The Food and Drug Administration has approved the drug Truvada for usage as pre-exposure prophylaxis, or PrEP, for adolescents.
In a Tuesday announcement, the government health agency recommended that the daily treatment be used by young men who have sex with men [YMSM] in combination with other safe-sex practices, like condom use, in order to prevent HIV infection. Youth are an at-risk group for HIV. People ages 13 to 24 accounted for 21 percent of new infections in 2016, reports the Centers for Disease Control. YMSM — especially black and Hispanic youth — account for 81 percent of those infections.
The FDA, which approved the use of PrEP for adults in 2012, issued the decision following new research into PrEP's effectiveness in YMSM. Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the study — referred to as ATN113 — provided daily PrEP treatment to 67 HIV-negative gay and bi males ages 15 to 17.
Sybil Hosek, a clinical psychologist at the Stroger Hospital in Chicago and the study's lead investigator, released a statement praising the results of the study.
"Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” Hosek said in a statement. “In addition to traditional risk-reduction strategies, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”
Many health advocates applauded the FDA's approval of PrEP for young people. "We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose, the policy and advocacy manager at NMAC at the National Minority AIDS Council.
Jim Pickett, the senior director of prevention advocacy at the AIDS Foundation of Chicago, called the decision "a major victory in our local and national efforts to end the HIV epidemic. After all, young people don't wait 'til they're 18 to have sex, and HIV doesn't wait around for people to mark their 18th birthday either." He also praised the "bold, brave and visionary work" of the study's team, which "make them heroes in the fight against HIV."
Dr. Kristin Kegolovitz-Baker — chief operating officer at Howard Brown Health, a Chicago LGBT organization that provides health services — called the FDA's approval of PrEP for adolescents "an exciting step that will broaden access and reduce barriers to care. Without FDA approval, it was easier for insurance companies to refuse to cover the costs of a medication, and the label change will encourage dialogue between young people and their practitioners about sexual health."
Studies in adults have shown that, when taken daily, PrEP can be up to 99 percent effective in preventing HIV. Common side effects in the participants of ATN113 — similar to those experienced by adults — included headache, weight loss, and abdominal pain.