By late this summer, the Food and Drug Administration could approve a widely used AIDS drug as the first pill to prevent transmission of HIV, the AIDS virus. The drug, Truvada (pronounced tru-VAH-duh), made by Gilead Sciences of Foster City, Calif., already is commonly used in combination with other drugs to treat patients with HIV infection. If approved for HIV prevention, as an FDA advisory panel recommended in May, it can be prescribed to healthy patients who are at high risk, such as partners of people who have HIV/AIDS and non-monogamous gay and bisexual men. Experts offer their thoughts on the drug.
Q: How effective is Truvada as a prevention tool?
A: Two large clinical trials involving couples and individuals found that Truvada significantly reduced the risk of transmission of HIV from a low of 44% to more than 90%. The greatest benefit came for patients who took the medicine as directed, as confirmed by blood tests.
Q: Are there dangers associated with use of this medicine?
A: If not taken properly, drug resistance could develop. In people already infected with HIV, Truvada is always taken in combination with other anti-retroviral drugs to avoid that problem. But taken alone, there's a risk, so doctors will need to be sure patients are free of HIV when they begin preventive treatment.
Making sure anyone who is prescribed Truvada is tested first is a critical step, says Howard Jaffe, president of the Gilead Foundation, a non-profit arm of Gilead Sciences. Truvada is an important tool, he says, but it doesn't mean other prevention strategies -- free condoms, free HIV testing, counseling and other health services -- aren't needed. "We're lucky we have airbags in cars," he says, "but they don't make seat belts obsolete."
Q: What are the obstacles to using this widely to stop the spread of HIV?
A: Price is one. The cost of Truvada has been placed between $11,000 and $14,000 per year. Jaffe says the drug has been "deeply discounted" for government health programs and clinics for use as treatment, and the same discounts will apply for its use in prevention.
"Cost is a hurdle, no doubt about it," says Carlos del Rio, co-director of the Emory Center for AIDS Research and a board member at HIVMA (the HIV Medicine Association). But "I think the price will come down." And, he says, it's cheaper than treating HIV.
Cost is only the beginning, though, del Rio says. Questions remain about who will prescribe the drug and how long it should be taken. "The implementation challenges we're going to face with this new approach are not insignificant."
Q: Can it be used to reduce the spread of HIV in developing countries?
A: "That's the promise," says James Loduca of the San Francisco AIDS Foundation. "In the U.S., if current prevention strategies were enough, we wouldn't be seeing the spread (of HIV) we do. It's the same in other countries," he says. "I can't imagine anyone saying individuals shouldn't have access to a tool that, when used appropriately, has 90% efficacy."
But del Rio, who also chairs the Department of Global Health at the Rollins School of Public Health at Emory, has doubts. "I don't think, honestly, in the short term, this is going to have much impact in the U.S., much less globally," he says. "It's a tool, but at the current price of up to $14,000 a year per individual, it's simply not possible to think this will have an immediate impact in the epidemic globally."
Q: What has been the reaction from the AIDS community?
A: Marjorie Hill, CEO of Gay Men's Health Crisis in New York City, says that overall, there is a sense of "cautious optimism and a great deal of interest in this as another option people can pursue as far as HIV prevention. The concern is about cost and access."
Loduca of the San Francisco AIDS Foundation says the FDA advisory committee's recommendation to allow Truvada to be marketed for HIV prevention is a "watershed moment" in the 30-year fight against HIV/AIDS. Despite all efforts to prevent HIV transmission, he says, the rate of new infections remains high, estimated by federal health officials at between 48,000 and 56,000 each year.
"We know this is no silver bullet, and this isn't going to be the right prevention strategy for everyone," Loduca says. "Here's what we as a community know to be true: Truvada won't end AIDS by itself. But we can't end AIDS without it."
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