US advisory panel recommends Truvada drug be marketed for HIV prevention

Stephen Gray May 11, 2012
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An FDA panel in the US has approved the administration of the drug Truvada to at-risk but uninfected people in an effort to prevent the spread of HIV, though experts warn condoms must remain the ‘bedrock’ of such efforts.

The technique for which the drug would be marketed, known as Pre-Exposure Prophylaxis or PrEP, uses antiretroviral drugs to decrease the likelihood of HIV infection in people who come into contact with the virus.

The FDA’s Antiviral Drugs Advisory Committee voted 19 to 3 in favour of allowing doctors to prescribe Truvada for this purpose to men who have sex with multiple male partners.

The committee also voted for it to be prescribed to the partners of HIV-positive people and other groups after a day of public comment and debate. The Food and Drug Administration usually adopts the decisions made by its panels of experts.

Truvada, a mixture of tenofovir and emtricitabine, can currently be administered to people living with HIV and used for prevention, but if the FDA adopts the recommendation, it could be marketed as a preventative measure.

The use of the drug in prevention efforts has prompted debate over whether at-risk people would consistently take a daily pill and if it could produce a drug-resistant strain of HIV.

The Washington Post said the senior vice president of the Gilead drugs company, which manufactures Truvada, told the committee it should be added to the “existing toolbox” of prevention efforts.

The AIDS Healthcare Foundation opposed the drug’s approval for prevention purposes. Joey Terrill, the Foundation’s Domestic Advocacy Manager told the committee gay men he spoke with believed the drug would mean they would no longer need to wear condoms.

Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition said the panel’s recommendation “brings us closer to a watershed for global HIV prevention efforts”.

He added: “PrEP, while not a panacea, will be an essential additional part to the world’s success in ending AIDS. For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope that we will achieve the end of the epidemic.”

Sir Nick Partridge, Chief Executive of Terrence Higgins Trust, said: “We have to take every new opportunity to improve the effectiveness of HIV prevention and slow the spread of this epidemic.

“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 behaviour which could outweigh the prevention effectiveness of Truvada.”

He added: “Whatever happens, condoms will continue to be the bedrock of HIV prevention as the easiest, cheapest and most effective way to stop HIV. If you’re worried that you’ve been at risk, get tested and look after your health.”

A clinical trial called PROUD, Pre-exposure Option for Preventing HIV in the UK, will begin to examine the efficacy of such a daily pill regimen in the UK this autumn.

The trial is a collaboration between the Medical Research Council and the Health Protection Agency.

More: Americas, drug, drugs, Health, HIV, medication, sexual health, Terrence Higgins Trust, Truvada, US

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