A pill that protects against the human immunodeficiency virus (HIV) can be safely used by young men who have sex with men, according to a new study.
In a diverse group of teen boys at high risk for HIV infection, pre-exposure prophylaxis (PrEP) in the form of a pill that combines the drugs emtricitabine and tenofovir disoproxil fumarate was well tolerated, researchers found.
'I do hope clinicians increase their comfort with being able to provide PrEP to adolescents,' said lead author Sybil Hosek, a clinical psychologist and HIV researcher at Cook County Health and Hospitals System's Stroger Hospital in Chicago.
She hopes the new data will be submitted to the U.S. Food and Drug Administration (FDA) and will encourage the agency to approve the pill for use by younger people. The pill is currently approved for HIV prevention in adults.
Few studies have looked at how PrEP would affect younger users, who are at highest risk of getting HIV through sex. Now research shows fears of side effects are unfounded (file image)
The drug was first approved by the FDA in 2012 as Truvada, which was marketed by Gilead. Trials found that the drug reduced the risk of HIV infection by over 90 percent.
But little evidence was collected on its use among gay and bisexual adolescent males, who are among those most at risk for HIV infection.
For the study, researchers enrolled 78 gay and bisexual young men, ages 15 to 17, from six U.S. cities. The participants all tested negative for HIV at the start of the study, but were at high risk for an infection.
Participants received a counseling session about HIV risk, plus access to daily doses of PrEP for the next 48 weeks.
Overall, 47 participants completed the study.
Only three adverse events occurred that were possibly related to PrEP, the researchers found.
'I think the safety piece is important,' Hosek told Reuters Health. 'It was well tolerated. We didn't see many complaints about side effects. We did not see many adverse events.'
The researchers also didn't find an increase in sexually risky