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May 25, 2018 - PrEP Now Approved by FDA for Adolescents at Risk for HIV

Photo of a doctor's stethoscopeAfter being first approved in 2012 for adults, on May 15, 2018, the FDA approved the use of the medication Truvada for Pre-Exposure Prophylaxis, or PrEP, for adolescents at risk for HIV infection.

This FDA approval was partially based on ATN 113, a study of HIV-negative adolescent boys aged 15-17, which showed that adolescents tolerated PrEP usage. Adherence to the daily PrEP regimen, however, markedly declined when office visits decreased from a monthly to quarterly visit schedule.

“Study ATN 113 provided supportive safety and adherence information from a cohort of U.S. adolescents at risk of acquiring HIV,” the FDA’s Division of Antiviral Products within the Office of Antimicrobial Products said in a statement to the ATN. “The adherence data from ATN 113 specifically helped inform Truvada labeling with respect to adolescent PrEP monitoring, by suggesting that adolescents may benefit from more frequent visits and counseling to maintain proper adherence to the drug.” ATN 113 was a 48-week study that also concluded that adolescents may need more frequent clinical visits to ensure they are adherent to taking PrEP.

“This approval will allow adolescent minors who may be at risk of HIV to access an effective biomedical prevention medication for the first time,” Bill Kapogiannis, study author and NIH program director for the ATN, said. “The addition of oral PrEP to the HIV prevention tool box for adolescents was made possible through vital research spearheaded by the ATN and is a landmark achievement for the Network and NICHD in our mission to reduce the numbers of new HIV infections among our nation’s youth.”

The lead investigator of the study was Sybil Hosek, clinical psychologist at the Cook County Health and Hospital System in Chicago.

“The FDA's decision is a milestone for HIV prevention among youth,” Hosek said. “It paves the way for easier adolescent access to a highly efficacious biomedical HIV prevention product that has been approved for adults for the past 6 years.”

PrEP is a strategy that prevents HIV infection by inhibiting the virus from infecting the body’s cells, and Truvada is the name of the daily oral medication used for PrEP. PrEP can reduce the risk of HIV infection from sex by over 90%, according to the U.S. Centers for Disease Control and Prevention (CDC). Before anyone begins PrEP, they must be tested for HIV and receive a negative result.

“With this indication, medical providers can feel confident about the safety and tolerability of oral PrEP for sexually-active adolescents,” Hosek said. “Additionally, financial barriers to PrEP may decrease as adolescents will now be eligible for a variety of patient medication assistance programs to defray costs associated with PrEP use.” 

The FDA’s Division of Antiviral Products also commented on the impact that the approval of PrEP for adolescents may have in the US. “While it is difficult to predict impact, especially with respect to HIV prevention efforts, it is anticipated that this approval will improve access to this safe and effective HIV prevention method for younger persons most at risk and may help address the ongoing epidemic in these groups,” the statement said. “We believe the availability of Truvada for HIV-1 PrEP provides an additional option within an overall comprehensive care plan needed for an at-risk adolescent.”

Read more about the ATN and the ongoing studies for HIV prevention in youth and helping youth living with HIV get care:

Read the NIH statement for more details about ATN 113: