FDA Announces Final Guidances Regarding HIV Prevention and Treatment

Recently, the White House announced its plan to eliminate the HIV epidemic in America within 10 years. Efforts will focus on four key strategies: Diagnose, Treat, Protect, and Respond. FDA will continue to encourage the development of HIV prevention and treatment tools to help accomplish this goal. Combatting HIV through the development of more effective treatments is a priority for the FDA.

To aid in HIV prevention and treatment, FDA’s Center for Drug Evaluation and Research (CDER) is announcing the availability of two final guidances, to include:

• Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis
• Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment

The purpose of the final guidance titled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis” is to provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection, known as PrEP medications. Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of PrEP medications.

The purpose of the final guidance titled “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment” is to provide general recommendations on the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients. The guidance addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug product development.

These final guidances aim to develop effective prevention and treatment therapies for those who need them most, including vulnerable and high-risk populations. FDA encourages the development, and ensures the safety and efficacy, of HIV drugs to assist in combating the HIV epidemic in the United States.

Please refer to the guidances for more details.