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Hepatitis C virus (HCV) enters the liver through the hepatic artery and the portal vein, which are the two blood vessels that transport blood into the liver. Identifying gaps in care for people with chronic hepatitis C virus (HCV) infection is important to clinicians, public health officials, and federal agencies.
We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews for articles published between January 2003 and July 2013. 9,581 articles were identified, 117 were retrieved for full text review, and 10 were included. The HIV treatment cascade (diagnosis, linkage to care, retention in care, prescription of antiretroviral therapy, and viral suppression) is an effective tool for improving the health of people living with HIV (PLWH) and for achieving the public health benefits of antiretroviral therapy [1], [2].
Similar to PLWH, people with chronic hepatitis C virus (HCV) infection need to fulfill several steps along a care continuum to achieve optimal health outcomes [8], [9].
This review identifies large gaps between current practice and treatment goals for people with chronic HCV infection. In 2012, the Centers for Disease Control and Prevention recommended one-time HCV testing without prior ascertainment of risk for persons born between 1945 and 1965 - a group estimated to account for three-fourths of all HCV infections in the U.S. Hepatic fibrosis assessment via liver biopsy is not required for HCV therapy, as per current professional guidelines [11].
The advent of new direct-acting antiviral agents will shorten treatment duration, likely increase the number of people offered treatment, and improve HCV cure rates (final two steps of the HCV treatment cascade) [15], [35]. Individuals' progression along the HCV treatment cascade varied widely, with large drop-offs occurring at diagnosis and awareness of infection, prescription of antiviral therapy, and achievement of SVR. In summary, our results suggest that continued efforts are needed to improve HCV care in the U.S. Data from each included study were extracted by one author (BRY) into tables stratified by HCV treatment cascade step and verified by another author (VLR) for accuracy. The number of chronic HCV-infected persons completing each step along the HCV treatment cascade was determined.
Since multiple studies were identified for HCV treatment cascade steps 5-7, we performed random-effects meta-analyses for these steps to determine pooled prevalence estimates with 95% confidence intervals (CIs). Our literature search yielded 9,581 citations (excluding duplicates), of which 117 met eligibility for full text review (Figure 1). Among those living with chronic HCV, approximately 50% are unaware of their diagnosis based on data from the NHANES Hepatitis C Follow-Up Survey [31], [32]. In this same study, participants who were aware of their chronic HCV status were also asked about their health insurance status [31], [32]. Once in care, measurement of HCV RNA is needed to confirm diagnosis of chronic HCV infection, and staging of liver disease is important for guiding HCV treatment decisions. Two non-VA studies evaluated prescription of pegylated interferon plus ribavirin treatment among patients with chronic HCV infection [27], [29]. Three non-VA studies examined SVR rates among chronic HCV-infected patients who received antiviral therapy [23], [28], [30]. Heim is at the Department of Biomedicine, University of Basel, 4031 Basel, Switzerland and at the Division of Gastroenterology and Hepatology, University Hospital Basel, 4031 Basel, Switzerland. Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection [14]. It also highlights multiple opportunities for improving engagement along the HCV treatment cascade, particularly in the diagnosis and awareness of infection, prescription of antiviral therapy, and achievement of SVR. However, staging of liver fibrosis remains important for determining the urgency and timing of HCV therapy and for identification of cirrhosis, which should prompt screening for hepatocellular carcinoma and monitoring for the development of hepatic decompensation [36], [37].
Studies are needed to evaluate and compare the population-level benefits and costs of interventions, such as screening and treatment efforts, at each step. First, our treatment cascade included seven steps, as identified by prior research [8], [9], evaluated at one time point. In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care.

