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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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1

Introduction

In June 2016 the World Health Assembly set the goal of eliminating viral hepatitis as a major public health problem by 2030 (WHO, 2016a). In the first strategy document of its kind, the organization concluded, “hepatitis has been largely ignored as a health and development priority until recently,” despite causing more deaths than HIV, tuberculosis, or malaria (Stanaway et al., 2016; WHO, 2016a; Wiktor and Hutin, 2016).

The world cannot afford to ignore viral hepatitis any longer. The Global Burden of Disease Study estimated 1.45 million deaths from viral hepatitis in 2013 (95 percent confidence interval [CI]: 1.38 to 1.54 million) (Stanaway et al., 2016). Together hepatitis B virus (HBV) and hepatitis C virus (HCV) account for 96 percent of these deaths (Stanaway et al., 2016), more than 21,000 of them in the United States (CDC, 2016). Such loss of life comes at a cost to society, both in the direct financial burden of treatment and indirectly through the loss of adults in their prime—most viral hepatitis deaths cull from the 45 to 64 age group (Ly et al., 2012).

There is no longer any reason to disregard these diseases. There is an effective vaccine to prevent hepatitis B, advances in treatment can prevent most deaths in those chronically infected with HBV, and hepatitis C is now curable with a short course of easily tolerated treatment (Afdhal et al., 2014; Feld et al., 2014). (Box 1-1 describes a national treatment program in Egypt.) Preventive measures against both infections abound (Thomas, 2013). Hepatitis B vaccine confers long-standing immunity in 95 percent of recipients (WHO, 2015); immunization of newborns prevents community acquisition in childhood (Mast et al., 2005). Mother-to-child transmission of HBV, once inevitable, can now be prevented in 85 to 95 percent of cases

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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(Nelson et al., 2014). Direct-acting antiviral treatments with cure rates of 95 percent and higher have revolutionized hepatitis C care (Afdhal et al., 2014; Zoulim et al., 2015). Although there is no vaccine for HCV, secondary prevention measures can impede the spread of infection. In the United States, where most new HCV infections are associated with injection drug use, syringe exchange programs have particular promise to interrupt transmission (Mehta et al., 2011). Treatment of all chronic infections would do the same.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

Yet this committee’s previous report concluded that while elimination of hepatitis B and C in the United States may be entirely feasible, it is not likely without meaningful changes to policy and directed research (Buckley and Strom, 2016; NASEM, 2016). Like a previous Institute of Medicine committee that commented on woefully underfunded surveillance systems and inadequate public spending on viral hepatitis prevention and treatment, this committee’s previous report discussed limitations with, among other things, surveillance, case detection, and access to care, as well as gaps in the current understanding of the viruses (IOM, 2010; NASEM, 2016). The report concluded that most of the barriers to preventing and treating viral hepatitis could be seen as consequences of another, more basic problem: viral hepatitis is not a public priority in the United States.

The United States is not alone in this, as the World Health Assembly resolution observed. The international movement toward eliminating hepatitis B and C as public health problems could help generate the impetus for change. A concrete action plan and clear goals could also do much to change attitudes domestically. The United States should not come late or halfheartedly to the global elimination effort. With this in mind, the Committee on a National Strategy for the Elimination of Hepatitis B and C issues this strategy document recommending actions that will hasten the end of HBV and HCV infections and deaths in the United States and advance the international goal of eliminating the public health problem of viral hepatitis by 2030.

THE CHARGE TO THE COMMITTEE

The Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) have a commitment to fighting viral hepatitis; the CDC Division of Viral Hepatitis and the HHS Office of Minority Health sponsored the first phase of this project. In phase two, the original sponsors were joined by the American Association for the Study of Liver Diseases, the CDC Division of Cancer Prevention and Control, the Infectious Diseases Society of America, and the National Viral Hepatitis Roundtable. Box 1-2 shows the statement of task for both phase one and two of this project, though this report is limited to the phase two task.

The Phase One Report

In the first phase of this project, the sponsors asked the committee whether it is feasible to eliminate hepatitis B and C from the United States. The first publication in this series briefly reviewed the literature on the

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

epidemiology and natural history of both infections.1 The committee then considered the feasibility of eliminating hepatitis B and C, dividing that question into smaller questions about ending transmission and reducing morbidity and mortality from chronic infection; for hepatitis C it also weighed the feasibility of eliminating chronic infection.

