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'An estimated 2.2 million Americans are currently living with Hepatitis C virus (HCV) infection.' +
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' The majority (55-85%) of those acutely infected with HCV will develop chronic infections, which can lead to cirrhosis, hepatocellular carcinoma, and extrahepatic manifestations, including depression and chronic renal disease.' +
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' In 2011, the treatment of chronic HCV was transformed with the approval of the first HCV protease inhibitor therapies, or direct-acting antivirals (DAAs).' +
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' The goal of HCV treatment with DAAs is sustained virologic response (SVR), consistent with cure of hepatitis C infection.' +
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' SVR rates following DAA treatment generally exceed 90%.' +
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' DAA treatment is also associated with substantial improvements in patient-reported outcomes' +
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' and few serious adverse events. ' +
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' Accordingly, recent guidelines strongly recommend the treatment of nearly all HCV-infected patients with direct-acting antivirals. These include 2018 guidelines promulgated by the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA),' +
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' the World Health Organization (WHO),' +
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' the European Association for the Study of the Liver (EASL)' +
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' and the Canadian Association for the Study of the Liver (CASL).' +
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'
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'Treatment failures with DAAs are often attributed to poor adherence,' +
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' and both the CASL' +
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' and the WHO' +
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' recommend that investigations of a failure to achieve SVR with DAA treatment include an examination of adherence. Further, the AASLD/IDSA' +
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' and EASL' +
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' cite adherence education as an essential component of treatment, and the Australasian Hepatology Association provided an in-depth discussion of adherence to DAAs in its 2016 consensus guidelines on the Provision of Adherence Support for People with Hepatitis C on DAAs.' +
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' A 2013 analysis of two Phase 3 clinical trials found that adherence to duration of treatment was a stronger predictor of SVR achievement than adherence to the dosing interval of the DAA boceprevir. In that analysis, previously untreated patients who adhered to > 80% of their assigned treatment duration had significantly higher SVR rates (89-90%) than their counterparts who adhered to <80% of their assigned treatment duration (19-32%, p < 0.0001).' +
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' A more recent study reported that the SVR rate among an entire cohort, including patients who discontinued treatment early, was significantly lower than among a per-protocol cohort that included only adherent patients (75% vs. 95%, p < 0.001).' +
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' The need for treatment persistence was further supported by real world evidence that 81% of patients who had not yet responded to sofosbuvir-based treatment at week 4 had SVR after week 12.' +
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' Therefore, this performance measure for use in adults who initiated antiviral therapy for treatment of chronic Hepatitis C evaluates the percentage who completed the minimum intended duration of therapy with no significant gap(s) in therapy.
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