This week, FDA announced the availability of a final guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.” The guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA Center for Drug Evaluation and Research for the treatment of HIV infection.

This guidance assists sponsors in all phases of drug development including nonclinical development, early phases of clinical development, phase 3 protocol designs, and endpoints for the treatment of HIV. This guidance specifically addresses HIV drug development in populations in need of additional HIV drugs for maintaining HIV suppression including trial designs for heavily treatment-experienced patients (multiple-drug-resistant patients with few remaining options); use of early virologic assessments as primary endpoints in trials evaluating antiretroviral drugs in heavily treatment-experienced patients; recommended trial durations based on medical need; and risk-benefit in the targeted patient population.

It does not address the use of antiretroviral drugs for preventing transmission of HIV-1 infection.