Part of the challenge of this task was first clarifying exactly what level of disease control could be considered elimination. Unlike eradication, which refers to a permanent, zero-level incidence of new infections without ongoing control measures, elimination is a softer target (CDC, 1993; Dowdle, 1998). CDC definitions of disease elimination emphasize cessation of transmission, and allow for circumstances where a disease may remain,

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1 The committee encourages readers who are unfamiliar with the basic virology and natural history of these infections to consult the first report.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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but its most devastating consequences avoided (e.g., trachoma remains, but with no further cases of blindness) (CDC, 1993). In this understanding, disease elimination can refer to a level of control where the disease is no longer considered a public health problem (CDC, 1993).

In considering the elimination of hepatitis B and C from the United States, it is important to remember that both infections are endemic abroad, making frequent importation of cases inevitable. Hepatitis C, though curable, is not vaccine-preventable. Chronic HBV infection, on the other hand, is incurable, but largely preventable with vaccination and prophylactic measures against vertical transmission. Antiviral treatment can reduce the risk of disease progression; there is no reason why people with chronic hepatitis B should not live long lives and die of unrelated causes. For these reasons, the committee concluded that, “hepatitis B and C could both be eliminated as public health problems in the United States, but that this would take considerable will and resources” (NASEM, 2016, p. 2). The report went on to define a public health problem as one that, “by virtue of transmission or morbidity or mortality commands attention as a major threat to the health of the community” (NASEM, 2016, p. 2). Tables 1-1 and 1-2 summarize the committee’s assessment of these questions, as well as critical factors relating to each step, and barriers to meeting the elimination goal.

This phase of the project builds off the conclusions of the phase one report. In this document, the committee has been asked to lay out appropriate goals for hepatitis reduction over time and specific actions to achieve them, being clear about possible barriers and ways to overcome them and articulating responsibilities for key stakeholders.

The Committee’s Approach to Its Charge

The committee met three times to prepare this report; see Appendix C. In closed session, the group evaluated the evidence and deliberated on the best strategy to eliminate hepatitis B and C as public health problems in the United States. Based on expert opinion and review of the evidence, the committee came to conclusions about a suitable strategy, recommending actions for specific organizations to reach this goal. The committee drew on published literature and presentations from expert speakers in its deliberations. Members of the public submitted written testimony to the committee (available from the National Academies of Sciences, Engineering, and Medicine’s Public Access Records Office, PARO@nas.edu).

The World Health Organization’s 2016 strategy document identified five areas in which action will be needed, referred to in the document as strategic directions. These five areas are meant to guide countries’ formation of their national strategies, each area addressing a set of essential questions (see Box 1-3). This report is organized around these five strate-

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

TABLE 1-1 The Feasibility of Eliminating Hepatitis B as a Public Health Problem in the United States with Critical Factors for Success and Crosscutting Problems

Goal Feasibility Critical Factors Crosscutting Barriers
Ending transmission Perinatal Highly feasible
  • Identifying HBV-infected mothers
  • Consistent birth dosing with hepatitis B vaccine
  • Surveillance is sporadic and underfunded.
  • Vaccine tracking across jurisdictions is poor.
  • Stigma keeps people from screening and care.
  • Foreign-born adults can be difficult to reach with screening and treatment programs.
  • Much of the burden for managing chronic hepatitis B falls on overworked primary care providers.
  • There is a need to better understand the virus and the management of chronic HBV infection.
Children Highly feasible
  • Consistent vaccination and attention to catch-up dosing
Adults Feasible
  • No system for vaccinating adults
  • Undiagnosed, asymptomatic chronic infections a reservoir for infection
Reducing morbidity and mortality attributable to ongoing infection Slowing progression to cirrhosis Reducing deaths Feasible
  • Need for physicians trained in the management of chronic HBV infection
  • The threat of reactivation in chronic or resolved infection
  • No available treatment eliminates cccDNA or cures the disease

NOTE: cccDNA = covalently closed circular DNA; HBV = hepatitis B virus.

SOURCE: NASEM, 2016.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

TABLE 1-2 The Feasibility of Eliminating Hepatitis C as a Public Health Problem in the United States with Critical Factors for Success and Crosscutting Problems

