FDA Expands Indication for PrEP to Reduce Risk of HIV in Adolescents

May 18, 2018

The FDA has approved an expanded indication for Gilead Science’s emtricitabine/tenofovir disoproxil fumarate (Truvada) to reduce the risk of HIV in at-risk adolescents. Truvada for pre-exposure prophylaxis (PrEP) was first approved for the use in adults in 2012.

Gilead Science’s emtricitabine/tenofovir disoproxil fumarate (Truvada) has gained an expanded indication from the FDA to reduce the risk of HIV in at-risk adolescents. Truvada for pre-exposure prophylaxis (PrEP) was first approved for the use in adults in 2012.

The expanded indication is based on Study ATN113, a single-arm, open-label trial consisting of 67 HIV-negative adolescents aged 15 to 17. Participants received the treatment once daily. The safety profile observed in the study was comparable to that observed in the adult trials. The most common side effects were headache, abdominal pain, and weight loss.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” said Sybil Hosek, PhD, clinical psychologist, Cook Counth Health and Hospital System’s Stroger Hospital, and lead investigator of the study, in a statement. “In additional 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.”

The treatment is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 77 pounds. Individuals must have a negative HIV test immediately prior to starting the treatment.

Gilead noted that the treatment should not be used to replace other prevention methods, such as condoms, and should not be used in individuals with unknown or positive HIV status.

“By expanding the number of at-risk individuals who can consider Truvada as a prevention options, 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, PhD, chief medical officer, Gilead Sciences, in a statement.

Since PrEP received FDA approval for HIV prevention in 2012, usage among people in the United States has significantly increased. Between 2012 and 2016, the number of PrEP users increased by 880%, with an average 73% increase year over year. But, significant gaps still exist among African Americans and Latinos. In 2015, 44% of those who could potentially benefit from PrEP in the United States were African American and 25% were Latino; however, just 1% of the African American population and 3% of the Latino population were prescribed PrEP.

While gaps are smaller among whites, they are still substantial.