Why Do 1 in 30 Baby Boomers Have Hepatitis C
Public Health Rep. 2016 May-Jun; 131(Suppl 2): 49–56.
Loftier Hepatitis C Infection Rate Among Baby Boomers in an Urban Main Intendance Dispensary: Results from the HepTLC Initiative
Alexander G. Geboy, MS, 
a Sandeep Mahajan, Doc,b, c Allison P. Daly, LICSW,a Candice F. Sewell, MS,b Ike C. Fleming,a Hyun A. Cha, LGSW,a Idene E. Perez,a Carmella A. Cole, MD,b Adebisi A. Ayodele, NP,b and Dawn A. Fishbein, Physiciana, b
Alexander Thousand. Geboy
aMedStar Wellness Research Institute, Hyattsville, MD
Sandeep Mahajan
bMedStar Washington Hospital Eye, Washington, DC
cCurrent affiliation: Georgetown University Hospital, Washington, DC
Allison P. Daly
aMedStar Health Research Constitute, Hyattsville, Dr.
Candice F. Sewell
bMedStar Washington Infirmary Middle, Washington, DC
Ike C. Fleming
aMedStar Health Research Plant, Hyattsville, Physician
Hyun A. Cha
aMedStar Health Research Institute, Hyattsville, MD
Idene East. Perez
aMedStar Health Inquiry Establish, Hyattsville, Doctor
Carmella A. Cole
bMedStar Washington Hospital Center, Washington, DC
Adebisi A. Ayodele
bMedStar Washington Infirmary Center, Washington, DC
Dawn A. Fishbein
aMedStar Health Inquiry Plant, Hyattsville, MD
bMedStar Washington Infirmary Heart, Washington, DC
Abstruse
Objective
CDC recommends that all people born between 1945 and 1965 exist tested for hepatitis C virus (HCV). We hypothesized that HCV testing in a large, urban primary intendance clinic would reveal higher rates of HCV infection than previously published.
Methods
Through the Hepatitis Testing and Linkage to Care initiative, the primary care clinic at MedStar Washington Hospital Eye in Washington, DC, provided HCV antibiotic (anti-HCV) testing and linkage to intendance from October 2012 through September 2013 for patients built-in between 1945 and 1965 without previously noted run a risk factors. We nerveless information on historic period, race/ethnicity, sex, anti-HCV and HCV ribonucleic acid (RNA) results, risk factors in those who tested anti-HCV positive, and health insurance type and made comparisons using c 2 and Student'due south t-tests.
Results
Of 1,123 patients tested, the mean age was 57 years, 742 (66.ane%) were women, 969 (86.3%) were black/African American, and 654 (58.2%) had public health insurance. Of the 99 (8.8%) patients who tested anti-HCV positive, the mean age was 58 years, 54 were men, and 93 were black/African American; 41 of 74 anti-HCV-positive patients were intravenous drug users. Of 82 anti-HCV-positive patients, 51 were HCV RNA positive. Of the blackness/African American patients tested, 49 of 317 men (xv.v%) and 44 of 652 women (6.7%) were anti-HCV positive (p,0.001). The HCV prevalence charge per unit in the birth cohort (8.viii%) was significantly higher than the U.South. (3.iii%) and DC (2.5%) rates (p,0.001), and the HCV prevalence rate amidst black/African American men in DC (15.5%) was essentially higher than the prevalence rate reported by CDC (8.one%).
Conclusion
Testing initiatives in primary intendance settings need to be more rigorously upheld, and internal champions are needed to advocate for increased screening to ensure linkage to care and appointment in the HCV care pour.
Hepatitis C virus (HCV) infection is the most common chronic blood-borne pathogen in the United States. An estimated iii.2 million people have chronic HCV infection in the United States, and an estimated 45%–85% of individuals have been tested. i–3 Diagnosing and treating at-risk people before complications such as cirrhosis or hepatocellular carcinoma (HCC) develop is imperative. Contempo studies show that 76% of people living with HCV infection in the Us are adults born betwixt 1945 and 1965, also known as the birth cohort or baby boomers. iv With such strong prevalence of illness inside this age grouping, the Centers for Disease Command and Prevention (CDC) recommended in 2012, and the U.S. Preventive Services Task Force (USPSTF) recommended in 2013, that HCV screening should include adults born betwixt 1945 and 1965 and exist routine for people at increased risk for infection. v–7
Analogous to those living with human immunodeficiency virus (HIV) infection who follow a treatment cascade consisting of diagnosis, linkage to intendance, memory in intendance, and treatment, people with HCV infection should pursue the same objectives to ameliorate their disease outcomes. 8 Individuals with HCV infection need to be diagnosed by HCV antibody (anti-HCV) and HCV ribonucleic acrid (RNA) testing to confirm chronic infection, followed past linkage to care with a provider who tin can prescribe HCV therapy to reach sustained virologic response (SVR) and provide other ways to decrease the risk of disease progression. nine Nevertheless, barriers remain between confirmation of infection and achievement of SVR; one study plant five%–6% of all people with HCV infection in the United states successfully progressed from detection of HCV infection to SVR. ten,xi In 2007, fewer than 85,000 people were treated for HCV infection. two As new, effective, direct-acting antiviral therapies become more readily available for patients, leading to SVR within a shorter time menstruum, fulfilling the handling cascade has become even more important and attainable.
