According to the research study conducted by National Institutes of Health (NIH) network has confirmed that a combination of the drug has the capability to reduce the risk of HIV infection. The NIH network study says that a combination of two drugs two drugs taken daily can minimize the risk of HIV infection among adults and with teen males who are 15 to 17 years old.
A single pill named Truvada containing the drug tenofovir and emtricitabine (TDF/FTC) have received approval for daily use in adults. This drug is the cornerstone of pre-exposure prophylaxis (PrEP), it is a strategy in which healthy people who are at risk of HIV infection take one or more anti-HIV drug to reduce the risk of infection.
ThBill Kapogiannis M.D., of NICHD’s Maternal and Pediatric Infectious Diseases Branch, said, “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. Our study suggests that this therapy can safely reduce HIV risk for those under 18.”
This study was published in JAMA Pediatrics and 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. The research study was conducted by the researchers in the NICHD-funded Adolescent Medicine Trials Network for HIV/AIDS Interventions.
When this study began, the participants in the age group 15-17 years were not infected with HIV. However, they were considered at risk for HIV due to certain factors like having unprotected sex with a male partner who is HIV positive or whose HIV status is unknown. The risk of HIV infection is more when having unprotected sex with at least three male partners or with those having a sexually transmitted infection other than HIV.
Teenagers with poor kidney function and history of bone fractures were generally excluded from the study because the combination of drug intake may sometimes stress the kidneys and can also lead to bone loss.
Around 72 participants took part in the study and received oral TDF/FTC for 48 weeks. As the study progressed, it was noticed that many participants skipped the doses of their medication. The level of drug was sufficient to prevent the risk of infection in 54 % of the participants by week four, 49% of the participants by week 12, 28 participants by week 24 and 22 % by week 48.
The main reason behind skipping the medication that most of the participants gave is that others will see me taking medications and think I am HIV positive. Around 32 % gave a reason because they were away from home, 28 % being too busy and 26% forgetting. Around 19 % gave the excuse as they were experiencing changes in routine.
During this study, the participants tolerated the drug well and there were no reports of side effects on the kidneys and bone. Three participants were diagnosed with HIV during the course of the study and among them one at week 32, 36 and 48. All three participants had no detectable blood levels of drugs TDF/FTC at the visit before getting diagnosed with HIV infection. This indicates that those three participants were missing the doses or not taking TDF/FTC at all.
According to the authors, the lack of significant health events during this research study indicated that the drug seems to be safe for teen males under 18. The lack of HIV infection among participants who were reported to have sufficient level of drug in their blood indicated that the drug can be effective for the population when taken appropriately.
NIH is also funding the studies of PrEP therapy for girls and young women. In the upcoming study in female participants between 16-21 years of age were tested for six months with oral PrEP.