PrEP Found to Be Safe For Gay, Bisexual Adolescent Boys

A pill that protects people from contracting HIV can now be safely prescribed and used by young men who have sex with men.

A recent report by Reuters Health reports that a new study found that pre-exposure phrophylaxis (PrEP) in the form of a pill like Truvada, which combines emtricitabine and tenofovir disoproxil fumarate was well-tolerated among adolescents.

"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.

Hosek hoped the new data will be submitted to the U.S. Food and Drug Administration (FDA), who would approve the pill for use by younger people for HIV prevention, as it is for adults.

Gilead's Truvada for PrEP was first approved by the FDA in 2010, after trials found that it reduced the risk of HIV infection by 90 percent. But there was little evidence on its use by gay and bisexual adolescent males, who are those at most risk for HIV infection.

For their study, researchers enrolled 78 gay and bisexual men aged 15-17 years old, from six U.S. cities. They were all at high risk for HIV infection, but all were negative at the start of the study.

They received daily doses of PrEP for 48 weeks, as well as a counseling session about HIV risk. About 47 participants completed the study, with only three adverse events possibly related to PrEP reported.

"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 said they didn't find any increase in sexually risky behaviors over the study period. However, three men did contract HIV. Blood samples suggested they were taking less than two doses of PrEP per week, at the time of infection.

"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 rate of HIV infection in the study was 6.4 cases per 100 people per year, which is about twice as high as the rate seen among men ages 18 to 22 years enrolled in a similar trial, the researchers write in JAMA Pediatrics. "I shudder to think what the (HIV infection) rate would be if we didn't offer PrEP," said Hosek.

She said the high rate of HIV infections is likely due to poor adherence. While more than 95 percent of the young men had evidence of the preventive medication in their blood during the first 12 weeks of the study, by week 48 only about 15 percent of participants had detectible levels of the drug.

Low adherence to medications is a common problem with adolescents, said Hosek, who suggested that doctors be more connected to their young patients on PrEP, to keep them engaged in the prevention.