US Considers Approving Drug to Prevent HIV

Studies show that a drug called Truvada can prevent HIV infections. The pill is taken once a day. Studies showed it was ninety percent effective when people took it every day. It was only half as effective when people did not take it every day. Currently, in the United States, the drug is only approved for use as a treatment for people already infected with HIV, the virus that causes AIDS. Now a government advisory committee says Truvada should become the first drug approved for use to prevent HIV. The Food and Drug Administration is not required to follow the advice of its Antiviral Drugs Advisory Committee, but it usually does. The FDA is expected to decide by June fifteenth.

The advisory committee held a twelve-hour hearing on May tenth to consider the evidence for Truvada. The committee urged the FDA to approve the drug for use by those considered at high risk for getting infected. These include gay and bisexual men and heterosexual couples where one partner has HIV. Mitchell Warren, head of the HIV prevention group AVAC, explains that Truvada is a combination pill. It contains two different antiretroviral drugs that had already been approved individually by the FDA. 

Then about eight years ago they were approved as a combination. But all of thoseapprovals only related to the use of the drug for treating people who are already infected with HIV.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.