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Multiple layers of safeguards, including donor screening and testing, are used to reduce the risk of transmitting infection through blood transfusion. However, a person may donate blood early in infection, during the period when the viral marker is not detectable by a screening test, but the infectious agent is present in the donor’s blood (the “window period”). For example, if an individual donates blood on a number of occasions and each donation tests nonreactive for antibody to HCV, but the donor returns and tests repeatedly reactive for antibody to HCV at a later date, prior collections from such a donor could be at increased risk for transmitting HCV. In addition, a recipient of a transfusion of blood or blood components collected during the “window period” from a donor who is now repeatedly reactive would not know that he or she might be at increased risk of infection with HCV through the transfusion, unless he or she is notified. Furthermore, untested collections from donors who later were found to be repeatedly reactive when tested for antibodies to HCV since 1990 (when antibody tests for HCV became available) might have been at increased risk for transmitting HCV due to a chronic infection in the donor.

Chronic hepatitis due to HCV is a major health problem in the U.S. The infection is usually clinically silent until the liver is seriously damaged. As a result, infected people usually are unaware of their disease. Although transfusion-transmitted infections account for only a very small proportion of HCV infections, it is possible to identify and “lookback” at prior donations that might have been collected during the “window period.”

This guidance document provides recommendations for complying with 21 CFR 610.47 and
21 CFR 610.481 to (1) blood establishments that collect blood or blood components, including Source Plasma and Source Leukocytes, (2) hospitals, and (3) other consignees. This guidance does not apply to autologous donations, pooled blood components intended solely for further manufacturing into products that are manufactured using validated viral clearance procedures, and blood and blood components that were intended for manufacture into non-injectable products subject to the labeling described in Section VI.

This document supersedes the guidance document of the same title, dated August 2007. The August 2007 document superseded the HCV sections of the Food and Drug Administration (FDA) memorandum of July 19, 1996, entitled “Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I).” The August 2007 guidance document also superseded the September 1998 guidance entitled “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV.” Additionally, the August 2007 guidance finalized FDA’s draft guidance dated June 1999 entitled “Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV).”

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The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV– 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry’’ dated May 2010. The guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV–1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV–1 ribonucleic acid (RNA) and HCV RNA. This guidance also contains recommendations regarding product disposition and donor management based on the results of NAT and serologic testing for markers of HIV–1 and HCV infection on samples, collected at the time of donation, from donors of human blood and blood components. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV–1 test results, HIV–1 p24 antigen test results, and anti-HCV test results that were provided in the FDA  memoranda entitled ‘‘Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV–1) Transmission by Blood and Blood Products,’’ April 23,  1992; ‘‘Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),’’ August 5, 1993; ‘‘Recommendations for Donor Screening with a Licensed Test for HIV–1 Antigen,’’ August 8, 1995.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

• The guidlines are focused on testing new therapies as add-on to current gold standard (Pegalated-interferon alpha 2a and 2b).
• A special concers is the high mutation rate of HepC with the attendant risk of selection of drug resistant variants.
• Initial studies should enrol subjects naive to Standard of Care who do not have advanced fibrosis or HIV co-infection.
• The next study coudl enrole patients with genotype 1 infections who have had a sub-optimal response to standard of care or relapsed.
• Once effect of the add-on therapy have been described later studies can look at specific groups such astumour types, HIV infected patients and mornull  responders to standard treatments

There is also discussion of epidemiology of infection  quoting around 3% of the worlds population has been infected and around 200 million people at risk of developing serious liver morbidity. The natural course of infection is also discussed around 60 to 80% of infected individuals becoming chronic carriers.and after about 20 years 20 to 30% of them have progressed cirrhosis, the five-year risk of hepatic decompensation is around 15 to 20% and that of hepatocellular carcinoma around 10%.

Guidance is provided on the design of exploratory and confirmatory clinical studies considered to be of relevance for the evaluation of direct acting anti-hepatitis C compounds as add on to standard of care in different populations. Guidance is given on subjects characteristics and selection of subjects, guidance is also provided on genotyping, primary endpoints the recommendation in this case sustained virological response defined as undetectable virus RNA six months after completion of therapy. Secondary endpoints are also described, end of treatment response and time to confirmed undetectable viral load, rapid viral response and early viral response, liver histology guidance is also provided.

Guidance goes on to describe the pharmacokinetic studies that are required the pharmacodynamic studies that are required, the guidance then goes on to describe appropriate for one studies in special populations; transplant patients and  studies in children.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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