Within Washington, D.C. (DC), alone, 9,819 newly confirmed cases of HCV infection and xv,915 full cases of HCV infection were documented from 2008 to 2012. The majority of new cases were among black/African American (hereinafter referred to as "black") men aged fifty–59 years (north=iv,701, 47.9%), which was twice that of than whatsoever other age group. 11 With such data and funding from the CDC Prevention and Public Health Fund (PPHF), MedStar Washington Infirmary Centre (MWHC) adult a testing center inside its master care dispensary (PCC). Using CDC and USPSTF guidelines, the goals of this study were to (1) estimate the prevalence of HCV infection within the MWHC PCC and (two) identify baseline characteristics of those testing positive for HCV infection. Nosotros hypothesized that HCV testing of the birth accomplice in a big, urban PCC would reveal higher rates than those previously published in DC and in the The states.
METHODS
Setting
MWHC is a not-for-profit, 926-bed instruction and research hospital located in DC that serves patients from all metropolis wards. The PCC'due south patient population is largely low-to-center income and black.
MedStar Wellness Research Institute, an entity of MedStar Health, provides scientific, administrative, and regulatory support for research and service programs that complement the primal clinical services and teaching programs in the MedStar Wellness system. Testing and linkage activities were conducted in the MWHC PCC with support from the MedStar Health Inquiry Institute.
Plan pattern and development
CDC'due south Hepatitis Testing and Linkage to Care initiative, which promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites, was established in 2012 at MWHC to ameliorate early on identification of HCV in clinical and community settings and raise linkage to intendance, treatment, and preventive services for infected people. MWHC's aim was to test three,000 patients for HCV infection and link those who tested positive to medical intendance. Patients were identified using Full general Electrical Centricity electronic health records technology and Crystal Reports. 12 A report was congenital via Crystal Reports that allowed for a systematic search of all clinic appointments within a given set of parameters. Reporting parameters mirrored eligibility criteria, which included people born betwixt 1945 and 1965 and with no record of previous HCV infection history or testing.
Once a report was generated, charts were manually screened for loftier-risk factors in medical history, social history, or a problems list (i.e., intravenous drug use and HIV infection). For patients without risk factors, pop-up reminders with focused messages were inserted into each eligible electronic medical tape (EMR) requesting anti-HCV testing based on CDC and (afterward) USPSTF recommendations, or offering a rapid finger stick if no anti-HCV test was ordered. Providers could not advance through the patient nautical chart until they closed the pop-up bulletin. It was the provider's choice to offer the test to the patient or order the examination as role of the laboratory requisition. To avoid disrupting dispensary menses, medical administration were also trained to attach birth cohort-specific HCV educational textile to all checkout paperwork. The flyers were printed on bright neon green newspaper for visibility, and the intentions were to provide additional educational material to patients without intervening in appointments and to reinforce the need to examination patients. If risk factors were observed, separate flags were sent to providers advising HCV testing, and providers were advised to exam all birth-cohort patients regardless of take a chance factors during educational in-services. Testing data were not collected for this group.
All HCV testing incorporated either venipuncture, performed in the PCC laboratory and processed at a hospital-contracted laboratory facility, or the U.Due south. Food and Drug Administration-approved, Clinical Laboratory Improvement Amendments-waived OraQuick® finger stick point-of-care test (OraSure Technologies Inc., Bethlehem, Pennsylvania) for detecting anti-HCV. Chief care testing followed this process: If a provider elected a venipuncture exam, the provider had the option to select either an anti-HCV test or an anti-HCV examination with reflex to quantitative HCV RNA. All results were automatically populated into the patient's EMR and monitored for both anti-HCV and HCV RNA tests. If a test was anti-HCV positive, just without a reflex HCV RNA test, an electronic communication was sent to the provider to alert the patient of the upshot and either social club an HCV RNA examination or provide the patient with an expedited referral to either infectious illness or gastroenterology providers for HCV RNA testing. If HCV RNA testing was negative, information was provided on risk factors, prevention counseling, manual, and reinfection risks. If HCV RNA was detected, an expedited referral was fabricated for an initial assessment with infectious disease or gastroenterology providers.
