Correspondence
Transfusion-Transmitted Viral Infections
N Engl J Med 1996; 335:1609-1610November 21, 1996
- Article
To the Editor:
Schreiber et al. (June 27 issue)1 estimate the risk of transmitting the human immunodeficiency virus (HIV), the human T-cell lymphotropic virus (HTLV), the hepatitis C virus (HCV), or the hepatitis B virus (HBV) from units of screened blood donated during the window period after recent infection. They conclude that the risk in the United States was very small during the three-year period of their study (1991–1993). We applied the same model of the incidence of seroconversion to data from the centers where 30 percent of all blood donations in France are collected.
We calculated incidence rates in the same manner as Schreiber et al. and adjusted our analysis of HBV infection to account for transient antigenemia. The only difference between our study and theirs concerned the length of the window periods for HCV and HBV infection. In the case of HCV, because since 1993 blood donations in France have been screened with third-generation assays, the window period corresponding to those assays was used.2 In the case of HBV, the window period used was the mean of those in two studies.3,4
We estimated the risk of infection in two three-year periods, 1992 through 1994 and 1993 through 1995. The results in the two periods were very similar. Table 1Table 1
Risk of Transfusion-Transmitted Viral Infection Associated with Window-Period Donations, 1993–1995. shows results for 1993–1995. For HIV, the estimated risks of giving blood during the window period were similar in the two countries (1 in 493,000 donations in the United States and 1 in 571,000 in France) despite the difference in the periods studied. For HCV and HBV, the rates in France were about half those in the United States. These differences can be explained in part by the differences in the length of the window period with the third-generation assays; in particular, the period in France was shorter for HCV (66 days, vs. 82 days in the United States).5 The highest transfusion-associated risks, in France as in the United States, were for HBV and HCV, which accounted for 87 percent of the aggregate risk of 1 in 67,000. HBV represented the principal risk despite the use of the vaccine, which should be encouraged among blood donors.The most important difference between the United States and France concerned the residual risk of HTLV infection (1.56 vs. 0.17 per million donations). This difference was due to the low prevalence and incidence of HTLV type I infection in France and to the great rarity of HTLV type II infection there.6 Donations during the window period are now the chief source of the risk of transfusion-transmitted viral infections. This risk has been reduced considerably and is now very small.
6 ReferencesAnne-Marie Couroucé, Ph.D.
Institut National de la Transfusion Sanguine, 75729 Paris Cedex 15, FranceJosiane Pillonel, Ph.D.
Réseau National de Santé Publique, 94000 St. Maurice, Francefor the Retrovirus and Viral Hepatitis Working Groups of the French Society of Blood Transfusion
1
Schreiber GB ,Busch MP ,Kleinman SH ,Korelitz JJ . The risk of transfusion-transmitted viral infections. N Engl J Med 1996;334:1685-1690
Full Text | Web of Science | Medline2
Barrera JM ,Francis B ,Ercilla G , et al. Improved detection of anti-HCV in post-transfusion hepatitis by a third-generation ELISA. Vox Sang 1995;68:15-18
CrossRef | Web of Science | Medline3
Mimms LT ,Mosley JW ,Hollinger FB , et al. Effect of concurrent acute infection with hepatitis C virus on acute hepatitis B virus infection. BMJ 1993;307:1095-1097
CrossRef | Web of Science | Medline4
Fong TL ,Di Bisceglie AM ,Biswas R , et al. High levels of viral replication during acute hepatitis B infection predict progression to chronicity. J Med Virol 1994;43:155-158
CrossRef | Web of Science | Medline5
Courouce AM ,Le Marrec N ,Girault A ,Ducamp S ,Simon N . Anti-hepatitis C virus (anti-HCV) seroconversion in patients undergoing hemodialysis: comparison of second- and third-generation anti-HCV assays. Transfusion 1994;34:790-795
CrossRef | Web of Science | Medline6
Pillonel J ,Courouce AM ,Elghouzzi MH ,Piquet Y ,Lemaire JM . Seroconversions to HTLV in blood donors. Vox Sang 1996;70:47-47
CrossRef | Web of Science | Medline
Author/Editor Response
The authors reply:
To the Editor: The French investigators' use of our incidence model for determining the residual risk of transfusion-transmitted infection shows the general applicability of this approach. The sole requirement is that a national or regional blood-collection system have reliable data on the incidence of new viral infections among blood donors. Given the heterogeneity of populations of donors with respect to demographic variables and the incidence of viral infections, it is important to have a method that will generate reliable estimates of risk to guide transfusion practices in different regions. Ongoing efforts to estimate window periods better will make these risk calculations more precise.
The findings from the French blood centers are strikingly similar to our recent estimates from centers participating in the Retrovirus Epidemiology Donor Study. As Couroucé and Pillonel suggest, there appears to be an important difference between France and the United States in the risk of HTLV — a difference attributable primarily to endemic HTLV-II infection in the United States. Of the nine seroconversions observed in our study, three involved HTLV-I, five involved HTLV-II, and one involved a type of HTLV that could not be identified. The residual risk of HTLV-I was 0.52 per million units as compared with the French rate of 0.17 per million, with considerable overlap between studies in the ranges of the risk estimates. HTLV-II infection, on the other hand, appears to be far more common in the United States (residual risk, 0.87 per million units) than in France.
Third-generation assays for HCV antibody and HIV p24 antigen have recently become available in the United States, which will further shorten the window periods of nondetectable transmissible infection for each of these viruses. Using the 66-day window period estimated for the third-generation HCV assay employed by Couroucé and Pillonel, we project that the residual risk of HCV in the United States has dropped 20 percent, to 7.9 per million units. This represents a remarkable improvement from the risk of 300 per million units with the first-generation HCV test first used in the United States in 1990.1 Similarly, we estimate that the recent introduction of HIV-antigen testing has decreased the risk of HIV by 27 percent, from 2.03 to 1.48 per million units.
The decreasing residual risks over the past decade are a function of several major factors: improvements in laboratory testing, vigilant screening of donors at the time of donation, and efforts by blood centers to recruit low-risk donors who give blood more than once. The low risks we reported and those reported by Couroucé and Pillonel demonstrate the success of these strategies.
1 ReferencesGeorge B. Schreiber, D.Sc.
Westat, Inc., Rockville, MD 20850Michael P. Busch, M.D., Ph.D.
Irwin Memorial Blood Centers and the University of California, San Francisco, CA 94118Steven H. Kleinman, M.D.
UCLA Medical Center, Los Angeles, CA 900241
Donahue JG ,Munoz A ,Ness PM , et al. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med 1992;327:369-373
Full Text | Web of Science | Medline
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