HIV PrEP Option Adds Truvada Once-Daily

A once-daily oral dose of Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) has been approved by the Food and Drug Administration to reduce the risk of sexually acquired HIV-1, in at-risk adolescents.

The pre-exposure prophylaxis (PrEP) strategy is a well established HIV prevention methodology.

Truvada for PrEP was first approved by the FDA for use in adults in 2012.

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

Truvada should not be used in individuals with unknown or positive HIV status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada.

Gilead Sciences, Inc. said the addition of the adolescent indication is based on the ATN113 study in HIV-negative individuals 15 to 17 years of age.

“In addition to the ATN113 study data, the safety and efficacy profile of Truvada for PrEP in at-risk adolescents weighing at least 35 kg is also supported by 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, Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate), in HIV-1 infected adults and pediatric subjects.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” said Sybil Hosek, Ph.D., Clinical Psychologist at the Cook County Health and Hospital System's Stroger Hospital, Chicago, and lead investigator of the study. 

In Study ATN113, 67 HIV-1 negative YMSM age 15 to 17 all received Truvada once daily for PrEP. The Truvada safety profile in the study was similar to the safety profile that has been observed in adult trials of Truvada for PrEP, in which the most common side effects were headache, abdominal pain, and weight loss. 

Bone mineral density (BMD) was also monitored and four study participants had a decrease in BMD through 48 weeks (three adolescents had a modest decrease and one had a >4 percent decline in total BMD at Week 24).

Matthew Rose, Policy and Advocacy Manager at NMAC, said “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it, particularly among communities disproportionately impacted by the disease, including young Black and Latino men in the United States.”

In the United States, adolescents and young adults 13 to 24 years of age comprised 21 percent of all new infections in 2016, according to the U.S. Centers for Disease Control and Prevention, and 81 percent of those infections were among young men who have sex with men.

As the efficacy of Truvada for PrEP is strongly correlated with adherence, uninfected individuals should be counseled to strictly adhere to the daily dosing schedule, and HIV-negative status should be confirmed every three months during treatment.

Some individuals, such as adolescents, may benefit from more frequent visits and counseling.

Truvada does not prevent other sexually transmitted infections or cure HIV infection or AIDS.