FDA In Brief: FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in pediatric patients, as part of efforts to end HIV infection

March 19, 2019

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"HIV is responsible for one of the most destructive pandemics in human history, and efforts to combat the disease through steps that advance the development of effective treatments, and broaden access to these medicines, has been one of the agency’s highest priorities for decades," said FDA Commissioner Scott Gottlieb, M.D. "Over the years, the FDA’s support of a broad-based, multi-disciplinary regulatory review program has played a significant role in the development of therapeutic agents for HIV, including the development of twenty-nine FDA-approved antiretroviral individual drug products to treat HIV infection. This progress has been the result of a broad collaboration among patients, scientists, government organizations, regulators, and many others to prioritize this work and our shared goal of ending this pandemic. Part of the FDA's commitment includes a focus on efforts to advance the development of life-saving treatments to vulnerable or at-risk populations. This includes about 1.8 million children younger than 15 years old living with HIV worldwide, who are often in the greatest need of help. And only about half of those children have received appropriate treatment for their infection. To advance our contribution to these goals, today we’re issuing two final guidances to aid in the development of HIV medications—one for HIV prevention and one for HIV treatment. Although aimed at different populations affected by HIV, the end goal of these guidances is the same. We must continue the work of ensuring the safety and effectiveness of drugs used in HIV treatment and prevention so that we can attain the healthier future and set as a goal the eradication of this disease."

The U.S. Food and Drug Administration today 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.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.