Spring 1999 Volume 4, Number 1		Federal blood safety committee finalizes expansion of hepatitis C targeted lookback plan (Washington) The federal Advisory Committee on Blood Safety and Availability (ACBSA) has finalized its recommendation to contact persons who were potentially exposed to hepatitis C virus through blood transfusions. The final plan, adopted at the Committee's January 1999 meeting, includes the mailing of individual letters to an estimated 500,000 Americans who received blood transfusions from donors later found to be infected with hepatitis C virus (HCV). The Committee's first recommendation, endorsed by DHHS Secretary Donna Shalala in January 1998, called on blood banks and transfusion services to notify about 300,000 recipients of blood from donors who tested positive to second generation screening and supplemental tests (i.e., in 1992 and beyond). But in November 1998, under pressure from a Congressional subcommittee, ACBSA expanded the recommendation to include several hundred thousand additional recipients of blood from donors who later tested positive on first generation anti-HCV screening tests (enzyme immunoassay 1, or EIA-1). Blood banks used first generation tests from May 1990 until July 1992, when the more accurate second-generation test became commercially available. At its meeting in January 1999, the Committee voted to proceed with the expansion but to limit its scope by creating three exceptions: (1) notification will not be triggered if the donor's blood was evaluated with a supplemental HCV antibody test (such as the recombinant immunoblot assay, or RIBA) and the test did not indicate a significant risk of HCV infection; (2) notification will not be triggered if, in the absence of a RIBA test result, the signal to cutoff ratio of the positive EIA-1 test was less than 2.5. The signal to cutoff ratio is a measure of the strength of reactivity of an enzyme immunoassay. Unpublished studies presented at ACBSA's January meeting showed that about 90% of specimens from truly infected donors had EIA-1 signal to cutoff ratios above 2.5; (3) notification will not be triggered if later follow-up testing of the donor was negative. The three exceptions will reduce the number of notifications based on first-generation tests by one-half to two-thirds. More importantly, it will greatly reduce the number of persons who are notified based on false positive tests. At the January meeting, representatives of blood collection agencies pointed out that the latest recommendation will greatly increase the work of notifying blood recipients. Records of signal to cutoff ratios are stored mostly on paper. Under the new recommendation, agencies will have to search thousands of paper lab records stored in cardboard boxes. The cost of this labor-intensive task will be passed along to transfusion recipients. For much of this decade, public health and blood banking authorities have debated whether targeted lookback is a good use of resources. Under the latest plan, of persons who are likely to be notified, 70­80% will have already died. Of the remaining persons who are alive, 50% will already know of their infections. Dr. James P. AuBuchon, a pathologist at Dartmouth Medical School and a member of ACBSA, told the Committee that only about one to two percent of all notifications will be made to recipients newly found to be HCV-seropositive. He based his estimate on the experience of other lookback programs at Stanford University, in Cincinnati and Milwaukee, and in Quebec and Denmark. AuBuchon said that the cost-effectiveness of targeted HCV lookback is about $1-2 million per year of life extended, much higher than the $50,000 per year claimed by most medical and surgical interventions. "That indicates that this is not as effective a use of health care resources as many other interventions," he said. But ACBSA has generally considered cost-effectiveness arguments less persuasive than considerations of individual ethics. The Committee has taken the view that recipients of potentially contaminated blood have a near-absolute right to know of their risk, especially in light of recent improvements in the treatment of chronic HCV infection. The current regimen combining interferon and ribavirin has a response rate of 40%, significantly higher than previous therapy. CDC launches "general notification" effort While blood collection agencies plod through targeted lookback, CDC and several private partners have begun an effort to educate healthcare providers and consumers about the risk of HCV infection from pre-1992 blood transfusions. This effort, sometimes called "general notification," is part of a larger CDC program to educate all providers and consumers about the risks of hepatitis C. The goal is to stimulate testing of persons who were exposed to the virus but who may be unaware of their infection. CDC estimates that about three million Americans are currently infected with HCV. In 1997, CDC and the Hepatitis Foundation International held a national satellite conference on the diagnosis, clinical management, and prevention of hepatitis C. In 1998, the agency published an MMWR supplement on prevention and control (MMWR 1998;47(RR19):1-39) followed by the mailing of audio tapes and educational brochures to 250,000 health professionals. In May of this year, the agency gave a press briefing in Washington to kick off its general notification effort, which will continue with more educational mailings, public service announcements, and advertising in buses and subway cars. The agency also plans cooperative agreements with external partners to develop, disseminate, and evaluate educational materials for people at risk for hepatitis C and the health professionals who serve them. Eventually, CDC envisions a federally funded coordinator for hepatitis C activities in most state health departments. The agency will also take the lead in evaluating both general and targeted lookback programs. CDC's future activities are dependent upon increased federal funding. So far, the agency has not received an appropriation for hepatitis C - all activities have been funded by shifting money (approximately $5 million so far) from other programs within the agency. President Clinton has included $5 million for hepatitis C prevention in his budget for FY 2000, about $15 million less than the agency had requested. The final decision on funding will be made in congressional appropriations committees later this year.