Washington, DC - The U.S. Food and Drug Administration issued two final guidances for industry to help product sponsors understand the FDA’s thinking about preventive treatments for HIV as well as treatments for pediatric patients with HIV.

The first guidance, “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis,” addresses the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection. The guidance provides sponsors with nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, including small molecules and monoclonal antibodies. This guidance finalizes the draft guidance issued in June 2018.

The second guidance issued today titled “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment” provides general recommendations on the development of antiretroviral drug products for the treatment of HIV infection in pediatric patients. It addresses when to initiate pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug development. This guidance finalizes draft guidance issued in May 2018.

In Feb. 2019 a new initiative, Ending the HIV Epidemic: A Plan for America, was announced by the U.S. Department of Health and Human Services, a once-in-a-generation opportunity to eliminate new HIV infections in our nation. This initiative will provide the hardest hit communities with the additional expertise, technology and resources required to address the HIV epidemic in their communities, focusing on certain geographic hotspots. The aim is to reduce new infections by 75 percent in the next five years and by 90 percent in the next ten years, averting more than 250,000 HIV infections in that span.