AIDS breakthrough: US gives nod for first-ever HIV prevention drug
July 18, 2012, Wednesday
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THE United States Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS.
The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.
The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the US, which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.
"I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic," said Dr Demetre Daskalakis of New York University's Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.
Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.
"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and preventive counselling and support," said James Loduca, vice president of the San Francisco AIDS Foundation.
The drug's label carries a warning that people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug, making their disease more difficult to treat.
Gilead Sciences Inc has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.
The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.
The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the US, which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.
"I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic," said Dr Demetre Daskalakis of New York University's Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.
Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.
"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and preventive counselling and support," said James Loduca, vice president of the San Francisco AIDS Foundation.
The drug's label carries a warning that people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug, making their disease more difficult to treat.
Gilead Sciences Inc has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.
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