- Category: HCV Testing & Diagnosis
- Published on Tuesday, 22 November 2016 00:00
- Written by Keith Alcorn
Grave weaknesses in hepatitis C virus (HCV) screening and linkage to care are still widespread in the United States and threaten to leave a large proportion of Baby Boomers with hepatitis C untreated, according to presentations at the 2016 AASLD Liver Meeting this month in Boston.
Just 10% of people diagnosed with chronic HCV infection at an Atlanta hospital between 2012 and 2014 during routine testing of the Baby Boomer generation have since been cured of hepatitis C. The vast majority of those diagnosed with HCV never progressed beyond a first clinic visit before being lost to follow-up, one study found.
A second study, looking at compliance with testing guidelines in outpatient and primary care settings in Chicago, found that just 15% of Baby Boomers presenting for care during a 1-month period had been tested for HCV, despite a Centers for Disease Control and Prevention (CDC) recommendation that all people born between 1945 and 1965 should be tested at least once for HCV antibodies.
And, in New York state, a comprehensive study of testing activity found that despite a spectacular increase in HCV antibody testing after passage of a state law mandating birth cohort testing in 2014, only 6.7% of those eligible were tested in 2014. The New York study also found that only a third of people on Medicaid who tested positive for HCV subsequently received a test for HCV RNA to confirm chronic infection and a genotype test, the first step in linkage to care for hepatitis C.
Birth Cohort Testing and the Continuum of Care
The birth cohort approach to screening for hepatitis C was adopted by the CDC due to the high prevalence of HCV among Baby Boomers and the cost-effectiveness of screening in an older population. Three-quarters of all chronic hepatitis C cases are estimated to be in Baby Boomers, and older people infected several decades ago are at higher risk for complications arising from advanced liver damage.
Monitoring of compliance with HCV screening guidelines is essential in order to see whether hepatitis C treatment is fulfilling its potential to avert large-scale morbidity and mortality, and to identify how services can be improved.
Monitoring further steps in the continuum of care, or treatment cascade, can identify barriers to being cured of hepatitis C.
NorthShore University Health System cares for around 250,000 Baby Boomers in Chicago. To check compliance with HCV testing recommendations, researchers identified all people born between 1945 and 1965 who visited a clinic in July 2015 and determined whether they were tested for HCV and why.
The study found that, out of 10,089 patients eligible for screening on a clinic visit, only 131 (1.3%) had been tested for HCV antibodies. Of these, 28 had been tested due to risk factors for HCV infection, 34 had been tested as part of a diagnostic investigation, and 69 had been tested as a member of the birth cohort. The testing rate was especially low for patients who saw a primary care physician.
The TILT-C program screened Baby Boomers from the 1945-1965 birth cohort at Grady Memorial Hospital Primary Care Center in Atlanta. Between 2012 and 2014, a total of 5239 people were screened, of whom 93% were African-American and 53% were uninsured. Of these, 412 (7.9%) tested positive for HCV antibodies and 92% underwent HCV RNA testing to determine chronic infection status, showing that 264 (69%) had chronic infection.
Of those with chronic infection, 96% were linked to care, 75% attended a second visit, and only 43% were referred for treatment. Just over half of those referred for treatment eventually started treatment within 20 months of the end of the screening program, and to date, 25 patients have been cured of HCV (confirmed SVR12).
New York State Birth Cohort Testing Law
In January 2014 New York state enacted a law mandating the offer of an HCV test to all Baby Boomers. The law applied to providers in inpatient settings and primary care facilities, and covered physician assistants and nurse practitioners as well as to physicians. The law also mandated linkage to care for those diagnosed with chronic HCV infection.
The New York state law was the first statewide attempt to improve rates of HCV diagnosis and to give CDC guidance the force of law, but it came with a major drawback. No funds were made available for implementation or to publicize the new responsibilities of healthcare workers and the new entitlements of patients, Colleen Flanigan of New York State Department of Health told a poorly attended session on public health aspects of hepatitis C at the Liver Meeting.
A New York State Department of Health evaluation looked at a number of different measurements to guage the success of the law in encouraging HCV testing of Baby Boomers. Data from 163 laboratories licensed to carry out HCV antibody tests showed a 51% increase in tests between 2013 and 2014, with 813,492 people tested during the first year the law was in effect.
An assessment of screening test offers in a sample of primary care facilities in New York City found that the proportion of people in the relevant age group tested for HCV increased from 4.8% in 2013 to 6.7% in 2014, with the largest increase occurring in hospital outpatient clinics. Analysis of Medicaid data showed that the testing rate increased by approximately 75% in 2014 compared to 2013, and the proportion of Medicaid recipients testing positive for HCV who were linked to care -- defined as testing for HCV RNA -- increased by 35% year on year. The evaluation further estimated that 33% of people were linked to care within 6 months of antibody testing in 2014, an increase of 39%.
Quantitative evaluation studies, by their nature, are not suited to providing explanations for shortcomings in diagnosis and linkage to care. Flanigan noted that in New York state, lack of awareness of the testing law among healthcare providers was a challenge, but the state health department was able to address this through communications among healthcare provider networks. A bigger challenge was the way in which healthcare facilities were left to implement the law without guidance on whether they should be offering the test on an opt-in or opt-out basis.
More research is needed to understand why testing uptake and linkage to care remain weak in the U.S. despite strong leadership from the CDC. Without substantial improvements in testing and linkage to care across a wide range of health facilities, many thousands of Baby Boomers with hepatitis C will continue to develop serious liver damage before being diagnosed.
C Flanigan, K Rowe, and SY Leung. The impact of a state-level hepatitis C testing law on hepatitis C screening and linkage to care. AASLD Liver Meeting. Boston, November 11-15, 2016. Abstract 226.
L Miller, CB Body, B Park, et al. What Happens After Screening and Linkage to Care? Examination of HCV Care Cascade Outcomes Among 5,000 Urban Baby Boomers Screened for HCV 2012-2014. AASLD Liver Meeting. Boston, November 11-15, 2016. Abstract 763.
A Yeboah-Korang, M Beig, JL Goldstein, et al. Adherence to HCV Birth Cohort Screening Guidelines by Primary Care and Subspecialty Physicians in an Integrated Healthcare System. AASLD Liver Meeting. Boston, November 11-15, 2016. Abstract 773.