Why Are Baby Boomers Subject to Hep C

Public Health Rep. 2016 May-Jun; 131(Suppl 2): 49–56.

High Hepatitis C Infection Rate Among Baby Boomers in an Urban Primary Care Clinic: Results from the HepTLC Initiative

Alexander G. Geboy, MS, ^a Sandeep Mahajan, MD,^{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, MD^{a, b}

Alexander G. Geboy

^aMedStar Health Research Institute, Hyattsville, MD

Sandeep Mahajan

^bMedStar Washington Hospital Center, Washington, DC

^cCurrent affiliation: Georgetown University Hospital, Washington, DC

Allison P. Daly

^aMedStar Health Research Institute, Hyattsville, MD

Candice F. Sewell

^bMedStar Washington Hospital Center, Washington, DC

Ike C. Fleming

^aMedStar Health Research Institute, Hyattsville, MD

Hyun A. Cha

^aMedStar Health Research Institute, Hyattsville, MD

Idene E. Perez

^aMedStar Health Research Institute, Hyattsville, MD

Carmella A. Cole

^bMedStar Washington Hospital Center, Washington, DC

Adebisi A. Ayodele

^bMedStar Washington Hospital Center, Washington, DC

Dawn A. Fishbein

^aMedStar Health Research Institute, Hyattsville, MD

^bMedStar Washington Hospital Center, Washington, DC

Abstract

Objective

CDC recommends that all people born between 1945 and 1965 be tested for hepatitis C virus (HCV). We hypothesized that HCV testing in a large, urban primary care 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 Center in Washington, DC, provided HCV antibody (anti-HCV) testing and linkage to care from October 2012 through September 2013 for patients born between 1945 and 1965 without previously noted risk factors. We collected data on age, 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's t-tests.

Results

Of 1,123 patients tested, the mean age was 57 years, 742 (66.1%) 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 black/African American patients tested, 49 of 317 men (15.5%) and 44 of 652 women (6.7%) were anti-HCV positive (p,0.001). The HCV prevalence rate in the birth cohort (8.8%) was significantly higher than the U.S. (3.3%) and DC (2.5%) rates (p,0.001), and the HCV prevalence rate among black/African American men in DC (15.5%) was substantially higher than the prevalence rate reported by CDC (8.1%).

Conclusion

Testing initiatives in primary care settings need to be more rigorously upheld, and internal champions are needed to advocate for increased screening to ensure linkage to care and engagement in the HCV care cascade.

Hepatitis C virus (HCV) infection is the most common chronic blood-borne pathogen in the United States. An estimated 3.2 million people have chronic HCV infection in the United States, and an estimated 45%–85% of individuals have been tested. ^1–3 Diagnosing and treating at-risk people before complications such as cirrhosis or hepatocellular carcinoma (HCC) develop is imperative. Recent studies show that 76% of people living with HCV infection in the United States are adults born between 1945 and 1965, also known as the birth cohort or baby boomers. ⁴ With such strong prevalence of disease within this age group, the Centers for Disease Control 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 between 1945 and 1965 and be routine for people at increased risk for infection. ^5–7

Analogous to those living with human immunodeficiency virus (HIV) infection who follow a treatment cascade consisting of diagnosis, linkage to care, retention in care, and treatment, people with HCV infection should pursue the same objectives to improve their disease outcomes. ⁸ Individuals with HCV infection need to be diagnosed by HCV antibody (anti-HCV) and HCV ribonucleic acid (RNA) testing to confirm chronic infection, followed by linkage to care with a provider who can prescribe HCV therapy to achieve sustained virologic response (SVR) and provide other means to decrease the risk of disease progression. ⁹ However, barriers remain between confirmation of infection and achievement of SVR; one study found 5%–6% of all people with HCV infection in the United States successfully progressed from detection of HCV infection to SVR. ^10,11 In 2007, fewer than 85,000 people were treated for HCV infection. ² As new, effective, direct-acting antiviral therapies become more readily available for patients, leading to SVR within a shorter time period, fulfilling the treatment cascade has become even more important and attainable.

