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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Tenofovir access for poor countries - Viread®
From AIDS Treatment News, 12/20/02 by John S. James

On December 17 Gilead Sciences announced that it would make its antiretroviral (tenofovir disoproxil fumarate, brand name Viread) available at cost to qualified organizations providing HIV treatment in all 53 nations in Africa, and 15 additional countries classified as "least developed" by the United Nations. The company said the program would be running by the second quarter of 2003. Information and technical assistance in applying for and using the drug will also be provided.

Also, Gilead will participate in the 3,000-patient Development of Antiretroviral Therapies (DART) study, sponsored by the UK's Medical Research Council, which will begin in 2003 in Uganda and Zimbabwe, to evaluate antiretroviral treatment strategies where resources are limited. In addition it is studying tenofovir to prevent transmission of HIV.

The text of the press announcement is at: http://www.gilead.com/wt/sec/pr_1040081128. For more information about the drug, see http://www.viread.com.

Comment

Tenofovir is an important drug because it is easy to use (one pill per day), has less problem with side effects than most antiretrovirals, and leads to relatively slow development of HIV drug resistance. However, side effects and drug resistance do occur--and resistant virus is likely to be cross-resistant to AZT and to some other HIV drugs as well. So when used to treat existing HIV infection, tenofovir must be combined with other antiretrovirals to reduce this resistance.

This is not the only program to provide an antiretroviral at cost in some poor countries. It may be better designed than some of the others, in reducing cumbersome country-by-country negotiation and administration.

There are some concerns. "At cost" can translate to several times the price at which a generic manufacturer could sell the same drug at a profit. This is because proprietary pharmaceutical companies have so high a profit margin on each pill sold that they have little incentive to automate production efficiently. Also, accounting practices can differ greatly, including which expenses to count in the "cost" of a particular operation. The real issue is not to get rid of profit, but to develop workable systems for getting treatment to people who cannot afford rich-country market prices, using both efficient production and public funding. If companies could profit by doing this right, everyone would be better off.

It is impossible to solve all problems at once. Gilead did not have to do anything, and we welcome its program as a step in the right direction.

COPYRIGHT 2002 John S. James
COPYRIGHT 2003 Gale Group

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