CDC Poised to Advise Screening Baby Boomers for HCV

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Universal Screening for Hepatitis C?

Improved, but very expensive, treatments for hepatitis C may result in a broadening of the current HCV screening recommendations, necessitating that patients of a certain age be screened for the viral infection. A recent study, funded by the Centers for Disease Control and Prevention, demonstrates the cost effectiveness of screening baby boomers for HCV (Ann. Intern. Med. 2011 Nov. 4 [epub ahead of print]).

Hepatitis C has a prevalence of about 3%, with middle aged African Americans having up to a 10% infection rate. In addition, screening for the hepatitis C antibody might not be the most cost-effective strategy for case finding. Over the years, in my practice, I have identified patients with hepatitis C by ordering a one-time serum transaminase. Patients with elevated liver enzymes should have an assessment and hepatitis C is a common cause for asymptomatic, unexplained lab abnormalities. Granted, patients with hepatitis C could have normal liver enzymes, but that population of patients that is not showing evidence of active cellular injury, will be at low risk for disease progression and would not be the highest priority candidate for antiviral therapy.

The cost-benefit analysis of future savings would be substantially different for this group compared to infected patients with ongoing transaminase elevations. Finally, the wisdom of universal treatment of hepatitis C patients in their 60’s warrants reflection. Progression to end-stage liver disease takes years, if not decades. Clearly, younger patients get the most benefit from treatment to clear the virus before years of erosive damage ensues. Older, asymptomatic patients might need to have a biopsy to understand if the prophylactic antiviral therapy will provide benefit within his or her expected lifetime. A 63-year-old patient with minimal hepatic damage on biopsy may not benefit from antiviral intervention.

William E. Golden, M.D., is professor of medicine and public health at the University of Arkansas, Little Rock. He reports having no

conflicts of interest.



SAN FRANCISCO – Hepatitis C–associated deaths are now more common in the United States than HIV-related deaths, according to the Centers for Diseases Control and Prevention.

That’s not just due to improved awareness and treatment of HIV. As deaths from HIV have fallen since 1999 to under 13,000 a year, deaths associated with hepatitis C virus (HCV) have climbed to over 15,000. CDC expects that number to jump to about 35,000 annually within 20 years.

Baby boomers – people born between 1945 and 1965 – currently account for about three-quarters of those who die with HCV-infection, which can take years to manifest as liver cancer or fibrosis.

"This is the population we are very concerned about," said Dr. Jake Liang, president of the American Association for the Study of Liver Diseases and chief of the Liver Diseases Branch of the National Institute of Diabetes and Digestive and Kidney Diseases.

As a result, CDC is poised to recommend one-time HCV screening of all baby boomers, which would be in addition to current screening recommendations for injection-drug users and other high-risk populations, as well as those with unexplained alanine aminotransferase (ALT) elevations, among others. An education campaign, dubbed "No More Hepatitis," also is set to launch next year to boost physician and consumer awareness of HCV, said Bryce Smith, Ph.D., a lead health scientist in CDC’s Division of Viral Hepatitis.

The efforts coincide with the May 2011 approval of two new protease inhibitors for HCV, telaprevir (Incivek) and boceprevir (Victrelis). Both significantly improve sustained viral responses when used in conjunction with peginterferon alfa and ribavirin.

More than 30 HCV agents are in development as well, including some in early phase III trials. The hope is that they will further improve responses, reduce pill burdens, shorten current months-long treatment regimens, and perhaps even end the need for concurrent interferon, a cause of substantial adverse events.

"I think in the next few years, we’ll see a lot of drugs approved," Dr. Liang said.

Meanwhile, "the index of suspicion for hepatitis C infection should be much higher," said Dr. Scott Holmberg, a branch chief in CDC’s Division of Viral Hepatitis.

The agency estimates that half of HCV infections are undiagnosed, largely because current screening recommendations aren’t often followed. "Even when you have a couple of elevated ALTs, about half the time doctors will not test for" hepatitis infection, he said.

"One of the problems is that if someone is drinking and they have an elevated ALT, doctors will think it’s because of the alcohol. Or if they are taking antiretrovirals or statins, that it’s because of the drug. There’s a tendency to dismiss elevated ALT when in fact it should be triggering a test, no matter what you think it’s caused by," Dr. Holmberg said.

CDC’s estimate of HCV-related deaths is based on a review of 21.8 million death records. Any mention of the virus was counted, regardless if HCV was listed as a primary cause of death or simply one of the person’s health problems.

One physician aware of the findings questioned if, in some cases, the virus may simply have been an incidental finding, as opposed to a cause of death. Dr. Holmberg countered that if anything, CDC underestimated the true extent of HCV-related deaths. Because screening rates are low, the virus might not have been noted in cases of chronic liver failure and other conditions in which it may have played a part.

The agency calculates that about 80 million baby boomers would be screened under its plan, and about 2.68 million infections diagnosed.

That’s millions more people screened, and a million more infections detected, than strategies based on ALT elevations. Even when the expense of the new protease inhibitors is factored in – a course of either can cost tens of thousands of dollars – CDC estimates baby-boomer screening is cost-effective, in line with cervical cancer and cholesterol screening (Ann. Intern. Med. 2011 Nov. 4 [epub ahead of print]).

Baby-boomer screening also would catch HCV-infected people who have normal ALTs, 20%-30% of whom can have significant fibrosis nonetheless.

"What we hope is that [screening] will be integrated" into electronic medical records so providers are prompted to test baby boomers. "We tried to make it as easy as possible," said Dr. Smith.

Dr. Liang, Dr. Smith, and Dr. Holmberg said they have no disclosures.

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