The FDA Has Just Approved Lexiva, a New Anti-HIV Medication

The Food and Drug Administration (FDA) approved, on October 20, 2003, Lexiva (Fosamprenavir calcium), manufactured by GlaxoSmithKline and Vertex Pharmaceuticals.

Lexiva is a prodrug of amprenavir, a protease inhibitor used to treat infection with the human immunodeficiency virus (HIV). Lexiva is rapidly converted to amprenavir by cellular or serum phosphatases in the body.

Lexiva should be taken in combination with other antiretroviral agents for the treatment of HIV infection in adults. The approval of Lexiva was based on two studies in antiretroviral naive patients and one study in protease inhibitor experienced patients.

Dr. Debra Birnkrant, director of FDA's division of antiviral products, said Lexiva offers patients a new option that allows them to reduce the number of pills they must take daily. Dosing options include taking two pills twice daily, or taking one pill twice daily with ritonavir, Birnkrant said, noting that some anti-HIV medications may require as many as eight pills twice daily. "Pill burden-wise, [Lexiva] is somewhat of an improvement, she said.

Lexiva Tablets may be taken with or without food.

If you are on salvage therapy, talk to your doctor to see if you are a good candidate for this new medication. Note that some medications carry resistance to the same mutation; this means that if you are resistant to certain other Protease Inhibitors, you could be resistant to Lexiva. Ask your healthcare provider for more information about resistance testing.