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Post Info TOPIC: FDA Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs


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FDA Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs
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Draft Guidance for Industry on HCV Virus Infection: Developing Direct-Acting Antiviral Drugs

The Food and Drug Administration (FDA) has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C from the initial pre-investigational new drug application through the new drug application and postmarketing stages.

This guidance revises the draft guidance for industry entitled "Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment" issued in September 2010. Significant changes in this revision include:

  • Details on phase 2 and phase 3 trial design options for the evaluation of interferon (IFN)-free and IFN-containing regimens in treatment-naļve and treatment-experienced populations, including DAA-experienced populations.

  • Revised primary endpoint to sustained virologic response at 12 weeks post-treatment cessation.

  • Greater emphasis on DAA drug development in special populations including trial design options for human immunodeficiency virus/hepatitis C virus co-infected patients, patients with decompensated cirrhosis, and patients pre- or post-liver transplant.

  • More details on clinical virology considerations for DAA drugs.

See full article...

http://hcvadvocate.blogspot.ca/2013/10/draft-guidance-for-industry-on-chronic.html



__________________

Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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