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New HCV Study Underscores Risk for Human Suffering, Need for Clinician Vigilance

Hepatitis C virus infection is one of our nation’s most pressing public health concerns for infectious disease specialists and hepatologists. Not only did acute HCV infections increase 250% from 2010 to 2014, a recent report from the CDC shows that more people die of HCV in the United States than any other infectious disease, with a total 19,659 reported HCV–related deaths in 2014. Almost all of these deaths are due to the impact of chronic HCV on the liver (cirrhosis, end-stage liver disease, liver transplantation, and/or hepatocellular carcinoma or primary liver cancer).

Policymakers and clinicians have worked aggressively in the past decade to address the HCV epidemic, developing and implementing new CDC screening recommendations and a sweeping strategic plan, the HHS national viral hepatitis action plan, to identify infected individuals, prevent transmission and reduce mortality by the year 2020. But the most significant obstacle of combatting HCV is that most HCV–infected individuals are asymptomatic, until late in the disease process, with at least half those chronically infected unaware of their status. Given the recent availability of highly curative, all-oral, short-duration antiviral therapies, this is both a tragedy and a major public health challenge.

Increasingly, more clinicians have become aware of the need to find people who are at risk for infection and encourage them to get tested. However, a new study underscores the human consequence if we are unsuccessful.

The study findings, from researchers at CDC and Quest Diagnostics, shows that nearly one in four individuals with HCV are diagnosed with the infection only after it has caused liver damage. Among HCV–infected individuals, 23% had advanced liver fibrosis or cirrhosis at first diagnosis, compared with 11% with resolved infection and 3% of uninfected individuals, at time of initial screening for HCV.

The rate was even higher in “baby boomers” (those born between 1945-1965). Twenty-seven percent of HCV–infected baby boomers had developed advanced fibrosis or cirrhosis by the time they were first diagnosed with HCV.

What can those of us who work in infectious diseases and liver disease glean from these findings to benefit patient care?

First, the study confirms what we already know: that we must do everything within our power to remove barriers keeping individuals in the U.S. from testing, linking to care, and receiving treatment for HCV. The study authors estimated that applying the overall 23% with advanced liver disease to the estimated 3.5 million infected individuals in the U.S. indicates “there may be over 800,000 persons in the U.S. with an urgent need for medical management,” given the advanced stage of their chronic liver disease. With the broad range of available therapies, this is unacceptable. Anyone who may be at risk for HCV should get tested, and almost all who test positive for the virus can now be cured, with the current advances in therapy. And, therapy should not be delayed until liver disease has advanced, due to the associated morbidity and mortality, including the risk for developing hepatocellular carcinoma.

Second, in addition to accelerating screening initiatives, we must do a better job at case management of infected individuals. Forty-six percent of individuals with advanced stages of disease in the study did not receive genotyping and antiviral resistance testing from Quest Diagnostics during the 4-year study period. The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) both recommend an HCV genotype test before initiating antiviral medication, and resistance testing may also be used to help monitor response to certain antiviral treatment. The lack of these tests suggests these individuals were not evaluated fully or in treatment despite having advanced disease (it should be noted that the study period preceded the FDA’s June 2016 approval of a new therapy that is active against all HCV genotypes).

A closer look at post-diagnosis test ordering suggests a discrepancy between primary and specialty care. The largest percentage of patients with advanced disease without follow-up testing (34%) had been originally tested for HCV infection by a primary care physician. By comparison, the largest percentage of patients in treatment had been originally tested by a gastroenterologist (35%), suggesting that specialists may be doing a better job of pursuing appropriate follow-up care for HCV–infected patients. To close this gap, there may be need for additional training of primary care physicians in HCV screening, management and referral of patients with advanced liver disease to specialists.

I am not discouraged by these findings, even though they are concerning. Those of us who work in the infectious diseases and/or liver disease field support primary care medical professionals who care deeply about their patients and have now become eager to better understand and address gaps in HCV guideline-based care and treatment of targeted populations. The advances in therapy, the new screening recommendations, the national updated treatment guidelines, and a national viral hepatitis action plan have helped us progress in fighting this disease. We are making inroads, but we must do even more. Today, with the availability of curative therapy, no one should have to suffer or die because of chronic HCV.

• References:
• CDC. Hepatitis C Kills More Americans than Any Other Infectious Disease. http://www.cdc.gov/media/releases/2016/p0504-hepc-mortality.html. Accessed November 15, 2016.
• HHS. Viral Hepatitis in the United States: Data and Trends. http://www.hhs.gov/hepatitis/learn-about-viral-hepatitis/data-and-trends/index.html. Accessed November 15, 2016.
• Klevens RM, et al. Clin Infect Dis. 2016;doi:10.1093/cid/ciw468.

• For more information:
• Carol L. Brosgart, MD, is clinical professor of medicine, biostatistics and epidemiology at the University of California, San Francisco. She serves as a member of the steering committee of the National Viral Hepatitis Roundtable, the executive committee of the Forum for Collaborative HIV Research, the steering committee of the HBV Forum, the public policy committee of the AASLD, and the HCV Task Force of the IDSA, and is a member of the board of directors of the Pangaea Global AIDS Foundation.

Disclosure: Brosgart reports no relevant financial disclosures.