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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Warning on two specific 3-drug regimens: Viread + Videx + either Sustiva or Viramune
From AIDS Treatment News, 10/29/04

On November 12 the U.S. Food and Drug Administration's AIDS listserve noted a Dear Doctor letter from Bristol-Myers Squibb, warning that the two particular three-drug combinations noted above had shown a high rate of virologic failure in treatment-naive patients with high viral loads (about half of those patients failed the treatment). The problem seems to be specific to these regimens, as Sustiva has worked with Viread-based regimens, and with Videx-based regimens, in different trials.

The FDA email is available on its archive, http://www.fda.gov/oashi/aids/listserve/listserve2004.html (you need to scroll down). And this page has the full BMS Dear Doctor letter attached.

Comment

There are now several antiretroviral regimens that failed to control the virus, and were not predicted to tail on the basis of clinical trials, physicians' experience, and known drug interactions. The leading theory seems to be that the bad combinations have a genetic barrier against the virus that is too low. If so, then it may be possible to better predict such failures from existing resistance data--and perhaps to improve other regimens as well, by avoiding possible weaknesses that are less serious but still important. Has anybody yet brought this information together into a model that works?

COPYRIGHT 2004 John S. James
COPYRIGHT 2004 Gale Group

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