Sept. 5 (UPI) -- A recent study found the use of preexposure prophylaxis, or PrEP, for the prevention of HIV in adolescent, sexually active men is safe and effective.
The study, published today in JAMA Pediatrics, tested the safety and efficacy of tenofovir disoproxil fumarate/emtricitabine, or TDF/FTC, in adolescents for HIV PrEP, which was approved for use in adults by the FDA in 2012.
"PrEP is used to prevent HIV by using a pill that is normally used to treat HIV," Dr. Sybil Hosek, a clinical psychologist at the Cook County Health & Hospitals System's Stroger Hospital in Chicago, told UPI. "It's a pill we've actually been using in HIV treatment for decades in adults with HIV. The most common side effects include start up syndrome where 10 percent of patients experience nausea and upset stomach when they start the PrEP. It's a really safe medication."
TDF/FTC has been approved for use for treatment of HIV in men under 18, but not for PrEP to prevent infection.
Researchers designed the Adolescent Medicine Trials Network for HIV/AIDS Interventions113 as a phase 2 safety study for adolescent men who have sex with other men age 15 to 17 in the United States.
The study included 78 male participants with an average age of 16 who were recruited from adolescent medicine clinics and community partners in six U.S. cities. All participants had negative HIV test results but were considered at high-risk for infection.
"It's always difficult to recruit adolescents into any study with all the issues around parental consent," Hosek said. "In this case, we had to find adolescents at risk for HIV and that's a smaller group. Adolescents were allowed to consent for themselves because study sites agreed if there were local laws allowing for HIV prevention services and STD prevention services for adolescents without parental consent, then the same would apply."
Hosek said that many of the study participants had not discussed their sexual orientation to friends or parents, and many identified as bisexual or questioning, not gay.
"Each clinic did recruitment differently, many on social media, Facebook and other sites, community organizations, and gay pride events," Hosek said. "Social media was the most productive way to find people to recruit by far."
Generally speaking, adolescent studies follow adult studies in order to gather more data and make sure there aren't different side effects for younger patients, Hosek said.
Over the 48-week study period, there were 23 sexually transmitted infections diagnosed in 12 participants. Three participants acquired an HIV infection during the study.
Most of the participants had detectable PrEP drug levels throughout the study, with more than 95 percent of participants having detectable levels over the first 12 weeks of treatment with declining levels after.
"Consistent with the development of adolescents, they struggled to take a pill every day," Hosek said. "They need more support than adults to adhere to taking a pill every day. This is expected in adolescents and for all types of medications. We see this in girls and birth control."
The study found adolescents taking the PrEP for prevention was safe and effective, and did not increase risky behavior as a result. Adherence was the biggest obstacle the participants faced, researchers reported.