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Screening strategies for hepatitis C: Is universal testing necessary?

An estimated 3.5 million people in the United States are living with the hepatitis C virus, and because the disease is typically asymptomatic until years after infection, more than half of those infected are unaware that they have the virus.

Even more concerning is that, according to CDC surveillance data, the number of reported cases of HCV increased almost threefold between 2010 and 2015. Although improvements in disease detection are responsible for the identification of some of these cases, the majority are due to an increase in injection drug use, with most of the new infections occurring among young white populations in rural areas with known injection drug problems such as Appalachia. And because the states with the highest rates of new HCV infection — Tennessee, Kentucky and West Virginia — do not receive CDC support for HCV screening, these numbers are largely underreported. The CDC estimates that in 2015 there were almost 34,000 new HCV infections in the U.S.

Identifying individuals with HCV infection is hugely important, as HCV is a treatable and, in some people, curable disease. Untreated HCV, however, has devastating effects, leading to cirrhosis, an increased risk for hepatocellular carcinoma and even liver transplant in those with chronic infection. In 2012, the CDC issued recommendations for one-time HCV testing for baby boomers, adults born between 1945 and 1965; based on historical data, approximately 75% of HCV infections occur in people born during this period, as these individuals are more likely to have received blood products prior to 1992. The CDC also recommends HCV screening for at-risk populations, including past and current injection drug users and those with HIV. The following year, the U.S. Preventive Services Task Force (USPSTF) issued a Final Recommendation for one-time screening for baby boomers, as well as screening for at-risk individuals.

Barriers to screening: Can they be overcome?

The issuance of the CDC and USPSTF recommendations is predicted to result in the diagnosis of 800,000 new cases of HCV, as well as the prevention of 120,000 deaths. Although these screening recommendations seem straightforward, implementing them may be difficult. Barriers to HCV screening include:

• lack of clinician education;
• lack of patient education;
• time constraints during office and clinic visits; and
• an unwillingness of patients to disclose certain risk behaviors for fear of judgement.

Some of these barriers are more easily overcome than others. Since these recommendations have been published, several studies have been performed to determine the best methods for increasing participation in HCV screening.

Most of these HCV screening studies involve baby boomers. Many of the interventions developed to address HCV screening in this population use electronic medical record (EMR)-based alerts. At the University of Alabama Birmingham Hospital Emergency Department, Galbraith and colleagues developed a series of HCV screening questions that were assimilated into the EMR preliminary assessment tool. If a patient did not decline HCV testing, an automatic order was generated. Out of 1,529 baby boomers tested in the ED over the 11-week screening period,

• 170 patients (11.1%) were seropositive for HCV;
• 102 of these were confirmed positive on follow-up polymerase chain reaction testing; and
• 100 of the 102 confirmed positive patients were linked to specialty care.

Similar interventions have been developed for primary care practices and hospital inpatient services. In the University of California, Los Angeles health care system, an electronic health record clinical decision support tool was used to alert clinicians to patients who were eligible for screening. A reminder that HCV testing was “due” appeared in the electronic chart for patients with no evidence of prior HCV testing. During the study period, 19,606 patients were screened; this amounted to a 145% increase in screening from the pre-intervention period. In a South Texas hospital, a similar EMR intervention was developed, alerting clinicians to eligible baby boomers and creating an electronic order for the test. A clinician education program was developed in addition to the EMR alert, informing staff about HCV epidemiology and screening guidelines for the baby boomer cohort. Patients had the ability to opt out of the testing. The program identified 240 new cases of HCV among the 3,168 eligible patients.

Best practice advisory

In a study involving 13 clinics associated with the University of Michigan health system, Konerman and colleagues created an EMR best practice advisory (BPA) to alert clinicians to patients in the baby boomer birth cohort; those eligible for testing had no prior diagnosis of HCV and no documentation of prior HCV testing. Like the program instituted at the South Texas hospital, this intervention included an associated electronic order, as well as HCV educational materials. The program resulted in a fivefold increase in HCV screening rates, identifying 53 new HCV patients. In follow-up care, 11 of these patients were found to have advanced liver disease; 20 patients started treatment, and 9 achieved a sustained virologic response, meaning that the hepatitis C virus was not detected in their blood after 24 weeks of treatment.

Researchers in the Mount Sinai health care system also used a BPA-based system. Alerts would appear in the electronic charts of patients eligible for screening and remain in the chart, alerting at each visit until testing was completed; 20.2% of eligible patients were tested at intervention sites, 27 of which (3.1%) tested positive for HCV. Another intervention was implemented at two primary care practices at Mount Sinai Hospital. The program included EMR alerts, staff education and patient navigation for those who tested positive. After the intervention, screening rates were at 75%, up 20% from the pre-intervention period, and 84 patients were identified as having HCV.

