FDA Approves Expanded Indication for Truvada to Lower Risk of HIV in Adolescents

This is the first agent indicated for uninfected adolescents at risk of acquiring HIV.

Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents.

The safety and efficacy profile of Truvada for HIV prevention in uninfected adults is well established. Truvada for pre-exposure prophylaxis (PrEP) was first approved for use in adults in 2012.

The addition of the adolescent indication is backed by a single-arm, open-label clinical trial, ATN113, conducted in HIV-negative individuals 15—17 years old by the Adolescent Medicine Trials Network for HIV/Aids.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” lead study investigator, Sybil Hosek, PhD, clinical psychologist, Cook County Health and Hospital System’s Stroger Hospital, said in a statement. “In addition to traditional risk-reduction strategies, health care providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”

In the study, 61 HIV-1 negative young men who have sex with men, 15—17 years old, received Truvada once daily for PrEP. The safety profile in the study is similar to the profile observed in adults. Common adverse reactions that greater than 2% and more frequently observed than in placebo include headache, abdominal pain and weight loss.

Bone mineral density was also monitored and 4 study participants were observed to have a decrease through 48 weeks (3 adolescents had a modest decrease and 1 had a >4% decline in total bone mineral density at week 24).

Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must test HIV negative immediately prior to initiating Truvada for PrEP.

The boxed warning in the product label indicates the risks of post treatment acute exacerbation of hepatitis B and risk of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection.

The safety and efficacy profile of Truvada for PrEP in at-risk adolescents weighing at least 35 kg is supported by both the ATN113 study data and adequate and well-controlled studies of Truvada for PrEP in adults, with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, emtricitabine (Emtriva) and tenofovir disoproxil fumarate (Viread) in both HIV-1 infected adults and pediatric patients.

Truvada is not intended to replace other prevention tools like condoms, but when taken as directed and used in combination with prevention strategies, Truvada for PrEP demonstrates the potential to reduce new HIV infections. Additionally, this should not be used in those with unknown or positive HIV status.

As the efficacy of Truvada for PrEP is significantly correlated with adherence, uninfected individuals should strictly adhere to daily dosing schedules, and HIV-negative status should be confirmed every 3 months during treatment. Some individuals, however, may benefit from additional visits and counseling.