Goal Feasibility Critical Factors Crosscutting Barriers
Ending transmission Feasible
  • No vaccine
  • Reaching people who inject drugs with harm reduction programs
  • Comprehensive drug and alcohol programs
  • Treating those transmitting the virus to prevent new infection
  • Reducing the possibility of reinfection
  • Surveillance is sporadic and underfunded.
  • Only about half of chronically infected people have been diagnosed.
  • Most new infection is associated with injection drug use, the group most affected is difficult to screen.
  • Poor, marginalized, and hard-to-reach populations are difficult to enroll and retain in care.
  • The high cost of direct-acting antiviral drugs makes universal treatment unfeasible.
  • Hepatitis C is not a public priority.
  • Stigma keeps highest risk people away from care.
  • The limited capacity of prison health systems to treat HCV-infected inmates.
Eliminating chronic infection Feasible
  • Increasing access to treatment
  • The threat of antiviral resistance
  • Understanding the role of treatment adherence
Reducing morbidity and mortality attributable to ongoing infection Slowing progression to cirrhosis Feasible
  • Problems assessing and staging fibrosis
  • Obesity, HIV, alcohol use can aggravate disease progression
  • Eradicating the virus before progression to advanced fibrosis can almost eliminate complications and risk of death
  • Need for reliable models of disease progression
Reducing deaths

NOTE: HCV = hepatitis C virus.

SOURCE: NASEM, 2016.

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

gic directions: information, interventions, service delivery, financing, and research. A separate chapter presents the results of commissioned models informing the committee’s goals on suitable targets, interim indicators, and a timeline for elimination in the United States.

HEPATITIS AND LIVER CANCER

The 2016 Annual Report to the Nation on the Status of Cancer celebrated continued declines in cancer deaths in the United States, attributing much of this progress to public health (Ryerson et al., 2016). Tobacco control measures have curbed the incidence of many cancers, especially lung cancer, long the most common and fatal cancer in the country (CDC, 2011; Henley et al., 2014; Jemal et al., 2008). Improved screening, early diagnosis, and treatment have contributed to declines in incidence and lengthened survival time for lung, colorectal, prostate, and breast cancers (Edwards

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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et al., 2010, 2014; Kohler et al., 2015; Ryerson et al., 2016). The recent annual report highlighted one troubling trend, however. The incidence of hepatocellular carcinoma, the most common form of primary liver cancer, increased 38 percent between 2003 and 2012, the most recent years for which data are available (Ryerson et al., 2016). Liver cancer deaths rose 56 percent in the same time, a sharper increase than that of any other cancer (Ryerson et al., 2016). Data from 2008 to 2012 indicate a disproportionate increase in racial and ethnic minorities: American Indian and Alaska Natives have the highest incidence of liver cancer (14.9 per 100,000), followed by Asian and Pacific Islanders (13.8 per 100,000) and Hispanics (12.7 per 100,000). Among non-Hispanic blacks, the age-specific rate of liver cancer has shifted over time and is now highest (around 60 per 100,000 people) at the relatively young ages of 55 to 59 (Ryerson et al., 2016). Another recent study confirmed the increase in hepatocellular carcinoma incidence,

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

especially among subgroups such as men aged 55 to 64, and highlighted geographic variation in the trend (White et al., 2016).

Hepatitis B and C are driving this increase. Together HBV and HCV account for about 80 percent of the world’s hepatocellular carcinoma (the most common form of liver cancer) (Arzumanyan et al., 2013).

Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×

Chronic hepatitis B increases odds of liver cancer 50 to 100 times, chronic hepatitis C by 15 to 20 times (El-Serag, 2012; Sherman and Llovet, 2011). Action against viral hepatitis is essential to combatting liver cancer. Box 1-4 describes Mongolia’s hepatitis elimination program in response to the country’s high rate of liver cancer mortality.

Much as public health measures have lessened the burden of lung, breast, colorectal, and prostate cancers over time, so can public health programs reverse troubling trends in liver cancer. This report outlines ways to reduce the burden of viral hepatitis in the United States and discusses the likely effects of such a reduction on the incidence of liver cancer and its frequent precursor, cirrhosis. The strategy of expanded screening and treatment, improved surveillance, harm reduction, adult vaccination, and ensured access to medicines would make hepatitis B and C rare diseases in the United States by 2030.

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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Page 23
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Page 24
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Page 25
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×
Page 26
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
×
Page 27
Suggested Citation:"1 Introduction." National Academies of Sciences, Engineering, and Medicine. 2017. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC: The National Academies Press. doi: 10.17226/24731.
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Page 28
Next: 2 Targets for Elimination »
A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report Get This Book
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Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world’s hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 viral hepatitis, of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common types, surpassed HIV and AIDS to become the seventh leading cause of death worldwide.

The world now has the tools to prevent hepatitis B and cure hepatitis C. Perfect vaccination could eradicate HBV, but it would take two generations at least. In the meantime, there is no cure for the millions of people already infected. Conversely, there is no vaccine for HCV, but new direct-acting antivirals can cure 95 percent of chronic infections, though these drugs are unlikely to reach all chronically-infected people anytime soon. This report, the second of two, builds off the conclusions of the first report and outlines a strategy for hepatitis reduction over time and specific actions to achieve them.

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