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Tenofovir Approved: Broad Indication

October 26, 2001

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

On October 26 the FDA approved Viread™ -- generic name tenofovir disoproxil fumarate, or tenofovir DF. The approval was expected; less expected was the broad indication, which both the company and treatment activists wanted, but which some of the advisory committee had questioned (see "Tenofovir: FDA Hearing on Important New Antiretroviral," AIDS Treatment News #372, October 19, 2001). From the package insert:


Indications and Usage
VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in a controlled study of VIREAD of 24 weeks duration and in a controlled, dose ranging study of VIREAD of 48 weeks duration. Both studies were conducted in treatment-experienced adults with evidence of HIV-1 viral replication despite ongoing antiretroviral therapy. Studies in antiretroviral naive patients are ongoing; consequently, the risk-benefit ratio for this population has yet to be determined.

Additional important information regarding the use of VIREAD for the treatment of HIV infection:

  • There are no study results demonstrating the effect of VIREAD on clinical progression of HIV.

  • The use of VIREAD should be considered for treating adult patients with HIV strains that are expected to be susceptible to tenofovir as assessed by laboratory testing or treatment history.

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A patient-oriented description of the drug appears here.

The Medscape drug-interaction calculator, recently updated to include tenofovir, is here. (Free registration required.)

An FDA Talk Paper is here.

And the complete package insert can be found on the Gilead site here.


ISSN # 1052-4207

Copyright 2001 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.


Back to the AIDS Treatment News October 26, 2001 contents page.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
 
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More News on Tenofovir (Viread)

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