Dueling HCV Screening Recommendations

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    Editorial Intern, Medpage Today

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened since we published the first 2012 piece on hepatitis C screening recommendations. In a nutshell: There's been controversy and concern.

Until recently, HCV screening was recommended only for those with elevated liver function tests or who were at risk for the virus. Risk factors included a history of injection drug use, blood transfusions before 1992, or long-term hemodialysis.

But in May, the CDC suggested updating its HCV screening recommendations to include a one-time test for all those born from 1945 through 1965 -- the "baby boomers" -- given the high burden of disease in this population. That suggestion, after some public comment, was made final in August.

The U.S. Preventive Services Task Force had a different opinion.

After reviewing a study on the clinical outcomes of HCV screening, by Roger Chou, MD, and colleagues published online in the Annals of Internal Medicine, the task force concluded in November that the evidence did not support the recommendation for the one-time screening.

But, given the higher prevalence of HCV in this population, the group made a weaker recommendation: to consider offering screening for HCV to the baby boomers.

The differences have divided the medical community. While some agree with the task force, many fear missing opportunities for diagnosis and treatment in a population that is largely unaware of the issue.

The CDC's recommendations were made because the agency estimated that between 45% and 85% of adults with chronic HCV do not know they are infected. HCV is often asymptomatic and without risk factors for screening, the infection could go undiagnosed until after the liver has sustained significant damage.

What's more, baby boomers account for 76.5% of all HCV infections in the U.S., even though they make up only 27% of the population, according to CDC data reported online in the Annals of Internal Medicine in August.

In that report, CDC researchers led by Bryce Smith, PhD, suggested that including birth between 1945 and 1965 as a risk factor for screening would detect the infection in those who otherwise would not have been screened.

The CDC estimates that a one-time HCV test for those born from 1945 to 1965 could identify more than 800,000 additional people with the virus, prevent the costly consequences of liver cancer and other chronic liver disease, and save more than 121,000 lives.

On the other hand, Chou and colleagues concluded that there was no direct evidence that screening asymptomatic people for the virus improves clinical outcomes, and there was no published evidence on the long-term effectiveness of treatment.

But there was evidence, they found, to support screening based on the risk factors with small numbers needed to screen of less than 20 to identify one case of HCV.

As a result, the USPSTF issued a draft recommendation – and gave it a "B" grade – urging that all people deemed to be at high risk for HCV be tested. For the baby boomers, the task force draft recommendation (with a "C" grade) said screening would yield only a small net benefit and therefore was not recommended, but the task force stated that clinicians could consider screening those patients.

These draft recommendations were open to public comment until Dec. 24 with the final recommendations to follow after further review.

The Infectious Diseases Society of America (IDSA) responded by saying it was "gravely concerned that an estimated 800,000 baby boomers may not realize they have a potentially deadly virus" if the USPSTF recommendations are adopted.

In that statement, issued by society president David A. Relman, MD, the society urged the task force to revise its final recommendations to align with those of the CDC.

The American Association for the Study of Liver Diseases took a similar tack. President Guadalupe Garcia-Tsao, MD, said on the society's website that if the "recommendation is allowed to stand, many people in the group most likely to be impacted (those born between 1945 and 1965) will not be tested."

She appealed to physicians to give feedback to the task force urging them to amend their recommendation.

A number of public advocacy groups, including the National Viral Hepatitis Roundtable, have also encouraged the public to urge the task force to strengthen its recommendation for the baby-boomer generation, arguing that -- in an age where new drugs show response rates as high as 70% and 80% -- the opportunity to make an impact on the virus is great.

Those who agree with the USPSTF say there is not enough evidence to support one-time screening, arguing that prospective studies are needed to better understand the effects of HCV screening strategies on clinical outcomes before making any changes, because screening can have direct harm including labeling, anxiety, and stigmatization.

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