Pre-Exposure Prophylaxis (PrEP)
FDA Approves Truvada PrEP for Adolescents
The U.S. Food and Drug Administration (FDA) has approved changes to the indications for the fixed-dose combination pill Truvada (emtricitabine and tenofovir disoproxil fumarate) that now allow Truvada to be used as pre-exposure prophylaxis (PrEP) for adolescents weighing at least 35 kg (about 77 pounds) who are at risk for HIV infection. Truvada was first approved for HIV PrEP in at-risk adults in 2012. According to drug-maker Gilead, FDA’s decision to allow the use of Truvada-based PrEP in adolescents is based on the findings of study ATN113, which examined the use of Truvada in HIV-negative adolescents 15 to 17 years old.
“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” noted study lead investigator Sybil Hosek of the Cook County Health and Hospital System's Stroger Hospital in Chicago. “In addition to traditional risk-reduction strategies, healthcare providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.” CDC surveillance data indicate that adolescents and young adults 13 to 24 years old comprised 21% of all new HIV infections in the U.S. during 2016, and that 81% of those infections were among young men who have sex with men.
“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose of the advocacy organization NMAC. “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.”
PrEP Use and Access in the U.S. Military
HIV infection is a substantial health concern for U.S. military service members stationed throughout the world. Each year, about 350 new HIV infections are diagnosed among military service members, and the majority of those infections acquired within the United States. HIV infections in the U.S. military mirror those in the U.S. civilian population, with the highest rates of new diagnoses among men and Blacks or African Americans. Blacks are disproportionally affected, and most new diagnoses occur among MSM. To examine the use of PrEP among military service members, researchers from the Walter Reed National Military Medical Center and elsewhere examined military health system and service records and surveyed military health care providers to assess their HIV PrEP knowledge and attitudes.
Among 769 service members prescribed PrEP during the period from February 1, 2014 through June 10, 2016, 87% were MSM. In addition, 60% of those receiving PrEP obtained prescriptions from an infectious disease provider, 19% were Black men, and 42% were more than 28 years old. Nearly half (49%) of surveyed military health care providers self-rated their PrEP knowledge as poor, and only 29% reported ever having prescribed PrEP.
“Despite the universal access to care afforded to service members by the military health care system, there is a recognized need to improve and expand access to PrEP for those patients at highest risk for HIV infection. Currently, the availability of PrEP services is heterogeneous, based on the individual patient’s geographic location,” the report authors note. “New DoD [Department of Defense] policy is being developed to address identified gaps through initiatives to improve health care provider education and so ensure universal access to PrEP at the primary care level, and to standardize pharmacy and laboratory service delivery at all military treatment facilities.”