People who inject drugs: An at-risk population

For all the studies and data involving screening of the baby boomer cohort, there is a noticeable lack of information regarding at-risk populations such as people who inject drugs (PWID). An 8-week study conducted in the ED at Johns Hopkins Hospital included both baby boomers and those who fell under “modified” CDC risk-based testing criteria. The modified criteria included patients with known HIV infection and patients with history of injection drug use; the Johns Hopkins Hospital ED has a current and former PWID prevalence of about 15%, as well as a high HIV-positive patient population. Of the 4,713 patients who were included in the study, 38% were in the birth cohort, and 62% were in the modified risk group. Six hundred fifty-two patients were found to be positive for HCV, and 31.3% of those patients had not previously been aware of their status. Of the 31.3% who were undocumented,

• 63% were in the birth cohort;
• 22% were current or former injection drug users; and
• 5% were HIV-positive.

In a large, multicity study, Blackburn and colleagues created an intervention to increase screening among injection drug users. Eighty-four sites were granted CDC support for participating in a CDC-led initiative called HepTLC (Hepatitis Testing and Linkage to Care). Of these 84 sites, 10 specifically tested PWID. These sites included syringe services programs, sexually transmitted disease clinics and health departments. Injection drug users were recruited to participate in the screening program using peer-based methods and targeted outreach. In total, 15,274 people with a median age of 37 years were tested; 73% of those tested reported current or former injection drug use, and 22.9% tested positive for HCV.

Many patients still being missed

By most measures, many of these screening programs have been successful in increasing the rate of HCV testing, but many more patients are being missed. Are the screening methods not effective enough, or are the recommendations not inclusive enough? Perhaps it is both. In the Johns Hopkins Hospital ED study, the researchers determined that approximately 6,700 patients with chronic HCV are seen in their ED each year, including:

• 49% diagnosed based on birth cohort testing;
• 26% diagnosed based on the modified risk-based screening; and
• 25% of patients that will remain undocumented.

Hsieh and colleagues suggest that extending the birth cohort to 1978, or even testing everyone over the age of 18, would identify many more of these HCV-positive patients. Nontargeted testing would also identify patients who have HCV infection due to injection drug use; clinicians asking these patients about engagement in risk behaviors is really not an effective method, as many are unwilling to disclose that information.

Similar results were seen in the study in the Mount Sinai health care system, where only one-fifth of eligible patients received HCV testing. Although the EMR intervention was created in an effort to facilitate screening without placing an additional burden on clinicians, Federman and colleagues note that heavy physician workloads, along with a lack of training and education, may be barriers to implementing screening practices. In addition, many EMR alerts are used for routine medical maintenance, including colonoscopy and vaccinations — and yet another alert may just add to the noise.

The recent outbreak of HCV is largely attributed to injection drug use, with a 294% increase in the incidence of HCV from 2010 to 2015. Identifying at-risk patients for screening is a difficult task, and even the current interventions for those in the baby boomer cohort, a defined group, have only been moderately successful. Nontargeted, universal testing may be the only way to effectively identify those with HCV. The more patients who are identified, and the earlier they are identified, the greater the chance of effectively treating, controlling and eradicating this disease.

References

• Surveillance for viral hepatitis – United States, 2015. Centers for Disease Control and Prevention. website. https://www.cdc.gov/hepatitis/statistics/2015surveillance/commentary.htm. Updated June 19, 2017. Accessed January 17, 2018.
• Campbell CA, Canary L, Smith N, Teshale E, Ryerson AB, Ward JW. State HCV incidence and policies related to HCV preventive and treatment services for persons who inject drugs — United States, 2015-2016. MMWR Morb Mortal Wkly Rep. 2017;66(18):465-469.
• Hsieh Y-H, Rothman RE, Laeyendecker OB, et al. Evaluation of the Centers for Disease Control and Prevention recommendations for hepatitis C virus testing in an urban emergency department. Clin Infect Dis. 2016;62:1059-1065.
• Final recommendation statement. Hepatitis C: screening. United States Preventive Services Task Force. Website. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/hepatitis-c-screening. Published June 2013. Updated December 2016. Accessed January 17, 2018.

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• Turner BJ, Taylor BS, Hanson JT, et al. Implementing hospital-based baby boomer hepatitis c virus screening and linkage to care: strategies, results, and costs. J Hosp Med. 2015;10:510-516.
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