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FDA is announcing the availability of a draft guidance for industry entitled ''Role of HIV Drug Resistance Testing in Antiretroviral Drug Development.'' This draft guidance addresses the role of HIV resistance testing during antiretroviral drug development and postmarketing. The draft guidance is based on the following: (1) A 2-day session of the Antiviral Drug Product advisory committee convened November 2 and 3, 1999, to address issues relating to HIV resistance testing; (2) the DAVDP's experience with reviewing resistance data for antiretroviral drugs; and (3) input from pharmaceutical sponsors and the HIV community.

The draft guidance discusses the nonclinical studies (mechanism of action; antiviral activity in vitro; cytotoxicity/therapeutic index; and the effects of serum protein binding on antiviral activity) we recommend be completed prior to the initiation of phase 1 clinical studies in HIV-infected patients. In addition, the draft guidance addresses the use of resistance testing in the

clinical phases of drug development and recommends the type of information that should be collected and the types of analyses that should be conducted to characterize an antiretroviral's resistance profile.

This draft guidance also reviews the role of resistance testing in initial activity and dose-finding, for study enrollment criteria, for background regimen selection, and to establish an indication. Included in the draft guidance are two appendices: (1) A

template for submitting HIV resistance data and (2) information on the genetic threshold for resistance.

The draft guidance represents the agency's current thinking on the role of HIV resistance testing in antiretroviral drug development. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

You can read the draft guidance document on the FDA website at

http://www.fda.gov/cder/guidance/5879dft.htm  (HTML version)
http://www.fda.gov/cder/guidance/5879dft.pdf   (pdf version) or at
http://www.fda.gov/cder/guidance/5879dft.doc  (Word version)

FDA encourages comments regarding this draft document.  Comments and suggestions should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (November 26, 2004).  Please submit comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD  20852. 

All comments should be identified with the Docket No. 2004D-0484. 

Richard Klein
Office of Special Health Issues 
Food and Drug Administration                          

 

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

 

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