HCV lookback in the United States: effectiveness of an extended lookback program.

BACKGROUND

In 1998, the FDA recommended look-back for HCV. The recommendation was initially limited, however, to donors who reacted on a multiantigen HCV screening test and to components collected since January 1, 1988. A lookback program was extended to include donors who reacted on the first-generation (single-antigen) HCV screening test and who were positive on a supplemental assay (RIBA-1 or -2) and all components for which transfusion records could be found (back to 1978).

STUDY DESIGN AND METHODS

The yield of the incremental lookback programs was compared to that originally recommended by the FDA by comparing the number of newly identified HCV-positive recipients in each program. The results of lookbacks were reviewed on 385 blood components for which 314 transfusion recipients were identified.

RESULTS

Of the 135 recipients in the FDA program, 70 percent were dead, 28 percent were living and notified, and 2 percent could not be located. In the incremental programs, there were 179 recipients, of whom 80.4 percent were dead, 16.2 percent were living and notified, and 3.4 percent could not be located. Most adult recipients were dead (81%), but the majority of pediatric recipients were alive (57%); 76 percent of tested recipients were HCV seropositive, with no significant difference between programs. One-half of test-positive recipients in each program were newly identified through the lookback program. Seven of the 20 newly identified HCV-positive recipients were found through the incremental programs. The yield, defined as newly detected HCV cases per total number of recipients, was 9.6 percent for the FDA and 3.9 percent for the incremental programs. This difference was significant (p = 0.04).

CONCLUSION

The yield of both programs was limited by the high percentage of recipients who had died. Pediatric recipients were more likely to be living at the time of notification. The incremental program was less efficacious than the FDA program in identifying newly HCV-positive recipients, but one-third of the newly detected HCV cases were identified through the incremental program.