Smarter Decisions,
Better Care

UpToDate synthesizes the most recent medical information into evidence-based practical recommendations clinicians trust to make the right point of care decisions.

  • Rigorous editorial process: Evidence-based treatment recommendations
  • World-Renowned physician authors: over 5,100 physician authors around the globe
  • Innovative technology: integrates into the workflow; access from EMRs

For more information, click below.


Subscribers log in here


Hepatitis C and transfusion: A 'lookback' primer

INTRODUCTION

In 2000, primary care physicians, surgeons, and other medical specialists began receiving notification from hospital blood banks that a patient they had previously treated or were currently treating may have been exposed to hepatitis C virus (HCV) as a result of blood transfusion. This United States Public Health Service (USPHS)-mandated notification, developed in conjunction with the Food and Drug Administration (FDA), came as a surprise to practitioners, who were faced with the task of locating patients, informing them about the possible exposure, providing appropriate testing and counseling, and possibly evaluating or treating those who were found to be HCV positive, in a process referred to as "lookback."

Lookback encompasses the activities associated with tracing and notifying patients who may have received blood or blood components infected with transfusion-transmissible pathogens (TTP) from a previously infectious disease test-negative, but now positive, donor. Lookback is required for other TTPs such as HIV, but hepatitis C was unique because of the Federal government's highly prescriptive requirements for patient notification, which involved community physicians who cared for or were caring for these patients.

Recognizing that involvement in an HCV lookback process is an infrequent and possibly new experience for many practitioners, the purpose of this discussion is to review the rationale for HCV lookback, define lookback, outline regulatory expectations, and provide physicians with resources that can make the patient notification process less onerous.

GOVERNMENT RESPONSE TO THE HCV EPIDEMIC AND THE HISTORY OF HCV LOOKBACK

It is estimated that up to four million Americans are infected with HCV [1]. The majority of these individuals have been exposed to the virus through the sharing of needles used in injection drug use, and a smaller percentage through sexual contact, perinatally, or occupationally. Approximately one-third of infected people do not identifiably fall into these risk categories, but have a history of behavior, such as multiple sex partners, that places them at higher risk [2,3]. (See "Epidemiology and transmission of hepatitis C virus infection".)

Transfusion transmission once accounted for 0.5 to 10 percent of HCV infections, but due to the use of increasingly sensitive blood donor screening assays, including nucleic acid testing (NAT), the HCV transfusion transmission risk is now about 1 per 2 million units. However, concerns remain within the FDA and the US Public Health Service that there is a population of individuals who may have been exposed to HCV through transfusions in the past.

             

