FDA Approves PrEP Drug for Adolescents

The U.S. Food and Drug Administration has expanded access to the only approved HIV-prevention drug, so that adolescents are included.

Adolescents between the ages of 13 and 24 have one of the highest rates of new HIV infection.  But the HIV-prevention pill, which is called PrEP or Pre-Exposure Prophylaxis, was previously only approved for adults over the age of 18 by the FDA, making it harder and potentially more expensive for adolescents to get access to the drug.

The decision comes after a study led by researchers at Cook County Health & Hospitals System (CCHHS), which was published in JAMA Pediatrics online in September, showed that the drug was well-tolerated by 15- to 17-year-old young men who were HIV negative.

The study’s lead author Dr. Sybil Hosek, a clinical psychologist and HIV researcher at Cook County Health & Hospitals System, said, “The approval of oral PrEP for adolescents is a milestone in HIV prevention for youth.  This indication allows prescribers to feel confident in the safety and tolerability of PrEP for sexually-active youth.”

Additionally, Dr. Hosek said financial barriers to PrEP, which is sold as Gilead Sciences’ Truvada, may decrease as adolescents will now be eligible for a variety of patient medication assistance programs to defray costs associated with PrEP use.

Before the FDA expanded the drug to adolescents, a physician could prescribe the drug to someone under 18 off-label—meaning not approved for that age group, dosage, or administration.  But being off-label for PrEP meant that no one under 18 was eligible for Gilead Sciences’ medication assistance program.  One-month supply of Truvada can cost at least $1,600, and in order to be effective, the drug must be taken once a day.

“So there were financial implications for the patient, and providers had to be comfortable with off-label use,” Dr. Hosek noted.

Removing that barrier is important, Dr. Hosek said, because “it is critical as providers that we do all we can to simplify access to HIV prevention products for adolescents and young adults.”

Jim Pickett, Senior Director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, agreed.

“The FDA’s decision to expand PrEP approval to include adolescents is a major victory in our local and national efforts to end the HIV epidemic. Young people don’t wait until they’re 18 to have sex, and HIV doesn’t wait around for 18, either,” said Pickett, who is also the head of the state’s Illinois PrEP Working Group, made up of over 300 individuals representing PrEP clinical delivery, research, education and advocacy.  “PrEP is incredibly effective, and this decision will help it get into the hands of young people who need options for safer sex that go beyond condoms.”

In 2016, young people ages 13 to 24 accounted for 1 out of 5 new HIV diagnoses in the United States, according to the Centers for Disease Control and Prevention (CDC).

If taken daily, trials have shown that Truvada can reduce the risk of HIV transmission by 92 percent for people who are at high risk for becoming infected. 

To get access to PrEP under the new FDA rules, an adolescent must be at risk for HIV.  Factors that would make a teenager or adolescent considered at risk include having a partner who is known to be HIV-infected or having been diagnosed with other sexually transmitted diseases.

For anyone interested in learning more about PrEP, CCHHS has PrEP clinics at four of its facilities: Ruth M. Rothstein CORE Center, Austin Health Center, Dr. Jorge Prieto Health Center and Provident Hospital.

As the largest provider of care to people living with HIV in the Midwest and one of the largest in the country, CCHHS also offers a variety of other services, including confidential counseling and testing for HIV and other sexually-transmitted diseases and HIV/AIDS treatment. Visit CORE Center’s Patient & Visitor Services for more information.