The Food and Drug Administration gave its approval to Truvada, the first drug to be used to reduce the risk of HIV infection.
The one-pill combination drug has already been approved by the FDA as an HIV treatment. But studies have also shown its effectiveness in decreasing the risk of becoming infected among high-risk people.
In one study of about 2,500 high-risk HIV-negative men and transgender women who have sex with men, the drug cut the risk of HIV infection by 42 percent compared with placebo. In another trial of about 4,700 heterosexual couples in which one was HIV-positive, Truvada reduced the risk of infection by 75 percent.
The approval comes with a number of prescription parameters. Patients must be HIV negative, at high risk for virus infection, and may be having sex with partners who are HIV-positive.
Administered prophylactically, the drug must be taken daily. But prevention doesn’t end there—in addition, patients must also practice safe sex, go through risk-reduction counseling, and undergo regular HIV testing.
Because of the stringent guidelines, the FDA is strengthening the box warnings that patients must be confirmed that they’re HIV negative and must be tested for the virus every three months while they’re on the medication.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Dr. Margaret Hamburg in a statement. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
The American Foundation for AIDS Research also threw its support behind the drug: “Now that the FDA has approved Truvada as part of a comprehensive approach to reduce HIV infection rates in the U.S. and globally, we need to quickly determine how we’re going to incorporate it into our prevention strategies and goals,” amfAR CEO Kevin Robert Frost said in a news release. “We know that Truvada, when taken as directed, works. Now we need to figure out how to properly use it to change the course of the epidemic.”
But not everyone was happy with the FDA’s decision. The AIDS Healthcare Foundation issued a statement calling the FDA “reckless” in its decision to approve the drug for prophylactic use.
Foundation president Michael Weinstein said the decision will “ultimately set back years of HIV prevention efforts. From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support.”
Concerns about Truvada are mostly focused on skepticism that patients will take it every day, reducing its effectiveness. Some also believe that the drug may give people a false sense of security, prompting them to engage in risky behavior.
At almost $14,000 a year, the cost of the drug may also be a barrier. The Associated Press reported that Gilead Sciences, which manufactures Truvada, said it won’t change the price, although some argue that it could be worth the price if it prevents HIV infection. Lifetime treatment for someone with AIDS has been estimated at hundreds of thousands of dollars.
What do you think of Truvada being used as a preventive measure for HIV infection? Tell us in the comments.