Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Immunology | Family Medicine | Infections and Infectious Diseases
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Viread (tenofovir disoproxil fumarate)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved October 2001
Treatment Area: HIV infection
Viread, an oral tablet indicated for the treatment of human
immunodeficiency virus (HIV) infection has been approved for use in
adults. This once-daily antiviral compound is administered in
combination with other antiretroviral agents for HIV treatment.
Viread is the first nucleotide analogue reverse transcriptase
inhibitor approved for HIV treatment.
Close to one million Americans are now infected with HIV, the
virus that causes acquired immunodeficiency syndrome (AIDS). Each
year only a little over one third of those infected receive
anti-HIV treatments regimens. Due to new treatment innovations such
as Viread, this number increases each year.
Approval of Viread is supported by placebo-controlled clinical
studies conducted with more than 1,000 HIV positive subjects.
Viread was administered both alone and in combination with
subjects' existing antiretroviral regimens. When used in
addition to other antiretroviral products, Viread was shown to
reduce the level of HIV in the blood for up to 48 weeks and to
reduce the viral load even in subjects whose HIV had previously
developed resistance to available antiretroviral medications.
Resistance to Viread was rare and slow to develop.
Adverse events associated with the use of Viread may include
(but are not limited to) the following:
Mechanism of Action
Viread is an HIV nucleotide analog reverse transcriptase
inhibitor that helps block an enzyme crucial to the production and
replication of HIV. Its active ingredient, tenofovir disoproxil
fumarate, is an acyclic nucleoside phosphonate diester analog of
adenosine monophosphate. In the body, this analog is converted to
tenofovir, then is formed to tenofovir diphosphate by cellular
enzymes. Lowering the amount of HIV in the blood, may in turn
increase the number of T cells. This would improve the immune
system, increasing its ability to defend the body against HIV