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3 The Elimination of Hepatitis C
Pages 83-134

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From page 83...
... . In addition to contaminated blood transfusions, HCV is primarily spread from person to person by injection drug use, and, less commonly, through sex (particularly 83
From page 84...
... . Chronic HCV infection can progress to end-stage liver disease, including liver cancer.
From page 85...
... When interferon treatments were standard of care for hepatitis C, sustained virologic response was defined as negative viral load 24 weeks after cessation of therapy. With direct-acting antivirals, this timeframe is shortened to 12 weeks.
From page 86...
... Disease elimination programs generally rely on clinically apparent signs of infection or complications. Identifying acute HCV infection requires active testing to identify seroconversion and repeated testing over time, unless a crosssectional incidence assay becomes available (Patel et al., 2016)
From page 87...
... This epidemiological challenge is aggravated by the heavy concentration of HCV infections in difficult-toreach populations, including people who inject drugs and the homeless, as well as marginalized groups such as the incarcerated. These groups are not generally represented, sometimes systematically under-represented, in national surveillance surveys such as NHANES (Edlin et al., 2015)
From page 88...
... Reducing morbidity and Slowing progression to Feasible • Problems assessing and staging • The high cost of directmortality attributable to cirrhosis fibrosis acting antiviral drugs ongoing infection • Obesity, HIV, alcohol use can makes universal treatment aggravate disease progression unfeasible. • Eradicating the virus before • Hepatitis C is not a public Reducing deaths progression to advanced priority.
From page 89...
... ENDING TRANSMISSION OF HEPATITIS C Eliminating hepatitis C will require stopping transmission of the virus. In the United States, people who inject drugs have the highest risk of transmitting the virus (Alter, 1997)
From page 90...
... . There is reason to believe that needle and syringe exchange programs, counselling, and opioid replacement therapy (collectively called harm reduction services)
From page 91...
... . As the burden of disease is heaviest among people who inject drugs, a 90 percent reduction in prevalence in the United States would require screening 20 percent of injection drug users and treating about a third of those infected (Durham et al., 2016)
From page 92...
... 3. stablish robust programs to link to care, treat, and cure patients E with hepatitis C The Cherokee Nation Health Service estimates there are 4,300 hepatitis C pa tients in the Cherokee Nation, of which 274 initiated treatment in 2015, 90 percent of those who started treatment achieved 12-week sustained virologic response.
From page 93...
... 4.  educe the incidence of new hepatitis C infections in the Cherokee R Nation Health Services Among Cherokee patients, injection drug use, tattoos from unlicensed artists, blood transfusion, and occupational exposure to blood are the most common risk factors for HCV.
From page 94...
... A 2013 analysis pooled data from seven studies on reinfection with HCV following treatment-induced sustained virologic response in men who have sex with men and people who inject drugs (Grady et al., 2013)
From page 95...
... The burden of HCV is also felt more among the poor and less educated; fewer than half of people with HCV infection have incomes greater than twice the poverty level or education beyond high school (Denniston et al., 2014)
From page 96...
... . One recent meta-analysis made clear that the sharpest drop in the continuum from infection to sustained virologic response was in the diagnosis of HCV infection (Yehia et al., 2014)
From page 97...
... Access to Direct-Acting Antiviral Therapies Direct-acting antiviral drugs make cure possible in 95 percent of chronic HCV infections, but their use is limited. The cost of these treatments is discussed later in this chapter, but briefly, the high cost and anticipated demand for these drugs have led many insurers to restrict access to these medications.
From page 98...
... The direct-acting antivirals are easier to tolerate, but to date no studies have evaluated the effects of adherence on serological markers of infection. Given the costs of these therapies and the possible consequences of non-adherence (i.e., drug resistance, continued progression of liver disease, potential to transmit HCV infection)
From page 99...
... Key Findings and Conclusions •  he direct-acting antiviral drugs that cure hepatitis C virus infection are expen T sive, so insurers restrict their access, usually asking for evidence of advanced fibrosis or consultation with a specialist; some also require confirmation of sobriety. •  tate Medicaid programs have widely different restrictions on treatment.
From page 100...
... . The Staging and Progression of Hepatitis C The progression of HCV infection is closely linked to the severity of fibrosis.
From page 101...
... . When HCV patients also have fatty liver disease,
From page 102...
... In follow-up studies over 5 years and longer, patients with sustained virologic response have undetectable HCV RNA; relapse is rare and associated with pre-treatment cirrhosis (George et al., 2009; Maylin et al., 2009) Eradicating the virus before the patient starts progression to advanced fibrosis can also largely eliminate the risk of hepatic complications.
From page 103...
... HCV patients with Child4 B and C cirrhosis not only had high response rates to direct-acting antiviral therapy, with 86 to 89 percent showing sustained virologic response, but also had improvements in Childs score, MELD score,5 albumin and bilirubin levels (Charlton et al., 2015)
From page 104...
... For those who already have advanced fibrosis, sustained virologic response is still an effective means to reducing cancer risk. A recently published meta-analysis showed that among 2,649 patients with advanced fibrosis only 4.2 percent of patients who achieved sustained virologic response developed hepatocellular carcinoma, compared to 17.8 percent of patients who did not respond to therapy (Morgan et al., 2013)
From page 105...
