September 6, 2017
This news release was released on NIH.gov.
NIH-funded study suggests PrEP therapy, approved for adults, is safe for youth.
A National Institutes of Health network study has confirmed that a combination of two drugs taken daily to reduce the chances of HIV infection among high-risk adults also works well and appears safe in males ages 15 to 17 years.
Truvada, a single pill containing the drugs tenofovir and emtricitabine (TDF/FTC), is currently approved for daily use in adults. The drug is the cornerstone of pre-exposure prophylaxis (PrEP), a strategy in which healthy people at risk for HIV infection take one or more anti-HIV drugs to reduce this risk.
The study published in JAMA Pediatrics, was funded by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse, and National Institute of Mental Health.
“Several studies have shown that daily oral PrEP is effective in preventing HIV among people at high risk of becoming infected, but none of them included adolescents under age 18,” said study author Bill Kapogiannis, M.D., of NICHD’s Maternal and Pediatric Infectious Diseases Branch. “Our study suggests that this therapy can safely reduce HIV risk for those under 18.”
The study was conducted by researchers in the NICHD-funded Adolescent Medicine Trials Network for HIV/AIDS Interventions. When the study began, participants ranging in age from 15 to 17 years old were not infected with HIV, and were considered at-risk for HIV because of factors such as having unprotected sex with a male partner who had HIV or whose HIV status was unknown, having at least three male partners, or having a sexually transmitted infection other than HIV. Youth with poor kidney function and a history of bone fractures were excluded from the study because the drug combination may sometimes stress the kidneys and cause bone loss.
Study participants received periodic tests for HIV and other sexually transmitted diseases, counseling (link is external), and other interventions to help them avoid risky behaviors. The 72 youth who took part in the study also received daily oral TDF/FTC for 48 weeks.