The Food and Drug Administration has delayed its decision on whether to approve the first pill that could prevent HIV infection.
Gilead Sciences announced on Friday that the FDA will take three more months to determine the fate of the drug, Truvada, according to the AP. In May, experts recommended that the FDA approve Truvada for people with a high risk of contracting HIV, but Gilead has since submitted new materials for review, which has delayed the process. The AP reported that the FDA is now expected to make its decision in September.
Truvada’s potential to curb the AIDS epidemic has been the subject of debate since 2010, when it was first discovered to help prevent HIV infection in healthy patients, although in 2004 the drug had been approved by the FDA as medication for people who were already HIV-positive.
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The New York Times reported in May that some experts questioned whether people would take the drug regularly, as only 10 percent of study participants followed the regimen correctly. Taking the drug sporadically and not as directed, or taking the drug when already infected with HIV could lead to the development of drug-resistant HIV strains. Another concern that has been cited by the AIDS Healthcare Foundation is a fear that people taking Truvada will have a false sense of safety and therefore will be less likely to use condoms. And because Truvada is not 100 percent effective, failure to take the drug regularly and failure to use condoms could have a disastrous effect on the effort to stem the AIDS epidemic.
Still, Truvada could prove an important advancement in the prevention of HIV, according to Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases. He told PBS Newshour, “Prevention for HIV is really a comprehensive, multifaceted group of prevention modalities.” He added, “This one can be potentially very effective. So if it's approved and added to the recognized prevention modalities, it would be an important advance in making available for certain people a very effective way to prevent HIV infection.”According to an article in The Washington Post, studies sponsored by Gilead show that Truvada lowers HIV infection risk by 90 percent.
According to the CDC, approximately 1.2 million people over the age of 13 were living with HIV in the United States as of 2008. Approximately 50,000 people in the U.S. are infected with the virus each year.
Both sides of the debate will now have to wait three more months to find out whether Truvada will become an FDA approved—albeit hotly contested—tool in the arsenal.
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