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The American Journal of Managed Care August 2019
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Late Diagnosis of Hepatitis C Virus Infection, 2014-2016: Continuing Missed Intervention Opportunities
Anne C. Moorman, MPH; Jian Xing, PhD; Loralee B. Rupp, MSE; Stuart C. Gordon, MD; Mei Lu, PhD; Philip R. Spradling, MD; Joseph A. Boscarino, PhD; Mark A. Schmidt, PhD; Yihe G. Daida, PhD; and Eyasu H. Teshale, MD; for the CHeCS Investigators
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Late Diagnosis of Hepatitis C Virus Infection, 2014-2016: Continuing Missed Intervention Opportunities

Anne C. Moorman, MPH; Jian Xing, PhD; Loralee B. Rupp, MSE; Stuart C. Gordon, MD; Mei Lu, PhD; Philip R. Spradling, MD; Joseph A. Boscarino, PhD; Mark A. Schmidt, PhD; Yihe G. Daida, PhD; and Eyasu H. Teshale, MD; for the CHeCS Investigators
Late hepatitis C virus infection diagnosis points to a need for earlier screening and treatment before the onset of severe liver disease leading to high cost and diminished outcomes.
Among persons with newly diagnosed abstractor-confirmed chronic HCV infection during 2014-2016 at CHeCS sites, we analyzed retrospective and prospective EHR and administrative data from the patient’s first-ever health system visit to January 1, 2017, to determine the frequency of having severe liver disease conditions that might develop after many years of chronic HCV infection, within 3 months before to 12 months after initial HCV diagnosis, termed “late diagnosis.”15 Severe liver disease was defined, as in our previous study, as having cirrhosis (mean FIB-4 score [based on ALT, aspartate aminotransferase, and platelet values collected within 7 days of each other] >5.88 or liver biopsy indicating cirrhosis,19 with the addition of transient elastography score >12.5 kPa20—a procedure that had not been widely in use during the earlier time period) or a diagnosis of ESLD.15 ESLD was defined as having an ICD-9/ICD-10 diagnosis or procedure code indicating liver transplant, hepatocellular carcinoma, liver failure, hepatic encephalopathy, portal hypertension, esophageal varices, other gastroesophageal hemorrhage, ascites, or other sequelae of chronic liver disease.15,19 As in the earlier analysis, date of initial HCV diagnosis was defined as the earliest of (1) an EHR report of a positive laboratory test for hepatitis C antibody or RNA or (2) an HCV-related diagnostic or procedure code. To mirror the previous report, analysis was restricted to patients with at least 12 months of observation time after initial HCV diagnosis to allow adequate time post diagnosis for detection of severe liver disease.15

For comparisons of characteristics of persons with and without late diagnosis, SAS procedure FREQ with χ2 tests was used to compare categorical variable percentages, and t tests were used to compare means of continuous variables. A P value of <.05 was considered significant. A stepwise multivariate logistic model comparing all demographic factors by late diagnosis status controlling for birth year, sex, and race was run using SAS (SAS Institute; Cary, North Carolina) to provide adjusted values based on the Wald χ2 test.

RESULTS

Among 4064 patients with HCV infection first diagnosed during 2014-2016, we again excluded those with initial HCV diagnosis prior to their first CHeCS health system visit (n = 1023 [25.2%]) for whom liver disease status at initial diagnosis could not be ascertained. To minimize confounding we conducted a separate analysis for those with other bloodborne pathogen coinfections, who are recommended for HCV screening, and excluded them from further analysis. Among patients who had coinfection with hepatitis B virus (n = 25 [0.6%]), 13 (52.0%) had severe liver disease at diagnosis; among those with HIV (n = 42 [1.0%]), 10 (23.8%) had severe liver disease; and among 2 (0.1%) patients with both coinfections, 1 had severe liver disease. We also excluded patients with less than 12 months of follow-up after initial HCV diagnosis (n = 277 [6.8%]).

Of the remaining 2695 patients, 576 (21.4%) were found to have concurrent severe liver disease at diagnosis (Table 115,19,20), with similar proportions of late diagnosis among the 387 (14.4%) given a diagnosis of HCV within their first 6 months in the health system versus later (23.8% vs 21.0%). The proportion with late diagnosis (19.5%) was substantial even among those excluded due to their having less than 12 months of postdiagnosis follow-up.

Most patients given a diagnosis during 2014-2016 were born between 1945 and 1965 (n = 1613 [59.9%]), and among these, 27.6% had late diagnosis. Late diagnosis was less frequent (10.0%) among the patients born after 1965 and more frequent (39.0%) among the small proportion born before 1945. Late diagnosis was more common among men than women (23.6% vs 18.3%), black than white patients (26.2% vs 19.4%), and those with public versus private insurance (Medicare, 29.7%; Medicaid, 24.8%; private, 18.2%). In an analysis of demographic factors adjusted for birth year, race, and gender, differences by birth year, gender, and insurance were significant (Table 115,19,20).

Both patients with and without late diagnosis had lengthy observation (mean and median, 9.1 and 9.1 vs 8.3 and 7.8 years, respectively) in the health systems prior to their HCV diagnosis. During this prediagnosis period, most of those with late diagnosis had prior healthcare visits (80.0%) and many had emergency department visits (46.5%) and prior hospitalizations (24.1%). Many had elevations in ALT levels (22.9%; first experienced on average 7 years earlier) (Table 215,19,20). About a quarter of patients with late diagnosis and 13% of those without late diagnosis had liver function and platelet count laboratory tests available for FIB-4 calculation,11 first available on average 5 years prior to HCV diagnosis for both groups. The highest FIB-4 in the period more than 1 year before initial HCV diagnosis was sufficiently elevated to indicate possible (>3.25) or likely (>5.88) hepatic cirrhosis among 34% of those with and 8% of those without late diagnosis, with first elevations at those levels occurring, on average, 5 years prior to HCV diagnosis for both groups. After HCV diagnosis, those with late diagnosis were more likely to have a hospitalization (32.5% vs 12.5%; P <.001) with a greater number of hospital days (358.8 vs 78.5 per 100 person-years; P <.001).


 
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