Truvada, if approved by the U.S. Food and Drug Administration (FDA), would be the first pill used to prevent healthy people from becoming infected with HIV.
Truvada is already on the market as part of a cocktail of drugs designed to treat HIV, but researchers have found that Truvada can also protect against the initial infection.
"A pill may soon be available to protect against HIV infection."
In a report, the FDA said that Truvada is “safe and effective” to prevent uninfected people from contracting HIV. The report is part of the process of approving Truvada for preventative use.
An alternative to condoms has long been a holy grail in the fight against the HIV and AIDS epidemic. But so far, an effective vaccine and preventative gels have proved elusive.
Truvada, marketed by Gilead Sciences, Inc., has been on the market since 2004. It's a combination of two drugs, designed to lower a patient's viral load – or amount of HIV that is in the body.
Low levels of the virus mean the patient is healthier, and the virus is more difficult to transmit.
In a three-year study, researchers found that Truvada could reduce the risk of infection. Daily doses for gay and bisexual men sent the risk down by 44 percent, while the treatment reduced infection in 75 percent of couples in which one partner was HIV positive and the other was not.
Most new infections occur within relationships with one HIV-positive partner, and that's where Truvada could be most effective in preventing infection.
But in order for it to work, Truvada must be taken consistently, every day. Some doctors worry that patients may forget their medication and weaken its protective potential, as was the case in one clinical trial.
The price tag is also steep: $900 a month, or $11,000 per year.
Still, proponents of FDA approval for Truvada as a preventative pill argue that the more options, the better. Truvada should be considered alongside condoms and counseling, they say.
The FDA will consider the report when it votes on approval on Thursday, May 10, 2012.