Hepatitis C Care Cascade Among Persons Born 1945-1965: 3 Medical Centers

ABSTRACT

Objectives: Effective screening, diagnosis, and treatment are needed to reduce chronic hepatitis C virus (HCV) infection–associated morbidity and mortality. In order to successfully increase HCV treatment, it is necessary to identify and understand gaps in linkage of antibody-positive patients with newly identified HCV to subsequent HCV RNA testing, clinical evaluation, and treatment.

Study Design: To estimate attainment of HCV care cascade steps among antibody-positive patients with newly identified HCV, we conducted chart reviews of patients with a new positive HCV antibody test at 3 academic medical centers participating in the Birth-Cohort Evaluation to Advance Screening and Testing of Hepatitis C (BEST-C) study.

Methods: We tracked receipt of RNA testing, clinical evaluation, treatment initiation, and treatment completion among individuals born between 1945 and 1965 who were newly diagnosed as HCV antibody–positive between December 2012 and October 2015 at 3 BEST-C centers, predominantly from the participating medical centers’ primary care practices and emergency departments.

Results: Of the 130 HCV-seropositive individuals identified, 118 (91%) had an RNA or genotype test, 75 (58%) were RNA-positive, 73 (56%) were linked to care, 22 (17% overall; 29% among RNA-positive) started treatment, and 21 (16%; 28% among RNA-positive) completed treatment.

Conclusions: This analysis showed that although linkage to care was largely successful in the target birth cohort, the largest gap in the HCV care cascade was seen in initiating treatment. Greater emphasis on linking patients to clinical evaluation and treatment is necessary in order to achieve the public health benefits promised by birth-cohort testing.

Am J Manag Care. 2018;24(9):421-427Takeaway Points

In this analysis of patients with newly diagnosed hepatitis C between December 2012 and October 2015, linkage to care was largely successful in the 1945-1965 birth cohort, but treatment initiation remained low.

• The largest gap in the hepatitis C virus care cascade was initiating treatment.
• Greater emphasis on linking patients to clinical evaluation and treatment is needed.
• Managed care is well poised to address barriers to initiating treatment.

Chronic hepatitis C virus (HCV) infection is undiagnosed in 50% of those infected.^1,2 Hoping to increase HCV case identification, in 2012 the CDC recommended a 1-time HCV antibody test for persons born between 1945 and 1965, the birth cohort that contains approximately 80% of individuals with HCV antibodies.^1,2 In 2013, the US Preventive Services Task Force recommended testing for the same group.^3,4 The Birth-Cohort Evaluation to Advance Screening and Testing of Hepatitis C (BEST-C) experimental evaluation demonstrated that birth-cohort testing interventions increase HCV case identification at a reasonable cost compared with that of other testing strategies.^5,6 However, observational studies have identified persistent gaps in the subsequent cascade of treatment services that are needed to achieve a virologic cure: confirmatory testing (HCV RNA), clinical evaluation, and antiviral treatment.^7-13 One meta-analysis estimated that only 50% of the 3.5 million Americans living with chronic HCV had been tested for HCV antibodies, 27% received confirmatory RNA testing, 16% had been treated, and 9% achieved sustained virologic response (SVR), defined as undetectable viral load at 12 weeks following end of treatment (EOT).⁷ A second study found that only 29% of high-risk primary care patients who tested positive for antibodies were evaluated for treatment, less than 4% started treatment, and only 2% achieved SVR.¹² The end of the BEST-C experiment, which compared testing interventions to promote birth-cohort testing with standard-of-care HCV antibody testing at 3 academic medical centers, created the opportunity to assess the rates of linkage to care in primary care and emergency departments affiliated with these centers.

Studying attainment of "care cascade" steps among patients identified at BEST-C medical centers is instructive in understanding the possible impact of future HCV testing interventions, especially in managed care settings. These settings have a long history of proactive health promotion activities, such as patient education and care coordination, that may be effective in addressing gaps in care experienced by patients with newly diagnosed HCV.

In this paper, we used electronic health records (EHRs) to examine HCV care and treatment among antibody-positive patients identified at BEST-C study centers during the study period.

METHODS

Study Population

Patients included in this analysis were those who tested HCV antibody–positive during the BEST-C study period (December 2012-October 2015) at any of the 3 participating healthcare systems (“centers”) as an enrolled participant of the BEST-C study or as an unenrolled patient who was identified during the same study period. All evaluated patients were born between 1945 and 1965 and had no previous record of being tested for HCV in the EHR.^5,6,14 Information about BEST-C has previously been described.^5,14 This study received institutional review board approval from the University of Alabama, Henry Ford Health System, Mount Sinai Hospital, and NORC at the University of Chicago.

Measures

We defined the care cascade as consisting of the following 7 consecutive steps: (1) a positive HCV antibody test; (2) a confirmatory test, defined as a qualitative or quantitative RNA or HCV genotype test; (3) receipt of a positive RNA result or genotype; (4) clinical evaluation (either concurrently with receipt of confirmatory RNA test result or at a subsequent encounter), defined as a visit with a specialty provider (hepatologist, gastroenterologist, or infectious disease specialist) or other HCV treatment provider (primary care provider trained to treat HCV); (5) initiation of antiviral therapy as indicated in the EHR; (6) treatment completion as indicated in the EHR by a provider; and (7) EOT virologic response, defined as an undetectable viral load at treatment completion (within 2 weeks of the end of intended course of treatment). Only 1 patient received a liver biopsy. Sustained viral load 12 weeks following EOT was not available at the end of the study; we therefore do not report on this step or the final outcome of the cascade.

Data Collection and Analysis

Using a standardized abstraction form, center coordinators collected data from the EHR of each patient from the date of his or her first positive HCV antibody test from December 1, 2012, through October 31, 2015. Coordinators identified relevant laboratory orders, encounters, and pharmacy records associated with each step of the HCV care cascade and sent deidentified person-level data to the coordinating center (NORC at the University of Chicago). Because of small sample sizes, the care cascade steps were not stratified by center. Data were analyzed using Microsoft Excel 2013 and SAS version 9.4 (SAS Institute, Inc; Cary, North Carolina).

We calculated the proportion of persons who progressed along the HCV care cascade as the number of individuals who completed each step (numerator) divided by the number of individuals with a positive HCV antibody test (denominator). We also calculated the proportion of individuals completing each step (numerator) divided by the number of individuals completing the previous step. Due to problems extracting pharmacy information from their EHR systems, 1 center did not report treatment of any patients. Therefore, we also calculated the care cascade and the percent of patients initiating treatment using data from the 2 centers with accessible treatment records (“treating centers”).

We estimated patients’ liver disease stage at initial evaluation using their first recorded AST (aspartate aminotransferase) to Platelet Ratio Index (APRI) scores. Disease stage was categorized using the following values: 0.0 to 0.54, 0.55 to less than 1.0, 1.0 to less than 2.0, and 2.0 or greater (ranging from no liver disease at 0.0 to advanced fibrosis/cirrhosis).¹⁵ Using χ² tests and Fisher’s exact tests and data from the 2 treating centers, we compared differences in treatment initiation by sex, race, birth year, insurance type, APRI score categories, and HCV genotype. A P value ≤.05 was considered statistically significant.