We searched MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews for English language articles published between January 2003 and July 2013 using keywords and structured language representing each step along the HCV treatment cascade [18]. Articles were selected for full-text review if they were relevant to HCV treatment cascade steps. A total of 500 participants who tested positive for HCV RNA between 2001 and 2010 were asked if they were aware of their HCV status before being notified by NHANES.
Data from the Chronic Hepatitis B and C Cohort Study, which included 8,810 patients with chronic HCV receiving care at four health systems in the U.S. Given the recent introduction of direct-acting antiviral agents, we did not identify any population-based studies evaluating these agents that met our selection criteria. Heim is Professor of medicine and Chief of the Division of Gastroenterology and Hepatology, University Hospital Basel, Switzerland. As different patient behaviors and health system mechanisms are required to successfully complete each step of the cascade, it also demonstrates the need for coordinated action to meet treatment goals [7]. Once in care, patients should have HCV RNA confirmation testing and undergo liver fibrosis staging to help inform prognosis and make decisions regarding HCV therapy [11]. As antiviral therapy for chronic HCV advances to become more convenient, effective, and better-tolerated, monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies [15]. In a recent cost-effectiveness simulation evaluating birth-cohort HCV screening and subsequent treatment of HCV-infected adults, Rein and colleagues note that birth-cohort screening followed by HCV treatment including direct-acting antiviral agents will increase quality-adjusted life-years (QALYs) by $532,200 and medical costs by $19.0 billion, for an incremental cost-effectiveness ratio of $35,700 per QALY saved (95% credible interval, $28,200 to $47,200) [40]. These data can further assist public health officials in allocating resources to increase the proportion of chronic HCV-infected patients completing the cascade steps. Veterans [42], we conducted a separate analysis to estimate the numbers of chronic HCV-infected people completing steps 5-7 in the HCV treatment cascade using VA-specific data. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments. Two independent reviewers (BRY and VLR) evaluated articles selected for full-text review using a standardized form. The use of data collected after January 1, 2000 corresponds with the introduction of dual therapy with a pegylated interferon and ribavirin for the treatment of chronic HCV infection that occurred in the early 2000 s, and was also selected to ensure the use of the most current data available. Because of differences in the prevalence of comorbid diseases, as well as the management and treatment of chronic HCV infection between U.S. Since NHANES did not sample high-risk groups, particularly incarcerated, homeless, or institutionalized individuals, the actual prevalence of chronic HCV infection was estimated to be 3.5 million [22].
Kanwal and colleagues examined prescription rates among 2,893 patients enrolled in one of the largest commercial health insurance carriers in the U.S.
Most patients do not develop substantial liver fibrosis or clinically relevant liver disease. His laboratory has an interest in signal transduction in liver disease, with a particular focus on the role of interferons in acute and chronic viral hepatitis.Contact Markus H. Lastly, individuals must receive and adhere to HCV treatment to achieve a sustained virologic response (SVR) [12]. This systematic review and meta-analysis builds on prior studies evaluating rates of HCV detection, referral to care, and treatment [16], [17], and integrates published data to provide estimates of the number of chronic HCV-infected persons living in the U.S. While these simulations accounted for common HCV-associated complications, funders, public health administrators, and providers should be aware of the financial burden of untreated HCV infection. Among chronic HCV-infected Veterans in care, the proportion of those who received hepatic fibrosis staging by liver biopsy and who were prescribed HCV treatment was 22% and 19% lower, respectively, compared to the general population. Only by increasing the number of persons completing each step in the cascade can the goals of the U.S.
Among those diagnosed and aware of their chronic HCV infection, we estimated the number with access to outpatient care (cascade step 3). Similarly, among Veterans with chronic HCV infection who were prescribed pegylated interferon plus ribavirin, a smaller proportion achieved SVR compared to the general population (44% vs. Further, since patients receive care over time, the studies included in this analysis may not have allowed sufficient time for certain steps in the HCV treatment cascade to take place.

If multiple publications resulted from the same patient sample or longitudinal cohort, we selected the most inclusive and current study.
Next, among chronic HCV-infected persons diagnosed and aware of their infection and with access to outpatient care, we estimated the number who had: HCV RNA confirmed (cascade step 4), underwent a liver biopsy (cascade step 5), and antiviral therapy prescribed (cascade step 6).
In contrast, an evaluation of the national VA Hepatitis C Clinical Case Registry from 1997 to 2006 indicated that only 16.7% (28,677 of 171,893) of VA patients with chronic HCV received a liver biopsy [25]. Decompensated cirrhosis and hepatocellular carcinoma are the most important causes of mortality in end-stage CHC. Monitoring the steps of the cascade over time may help to define overall progress toward population-based goals and barriers at individual steps. Since cascade steps 4-6 had the same denominator, the proportion of persons prescribed HCV treatment was not conditioned on the number with HCV RNA confirmation and liver biopsy. In addition, the proposed HCV treatment cascade provides a framework for evaluating the delivery of HCV care over time and within subgroups, which will be necessary to monitor the impact of new screening efforts [33], [34] and advances in antiviral therapy [34], [35] which will likely increase the number of people completing each step along the cascade. These variations may be due to differences in patient populations or in VA provider practices. Second, our systematic review was limited by the relatively small number of studies identified, particularly for cascade steps 1-3. Finally, among persons prescribed HCV treatment, we estimated the number that achieved a sustained virologic response (cascade step 7).
Prior studies indicate that Veterans with chronic HCV have higher rates of absolute and relative contraindications to HCV treatment than persons seen at non-VA clinics [43]-[45]. Many studies excluded prisoners and homeless individuals, populations heavily affect by chronic HCV infection. Using the above estimates, we calculated the proportion of chronic HCV-infected persons completing each step along the HCV treatment cascade by dividing the number of people who completed each step (numerator) by the number of chronic HCV-infected persons in the U.S. In addition, differences in medication adherence [12], provider management, and health system factors may contribute to the lower proportion of Veterans completing the final steps of the HCV treatment cascade. This estimate differed from data reported by the VA system, where 17.9% (6,224 of 34,749) of chronic HCV-infected patients have been prescribed pegylated interferon plus ribavirin treatment [26].
Third, we broadly focused on estimating the number of chronic HCV-infected people in the general population.
Fourth, HCV RNA confirmation in evaluated studies was restricted to patients' healthcare network.
This may underestimate HCV RNA testing, particularly for patients who transfer care between providers. Similarly, liver biopsy was used as the marker for HCV disease staging; however, this may underestimate the number of people who were staged through the use of noninvasive tests. Fifth, not all patients immediately require or are eligible to receive antiviral therapy for chronic HCV, which may underestimate the proportion of patients treated.
Further, failure to achieve SVR may be a consequence of biological factors, including HCV genotype, treatment efficacy and tolerability, or adherence to therapy. Differentiating between these causes may be important because each requires a different intervention strategy.
In addition, data on prescription and SVR rates of newer direct-acting anti-HCV medications were not available. Monitoring how these steps change as providers increasingly use these new therapies will be critical.

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