Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (Free Summary)
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Free Summary
ISBN: 978-0-309-14628-9, 252 pages, 6 x 9, hardback (2010)
This summary plus thousands more available at www.nap.edu.
Hepatitis and Liver Cancer: A National Strategy for
Prevention and Control of Hepatitis B and C
Heather M. Colvin and Abigail E. Mitchell, Editors;
Committee on the Prevention and Control of Viral
Hepatitis Infections; Institute of Medicine
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The global epidemic of hepatitis B and C is a serious public health problem. Hepatitis B
and C are the major causes of chronic liver disease and liver cancer in the world. In the
next 10 years, 150,000 people in the United States will die from liver disease or liver
cancer associated with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV)
infections. Today, between 800,000 and 1.4 million people in the United States have
chronic hepatitis B and between 2.7 and 3.9 million have chronic hepatitis C. People most
at risk for hepatitis B and C often are the least likely to have access to medical services.
Reducing the rates of illness and death associated with these diseases will require greater
awareness and knowledge among health care workers, improved identification of at-risk
people, and improved access to medical care.
Hepatitis B is a vaccine-preventable
disease. Although federal public health officials recommend that all newborns, children,
and at-risk adults receive the vaccine, about 46,000 new acute cases of the HBV infection
emerge each year, including 1,000 in infants who acquire the infection during birth from
their HBV-positive mothers. Unfortunately, there is no vaccine for hepatitis C, which is
transmitted by direct exposure to infectious blood.
Hepatitis and Liver Cancer identifies
missed opportunities related to the prevention and control of HBV and HCV infections.
The book presents ways to reduce the numbers of new HBV and HCV infections and the
morbidity and mortality related to chronic viral hepatitis. It identifies priorities for research,
policy, and action geared toward federal, state, and local public health officials,
stakeholder, and advocacy groups and professional organizations.
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Summary
In the next 10 years, about 150,000 people in the United States will die
from liver cancer and end-stage liver disease associated with chronic
hepatitis B and hepatitis C. It is estimated that 3.5–5.3 million people—
1–2% of the US population—are living with chronic hepatitis B virus
(HBV) or hepatitis C virus (HCV) infections. Of those, 800,000 to 1.4 million
have chronic HBV infections, and 2.7–3.9 million have chronic HCV
infections. Chronic viral hepatitis infections are 3–5 times more frequent
than HIV in the United States.
Because of the asymptomatic nature of chronic hepatitis B and hepatitis
C, most people infected with HBV and HCV are not aware that they have
been infected until they have symptoms of cirrhosis or a type of liver cancer,
hepatocellular carcinoma (HCC), many years later. About 65% and 75% of
the infected population are unaware that they are infected with HBV and
HCV, respectively. Importantly, the prevention of chronic hepatitis B and
chronic hepatitis C prevents the majority of HCC cases because HBV and
HCV are the leading causes of this type of cancer.
Although the incidence of acute HBV infection is declining in the
United States, due to the availability of hepatitis B vaccines, about 43,000
new acute HBV infections still occur each year. Of those new infections,
about 1,000 infants acquire the infection during birth from their HBVpositive
mothers. HBV is also transmitted by sexual contact with an infected
person, sharing injection drug equipment, and needlestick injuries.
African American adults have the highest rate of acute HBV infection in
the United States and the highest rates of acute HBV infection occur in the
southern region. People from Asia and the Pacific Islands comprise the largCopyright
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HEPATITIS AND LIVER CANCER
est foreign-born population that is at risk for chronic HBV infection. The
number of people in the United States who are living with chronic HBV
infection may be increasing as a result of immigration from highly endemic
countries. On the basis of immigration patterns in the last decade, it is estimated
that every year 40,000–45,000 people from HBV-endemic countries
enter the United States legally.
There is no vaccine for hepatitis C. HCV is efficiently transmitted by
direct percutaneous exposure to infectious blood. Persons likely to have
chronic HCV infection include those who received a blood transfusion before
1992 and past or current injection-drug users (IDUs). Most IDUs in the
United States have serologic evidence of HCV infection (that is, they have
been exposed to HCV at some time). While HCV incidence appears to have
declined over the last decade, a large portion of IDUs, who often do not
have access to health-care services, are not identified by current surveillance
systems making interpretation of that trend complicated. African Americans
and Hispanics have a higher rate of HCV infection than whites.
