The Food and Drug Administration (FDA) took a big step in the 30-year battle against the virus that causes AIDS by approving Truvada, a new preventative drug for healthy people who are at high risk of acquiring the deadly infection.
According to the Associated Press (AP), Truvada will be prescribed to persons who are most at risk for acquiring HIV through sexual activity, such as those with HIV-infected partners. Developed by Gilead Sciences Inc., Truvada has been on the market since 2004 as a treatment for people who already have the virus. Taken once a day, it is a combination of two older HIV drugs, Emtriva and Viread.
However, studies showed the drug could actually prevent people from contracting HIV when used as a precautionary measure.
“A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling,” the AP reports. “Last year, another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.”
FDA approval means that Gilead Sciences will now be permitted to market the drug for that use, which could dramatically increase sales.
The drug is not without its drawbacks, however. First of all, it’s expensive, costing up to $13,000 a year and it is not certain that insurers will cover it. Second, people must be tested for HIV first before taking the drug because patients who already have the virus could develop resistance to the drug that will make their condition more difficult to treat. Third, it could cause people in high risk groups, such as homosexual men, to relax their “safe sex” precautions.
HIV experts are also concerned that the drug must be taken correctly to be effective, and will benefit a relatively small group of people.
“It’s been most effective in people who are at very high risk and are able to take the drug on a regular basis,” said Dr. Tom Giordano of Baylor College of Medicine who served on the FDA panel that recommended approving the drug. “When you really boil it down that’s going to be a relatively focused population, but it’s an important population to treat.”
The approval of Truvada comes just two weeks after the FDA approved OraQuick, the first over-the-counter HIV test that can be used at home.
“The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S.,” the AP reports.
Every year, about 50,000 new infections are diagnosed, with the majority occurring among homosexually active men. An estimated 1.2 million Americans are living with HIV which can develop into AIDS if not treated with antiviral drugs. About one-fifth of those infected, which amounts to 240,000 people, don’t know they have it.
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