Regulatory Focus™ > News Articles > New FDA Guidance Clarifies Standards for Submission of HIV-1 Virology Data

New FDA Guidance Clarifies Standards for Submission of HIV-1 Virology Data

Posted 27 February 2014 | By Alexander Gaffney, RAC

A new guidance document released by the US Food and Drug Administration (FDA) intends to clarify the agency's recommended approach for submitting resistance data for drugs intended to treat HIV-1.


FDA periodically releases guidance "Attachments" to other guidance documents, which are intended to apply the recommendations of the guidance to a specific disease.

For example, in October 2013 FDA released its draft guidance Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.

That document was also an attachment to a parent guidance, Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency. Since its release in 2009, FDA has released three guidance attachments for it covering the submission of resistance data for influenza, hepatitis B and hepatitis C treatments.

New HIV Guidance

Now the agency is out with a fourth attachment, entitled Guidance for Submitting HIV-1 Resistance Data. Like the other guidances, it's relatively short (seven pages) but highly focused and technical.

FDA writes in the guidance that sponsors are "encouraged" to use a sample data format when submitting HIV-1 resistance data to the agency.

"One dataset combines patient data, endpoint data, genotypic data, and phenotypic data," FDA explained, noting that these data can be divided in a variety of different ways. "To identify any potential formatting problems as early as possible, all sponsors are encouraged to submit preliminary (or mock) resistance datasets to the DAVP before assembling formal clinical trial resistance datasets."

FDA's guidance goes on to include specific recommendations for how to construct datasets, which formats to use, how to format the data into columns and rows, the use of standardized column headings, as well as criteria for defining virological failures.

Comments on the guidance are due in 60 days.



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