For negative anti-HCV rapid finger stick tests, information was provided past the rapid tester on take chances factors, prevention counseling, transmission, and reinfection risk. For positive anti-HCV tests, initial counseling was provided, an HCV RNA examination was ordered, and an expedited referral to infectious disease or gastroenterology providers was given for an initial medical assessment.
If a patient presented to the PCC already anti-HCV positive or HCV RNA positive, only not engaged with infectious disease or gastroenterology providers, the medical assistants and providers were trained to telephone call the HCV squad for an expedited referral and evaluation. On-the-spot HCV counseling was besides provided at the providers' and patients' request.
Data drove and analysis
We collected HCV testing data from Oct 2012 through September 2013. De-identified data were submitted monthly co-ordinate to projection-specific guidelines. We followed patients testing anti-HCV positive through their outset HCV date. Data collected included age, race/ethnicity, sex, anti-HCV and HCV RNA results, gamble factors in those testing anti-HCV positive, and health insurance blazon. CDC imposed a data lock on June xxx, 2014. After this date, new information (e.g., HCV RNA results and first appointment information) could not exist uploaded to the Internet-based collection portal. We performed inter-group and intragroup comparisons using c ii and Student's t-tests. We conducted analyses using SAS® version 9.iii. thirteen
RESULTS
From October one, 2012, to September 30, 2013, 1,123 patients were tested. The mean historic period was 57.1 half dozen 5.7 years; 654 (58.2%) patients had public health insurance (i.e., Medicare or Medicaid); 993 (88.4%) patients were tested via enzyme immunoassay venipuncture and 130 patients (11.6%) were tested via rapid exam; 969 (86.iii%) patients self-identified as black; and 742 (66.i%) patients were women. Of the ane,123 patients tested, 99 (8.viii%) were anti-HCV positive, and men were more than likely than women to examination anti-HCV positive (odds ratio [OR] = 2.6, 95% confidence interval [CI] one.7, 3.ix) (Table 1).
Tabular array i.
Characteristics of patients tested for hepatitis C virus every bit part of the Hepatitis Testing and Linkage to Care (HepTLC) initiative, MedStar Washington Infirmary Center, Washington, D.C., October 1, 2012, to September 30, 2013 a
Of the 99 anti-HCV-positive patients, 93 (93.nine%) were blackness and 54 (54.5%) were men. Overall, 54 of 381 men (fourteen.ii%) tested were anti-HCV positive; of the 969 black patients who were tested, 49 of 317 men (15.5%) and 44 of 652 women (half dozen.7%) were anti-HCV positive (OR=2.eight, 95% CI 1.8, 4.ii) (Table ii). Xl-one of 74 (55.4%) anti-HCV-positive patients reported intravenous drug use (intravenous drug use was never ascertained for 25 of the 99 patients), of whom 28 were men and 13 were women (OR=two.7, 95% CI 1.i, 6.1). Fifty-1 of 82 people who tested anti-HCV positive (62.2%) tested HCV RNA positive (indicating chronic infection), of whom 49 (96.1%) were blackness and 28 (54.ix%) were men; we institute no statistical difference betwixt sexes. Of the 31 patients who spontaneously cleared infection, the hateful age was 58.4 6 4.6 years, fifteen were men, 30 were black, and 15 reported intravenous drug utilise (fourteen reported no intravenous drug apply, and two patients were not asked). The remaining 12 patients were lost to follow-up (Table 1).
Tabular array 2.
Characteristics of patients born between 1945 and 1965 who were tested for hepatitis C virus, past race/ethnicity, sex, and anti-HCV and HCV RNA results, during the Hepatitis Testing and Linkage to Care (HepTLC) initiative, MedStar Washington Hospital Heart, Washington, D.C., Oct 1, 2012, to September 30, 2013 a
At the fourth dimension of data lock past CDC on June 30, 2014, 43 of 51 patients (84.3%) who were HCV RNA positive or chronically infected with HCV had attended a kickoff medical appointment with either infectious disease or gastroenterology providers, with a median time to outset medical appointment (i.due east., time between date of the anti-HCV test and the first medical engagement) of 110 days (range: nine–406). No patients were on HCV medications at the fourth dimension of the data lock. Supplemental information was collected post-data lock for all 51 HCV RNA-positive patients. Of the 51 patients with chronic infection, 47 (92.2%) were seen at an date and four were lost to follow-up; HCC screening was ordered for 45 of 47 patients (95.7%), with 36 (80.0%) screenings completed; and liver staging was ordered for 37 of 47 patients (78.seven%), with 36 (97.3%) liver stagings completed (Effigy). Additionally, xiv of 47 prescriptions (29.8%) were written, with five of 14 patients completing treatment and achieving SVR for 12 weeks posttreatment.