Subscribers log in here

To continue reading this article you must have access through your hospital or your group practice, log in to your personal subscription, or purchase a personal subscription. For more information, click below.
Literature review current through: Apr 2013. | This topic last updated: Mar 1, 2012.
The content on the UpToDate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. The use of this website is governed by the UpToDate Terms of Use ©2013 UpToDate, Inc.
References
Top
  1. www.cdc.gov/hepatitis/HCV/index.htm (Accessed on March 24, 2010).
  2. Alter MJ. Epidemiology of hepatitis C. Hepatology 1997; 26:62S.
  3. Alter MJ, Hadler SC, Judson FN, et al. Risk factors for acute non-A, non-B hepatitis in the United States and association with hepatitis C virus infection. JAMA 1990; 264:2231.
  4. Alter MJ. Public Health Service, Centers for Disease Control and Prevention. August 22, 1997 Memorandum.
  5. Guidance for Industry. Current Good Manufacturing Practice of 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. US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research Center, September, 1998.
  6. Busch MP, Glynn SA, Stramer SL, et al. A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 2005; 45:254.
  7. Dodd RY, Notari EP 4th, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion 2002; 42:975.
  8. Wang B, Schreiber GB, Glynn SA, et al. Does prevalence of transfusion-transmissible viral infection reflect corresponding incidence in United States blood donors? Transfusion 2005; 45:1089.
  9. Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Products at Increased Risk of Transmitting Hepatitis C Infection; Final Rule. Federal Register, 72(160), August 24, 2007.
  10. Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med 1999; 341:556.
  11. Wall A, Lau W, Lewis J, et al. Hepatitis C virus (HCV) targeted lookback program. Transfusion 1997; 37:98S.
  12. Christensen PB, Groenbaek K, Krarup HB. Transfusion-acquired hepatitis C: the Danish lookback experience. The Danish HCV [hepatitis C virus] Lookback Group. Transfusion 1999; 39:188.
  13. Vrielink H, van der Poel CL, Reesink HW, et al. Look-back study of infectivity of anti-HCV ELISA-positive blood components. Lancet 1995; 345:95.
  14. Lau W, Bischochio M, Poon A. Hepatitis C targeted lookback in pediatric patients. Transfusion 1997; 37:99S.
  15. Goldman M, Juodvalkis S, Gill P, Spurll G. Hepatitis C lookback. Transfus Med Rev 1998; 12:84.
  16. Tong MJ, el-Farra NS, Reikes AR, Co RL. Clinical outcomes after transfusion-associated hepatitis C. N Engl J Med 1995; 332:1463.
  17. Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet 1997; 349:825.
  18. Gumber SC, Chopra S. Hepatitis C: a multifaceted disease. Review of extrahepatic manifestations. Ann Intern Med 1995; 123:615.
  19. Koff RS, Dienstag JL. Extrahepatic manifestations of hepatitis C and the association with alcoholic liver disease. Semin Liver Dis 1995; 15:101.
  20. Seeff LB, Buskell-Bales Z, Wright EC, et al. Long-term mortality after transfusion-associated non-A, non-B hepatitis. The National Heart, Lung, and Blood Institute Study Group. N Engl J Med 1992; 327:1906.
  21. Di Bisceglie AM, Order SE, Klein JL, et al. The role of chronic viral hepatitis in hepatocellular carcinoma in the United States. Am J Gastroenterol 1991; 86:335.
  22. Di Bisceglie AM, Goodman ZD, Ishak KG, et al. Long-term clinical and histopathological follow-up of chronic posttransfusion hepatitis. Hepatology 1991; 14:969.
  23. Everhart JE, Di Bisceglie AM, Murray LM, et al. Risk for non-A, non-B (type C) hepatitis through sexual or household contact with chronic carriers. Ann Intern Med 1990; 112:544.
  24. Dienstag JL. Sexual and perinatal transmission of hepatitis C. Hepatology 1997; 26:66S.
  25. Alter MJ, Coleman PJ, Alexander WJ, et al. Importance of heterosexual activity in the transmission of hepatitis B and non-A, non-B hepatitis. JAMA 1989; 262:1201.
  26. Ohto H, Terazawa S, Sasaki N, et al. Transmission of hepatitis C virus from mothers to infants. The Vertical Transmission of Hepatitis C Virus Collaborative Study Group. N Engl J Med 1994; 330:744.
  27. Resti M, Azzari C, Mannelli F, et al. Mother to child transmission of hepatitis C virus: prospective study of risk factors and timing of infection in children born to women seronegative for HIV-1. Tuscany Study Group on Hepatitis C Virus Infection. BMJ 1998; 317:437.
  28. Wiley TE, McCarthy M, Breidi L, et al. Impact of alcohol on the histological and clinical progression of hepatitis C infection. Hepatology 1998; 28:805.
  29. Menozzi D, Udulutch T, Llosa AE, Galel SA. HCV lookback in the United States: effectiveness of an extended lookback program. Transfusion 2000; 40:1393.
  30. Bowker SL, Smith LJ, Rosychuk RJ, Preiksaitis JK. A review of general hepatitis C virus lookbacks in Canada. Vox Sang 2004; 86:21.
  31. Goldman M, Patterson L, Long A. Recent Canadian experience with targeted hepatitis C virus lookback. Transfusion 2006; 46:690.
  32. Williams JL, Cagle HH, Christensen CJ, et al. Results of a hepatitis C general transfusion lookback program for patients who received blood products before July 1992. Transfusion 2005; 45:1020.
  33. Luban NL, Colvin CA, Mohan P, Alter HJ. The epidemiology of transfusion-associated hepatitis C in a children's hospital. Transfusion 2007; 47:615.
  34. Whitlock M, Lord S, Buxton JA, et al. Evaluating the impact of public health notification of suspected transfusion-transmissible hepatitis C virus infection and effectiveness of lookback and traceback investigations by Canadian Blood Services in British Columbia, Canada, August 2002 through February 2005. Transfusion 2007; 47:1534.