Wednesday, May 9, 2012
FDA Will Review New Drug For HIV Prevention
(AP) A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.
The Food and Drug Administration said Tuesday that Gilead Sciences' Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare patients "infection with a serious and life-threatening illness that requires lifelong treatment."
An estimated 1.2 million Americans have HIV, which attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off infections. If Truvada is approved, it would be a major breakthrough in the 30-year campaign against the AIDS epidemic.
Researchers first reported that Truvada could prevent people from contracting HIV in 2010. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44 percent, when accompanied by condoms and counseling. 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.
"If we're going to reduce the more than 50,000 new HIV infections in this country each year, we need to increase the available options for people," said Ronald Johnson, AIDS United's vice president.
Although the FDA is legally barred from considering cost when reviewing drugs, health care providers have raised concerns about Truvada's price tag: $900 a month, or just under $11,000 per year. Medicare and Medicaid, the nation's largest health insurance plans, generally cover drugs approved by the FDA, and analysts expect most large health insurers to follow suit.
Some researchers worry about Truvada's mixed success rate in preventing infection among women: Last year, a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo.
Researchers speculated that women may require a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.