Jan. 20, 2009 -- In a massive medical trial on three continents, doctors are testing a controversial pill that could temporarily boost immunity against HIV before a person is even exposed to the virus. If the pill works safely, doctors must then address whether such a drug, if made widely available, could actually worsen the AIDS epidemic.
The pre-exposure pill undergoing testing seems promising, since HIV drugs taken within days after exposure to the virus have been shown to reduce the risk of infection by 80 percent. But public health officials debate whether people at high risk for the virus, such as men who have sex with men, would be more likely to set aside the use of condoms to instead rely on a drug regimen that doesn't provide full protection against the disease, which is spread by contact with the blood or semen of an infected person.
Dennis, a 47-year-old gay man from Atlanta, is one of the test subjects for the new pill. He calls himself "blessed" for escaping the HIV epidemic that hit many of his friends in the 1980s. But his HIV-negative status hasn't stopped him from having sex with infected partners.
"If you just say that you're not going to have sex with anyone who's HIV positive , here you're eliminating a whole bunch of wonderful people," said Dennis, who asked that his last name be withheld. "How shallow would that be?"
He was recruited for the clinical trial for PreP, or pre-exposure prophylaxis for HIV prevention, with a drug called tenofovir.
"I was eager to take it," said Dennis. Since he was already using condoms, he said, "It couldn't hurt. I'll know in June if I was taking the real McCoy, or if it was the fake pill."
Soon after he started the trial, he noticed the doctors were trying to study his behavior as much as the drug's side effects. Each time he went for a monthly checkup, HIV test and counseling, Dennis said the director of the study, Lynwood Miller at the AIDS Research Consortium of Atlanta, kept asking him about his sex practices.
"I don't think I was any more promiscuous just because I was taking the drug," he said. "I didn't put myself at risk just to test the drug. I'm not that crazy."
Behavior Could Determine Fate of HIV Drug
But doctors worry that others who are at risk for HIV might well put aside their condoms for unprotected sex -- relying on the partial protection of the drug.
The stakes are high in terms of human lives and health costs. Statistics released by the Centers for Disease Control and Prevention in mid-2008 show that in 2006 some 56,000 new cases of HIV infections were reported in the United States, and 1.1 million people have HIV, 25 percent of whom don't know they have it. Worldwide, some 33 million people are infected and 25 million have died of the disease.
Doctors in the trial say they are acutely aware of the possibility the drug may be misused.
"There have been reports that people may be using PreP out in the community even before it was in trial," said Dr. Albert Liu, director of HIV prevention intervention studies at the San Francisco Department of Public Health.
So Liu and his colleagues decided to investigate. They did studies in San Francisco, traveled to large "circuit parties" in Palm Springs, Calif., and San Diego, where gay and bisexual men go to dance and have sex on weekends.
Liu said out of 1,800 men questioned, only 16 percent had heard of using antiretroviral drugs to prevent HIV transmission, and 1 percent admitted to ever trying them on their own.
A similar study of more than 227 men in Boston, from the Fenway Community Health Center, found one person who had tried using PreP in place of a condom.
While those numbers seem low, doctors, HIV activists and public health officials believe that the number of people using PreP as an ill-advised condom replacement would grow with an FDA approval of a PreP regimen.
Can Drugs Do More Harm Than Good?
"The problem with it is the idea of a disinhibitor," said Sean Strub, founder of POZ magazine (www.poz.com/).
"I think of it more in terms of Gardasil and also, even birth control," said Strub. "Virtually every woman who becomes pregnant and did not want to be knows how to avoid it. It's applying that knowledge at the moment of sexual interaction that gets complicated."
Just as with many drugs or treatments that protect against risk, activists and doctors must evaluate whether people will gamble with semi-effective protection and further spread more disease than if they'd never had access to the protection in the first place.
But Strub, who had heard about the possibility of PreP years ago, said the public could also encourage safe-sex advances.
"Quite frankly, it surprises me that people aren't doing this," he said. "Most of the major advances of HIV prevention have not come from the CDC or the doctors or the government. It comes from the community."
HIV Protection and Epidemic
Strub said this year marks the 26th anniversary of a pamphlet "How to Have Safe Sex in an Epidemic," first calling for the use of condoms to protect against HIV, written by community activists. Since that time, controversial additional behaviors, such as serosorting (restricting partners to your HIV status) have evolved.
But, unlike the condom, a pre-exposure pill comes with many more nagging medical details.
"The important thing to realize is that it's not just an evening-before pill that people pop," said Liu, who is currently directing the Prepare trial of a combination drug called Truvada among 3,000 men in the United States, South America, Asia and Africa.
Liu said the current testing is for a daily pill. Doctors still are checking for side effects of liver or kidney damage. Moreover, people in the study need routine HIV testing and follow-up care.
"These are men who are at risk for HIV, and since we don't know yet whether this approach works, we want to keep them on the best prevention," he said.
Costs of the drug may also be an issue.
"The medications that are involved are costly, and depending on whose paying for them, different payers or insurance, it could be a problem," said Dana Van Goder, executive director of Project Inform, a community-based HIV/AIDS awareness program in San Francisco.
Van Goder estimates the drugs, as they are sold now, would cost $500 to $900 a month. That would presumably go down if the drugs were made more widely available.
Whatever the future of the pill may be, Dennis believes he helped somebody in the trial.
"Having the knowledge that there's such a drug out there was real encouraging," said Dennis. "It's a very small part, but if I could do something to help this along I felt like I should."