FDA Expands Truvada PrEP for Use in Teen Patients
The FDA recently approved the pre-exposure prophylaxis Truvada (emtricitabine and tenofovir/disoproxil/fumarate; Gilead) for use in adolescent patients, according to a press release from the drugmaker.
The expanded indication was based on findings from a clinical trial that studied Truvada use in 67 adolescent patients aged 15 to 17 years, at high-risk for HIV infection. Study results showed that Truvada was effective as a preventative therapy and demonstrated similar tolerability compared with trials in adult cohorts.
“[The clinical trial] demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” Sybil Hosek, PhD, clinical psychologist at the Cook County Health and Hospital System's Stroger Hospital, and lead investigator of the study, said in a press release. “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.”
According to Gilead, patients aged 13 to 24 made up 21% of new HIV infections in 2016.
The indication recommends prescribing once-daily Truvada to high-risk adolescents who weigh at least 35kg. The indication also recommends prescribing PrEP therapy with recommended safer sex practices, and emphasized that Truvada is not a replacement for other preventative measures, such as condom use.
“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” Matthew Rose, Policy and Advocacy Manager at NMAC, said in the press release. “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it.”
Clinical trials found that common side effects of Truvada utilization among teenage patients were headache, abdominal pain, and weight loss. Bone mineral density loss was reported in 4 study participants, with one patient losing 4% bone mineral density by week 24. The researchers noted that decreased bone mineral density observed in the remaining 3 patients may have been a result of poor adherence.
—David Costill
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