Truvada, an HIV treatment pill, one step closer to being approved for prevention by FDA
HIV/AIDS activists, some of them living with the virus, yell during a demonstration April 25, 2012 in Nairobi on the sidelines of a joint conference sponsored by the US embassy here and Kenya’s vision 2030 about health and reducing mortality in the East African nation.
Truvada, a pill long used to treat HIV, may be approved by the FDA for use by healthy people to prevent the disease that causes AIDS, the Associated Press reported.
Food and Drug Administration officials said Tuesday that Truvada is well tolerated by uninfected people, and argue that it could prevent infection in high-risk individuals when used in combination with condoms and counseling, Reuters reported.
"The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment," the FDA report said, according to Reuters.
However, some AIDS advocates worry that using a pill to prevent a virus that can be avoided by other means may encourage unprotected sex and increase infections, Bloomberg Businessweek reported.
“That’s an issue many of us have talked about for years,” said Mitchell Warren, executive director of AVAC: Global Advocacy for HIV Prevention, according to Bloomberg. “If you have this new option, would you be riskier? There is no evidence to show that that might be the case, but that doesn’t mean it’s not a concern.”
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An FDA panel will meet on Thursday to weigh the pros and cons of allowing healthy patients to take Truvada, which is manufactured by Gilead Sciences in Foster City, California. Though it is not a requirement that the FDA take its panels' advice, it usually does, the AP reported.
HIV affects an estimated 1.2 million Americans, according to the Centers for Disease Control and Prevention, and nearly half of the virus' sufferers are men who have sex with men. The number of people infected with HIV rose to 34 million worldwide in 2009, according to Bloomberg.
Truvada has been proven to cut the risk of HIV by up to 44 percent in gay and bisexual men in conjunction with other treatments, and up to 75 percent in heterosexuals with HIV-positive partners, according to the AP.
The pill would be targeted towards 415,000 Americans who are at high risk for contracting HIV from sexual activity, according to the Centers for Disease Control and Prevention, including people whose spouses or partners have the disease, as well as gay men who had more than two partners in the past year and didn’t wear condoms during sex, Bloomberg reported.
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