Within Washington, D.C. (DC), alone, 9,819 newly confirmed cases of HCV infection and 15,915 total 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 50–59 years (n=4,701, 47.9%), which was twice that of than any other age group. ¹¹ With such data and funding from the CDC Prevention and Public Health Fund (PPHF), MedStar Washington Hospital Center (MWHC) developed a testing center within its primary care clinic (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 (2) identify baseline characteristics of those testing positive for HCV infection. We hypothesized that HCV testing of the birth cohort in a large, urban PCC would reveal higher rates than those previously published in DC and in the United States.

METHODS

Setting

MWHC is a not-for-profit, 926-bed teaching and research hospital located in DC that serves patients from all city wards. The PCC's patient population is largely low-to-middle income and black.

MedStar Health Research Institute, an entity of MedStar Health, provides scientific, administrative, and regulatory support for research and service programs that complement the key clinical services and teaching programs in the MedStar Health system. Testing and linkage activities were conducted in the MWHC PCC with support from the MedStar Health Research Institute.

Program design and development

CDC's 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 improve early identification of HCV in clinical and community settings and enhance linkage to care, treatment, and preventive services for infected people. MWHC's aim was to test 3,000 patients for HCV infection and link those who tested positive to medical care. Patients were identified using General Electric Centricity electronic health records technology and Crystal Reports. ¹² A report was built 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 between 1945 and 1965 and with no record of previous HCV infection history or testing.

Once a report was generated, charts were manually screened for high-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 record (EMR) requesting anti-HCV testing based on CDC and (later) USPSTF recommendations, or offering a rapid finger stick if no anti-HCV test was ordered. Providers could not advance through the patient chart until they closed the pop-up message. It was the provider's choice to offer the test to the patient or order the test as part of the laboratory requisition. To avoid disrupting clinic flow, medical assistants were also trained to attach birth cohort-specific HCV educational material to all checkout paperwork. The flyers were printed on bright neon green paper for visibility, and the intentions were to provide additional educational material to patients without intervening in appointments and to reinforce the need to test patients. If risk factors were observed, separate flags were sent to providers advising HCV testing, and providers were advised to test all birth-cohort patients regardless of risk 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.S. 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. Primary care testing followed this process: If a provider elected a venipuncture test, the provider had the option to select either an anti-HCV test or an anti-HCV test 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, but without a reflex HCV RNA test, an electronic communication was sent to the provider to alert the patient of the result and either order an HCV RNA test or provide the patient with an expedited referral to either infectious disease or gastroenterology providers for HCV RNA testing. If HCV RNA testing was negative, information was provided on risk factors, prevention counseling, transmission, and reinfection risks. If HCV RNA was detected, an expedited referral was made for an initial assessment with infectious disease or gastroenterology providers.

For negative anti-HCV rapid finger stick tests, information was provided by the rapid tester on risk factors, prevention counseling, transmission, and reinfection risk. For positive anti-HCV tests, initial counseling was provided, an HCV RNA test 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, but not engaged with infectious disease or gastroenterology providers, the medical assistants and providers were trained to call the HCV team for an expedited referral and evaluation. On-the-spot HCV counseling was also provided at the providers' and patients' request.

Data collection and analysis

We collected HCV testing data from October 2012 through September 2013. De-identified data were submitted monthly according to project-specific guidelines. We followed patients testing anti-HCV positive through their first HCV appointment. Data collected included age, race/ethnicity, sex, anti-HCV and HCV RNA results, risk factors in those testing anti-HCV positive, and health insurance type. CDC imposed a data lock on June 30, 2014. After this date, new data (e.g., HCV RNA results and first appointment information) could not be uploaded to the Internet-based collection portal. We performed inter-group and intragroup comparisons using c ² and Student's t-tests. We conducted analyses using SAS^® version 9.3. ¹³

RESULTS

From October 1, 2012, to September 30, 2013, 1,123 patients were tested. The mean age was 57.1 6 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 test; 969 (86.3%) patients self-identified as black; and 742 (66.1%) patients were women. Of the 1,123 patients tested, 99 (8.8%) were anti-HCV positive, and men were more likely than women to test anti-HCV positive (odds ratio [OR] = 2.6, 95% confidence interval [CI] 1.7, 3.9) (Table 1).

