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FDA Panel Back Preventative HIV Drug

FDA Panel Back Preventative HIV Drug

Preventative HIV drug gets FDA panel backing for the first time…

A panel of US health experts has for the first time backed the use of a drug, which has been shown to prevent HIV infection in healthy people.

The drug, Truvada, is not a cure all solution as it must be taken in conjunction with existing anti-retroviral medications, however studies have shown that it can help reduced the of HIV in healthy gay man and heterosexual partners by between 44% and 73%.

The US Food and Drug Administration (FDA) is not legally obligated to follow the panel’s advice, but it usually does.

Truvada, which is made by California-based Gilead Sciences, already has FDA approval for patients who are HIV positive. However the Antiviral Drugs Advisory Committee, which advises the FDA, voted 19-3 in favor of prescribing the drug to the highest risk group – non-infected men who have sex with multiple male partners – and by majority votes, for ‘uninfected people with HIV-positive partners and for other groups considered at risk of acquiring HIV through sexual activity.’

Many experts say the move could be the new milestone in the battle against HIV/Aids, however those who oppose the approval worry that easy access to the drug could give people a false sense of security, and could eventually cause the virus to mutate into a drug-resistant strain.

There are also concerns that the high cost of Truvada could divert the already limited funding from more cost-effective options.

Another possible problem is that the drug is said to be ineffective if the patient misses their daily dosage. Nurse Karen Haughey told the panel:

“Truvada needs to be taken every day, 100% of the time, and my experience as a registered nurse tells me that won’t happen…

“In my eight years, not one patient that I’ve cared for has been 100% adherent.”

Nevertheless a majority welcomed the panel’s recommendation. Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition, hoped the decisions, which will be announced by 15th June, will ‘brings us closer to a watershed for global HIV prevention efforts.’

In the UK, Sir Nick Partridge, chief executive of Terrence Higgins Trust, told reporters:

“There is no single method of prevention that can on its own stop the transmission of HIV…

“Adding Truvada to our existing range of prevention programmes, including safer sex campaigns, using condoms and regular testing for HIV is an exciting prospect…

“But we need to know if people at highest risk of infection are prepared to take a pill every day and whether there would be an increase in risk-taking behavior which could outweigh the prevention effectiveness of Truvada.”

He said a similar clinical trial to investigate the effectiveness of Truvada would begin in the UK in the autumn.

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  1. HIV prevention pill Truvada backed by US experts. BBC, 05/11/2012.

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