Monday, May 14, 2012

F.D.A. Advisory Panel Backs Preventive Use of H.I.V. Drug


Helen W.
Current Event Posing # 4Topic: HealthTitle of Article:  F.D.A. Advisory Panel Backs Preventive Use of H.I.V. DrugAuthor: Denise Grady Publication Name: New York Times
Date of Published: May 10, 2012
Length of Article: 1220 words/2 pages



An advisory panel to the U.S. Food and Drug Administration (FDA) 
recommended last Thursday that a drug which had already been approved to treat AIDS should now also be used to prevent HIV infections in healthy people, who may be exposed to the virus.The FDA is the government agency whose approval is needed to sell any drug or medicine in the U.S. The recommendation is by a panel of doctors and scientists advising the FDA; the FDA normally follows the advice of its advisory panels.This decision was based on various studies, one of which first found a risk reduction of only 44% in 2,499 gay men, but a closer examination showed that many of them had not taken the drug every day; among those who took it correctly, the risk reduction was about 90%. Considering that there are about 50,000 new HIV infections in the U.S. alone, the need for any preventative measures is obvious. The drug recommended is the antiviral Truvada, which since its initial approval in 2004 has been used to treat people with HIV infection. In the treatment of HIV, Truvada is always used in combination with other drugs, to assure that no HIV strain evolves which is resistant to Truvada. The new approval would cover the use of the one-pill-a-day drug for the prevention of AIDS in people possibly exposed to the HIV virus. People who plan to take Truvada by itself for prevention need to be tested beforehand to assure they do not have an active HIV infection, where use of a single drug might led to HIV strains resistant to it. Panel members did express concern over the possibility of

evolution of drug-resistant HIV, and some members voted against or abstained from approval.-- Other critics, such as the AIDS Healthcare Foundation, pointed out that the availability of a prevention drug might give people a false sense of security and make them neglect other preventative measures, such as condoms. On the other hand, any additional layer of protection against the spread of AIDS is certainly a good thing. Truvada is a product of Gilead Sciences, in Foster City, CA. It is one of the best-selling HIV drugs, with sales of $758.3 million in the first quarter of this year (about 3 billion/year!). A yearly dose costs about $14,000. The new approval would certainly increase its sales.--

This new approval would be the first one for a drug use for the prevention of AIDS (as opposed to its treatment). Having another method to contain the AIDS epidemic is certainly welcome. However this drug is certainly not perfect. Like other AIDS prevention methods, it relies on its users carfully following the instructions, here for the pre-use test and taking the drug daily, and continuing in the use of other preventative measures, such as condoms. Also the high price of the drug might make its adoption difficult for most people who might benefit from it.

2 comments:

  1. A drug that has been approved to treat AIDS and possibly treat HIV infections is on its way, as advised from an advisory panel to the FDA: in one study, it has shown that there is a risk reduction of only 44% in 2499 tested gay men (closer examination shows some subjects did not take the dosage daily). A 90% reduction risk, however, was shown in the sample of subjects that have, indeed, followed the daily dosage as prescribed by the study. The drug under recommendation is known as the antiviral Truvada, with the combination of other drugs (to prevent any growth of HIV strains), and has been approved to be taken as a one-pill-a-day drug: people who plan to take this pill should be tested for an active HIV infection beforehand to prevent development of Truvada-resistant strains. Critics believe that this drug may give consumers a false sense of security and lead them to neglect other preventative measures (condoms), while other believe that any additional layer of protection is good against the spread of infections and disease: with sales of $758.3 million in the first quarter of this year, it is one of the best-selling HIV drugs on the market today, and there is no doubt that with the recommendation of HIV infection prevention, a yearly dosage cost would be subject to increase.

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  2. Last Thursday, it was recommended to the FDA that we start using a drug, already approved to treat AIDS, as a way to treat HIV infections. On a recent study, it was shown that at closer examination, this drug provided a 90% reduction risk, if used daily and correctly. This drug is known as the antiviral Truvada, approved in 2004, and combined with other drugs to ensure its prevention of any growth of HIV strains. However, people must be tested beforehand for an HIV infection to prevent the development of Truvada resistant strains. Controversy over this drug exists, as critics believe the drug may give consumers a false sense of security, letting them neglect other preventative measures such as condoms. This drug has sold $758.3 million in the first quarter of this year, and will most likely grow in sales in the next years, with its new approval.

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