AIDS TREATMENT NEWS Issue #373, October 26, 2001
John S. James
On October 26 the FDA approved Viread (tm) -- 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."
A patient-oriented description of the drug appears at: http://www.aidsmeds.com/drugs/tenofovir.htm
The Medscape drug-interaction calculator, recently updated to include tenofovir, is at: http://hiv.medscape.com/Medscape/HIV/DrugInteractions/index.cfm
An FDA Talk Paper is at: http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01111.html
And the complete package insert can be found on the Gilead site at: http://www.gilead.com/prod_pdf/viread_pi.pdf
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