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July, 1998

 

Hepatitis C Virus Lookback

Arell Shapiro, M.D.


Introduction

Hepatitis C has infected nearly 4 million Americans and is the leading reason for liver transplantation in the United States. Transmission is primarily by the parenteral route, but sporadic and community acquired cases do occur. Parenteral sources of infection include injection drug use, needle-stick accidents, and transfusions of blood or blood products. Since 1990 and the introduction of tests for anti-HCV, new cases of post-transfusion hepatitis C have virtually disappeared. In a 1992 surveillance study performed by the CDC, blood transfusion was reported as a risk factor in only 4.3% of acute non-A and non-B hepatitis cases2. As a public health measure to identify individuals infected with hepatitis C virus (HCV), the Food and Drug Administration (FDA) provided information to the public regarding the need to identify and notify patients who have received blood from donors who later showed laboratory evidence of Hepatitis C infection. The March 1998 FDA guidelines document3 provides recommendations for Blood Collection facilities and Transfusion Services: 1) to identify donors who now test, or in the past have tested confirmed positive for Anti-HCV, 2) to determine who were the recipients of their previous donations, 3) to retrieve non-transfused products and 4) delineates the requirements for notification of the recipients.

 

Background

There are currently similar Lookback programs for recipients of blood from donors who have evidence of infection for HIV, HTLV and for donors who test screen positive for HBV. Because of recent improvements in the treatment and management of HCV infections, and in the specificity of tests for HCV, Lookback has been recommended at this time.

 

Obligations of the Blood Collection Facility

For donors who currently test repeatedly reactive for anti-HCV by the EIA screening test (used since 3/92), the FDA guidance defines acceptable algorithms for further supplemental testing. If the donor is confirmed positive, the blood collection facility is obligated to identify previously distributed units collected from the same donor, dating back 10 years prior to the anti-HCV repeatedly reactive donation. If the donor had previously tested negative by the EIA screening test, only those units from the 12 months before that negative result, need to be identified. The blood collection facility then has 30 calendar days to notify the hospitals of such identified units and that these previously distributed units are potentially contaminated with HCV.

For donors who previously tested repeatedly reactive for anti-HCV by the EIA screening test (used since 3/92), this again defines acceptable algorithms for further supplemental testing. If the donor is confirmed positive or, indeterminate (without further testing), the blood collection facility is obligated to identify previously distributed units collected from the same donor, dating back to January 1, 1988 or the 12 months prior to the donor's most recent negative EIA screening test for anti-HCV. For these units, the blood collection facility must begin notification by September 1998 and complete notification to the hospitals of such identified units within 2 years.

 

Obligations of the Transfusion Facility

The transfusion facility is required to establish policies and procedures for recipient notification and documentation in accordance with FDA guideline documents and any other state and local laws. Once notified by the blood collection facility of having received an HCV Lookback unit, the Transfusion Facility is responsible for determining the final status of that unit. If transfused, the Transfusion Facility must notify the physician of the patient who received that unit (three attempts is specified). The physician is also asked to promptly notify that patient. Furthermore, the physician must document in the patient's chart either notification, or the attempt to notify the recipient of the risk, and the need for HCV testing and counseling. If the patient's physician either refuses, is unavailable, or is unable to notify the recipient, it becomes the Transfusion Service /Hospital’s responsibility to notify the patient. Integral to notification is an explanation to the patient of the need for HCV testing, counseling, and information on programs and places where testing and counseling may be obtained. Sufficient information should be provided to the patient to enable an informed decision about testing for HCV. The Transfusion Service has 8 weeks to perform recipient tracing on "currently" tested donors, and up to one year on notifications about units that were from donors who had tested HCV positive in the past. The notification letter to the hospital will indicate the appropriate time frame.  The U.S. Public Health Service has plans to provide a comprehensive set of patient educational materials to use as part of patient notification and counseling.

 

WHAT IS NEXT?

Your transfusion service will begin receiving HCV Lookback notification letters in August.   Hospitals should be developing policies and procedures to comply with Lookback requirements.

 

Summary

As a result of the recent improvements in the treatment and understanding of HCV infection, the Surgeon General and FDA have provided guidance on identifying patients who may have been exposed to HCV through transfusion. Since only a small portion of individuals infected with HCV are infected by transfusion, the HCV Lookback effort is part of a comprehensive public health plan to identify all individuals infected with HCV, to offer testing, treatment, and counseling.

 

References

NIH Consensus Statement: Management of Hepatitis C., Volume 15, Number 3, National Institutes of Health, March 24-26, 1997.  May be ordered by calling toll free: 1-888-NIH-CONSENSUS (888-644-2667).

CDC: Hepatitis Surveillance Report No. 55, p. 1., Centers for Disease Control and Prevention, Atlanta, 1994.

"Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for Antibody to Hepatitis C Virus (Anti-HCV), U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), March 1998.


Copyright 1998, Institute For Transfusion Medicine


For questions regarding the HCV Lookback Program please contact the Blood Center Physicians at (CBB) (412) 209-7320 or LifeSource at (847)803-7825.

Copies of the Transfusion Medicine Update can be obtained by calling Deborah Small at (412)209-7320; or by e-mail: dsmall@itxm.org

Visit our web page for information and previous issues of the TMU newsletter at www.itxm.org