Clinical studies that rely on diagnostic codes or biopsies to provide evidence of cirrhosis may be underestimating the extent of the disease among hepatitis C patients, according to a new study.
An estimated 2.7 to 3.9 million people in the United States have chronic hepatitis C infections, but many of these patients may be unaware of the severity of their liver damage.
“We looked at evidence of cirrhosis among hepatitis C patients by examining four different parameters: ICD-9 codes; liver biopsy reports; evidence of liver failure; and the FIB-4 test, an easily calculated biomarker. By using all four indicators of cirrhosis, we found a four-fold higher prevalence of cirrhosis than would be indicated by biopsy alone,” Stuart Gordon, MD, director of the division of hepatology and hepatology research at the Henry Ford Liver Disease Center in Detroit, Michigan, told Medical Economics.
Gordon and colleagues analyzed records from a large, geographically and racially diverse group of 9,783 patients receiving care at four large U.S. health systems: Henry Ford Health System in Detroit; Kaiser Permanente Northwest in Portland, Oregon; Kaiser Permanente in Honolulu; and Geisinger Health System in Danville, Pennsylvania.
Their results indicated evidence of cirrhosis in 2,788 of the hepatitis C patients, but, surprisingly, 1,727 of those patients (62%) had no formal documentation in their medical records that they had cirrhosis. Among 661 patients with biopsy-confirmed cirrhosis, only slightly more than half (54%) had a code for cirrhosis.
Gordon suggests that clinicians use FIB-4 scores to identify their hepatitis C patients who may have cirrhosis yet may not be aware of the diagnosis. He notes that FIB-4 scores may be easily calculated from routinely obtained laboratory parameters, and laboratory reporting could be enhanced by the inclusion of this score.
“Knowledge of the prevalence of cirrhosis will help decision making regarding screening for the effects of hepatitis C, timing of initiation of anti-viral therapy, and follow-up counseling,” he says.
According to the study, hepatitis C patients with higher odds of cirrhosis include those who are older, males, Asian race, Hispanic ethnicity, genotype 3 infection, HIV coinfection, are diabetic, and have a history of antiviral therapy and a history of alcohol abuse.
“We can now offer interferon-free antiviral therapy for patients with hepatitis C, including those with cirrhosis, using direct acting agents. These 12- to 24-week regimens are highly effective and easily tolerated by most patients,” Gordon says.
He notes that patients who achieve a sustained viral response to therapy are no longer at risk for decompensation and may even experience a regression of their cirrhosis.
In the future, researchers should investigate the value of indirect markers of cirrhosis, he suggested. “This could result in earlier diagnosis and prevention of liver disease complications,” Gordon says. “The presence of cirrhosis in hepatitis C may be hidden or not easily recognizable. It is often asymptomatic in its early form and may require a high degree of suspicion by physicians in order to diagnose.”