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  The SF Dept of Health, along with its counterpart in Miami, will start enrolling patients next month in a new Truvada project that will study their sexual practices and medication adherence over a 12-month period to determine whom to target and how to support people using the drug.

"Our hope is that this strategy could have a potential impact on the HIV epidemic, and the goal of these projects is how best to roll out these prevention programs," said Dr. Albert Liu, director of HIV prevention intervention studies in the San Francisco Public Health Department.

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"Ken Mayer says it would be more important to get Truvada to men and women who have a much higher risk of infection. They might live in places like Washington, where men have a one-in-17 chance of getting infected and thus are at risk of infecting their partners.

Dr. Deborah Chan, an obstetrician-gynecologist at the University of California San Francisco, says Truvada will be really important for women in such couples.


"She is not particularly able to ensure condom use consistently," says Cohen of such women. "She does not have control in that way in their sexual dynamics. He may or may not be on anti-retroviral therapy. But certainly there's no way for her to force him to take those medications."

Cohan has already been prescribing Truvada for women in these situations. Even before FDA approval, individual doctors could do that because the drug's already on the market for treating HIV.

"The woman who I've given Truvada are so immensely appreciative that they have some control over whether they get HIV or not," Cohan says.

And there's one subset of heterosexual couples for whom Truvada will be a special boon - one where the woman is uninfected, the man has HIV, and they want to conceive a child.

Currently the only safe way to do that is a complicated and expensive process called sperm-washing. The man's sperm is treated so it's free of the virus, and then the woman's egg is fertilized in the laboratory and implanted in her uterus.

Prescribing Truvada for her can avoid all that.

Cohan says about 75,000 US couples could benefit."

Recruiting Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men

Not yet recruiting Assessment of Pre-Exposure Prophylaxis (PrEP) Administered at Sexually Transmitted Disease (STD) Clinics

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Truvada First pill for HIV prevention gets US nod

pharmatimes World News | July 17, 2012

There will no doubt be big celebrations at Gilead after it got the final seal of approval to market its Truvada for the prevention of HIV in the US, making it the first pill OK'd to protect against infection with the disease.

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Despite some opposition to the move, the US Food and Drug Administration has given the green light for Truvada (emtricitabine and tenofovir) to reduce the risk of HIV infection in high-risk, uninfected individuals who may engage in sexual activity with infected partners.

The move came as no real surprise, however, as the agency's advisory committee had voted in favour of approving the drug back in May, based on data from several clinical studies showing it to be safe and effective for HIV pre-exposure prophylaxis (PrEP), with one trial showing 43% fewer infections in patients given Truvada compared with the placebo group.

As part of the approval, Gilead has developed a Risk Evaluation and Mitigation Strategy (REMS) with the FDA to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy for the disease.

And to further support the safe use of Truvada for PrEP, Gilead said it will also provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing, and subsidised HIV resistance testing for any individual who becomes HIV-positive while taking its drug.

"Today's approval marks an important milestone in our fight against HIV," commented FDA Commissioner Margaret Hamburg. "Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease."

"It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy," said Connie Celum, Professor of Global Health and Medicine at the University of Washington.

Mixed opinion

However, opinion over the use of Truvada - which has been on the markets as a treatment for HIV since 2004 - for disease prevention is somewhat divided.

The AIDS Healthcare Foundation argues that its availability for PrEP would actually increase HIV infections, and notes that recent research has linked one of the components of Truvada - tenofovir - to a significant risk of kidney disease and damage, whereas simply using a condom is 95% effective and carries no such risk.

"Widespread use of PrEP has all the makings of a public health disaster - increased HIV infections, drug resistant strains of HIV, and tens of thousands of damaged kidneys," Michael Weinstein, AHF's president, said earlier this year.

GlobalData also previously said it anticipates FDA approval could "significantly increase" sales of the Truvada, which are about $2.88 million a year, given that the Centre for Disease Control estimates that 415,000 in the US alone are at high risk for contracting HIV.

 
 
 
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