HIV Prevention Pill Receives FDA Panel Support

HIV Prevention Pill Receives FDA Panel Support

Featured Article
Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 May 2012 - 8:00 PDT

email to a friend   printer friendly   opinions   <!-- rate article

Patient / Public:

Healthcare Prof:

Article Opinions: 1 posts
On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support approval of the daily pill Truvada to prevent HIV in healthy people.

The FDA is not obliged to follow the advice of its Antiviral Drugs Advisory Committee, but should it do so, then Gilead Sciences Inc's Truvada will be the first drug indicated for reducing the risk of uninfected individuals acquiring the AIDS virus.

Truvada (emtricitabine and tenofovir disoproxil fumarate) has been used to treat people already infected with HIV-1 in the United States since 2004. According to Gilead, it is currently the most-prescribed antiretroviral treatment in the US.

The 22-member panel voted 19 to 3 in favor of approving the pill as a pre-exposure prophylaxis or PrEP in non-HIV-infected men who have sex with men (the highest risk group).

It also voted 19 to 2 (with 1 abstaining) in favor of use in uninfected partners of HIV-infected individuals, and 12 to 8 (with 2 abstaining) in those at risk of HIV infection through sexual activity.

The voting took place after 11 hours of deliberations and public consultation in Silver Spring, Maryland.

The panel reviewed efficacy and safety data from several clinical studies of Truvada for PrEP. These included two large placebo-controlled Phase 3 trials, and several other clinical studies on the use of Truvada for HIV risk reduction. The Phase 3 trials were supported by the US National Institutes of Health and the University of Washington.

According to a report from Reuters, one of the panel members who voted against using the drug to prevent HIV infection, said she did so because the clinical studies did not measure the risk of kidney problems in black people, considered to be the group most at risk of developing kidney side effects when taking AIDS drugs.

Dr Lauren Wood of the National Cancer Institute said:

"I don't think that is adequate when you're talking about the population that is most at risk."

Those who welcome the panel's decision see it as another tool for preventing HIV infection, alongside safer sex, condom use and regular HIV testing.

Others are against the drug because of concerns that it could give users a false sense of security, and that it could also lead to a drug-resistant strain of HIV.

The FDA is expected to reach a decision by 15 June.

Click here for important safety information about Truvada (from the manufacturer).

Written by Catharine Paddock PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

• Additional
• References
• Citations

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

---

APA

---

Please note: If no author information is provided, the source is cited instead.

---

Visitor Opinions (latest shown first)

Its not your decision

posted by JR on 11 May 2012 at 8:42 am

Is it right for the government to decide wether or not people should get a life saving drug? What if a patient agrees to waive all liability with the manufacturer in exchange for getting the drug pre FDA approval? Is that not a basic human right? Guess what, that is a felony in the USA, even if they will certainly die prior to the FDA completing its lengthy approval process.

Americans are not allowed to make their own medical risk/benefit decisions in the Land of the Free; we have to go to truly free countries to save our loved ones. What decent parent would not commit such a horrific drug crime to save their child?

| post followup | alert a moderator |

Add Your Opinion On This Article

'HIV Prevention Pill Receives FDA Panel Support'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Privacy Policy | Terms and Conditions

MediLexicon International Ltd
Bexhill-on-Sea, United Kingdom
MediLexicon International Ltd © 2004-2012 All rights reserved.
MNT (logo) is the registered EU trade mark of MediLexicon Int. Limited.

back to top | home | privacy policy

MediLexicon International Ltd
Bexhill-on-Sea, United Kingdom
MediLexicon International Ltd © 2004-2012 All rights reserved.
MNT (logo) is the registered EU trade mark of MediLexicon Int. Limited.