The advisory committee held a twelve-hour hearing on May tenth to consider the evidence. The committee urged the FDA to approve the drug for use by those who are considered at high risk for getting infected. The committee held two separate votes on recommending Truvada. One vote dealt with gay and bisexual men. The other dealt with heterosexual couples where one person has HIV.
Mr. Warren says Truvada offers hope for a new way to fight HIV.
MITCHELL WARREN: "If you are at risk of HIV, if you perceive yourself to be at risk, if you're able to take this pill every day as part of a combination of activities, including getting frequent HIV testing, you can reduce your risk of infection quite substantially."
The manufacturer of Truvada, Gilead, would have to produce what is known as a risk evaluation and mitigation strategy. This would be a plan to help ensure the safe and effective use of Truvada. The plan would include extensive training for health care providers. It would also include testing to make sure people are not already infected with HIV before they take the pill.
Some doctors say Truvada is a step toward ending the threat from AIDS. But some critics say the drug could give people a false sense of security and make them less likely to use condoms. Critics say it could also take financial resources away from more cost-effective methods of prevention, like using condoms.
Truvada currently sells for about fourteen thousand dollars a year. The drug would cost much less in developing countries, possibly several hundred dollars a year. But that could still be too high for some countries.
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2013-11-25
2013-11-25
2013-11-25
2013-11-25
2013-11-25
2013-11-25