Table 1.

Characteristics of patients tested for hepatitis C virus as part of the Hepatitis Testing and Linkage to Care (HepTLC) initiative, MedStar Washington Hospital Center, Washington, D.C., October 1, 2012, to September 30, 2013 ^a

Of the 99 anti-HCV-positive patients, 93 (93.9%) were black and 54 (54.5%) were men. Overall, 54 of 381 men (14.2%) tested were anti-HCV positive; of the 969 black patients who were tested, 49 of 317 men (15.5%) and 44 of 652 women (6.7%) were anti-HCV positive (OR=2.8, 95% CI 1.8, 4.2) (Table 2). Forty-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=2.7, 95% CI 1.1, 6.1). Fifty-one of 82 people who tested anti-HCV positive (62.2%) tested HCV RNA positive (indicating chronic infection), of whom 49 (96.1%) were black and 28 (54.9%) were men; we found no statistical difference between sexes. Of the 31 patients who spontaneously cleared infection, the mean age was 58.4 6 4.6 years, 15 were men, 30 were black, and 15 reported intravenous drug use (14 reported no intravenous drug use, and two patients were not asked). The remaining 12 patients were lost to follow-up (Table 1).

Table 2.

Characteristics of patients born between 1945 and 1965 who were tested for hepatitis C virus, by race/ethnicity, sex, and anti-HCV and HCV RNA results, during the Hepatitis Testing and Linkage to Care (HepTLC) initiative, MedStar Washington Hospital Center, Washington, D.C., October 1, 2012, to September 30, 2013 ^a

At the time of data lock by CDC on June 30, 2014, 43 of 51 patients (84.3%) who were HCV RNA positive or chronically infected with HCV had attended a first medical appointment with either infectious disease or gastroenterology providers, with a median time to first medical appointment (i.e., time between date of the anti-HCV test and the first medical appointment) of 110 days (range: 9–406). No patients were on HCV medications at the time 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 appointment 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 (78.7%), with 36 (97.3%) liver stagings completed (Figure). Additionally, 14 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 born 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, 2013^a

^aThe HepTLC initiative promoted viral hepatitis B and hepatitis C screening, posttest counseling, and linkage to care at 34 U.S. sites.

HCV = hepatitis C virus

RNA = ribonucleic acid

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.e., counted on a one-patient, one-appointment-event basis), 855 (33.4%) patients were tested at first presentation to their appointment. However, of the 2,558 appointments made, 610 (23.8%) 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.e., if a patient was not 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, 1,081 (26.8%) patients were missed opportunities, and 1,829 (45.4%) patients were cancellations or no-shows (Table 3).

Table 3.

Primary care clinic appointment outcomes during the Hepatitis Testing and Linkage to Care (HepTLC) initiative for patients born between 1945 and 1965, MedStar Washington Hospital Center, Washington, D.C., October 1, 2012, to September 30, 2013 ^a

DISCUSSION

Increased HCV screening of the birth cohort revealed an anti-HCV-positive prevalence of 8.8%, which is substantially higher 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 birth cohort). HCV chronicity in the MWHC data, with the addition of five patients who were HCV RNA tested and positive after the data lock, revealed a rate of 68.3%, but still 5% of those tested. This rate is lower than the widely reported national rate of 75%–80%, although it falls within the typically cited 55%–85% ¹³ range for HCV chronicity ¹⁴ and should be explored further in the birth cohort. We found 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 group 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 risk factors in the EMR, and only 52.2% were ever intravenous drug users, these patients likely would not have been tested if not for the CDC and USPSTF recommendations.

