FDA Approves Truvada for Use in Adolescents

The US Food and Drug Administration (FDA) has approved Gilead's once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents weighing at least 35kg when used in combination with safe sex practices. When taken consistently, pre-exposure prophylaxis, such as Truvada, can reduce the risk of HIV infection by 92%.

According to the US Centers for Disease Control and Prevention (CDC), adolescents and young adults 13 to 24 years of age comprised 21% of all new infections in the United States in 2016. A total of 81% of those infections were among young men who have sex with men (YMSM). Previous studies have shown that HIV testing remains low in young individuals between the ages of 13 and 24, compared with other age groups. Only about 10% 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% had not even received a diagnosis. The organization states that is “the highest rate of undiagnosed HIV in any age group,” and that, out of all age groups, this group is the “least likely” to be linked with the care that they need, perhaps due to the lack of testing.

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 funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). A total of 67 HIV-1 negative young men who have sex with men (YMSM) in the trial received oral Truvada once daily, for PrEP. According to a press release on the approval, "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 4 study participants had a decrease in BMD through 48 weeks (3 adolescents had a modest decrease and 1 had a >4 percent decline in total BMD at Week 24)."

Sybil Hosek, PhD, clinical psychologist at the Cook County Health and Hospital System's Stroger Hospital, Chicago, and lead investigator of the study stated in a press release that, "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, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations."

Before starting the medication, individuals must have a negative HIV test. The risk of post treatment acute exacerbation of hepatitis B and drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection is indicated with Truvada.

Andrew Cheng, MD, PhD, chief medical officer, Gilead Sciences stated, "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."

There is no doubt that the use of PrEP in combination with safe-sex practices is effective in reducing transmission of HIV; however, some researchers have argued that the cost of the medication has disproportionately affected its use in the population that needs it the most: MSM. It remains to be seen if this expanded indication from the FDA will positively impact the challenges seen with the cost of the medication.