FDA Approves PrEP For Use By Teens At Risk Of HIV

In 2012, HIV medication Truvada was approved by the Food and Drug Administration (FDA) for use by adults as pre-exposure prophylaxis (PrEP) against HIV.

The results have been excellent to say the least as studies show the use of PrEP reduces the chances of HIV exposure by over 90%.

Now, the FDA has expanded the approval of Truvada as PrEP to include adolescents. The new approval will now include teens at risk for HIV who weigh at least 77 pounds.

The decision was based on the ATN113 study, which enrolled 78 high-risk adolescents ages 15 to 17.

Over the course of 48 weeks, the participants checked in on a monthly basis for the first three months, and then moved to clinic visits every three months.

Adherence to taking the drug on a daily basis was fairly high during the first three months. But once the study moved to checking in only every three months, researchers found the teens were more likely to skip a dose.

That drop off in adherence led to the conclusion that teens may need monthly monitoring in order to achieve the best results on PrEP.

(photo by Jeremy McKnight)

The side effects reported among the adolescents were similar to those observed in adults on Truvada, the most common being weight loss, headaches and abdominal pains.

In a press release from Gilead Sciences, which manufactures Truvada, Sybil Hosek, PhD, clinical psychologist at the Cook County Health and Hospital System’s Stroger Hospital in Chicago and lead investigator of the study wrote, “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, health care providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations,” she added.

(h/t Poz)