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FDA Panel OKs Truvada as First HIV-Preventive Drug

AIDS Activists Divided Over Whether Drug Will Help or Harm Epidemic

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.

Truvada: The Research

Gilead presented numerous study results to the advisory panel.

  • In one study of nearly 2,500 high risk HIV-negative men who had sex with men, the risk of getting HIV was reduced by 44% in those who took Truvada compared to those who took placebo.
  • Among the men in the study (known as iPrEx), those who took the drug at least 90% of the time reduced their risk of getting HIV up to 73% compared to placebo.
  • In the Partners PrEP Study, including 4,747 couples in which one partner was HIV-positive, those who took the pill daily had a 75% lower risk of getting infected compared with those who took placebo.

However, a study conducted in women by Family Health International was stopped in April 2011. After enrolling nearly 2,000 women, it did not find the daily dose effective in preventing infection in HIV-negative women.

Side effects include diarrhea, nausea, fatigue, and dizziness when the drug is begun.

More serious reported problems have included lactic acid buildup and an enlarged liver, which is potentially fatal.

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