Blood Safety Correspondence

Followup

DATE: August 20, 1997

TO: Interested Parties

FROM: Stephen D. Nightingale, M.D, Executive Secretary
Advisory Committee on Blood Safety and Availability

SUBJECT: Recommendation of Advisory Committee on August 13, 1997 - Followup 8/3/00

The following is the final text of the Recommendation made by the Advisory Committee on Blood Safety and Availability on August 13, 1997. A draft of this Recommendation was approved by all members before it was communicated by Dr. Caplan to the Secretary on August 20, 1997.

Hepatitis C virus (HCV) is a major cause of chronic liver disease which can progress to cirrhosis and liver failure in some infected persons, usually over the course of 20 or more years. An estimated 4 million Americans have been infected with HCV, of whom about 7% may have acquired their infection from blood transfusion, most before 1992. The first donor screening test for HCV infection was introduced in 1990, and an improved second generation screening test was introduced in 1992. Since 1992, the availability of a confirmatory test has made possible the more precise identification of persons who may have been infected with HCV, and it has become apparent that

1. Many HCV-infected persons are unaware of their infection because it may remain silent for many years; and

2. Persons with HCV infection may benefit from treatment or behavioral interventions.

In view of these considerations and the Committee's belief that persons who may have received blood or blood components from an HCV-infectious donor should be notified of the risks associated with transfusion of the blood or blood components they received, we recommend to the Secretary of Health and Human Services the following:

1. A program to educate providers of medical care regarding the importance of identification of persons at risk for HCV infection, including those who received blood or blood components prior to 1992, and the appropriate measures for prevention, counseling, diagnosis, and treatment;

2. An aggressive and sensitive public education campaign to notify and test recipients transfused prior to 1992; and

3. A targeted lookback program triggered by donors detected as HCV-confirmed positive by a second generation screening and supplemental testing (1992 and after). This lookback should extend to January 1987 or 12 months prior to the donor's most recent negative second generation HCV test and should include tracing:

a. Recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a second generation test for HCV infection between 1992 and the present;

b. Recipients of blood or blood components from HCV-confirmed positive donors who had previously tested negative by a first generation test for HCV infection between 1990 and 1992; and

c. Recipients of blood or blood components from HCV-confirmed positive donors who had no prior HCV test.

See at www.fda.gov/cber/guidelines.htm:

Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV). March 20, 1998

Withdrawal of "Guidance to Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV)" - Information Sheet. September 8, 1998

Draft Guidance to 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); Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV) - June 17, 1999.

SDN August 3, 2000

Last Revised: October 27, 2003

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