FDA Approves PrEP for Adolescents

Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada to reduce the risk of HIV in at-risk adolescents.

According to the U.S. Centers for Disease Control and Prevention (CDC), adolescents and young adults 13 to 24 years of age comprised 21 percent of all new infections in the United States in 2016. A total of 81 percent of those infections were among young men who have sex with men.

Only about 10 percent of sexually-active high school students in the United States have been tested for HIV. Perhaps even more troubling is that of the 60,900 younger individuals who were living with HIV in 2013, according to the CDC, about 51 percent had not even received a diagnosis.

The addition of the adolescent indication is based on a single-arm, open-label clinical trial in HIV-negative individuals 15 to 17 years of age conducted by the Adolescent Medicine Trials Network for HIV/AIDS, a research network. A total of 67 HIV-1 negative young men who have sex with men in the trial received oral Truvada once daily, for PrEP. When taken consistently, pre-exposure prophylaxis such as Truvada can reduce the risk of HIV infection by 92 percent.

According to a press release:

“The Truvada safety profile in the study was similar to the safety profile that has been observed in adult trials of Truvada for PrEP, in which the most common side effects were headache, abdominal pain, and weight loss. Bone mineral density (BMD) was also monitored and four study participants had a decrease in BMD through 48 weeks (three adolescents had a modest decrease and one had a >4 percent decline in total BMD at Week 24).”

Andrew Cheng, MD, PhD, chief medical officer, Gilead Sciences said , “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.”

This is a huge step forward for youth, HIV prevention, and a more proactive and realistic attitude towards sex ed for queer people.