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HCV lookback in the United States: effectiveness of an extended lookback program
D Menozzi1, T Udulutch, A E Llosa
1Stanford Transfusion Service, Stanford Hospitals and Clinics, Stanford Medical School Blood Center, Palo Alto, California 94304, USA.
Insights
The FDA's hepatitis C virus (HCV) lookback program identified more positive recipients than incremental programs, despite high recipient mortality. Pediatric recipients were more likely to be notified.
Area of Science:
- Blood Transfusion Safety
- Hepatitis C Virus (HCV) Screening
- Public Health Recommendations
Background:
- FDA recommended HCV lookback in 1998, initially for donors testing positive on multi-antigen tests since 1988.
- Expanded lookback included donors positive on first-generation tests and supplemental assays (RIBA-1/-2) back to 1978.
- This study evaluates the efficacy of expanded HCV lookback programs.
Purpose of the Study:
- To compare the yield of incremental HCV lookback programs against the original FDA recommendation.
- To determine the number of newly identified HCV-positive transfusion recipients in each program.
- To assess the impact of recipient mortality on lookback program effectiveness.
Main Methods:
- Compared newly identified HCV-positive recipients between the FDA program and incremental lookback programs.
- Reviewed 385 blood components and identified 314 transfusion recipients for analysis.
- Analyzed recipient status (deceased, living, unlocated) and HCV seropositivity.
Main Results:
- The FDA program identified 9.6% new HCV cases, while incremental programs yielded 3.9% (p=0.04).
- Recipient mortality was high (70% FDA, 80.4% incremental), limiting notification success.
- Pediatric recipients had higher survival rates (57%) compared to adults (19%).
Conclusions:
- High recipient mortality significantly limited the yield of both HCV lookback programs.
- Incremental programs identified one-third of newly detected HCV cases, despite lower overall efficacy.
- Pediatric recipients were more likely to be alive for notification, suggesting targeted outreach benefits.
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.