html.


ISSN # 1052-4207

Copyright 2003 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.


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