... HCV-related cirrhosis is the leading indication for liver transplantation in the United States. •  wenty to 40 percent of people with chronic HCV infection will develop cirrho T sis.
From page 106...
... . People who inject drugs are less likely to receive medical care, and are therefore less commonly reported to the health department.
From page 107...
... A proper understanding of HCV burden would also attempt to capture the consequences of chronic infection, linking surveillance to health insurance claims, electronic health records, and birth, death, and cancer registries. There is also a need for deliberate attention to those populations at high risk for the disease: people who inject drugs, the homeless, and incarcerated.
From page 108...
... Research in sexually transmitted disease clinics found that HCV counselling, testing, and referral for people who inject drugs cost about $25 per patient tested (Honeycutt et al., 2007) .6 About 45 percent of participants who inject drugs returned to the clinic for their results, a far better rate of return that found among the non drugusing patients of whom less than 13 percent returned (Honeycutt et al., 2007)
From page 109...
... It can be difficult to separate the benefits directly due to the chronic care model from those due to an observer bias, but the BOX 3-3 Wagner's Chronic Care Model Much of the medical system was designed to respond to acute health crises, but nowadays the more common health problems are chronic ones. The Chronic Care Model was developed in response to this observation and aims to improve care of patients with chronic illness by encouraging informed, motivated patients and prepared, responsive practice teams.
From page 110...
... . Cost An emphasis on diagnosis and bringing patients to care will do much to reduce the burden of disease from HCV, but the most promising tool to eliminate chronic disease is the direct-acting antiviral drugs that elicit sustained virologic response in more than 95 percent of patients (Kohli et al., 2015)
From page 111...
... Taken together these estimates imply that roughly 350,000 patients have initiated treatment with direct-acting agents since their introduction in late 2013. Given the estimated HCV prevalence in the United States, one can assume between seven and fourteen percent of people with HCV infection have initiated treatment with direct-acting agents (Edlin et al., 2015)
From page 112...
... . Three-quarters of states' Medicaid programs limit access to persons with advanced liver disease, two-thirds of states have restrictions based on prescriber type, and half require a period of abstinence (Barua et al., 2015)
From page 113...
... . Second, proponents of the current pricing model maintain that high prices are needed to encourage innovation.
From page 114...
... . Eliminating HCV infection would require near universal access to treatment, something that appears infeasible given the current pricing and policy environment.
From page 115...
... . Almost 30 percent of chronic hepatitis C patients in a cohort study met the criteria for depression, though sustained virologic response post-treatment was found to improve these symptoms (Boscarino et al., 2015)
From page 116...
... Prison health systems are not generally large enough to negotiate a substantial discount on direct-acting agents. As the director of the Rhode Island Department of Corrections explained in an interview with National Public Radio, treating HCV can be assumed to cost roughly $150,000 per patient and hundreds of Rhode Island inmates have chronic 12  2013 estimate.
From page 117...
... Key Findings and Conclusions •  njection drug use drives most hepatitis C virus (HCV) transmission in the I United States, and people who inject drugs are less likely to be tested for HCV or captured in disease surveillance data.
From page 118...
... Only about one in ten people with chronic HCV infection receives curative treatment. •  he introduction of direct-acting antivirals for hepatitis C drove most of the T acceleration in prescription drug spending between 2013 and 2014.
From page 119...
... 2011. A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C
From page 120...
... 2015. Prevention, treatment and care of hepatitis C virus infection among people who inject drugs.
From page 121...
... 2015. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease.
From page 122...
... 2001. The influence of human immunodeficiency virus coinfection on chronic hepatitis C in injection drug users: A long-term retrospective cohort study.
From page 123...
... 2011. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases.
From page 124...
... 2004. Hepatitis C virus infection among injection drug users: Survival analysis of time to seroconversion.
From page 125...
... 2010. Quality of care in patients with chronic hepatitis C virus infection: A cohort study.
From page 126...
... 2012. Chronic hepatitis C virus infection increases mortality from hepatic and extrahepatic diseases: A community-based long-term prospective study.
From page 127...
... 2013b. Hepatitis C virus treatment for prevention among people who inject drugs: Modeling treatment scale up in the age of direct-acting antivirals.
From page 128...
... 2013. Eradica tion of hepatitis C virus infection and the development of hepatocellular carcinoma: A meta-analysis of observational studies.
From page 129...
... 2015. Underascertainment of acute hepatitis C virus infections in the U.S.
From page 130...
... 2003. Nonalcoholic fatty liver disease in patients with hepatitis C is associ ated with features of the metabolic syndrome.
From page 131...
... 2014. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012.
From page 132...
... 2007. Seroprevalence of hepatitis C virus and hepatitis B virus among San Francisco injection drug users, 1998 to 2000.
From page 133...
... 2007. Sustained virologic re sponse and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis.
From page 134...
... 2015. Increases in hepatitis C virus infection related to injection drug use among persons aged ≤30 years -- Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012.


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