Hepatitis C virus care cascade for HCV RNA-positive patients built-in between 1945 and 1965 and tested during the Hepatitis Testing and Linkage to Care (HepTLC) initiative, MedStar Washington Hospital Center, Washington, D.C., October 1, 2012, to September 30, 2013a
aThe HepTLC initiative promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.South. sites.
HCV = hepatitis C virus
RNA = ribonucleic acrid
anti-HCV = hepatitis c virus antibody
appt = appointment
HCC = hepatocellular carcinoma
Rx = prescription
Tx = treatment
SVR = sustained virologic response
We collected additional PCC appointment data to supplement these findings, although it was not required. Of the 2,558 total unique appointments made for the PCC (i.due east., counted on a one-patient, 1-appointment-event basis), 855 (33.four%) patients were tested at starting time presentation to their appointment. However, of the ii,558 appointments made, 610 (23.viii%) patients who presented to their first appointment were missed opportunities (i.e., they attended their appointment but were not anti-HCV tested). The total observed birth-cohort appointment count was 4,033 (i.due east., if a patient was non tested during the first appointment, the patient was still followed over time until an HCV test was completed) from program inception to September 30, 2013. Of the 4,033 appointments made, 1,123 (27.8%) patients were anti-HCV tested, ane,081 (26.8%) patients were missed opportunities, and 1,829 (45.4%) patients were cancellations or no-shows (Table iii).
Table 3.
Primary intendance clinic appointment outcomes during the Hepatitis Testing and Linkage to Intendance (HepTLC) initiative for patients built-in between 1945 and 1965, MedStar Washington Hospital Center, Washington, D.C., October ane, 2012, to September thirty, 2013 a
Give-and-take
Increased HCV screening of the nativity accomplice revealed an anti-HCV-positive prevalence of eight.8%, which is substantially college than both the 3.3% (p,0.001) CDC rate and the 2.5% (p,0.001) overall DC anti-HCV-positive prevalence rate (inclusive of the nativity accomplice). HCV chronicity in the MWHC data, with the improver of v patients who were HCV RNA tested and positive later on the data lock, revealed a rate of 68.3%, just nonetheless five% of those tested. This rate is lower than the widely reported national rate of 75%–eighty%, although it falls inside the typically cited 55%–85% 13 range for HCV chronicity 14 and should be explored farther in the birth accomplice. We institute no differences between sexes or those who used intravenous drugs in those who spontaneously cleared infection compared with those who remained chronically infected. This latter grouping of patients runs the risk of developing fibrosis, cirrhosis, and HCC. 14,15 Given that those with chronic HCV infection did not have any previously identified chance factors in the EMR, and but 52.2% were always intravenous drug users, these patients probable would not have been tested if not for the CDC and USPSTF recommendations.
The 45.4% appointment cancellation rate reflects a systemic consequence of urban clinics. Yet, the 26.8% missed opportunity rate is concerning and should be explored. One time patients present to their engagement, providers often address the most emergent trouble, especially in the express fourth dimension available and in patients with multiple comorbidities. Therefore, given this high HCV prevalence rate of 8.8% in those without previously identified risk factors, and considering both the increased availability of highly efficacious therapeutics and major testing recommendations of CDC, USPSTF, and, more than recently, the Centers for Medicare & Medicaid Services, testing initiatives must become automated and fully integrated into standard-of-care practices. Testing needs to get more comprehensive, integrated with convenient EMR prompts, and maintained as sustainable models, particularly within PCCs.
The low numbers of prescriptions written and the lack of patients on treatment prior to the information lock can probable be attributed to two primary factors: the HCV handling landscape and public health insurance complications. Although the medication mural inverse dramatically after the release of straight-acting antiviral Sovaldi® Sofosbuvir (Gilead Sciences Inc., Foster City, California) in December 2013, previous medication options were suboptimal, and providers were more likely to look to treat, specially if identified early on in illness progression. 2d, although 100% of patients seen had some health insurance, and some insurance providers were covering early prescriptions for Sofosbuvir, the costs were loftier, and it was unlikely that patients who had early-stage infections were going to exist approved and treated.
