US APPROVES HIV ‘PREVENTION PILL’
Mon, 16 July 2012
America’s Food and Drug Administration (FDA) has approved the first daily pill for reducing the risk of contracting HIV through sex.
On Monday, the FDA announced that it had given the go ahead to sell and market Truvada as a pill to reduce the risk of HIV infection in uninfected people who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.
The drug has previously been used as ARV treatment for people already infected with HIV but is now also officially classified in the US as a preventative option.
HIV-negative individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus, a strategy known as pre-exposure prophylaxis (PrEP).
The pill does not provide complete protection and the FDA still recommends that the pill be used with a combination of safer sex practices, such as consistent use of condoms and water-based lube.
In two large clinical trials Truvada was effective in reducing the risk of HIV infection by between 42 percent and 75 percent.
Other studies have found that if the HIV positive partner is also on ARV treatment (which has successfully lowered his viral load to undetectable levels) the risk to the uninfected partner taking Truvada every day is reduced by up to 90%.
As a condition of its approval, Truvada’s manufacturer, Gilead Sciences, Inc., is required to test individuals who acquire HIV while taking Truvada to monitor for the presence of resistance.
"Today’s approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D.
"Every year, about 50,000 U.S. 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. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country," she said.