FDA Approves Administration of LEXIVA(R) with Lower Dose of 'Boosting' Medication...(VA is indicated for the treatment of HIV...)

Date:10/12/2007

VA is indicated for the treatment of HIV infection in combination with other antiretroviral medications. The following points should be considered when initiating therapy with LEXIVA plus ritonavir (LEXIVA/r) in protease inhibitor (PI)-experienced patients: the PI-experienced patient study was not large enough to reach a definitive conclusion that LEXIVA/r and lopinavir/ritonavir are clinically equivalent. Once-daily administration of LEXIVA plus ritonavir is not recommended for PI-experienced patients.

The recommended dosing for LEXIVA is:

-- Therapy naive adults

-- LEXIVA 1400mg twice daily

-- LEXIVA 1400mg once daily plus ritonavir 100mg once daily

-- LEXIVA 1400mg once daily plus ritonavir 200mg once daily

-- LEXIVA 700mg twice daily plus ritonavir 100mg twice daily

-- Protease inhibitor experienced adults

-- LEXIVA 700mg twice daily plus 100mg ritonavir twice daily

LEXIVA was initially approved by the FDA for use in the US in 2003. It is the first PI to offer flexible dosing options (for PI-nave patients) with no food or water restrictions.

Important Safety Information about LEXIVA

HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

Patients should not take LEXIVA if they have had an allergic reaction to LEXIVA or AGENERASE(R) (amprenavir). High blood sugar, diabetes or worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors. When patients start taking HIV medicines, their immune system may get stronger and could begin to fight infections that have been hidden in their body, such as pneumonia, herpes virus, or tuberculosis. If patients have new symptoms after starting their HIV medicines, they should tell their doctor. Changes in body fat may occur in some patients taking antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Skin rashes ca
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SOURCE GlaxoSmithKline Copyright©2007 PR Newswire. All rights reserved

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