Local HIV/AIDS advocates and health officials hailed a decision by the Food and Drug Administration approving the use of the oral medication Truvada as a PrEP ( pre-exposure prophylaxis ) intervention for adolescents.
PrEP has been shown to be over 90 percent effective in preventing new infections for at-risk individuals. Truvada was approved fas PrEP for adult patients in 2012.
The approval was announced May 15 in a statement from Foster City, California-based Gilead Sciences, the drug's manufacturer.
"By expanding the number of at-risk individuals who can consider Truvada as a prevention option, we have taken another important step toward helping to reduce HIV transmission rates and improve public health in the United States," said Andrew Cheng, MD, chief medical officer for Gilead Sciences. "Gilead is committed to addressing unmet needs in HIV prevention and treatment and we look forward to continuing that work with our research and advocacy partners."
According to Gilead, Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kilograms. According to the Centers for Disease Control and Prevention, adolescents and young adults comprise about 21 percent of new HIV infections.
AIDS Foundation of Chicago Senior Director of Prevention Advocacy and Gay Men's Health Jim Pickett called the approval "a huge win." He noted that, though providers could previously prescribe Truvada as PrEP for adolescents previously, it was designated as an off-label prescription, which many physicians are reluctant to write. Furthermore, patients frequently had difficulty receiving financial assistance to help pay for Truvada off-label, which is extremely costly.
"The fact that it is now an on-label prescription provides a lot of reassurance," he said.
Pickett further praised the work of the staff at Cook County Health & Hospitals System's (CCHHS) Ruth M. Rothstein CORE Center and Stroger Hospital, which participated in research that ultimately went into the FDA decision, adding, "Now it's up to all of us to make good on it."
Lisa Henry-Reid, MD, who is chair of the division of adolescent medicine and young adult medicine at CCHHS' Stroger Hospital, acknowledged that getting the word out about PrEP and its potential to help youth would be a challenge, but said the intervention could be an "important part of the toolbox" in preventing new infections among that demographic.
"Our Chicago Department of Public Health and Illinois Department of Public Health, and our Chicago Public Schools system, need to be leaders in the effort to engage around this message," explained Henry-Reid. "This is really a big deal in terms of prevention."