The lower guild rate of liver staging could be attributed to a difference between gastroenterology and infectious illness providers. Although data were limited, it appears gastroenterology providers were not every bit inclined to gild both HCC screening (i.eastward., ultrasound, magnetic resonance imaging, computerized tomography) and liver staging tests (i.e., FibroSURE", Laboratory Corporation of America, Raritan, New Jersey), at least during early appointments. Of the 36 patients who received either a FibroSURE or FibroScan® (Echosens, Paris, France) test, or underwent a liver biopsy, 11 were seen by a gastroenterologist and 25 were seen by an infectious disease provider. Although guidelines do non mandate testing to evaluate advanced fibrosis, these tests are recommended for prognostic purposes. 16–18 These patients run the risk of falling out of care while awaiting follow-upwards appointments, and workups should be washed expeditiously.
The long wait between the anti-HCV examination and the start medical appointment can be attributed to a filibuster in implementing reflex HCV RNA testing, patient barriers to care, and clinic capacity. Information technology was not until almost the end of the study period that reflex HCV RNA tests were implemented as a testing option. If a patient tested anti-HCV positive, the patient would need to be called and told to come in for a laboratory-only visit or schedule some other engagement with either a primary care provider or a specialist for HCV RNA testing. Nonetheless, patients did non always return immediately after receiving notice of their anti-HCV status. The limited availability of a specialist in infectious diseases or gastroenterology was also regarded as a barrier. A nurse practitioner was hired during the study flow to overcome this barrier.
Limitations
These data were subject to several limitations. Take a chance factors were only collected for those who were anti-HCV positive, and although take a chance factors can exist quantified, the EMR often contains express information. Providers do non necessarily ask for, and patients exercise non always offering their adventure behaviors. Although testing for HCV without ascertainment of gamble is in line with nativity-cohort recommendations, it is probable a reason for depression testing uptake, as clinical judgments and bias often dictate testing practices.
Testing uptake inside the PCC and clinic catamenia was as well a limiting cistron, especially in achieving the goal of testing 3,000 people. Although CDC and USPSTF recommendations provided evidence for increased screening, birth-cohort testing occurred in approximately 30% of all appointments scheduled yet occurred in more than 50% of patients who fabricated information technology to their appointments. It is likely that low uptake was the outcome of both the asymptomatic nature of HCV infection and provider discretion to care for and discuss the most emergent comorbidity start. In a PCC that in 2011 provided primary medical intendance to more than 9,000 individuals within the birth cohort, it is possible that there was non enough fourth dimension per patient to discuss testing. Furthermore, the testing team was not able to fully utilize the EMR to meliorate integrate testing options inside the full functionality of the EMR. Provider and patient surveys are currently being quantified to assess these barriers.
Determination
These information, which are comparable with that of the 2012 DC Section of Health'due south Annual Epidemiology and Surveillance Report, 11 advise that the 8.8% HCV infection prevalence at this PCC should enhance concerns, especially considering that the previously reported DC HCV prevalence rate of 2.v% is already regarded as an epidemic and comparable with that of HIV. xi Furthermore, not only is the employ of wellness-care resource by birth-cohort people infected with HCV infection disproportionately large, 19 but those infected with HCV in the United States account for more than chronic liver disease, HCC, and liver transplantation than other groups, and are now more likely to die from HCV infection than people living with HIV. 20 Thus, the high anti-HCV-positive prevalence revealed within this one DC PCC demands further investigation through increased and expanded testing and linkage-to-intendance initiatives.
Footnotes
MedStar Health Research Plant (MHRI) at MedStar Washington Infirmary Center (MWHC) was granted Centers for Illness Control and Prevention (CDC) funding under the Prevention and Public Health Fund 2012 Viral Hepatitis, Early Identification and Linkage to Care for Persons with Chronic HBV and HCV Infections, Category B, Part 3: Testing for HCV Infection and Enhancing Linkage to Medical Care for Persons with Hepatitis C.
Equally this program intended to implement CDC recommendations for routine hepatitis C virus testing as part of the standard of intendance within the primary intendance setting, the MHRI Institutional Review Board deemed information technology unnecessary to obtain approval. The commutation of de-identified clinical information necessary to study on this programme, yet, was conducted in accordance with all Health Insurance Portability and Accountability Act (HIPAA) regulations. As divers by the U.South. Section of Health and Human Services and observed by MedStar, HIPAA standards are required of all MedStar employees. Access to medical records and other patient information for standard-of-care birth-cohort screening and identification was permitted by MWHC.
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