FDA Panel OKs Truvada as First HIV-Preventive Drug
AIDS Activists Divided Over Whether Drug Will Help or Harm Epidemic
More About Truvada continued...
As the advisory committee listened to evidence about the drug, some expressed concerns that people would share the medication. Others wondered if approval for healthy persons would result in a decline in safer sex practices such as condom use.
If people who took the medication got infected anyway, some worried that drug-resistant strains might develop.
Other questions addressed by the expert panel, such as whether to require doctors who prescribe it to receive education about the drug, were not voted on. Nor was the question about how often those who take the preventive drug would get HIV testing.
Truvada as Preventive: Advocates
"It's pretty clear from clinical data and a number of clinical trials that there really is a protective effect from Truvada," says McColl of AIDS United. "Our organization does support the use of Truvada for HIV prevention."
"We don't send people to places where malaria is present and say, 'You can only have netting or the [anti-malarial] vaccine,'" he says.
Truvada as Preventive: Critics
Approving an HIV preventive drug is not productive and may backfire, says Michael Weinstein, president of AIDS Healthcare Foundation.
"We're opposed to the FDA indication for prevention of HIV [with Truvada]," he tells WebMD.
The data do not support its value as a preventive, he says. He worries, too, that the drug may give people at risk a false sense of security.
"If people think they are protected they won't use condoms, and the rate of infection will actually increase," he says.
Truvada as Preventive: Limited Role
Rodney Wright, MD, director of HIV programs in the department of obstetrics and gynecology at Montefiore Medical Center in New York, sees a limited preventive role for the drug.
"I'm not in favor of widespread use of it as a preventive because of concerns over adherence," he says. "We know it does not work if it is not taken every day."
He does see a role, he says, for the HIV-negative partner of a couple trying to conceive. If the HIV-negative partner would take the drug as a preventive, it could help them have a safer pregnancy and not pass the infection to the baby, Wright tells WebMD.