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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Once-a-day HIV drug viread ok'd - Brand Watch - Gilead Science's Viread - Brief Article
From Drug Store News, 11/19/01 by James Frederick

Gilead Science has received Food and Drug Administration approval for its antiretroviral agent Viread (tenofovir disoproxil fumarate) for the treatment of HIV infection when taken in combination with other antiretroviral agents. It is the first nucleotide analogue approved for the treatment of HIV, meaning it is absorbed more easily and retained longer by the body's cells than other available treatments. This allows for a one-pill, once-a-day dosage, which may help increase patient adherence to what is often a difficult drug regime. The FDA approval of the 300 mg tablet came just six months after FDA submission and was scheduled to arrive in pharmacies earlier this month.

More than 900,000 Americans have HIV. About 350,000 receive anti-HIV treatment regimens, and an estimated 15,000 new ones begin each year.

COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2001 Gale Group

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