FDA Approves PrEP for Adolescents

May 15, 2018

Gilead Sciences announced today that the U.S. Food and Drug Administration (FDA) approved Truvada to reduce the risk of contracting HIV in vulnerable adolescent individuals.

Truvada is the medication component of the HIV prevention medical regimen called “PrEP (Pre-Exposure Prophylaxis) “. The PrEP medical regimen includes regular doctor visits, labs, HIV prevention education and taking 1 pill once a day. It can be up to 99% effective at preventing HIV transmission when taken daily. The FDA approved Truvada for PrEP to prevent HIV in adults in 2012.

The FDA approval is based on a single-arm, open-label clinical trial conducted by the Adolescent Medicine Trials Network for HIV/AIDS, a research network. The study included HIV-negative individuals 15 to 17 years of age.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV. 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.” – Sybil Hosek, PhD, Clinical Psychologist at the Cook County Health and Hospital System’s Stroger Hospital, Chicago, and lead investigator of the study.

According to the Centers for Disease Control (CDC), in 2016, youth aged 13-24 made up 21% of all new HIV in the US. 81% of those new HIV infections occurred among young gay and bisexual men. Young black/African American and Hispanic/Latino gay and bisexual men were especially effected.

“Truvada for PrEP in adults is a highly effective tool at preventing HIV and the expansion to include vulnerable adolescent individuals is a very welcomed development. Considering in our own backyard, Orange County, Florida from 2013-2016 there has been a 100% increase in HIV cases in the adolescent population, this additional HIV prevention option can be an vital component of comprehensive HIV plan for those that may benefit from it.” – Edwin Dejesus, MD, FACP, FIDSA,  Medical Director at Orlando Immunology Center

This announcement a major step in HIV prevention and youth. It’s also one step closer to zero new HIV transmissions.

So I guess that’s actually two steps forward.

-Sam Graper
Community Relations Manager, Orlando Immunology Center