Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis March 2019

GUIDANCE DOCUMENT

• Docket Number: FDA-2018-D-1918
• Issued by: Center for Drug Evaluation and Research

The purpose of this guidance 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, regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA) for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of systemic drug products for the prevention of HIV-1 infection. Investigational drug products for further development as pre-exposure prophylaxis (PrEP) can include the following: (1) an oral drug product approved for the treatment of HIV-1 infection that is subsequently developed as oral PrEP; (2) an oral drug product approved for the treatment of HIV-1 infection that is reformulated as a long-acting drug product or other delivery system for PrEP; or (3) a new investigational drug product.

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