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New Guidance for Industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment

The Food and Drug Administration recently published new Guidance for Industry Human Immunodeficiency Virus-1 Infection:  Developing Antiretroviral Drugs for Treatment

The new guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA's Center for Drug Evaluation and Research (CDER) for the treatment of human immunodeficiency virus-1 (HIV-1 or HIV) infection. Specifically, this guidance addresses the overall development program and clinical trial designs for antiretroviral drugs to support an indication for the treatment of HIV-1 infection.

This guidance revises the October 2002 guidance for industry Antiretroviral Drugs Using Plasma HIV-RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval.

Significant changes from the 2002 version include:

  1. more details on nonclinical development of antiretroviral drugs
  2. a greater emphasis on recommended trial designs for HIV-1-infected heavily treatment-experienced patients (those with multiple-drug resistant virus and few remaining therapeutic options)
  3. use of a primary endpoint evaluating early virologic changes for studies in heavily treatment-experienced patients; and
  4. use of the traditional approval pathway for initial approval of new antiretrovirals with primary analysis time points dependent on the indication sought.

This guidance does not address the use of antiviral drugs for preventing the transmission of HIV-1 infection, development of therapeutics (without antiviral mechanisms) intended to mitigate or reverse clinical or pathophysiological outcomes of immunologic suppression of HIV-1 infection, and general issues of clinical trial design or statistical analyses for HIV antiretroviral trials.

 

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

Page Last Updated: 09/16/2014
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