The 45.4% appointment cancellation rate reflects a systemic issue of urban clinics. However, the 26.8% missed opportunity rate is concerning and should be explored. Once patients present to their appointment, providers often address the most emergent problem, especially in the limited time 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 recently, the Centers for Medicare & Medicaid Services, testing initiatives must become automated and fully integrated into standard-of-care practices. Testing needs to become more comprehensive, integrated with convenient EMR prompts, and maintained as sustainable models, especially within PCCs.

The low numbers of prescriptions written and the lack of patients on treatment prior to the data lock can likely be attributed to two primary factors: the HCV treatment landscape and public health insurance complications. Although the medication landscape changed dramatically after the release of direct-acting antiviral Sovaldi^® Sofosbuvir (Gilead Sciences Inc., Foster City, California) in December 2013, previous medication options were suboptimal, and providers were more likely to wait to treat, especially if identified early in disease progression. Second, although 100% of patients seen had some health insurance, and some insurance providers were covering early prescriptions for Sofosbuvir, the costs were high, and it was unlikely that patients who had early-stage infections were going to be approved and treated.

The lower order rate of liver staging could be attributed to a difference between gastroenterology and infectious disease providers. Although data were limited, it appears gastroenterology providers were not as inclined to order both HCC screening (i.e., 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 not 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-up appointments, and workups should be done expeditiously.

The long wait between the anti-HCV test and the first medical appointment can be attributed to a delay in implementing reflex HCV RNA testing, patient barriers to care, and clinic capacity. It was not until near 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 another appointment with either a primary care provider or a specialist for HCV RNA testing. However, patients did not 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 period to overcome this barrier.

Limitations

These data were subject to several limitations. Risk factors were only collected for those who were anti-HCV positive, and although risk factors can be quantified, the EMR often contains limited information. Providers do not necessarily ask for, and patients do not always offer their risk behaviors. Although testing for HCV without ascertainment of risk is in line with birth-cohort recommendations, it is likely a reason for low testing uptake, as clinical judgments and bias often dictate testing practices.

Testing uptake within the PCC and clinic flow was also a limiting factor, 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 made it to their appointments. It is likely that low uptake was the result of both the asymptomatic nature of HCV infection and provider discretion to treat and discuss the most emergent comorbidity first. In a PCC that in 2011 provided primary medical care to more than 9,000 individuals within the birth cohort, it is possible that there was not enough time per patient to discuss testing. Furthermore, the testing team was not able to fully utilize the EMR to better integrate testing options within the full functionality of the EMR. Provider and patient surveys are currently being quantified to assess these barriers.

CONCLUSION

These data, which are comparable with that of the 2012 DC Department of Health's Annual Epidemiology and Surveillance Report, ¹¹ suggest that the 8.8% HCV infection prevalence at this PCC should raise concerns, especially considering that the previously reported DC HCV prevalence rate of 2.5% is already regarded as an epidemic and comparable with that of HIV. ¹¹ Furthermore, not only is the use of health-care resources by birth-cohort people infected with HCV infection disproportionately large, ¹⁹ but those infected with HCV in the United States account for more 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-care initiatives.

Footnotes

MedStar Health Research Institute (MHRI) at MedStar Washington Hospital Center (MWHC) was granted Centers for Disease 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.

As this program intended to implement CDC recommendations for routine hepatitis C virus testing as part of the standard of care within the primary care setting, the MHRI Institutional Review Board deemed it unnecessary to obtain approval. The exchange of de-identified clinical information necessary to report on this program, however, was conducted in accordance with all Health Insurance Portability and Accountability Act (HIPAA) regulations. As defined by the U.S. Department 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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Why Are Baby Boomers Subject to Hep C

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4853329/

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