Tenofovir disoproxil fumarateTenofovir
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Viread

Tenofovir disoproxil fumarate (TDF), with the trade name Viread®, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (NtRTIs), which block reverse transcriptase, an enzyme crucial to viral production in HIV-infected people. more...

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Tenofovir is marketed by Gilead Sciences with the brand name Viread®. It is also available in a fixed-dose combination with emtricitabine in a product with the brand name Truvada® for once-a-day dosing. (Emtricitabine is marketed as a single-compound product called Emtriva®, also marketed by Gilead.) A fixed-dose triple combination of tenofovir, emtricitabine and efavirenz (Sustiva®, marketed by Bristol-Myers Squibb) is in development.

Tenofovir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of tenofovir in treatment-naïve and treatment-experienced adults. There are no study results demonstrating the effect of tenofovir on clinical progression of HIV.

History

Tenofovir was discovered through a collaborative research effort between Dr Antonin Holy at the Academy of Sciences of the Czech Republic (IOCB) in Prague, and Dr Erik DeClercq, Rega Institute for Medical Research, Katholic University, Belgium.

Tenofovir was approved by the U.S. Food and Drug Administration (FDA) on October 26, 2001 and is marketed by Gilead Sciences. It is currently in late-stage clinical trials for the treatment of hepatitis B.

The fixed-dose combination of tenofovir with emtricitabine was approved on 2004-08-02 for once-a-day dosing. The fixed-dose triple combination of tenofovir, emtricitabine and efavirenz is in development.


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New Antiretroviral for HIV Infection. approved by the FDA - tenofovir disoproxil fumarate Viread
From American Family Physician, 3/1/02 by Elaine Kierl Gangel

The U.S. Food and Drug Administration has approved tenofovir disoproxil fumarate (Viread), a 300-mg once-daily tablet, to treat patients with human immunodeficiency virus (HIV) infection when taken in combination with other antiretrovirals. In clinical trials, patients who had stopped responding optimally to other antiretroviral therapy because of viral resistance, experienced significant antiviral responses with Viread.

Viread works by blocking an enzyme--reverse transcriptase-- that has a role in replicating HIV. Because the drug is a nucleotide, it remains in cells longer than other antiretroviral drugs. In clinical studies, it was added to patients' existing antiretroviral regimens and reduced HIV levels for up to 48 weeks. Resistance to Viread rarely developed and, when it did, it developed slowly.

Adverse side effects included mild to moderate gastrointestinal symptoms such as nausea, vomiting, flatulence, and diarrhea.

COPYRIGHT 2002 American Academy of Family Physicians
COPYRIGHT 2002 Gale Group

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