FDA Approves Truvada as PrEP for Adolescents: Fordham University’s Dr. Celia Fisher Weighs In

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According to the U.S. Centers for Disease Control and Prevention (CDC), adolescents and young adults 13-24 comprised 21 percent of all new HIV infections in 2016, with 81 percent of those infected among young men who have sex with men (YMSM).

Last week, Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) approved once-daily oral Truvada® to reduce the risk of HIV-1 in at-risk adolescents. The safety and efficacy of Truvada for HIV prevention in uninfected adults, or pre-exposure prophylaxis (PrEP), is well established, according to the Gilead Press Release.

The approval was based on a study in HIV-negative individuals between the ages of 15 to 17 years of age. Lead investigator and Clinical Psychologist at the Cook County Health and Hospital System’s Stroger Hospital, Chicago, Sybil Hosek, PhD, said “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.”

This approval is raising questions, but the greatest debate currently is whether or not teens will adhere to a “regular pill schedule,” as well as continue with safe sex practices, according to Healthline. The ATN113 study showed that while many adolescents can “do well on PrEP,” the results are better with “more frequent monitoring and support.”

Celia B. Fisher, PhD, Director of Fordham University’s Center for Ethics Education and the HIV and Drug Abuse Prevention Research Ethics Training Institute, explained to Healthline, “…the adherence problems don’t appear to be greater in adolescents than those in young adults. Additionally, in studies we’ve conducted at Fordham and Northwestern, youth report that they wouldn’t take PrEP if they know they have difficulty remembering to take other pills or are forgetful in general.”

In terms of teens on PrEP and support, Dr. Fisher said, “This will be up to the physician, as noted by Sybil Hosek and her colleagues who conducted the study. Since PrEP requires a prescription, physicians can limit the prescription to two months in order to ensure greater monitoring and frequency of support.”

Another raised concern regarding the use of PrEP is the possibility that it will encourage “risky sexual practices” in adolescents. Dr. Fisher told Healthline, “There’s no evidence supporting the concern that PrEP encourages risky sexual behavior among adolescents.” “Research disconfirms beliefs that providing youth with sexual health information, condoms, or other forms of information and protection increases risk behavior. In fact, since PrEP can only be obtained with a physician’s prescription (whereas condoms can be acquired in stores without prescription), this means that physicians will have an opportunity to discuss sexual health risk and protections with youth in situations in which the topic may not have previously come up. In addition, the CDC recommends PrEP only for individuals that are already engaged in high-risk sexual behaviors,” said Dr. Fisher.

For more from Dr. Fisher and others on this topic, please visit the full article “Teens Can Now Get HIV Drug…Will They Use It” on Healthline.




Celia B. Fisher, Ph.D. is the Fordham University Marie Ward Doty University Chair in Ethics and Director of the Center for Ethics Education. In addition to chairing the 2002 revision of the American Psychological Association’s Ethics Code, Fisher’s  Decoding the Ethics Code: A Practical Guide for Psychologists, is now in its fourth edition from Sage Publications.

 

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