The Food and Drug Administration (FDA) has approved the use of Truvada, an HIV drug, for preventing new infections, after several months of heated debate over the readiness of that strategy.
While some have argued that the approval of the drug came prematurely, others have hailed the news as landmark in the fight against AIDS.
"This is an enormous turning point, a real game changer, in the fight against HIV," said Jim Pickett, AFC's director of prevention advocacy and gay men's health, in a press statement. "The toolbox we have been working for decades to expand now has Truvada as PrEP."
Truvada is an HIV medication that combines two virus-fighting drugs, tenofovir disoproxil fumarate and emtricitabine. The medication was approved for HIV treatment in 2004 and is typically taken in the form of a daily pill, in combination with other HIV therapies.
Over the past two years, separate studies have shown Truvada can significantly reduce the chances of infection in people who are HIV-negative.
That method is known as Pre-Exposure Profylaxis, or PrEP for short, and it is the same method used to prevent malaria in travelers. An at-risk patient takes the drug before being exposed to a disease or virus.
Those who might benefit from PrEP could be sex partners where one person is HIV-positive and the other is negative, people engaging in high-risk sex and HIV negative people who may not always have a choice about condom use.
"We can make a huge dent in new infections if we incorporate this tool into our prevention programming, and provide people more methods to avoid HIV," said Pickett in a statement. "We can look forward to more sex acts being protected, especially among individuals who have already chosen, for whatever reason, to not use condoms consistently."
But experts stress that Truvada should be used with condoms, providing an extra layer of protection against the virus, rather than circumventing safer-sex practices. And some experts worry that those on PrEP will now be less likely to use condoms.
Further, experts worry that the use of Truvada for PrEP could create a resistance to the drug if the user becomes infected with HIV while taking it. Because those taking Truvada for PrEP are not receiving a full HIV treatment, those who become infected while on PrEP are at risk of building a resistance to Truvada.
Dr. James Kublin, executive director of the HIV Vaccine Trials Network, stressed that PrEP should be used as part of a comprehensive approach to preventing HIV that includes condom use and regular HIV testing.
"PrEP should not be seen as a 'silver bullet,'" he said. "It comes with its own challenges, which include cost, possible long-term side effects and adherence… but can play a role in key, high-risk populations when used as part of a comprehensive, harm-reduction package."
David Ostrow, a Chicago-based veteran AIDS researcher, also has mixed feelings about PrEP.
"My reaction is that properly implemented, the use of PrEP will be a very important new way of preventing HIV, but I haven't seen much in the way of how that is going to be accomplished," said Ostrow.
Ostrow worried that not enough research has been done to identify who exactly is at highest risk for contracting the virus, and he said the cost of Truvada, which might be more than $1,000 a month for PrEP, is so steep that it may not be a viable option for curbing new infections. Moreover, Ostrow said he is concerned about resistance. He said more studies on Truvada for PrEP are needed.
"I just don't know why [the FDA] didn't want to wait a little longer," he said.
But the real test, said Ostrow, will be in if PrEP is implemented in a way that is safe.
Side effects for Truvada can include nausea, diarrhea, abdominal pain, weight loss and headaches, according to the FDA. More serious side effects in trials were uncommon, the FDA said, but included bone toxicity and kidney problems.
But despite possible drawbacks, many service providers say the approval of Truvada for PrEP marks a new day in HIV prevention.
"I think it's a monumental decision, really," said Jeff Berry, director of publications at Chicago's Test Positive Aware Network. "It's the first drug approved for prevention of HIV… It's just one more tool, I think, in the prevention tool kit."
Berry notes that while more research might help identify at-risk populations better, service providers already know generally who may be at-risk, and he notes that while the cost of Truvada can be steep, the cost of infection is far steeper.
"I think it's absolutely cost-effective when you look at it that way," he said.
