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AASLD 2014: Screening Baby Boomers for HCV More Effective than Risk-based Testing

Age cohort screening for hepatitis C virus (HCV) identified 4 times as many people as prevailing screening protocols and can be "feasibly implemented," according to research presented at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting last month in Boston.

Anthony Yartel from the Centers for Disease Control and Prevention (CDC) presented findings from randomized, controlled trials comparing prevailing or "usual" HCV screening protocols based on risk factors versus testing people born between 1945 and 1965. Studies have shown that Baby Boomers have a substantially higher hepatitis C prevalence than the general U.S. adult population, accounting for some 80% of all cases. The CDC and U.S. Preventive Services Task Force therefore recommend that everyone in this age group should undergo HCV testing regardless of risk.

This analysis, conducted between December 2012 and March 2014, included 3 randomized trials using data from 3 large primary healthcare centers. Participants were people in the 1945-1965 birth cohort who had no documentation of prior HCV infection or testing.

Trial #1 included 3000 patients offered birth cohort screening (the intervention) and 6000 offered the usual care at 9 clinics. In the intervention group a random sample of patients received repeated mailings inviting them to go to the nearest lab for testing. In Trial #2, more than 13,000 patients in 10 clusters were randomized to either the intervention or usual care; here, medical assistants or clinicians were alerted to offer HCV testing to people in the targeted age group. In Trial #3, participants in the intervention group were offered HCV testing by a recruiter in the clinic waiting room.

Participants were about evenly divided among people born during 1945-1949, 1950-1954, 1955-1959, and 1960-1965. More than half were women. In Trial #1, half were white, nearly one-third were black, and 84% had private insurance. Trial #2 included more whites (about 65%), fewer blacks (about 8%), and fewer people with private insurance (65%).

In Trial #1, the risk ratio of identifying patients with HCV was 8.0, or an 8-fold greater likelihood than the usual care. In Trial #2, the intervention identified about 3 times as many patients with HCV as the usual care (risk ratio 3.2). In this trial, 31% of people in the birth cohort group were tested compared with only 4% in the usual care group.

In a meta-analysis of risk ratios across 2 sites in Trials #1 and #2, the pooled probability of identifying HCV positive patients was 4 times higher using birth cohort screening compared with usual care. (Data from Trial #3 were being re-analyzed and not included in the meta-analysis.)

"Overall, HCV testing of persons born during 1945-1965 without prior ascertainment of HCV risk was 4 times more effective in identifying persons with previous or current HCV infection compared with usual care," the researchers concluded. "Birth cohort testing policy can be feasibly implemented and be effective."

However, speaking from the audience, Jay Hoofnagle from the National Institutes of Health noted that these trials only found about 1% of patients in the birth cohort to be infected. "Why test billions of people rather than more focused risk-based testing?" he asked, expressing concern about the cost.

Yartel said that another component of this research will include a cost-benefit analysis.

12/9/14

Reference

BD Smith, AK Yartel, KA Brown, et al. Effectiveness of Hepatitis C Virus (HCV) Testing for Persons Born during 1945-1965 -- Summary Results from Three Randomized Controlled Trials. American Association for the Study of Liver Diseases (AASLD) Liver Meeting. Boston, November 7-12, 2014. Abstract 194.

Other Source

AASLD. Does Screening Baby Boomers for Hepatitis C Work? Press release. November 11, 2014.