May 9, 2012 -- AIDS advocates say a pill proven to protect against the HIV virus could promote unsafe sex by creating a false sense of security.
The U.S. Food and Drug Administration will meet Thursday to discuss whether Truvada, a drug already approved to manage HIV, should be approved to prevent the infection in high-risk patients, including men who have sex with other men, and heterosexuals with HIV-positive partners. But advocacy groups argue the drug would encourage risky behavior and undo decades of safe-sex advocacy.
"I think it will be a catastrophe for HIV prevention in this country," said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the largest provider of AIDS and HIV care in the U.S. "Men don't need more excuses to not use condoms."
An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention. Nearly half are men who have sex with men.
When taken daily, Truvada has been shown to cut the risk of HIV by up to 44 percent in gay and bisexual men in conjunction with condom use and counseling, and up to 75 percent in heterosexuals with HIV-positive partners.
"Why would a person use a condom if they're taking this serious, heavy duty medication?" said Weinstein. "When used properly, condoms are 95 percent effective at preventing infection. We don't want to reduce condom use."
Weinstein described the pill approach to HIV prevention as "the typical American easy way out" of a public health problem worthy of a bigger effort aimed at changing the culture of sex.
"We've done a really poor job in this country of promoting safer sex," he said, describing the "failure" of sex education in schools. "It's not that safe sex has failed, it's that it's barely been tried in this country."
But Dr. Barry Zingman, medical director of the AIDS Center at Montefiore Medical Center in New York, said Truvada would give high-risk patients one more layer of protection.
"It's not a panacea by any means, but there is still a tremendous fear of becoming HIV-positive, even when couples are using all the proper protection," he said. "When used in carefully selected patients getting significant support and close follow-up, it can clearly make a difference in people's lives."
FDA approval would allow Gilead Sciences, the maker of Truvada, to market the drug for HIV prevention. It could convince insurers to cover the cost, estimated at $11,000 per year.
"Getting insurers on board will make a huge difference in its use," said Zingman, adding that some doctors already prescribe Truvada "off-label" for HIV prevention, with patients picking up the tab. "There's no doubt cost is prohibitive for the vast majority of people."
Zingman said there's no evidence that Truvada would promote risky behavior, but added that he understands the controversy.
"Look at needle exchange programs. They're controversial, but they've dramatically cut rates of HIV and hepatitis among intravenous drug users," he said. "Providing clean needles is an attempt to reduce the risk in people who are already at high risk. It's the same thing here."
"You wouldn't put every patient in the hospital on antibiotics just because they might get an infection," he said. "If something comes along that is better than condoms, we will be the first to get behind it. We don't want to see one more person get infected."