The Charge to the Committee
Despite federal, state, and local public health efforts to prevent and
control hepatitis B and hepatitis C, these diseases remain serious health
problems in the United States. Therefore, the Centers for Disease Control
and Prevention (CDC) in conjunction with the Department of Health and
Human Services Office of Minority Health, the Department of Veterans
Affairs, and the National Viral Hepatitis Roundtable sought guidance from
the Institute of Medicine (IOM) in identifying missed opportunities related
to the prevention and control of HBV and HCV infections. IOM was asked
to focus on hepatitis B and hepatitis C because they are common in the
United States and can lead to chronic disease. The charge to the committee
follows.
The IOM will form a committee to determine ways to reduce new HBV
and HCV infections and the morbidity and mortality related to chronic
viral hepatitis. The committee will assess current prevention and control
activities and identify priorities for research, policy, and action. The committee
will highlight issues that warrant further investigations and opportunities
for collaboration between private and public sectors.
Findings and Recommendations
Upon reviewing evidence on the prevention and control of hepatitis B
and hepatitis C, the committee identified the underlying factors that impede
current efforts to prevent and control these diseases. Three major factors
were found:
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SUMMARY
1. There is a lack of knowledge and awareness about chronic viral
hepatitis on the part of health-care and social-service providers.
2. There is a lack of knowledge and awareness about chronic viral
hepatitis among at-risk populations, members of the public, and
policy-makers.
3. There is insufficient understanding about the extent and seriousness
of this public-health problem, so inadequate public resources are
being allocated to prevention, control, and surveillance programs.
That situation has created several consequences:
• Inadequate disease surveillance systems underreport acute and
chronic infections, so the full extent of the problem is unknown.
• At-risk people do not know that they are at risk or how to prevent
becoming infected.
• At-risk people may not have access to preventive services.
• Chronically infected people do not know that they are infected.
• Many health-care providers do not screen people for risk factors
or do not know how to manage infected people.
• Infected people often have inadequate access to testing, social support,
and medical management services.
To address those consequences, the committee offers recommendations
in four categories: surveillance, knowledge and awareness, immunization,
and services for viral hepatitis. The recommendations are discussed below,
and listed in Box S-1.
Surveillance
The viral hepatitis surveillance system in the United States is highly
fragmented and poorly developed. As a result, surveillance data do not provide
accurate estimates of the current burden of disease, are insufficient for
program planning and evaluation, and do not provide the information that
would allow policy-makers to allocate sufficient resources to viral hepatitis
prevention and control programs. The federal government has provided
few resources—in the form of guidance, funding, and oversight—to local
and state health departments to perform surveillance for viral hepatitis.
Additional funding sources for surveillance, such as funding from states
and cities, vary among jurisdictions. The committee found little published
information on or systematic review of viral hepatitis surveillance in the
United States and offers the following recommendation to determine the
current status of the surveillance system:
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HEPATITIS AND LIVER CANCER
BOX S-1
Recommendations
Chapter 2: Surveillance
• 2-1. The Centers for Disease Control and Prevention should conduct
a comprehensive evaluation of the national hepatitis B and
hepatitis C public-health surveillance system.
• 2-2. The Centers for Disease Control and Prevention should develop
specific cooperative viral-hepatitis agreements with all state and
territorial health departments to support core surveillance for
acute and chronic hepatitis B and hepatitis C.
• 2-3. The Centers for Disease Control and Prevention should support
and conduct targeted active surveillance, including serologic
testing, to monitor incidence and prevalence of hepatitis B virus
and hepatitis C virus infections in populations not fully captured
by core surveillance.
Chapter 3: Knowledge and Awareness about Chronic Hepatitis B
and Hepatitis C
• 3-1. The Centers for Disease Control and Prevention should work
with key stakeholders (other federal agencies, state and local
governments, professional organizations, health-care organizations,
and educational institutions) to develop hepatitis B and
hepatitis C educational programs for health-care and socialservice
providers.
• 3-2. The Centers for Disease Control and Prevention should work
with key stakeholders to develop, coordinate, and evaluate innovative
and effective outreach and education programs to target
at-risk populations and to increase awareness in the general
population about hepatitis B and hepatitis C.
Chapter 4: Immunization
• 4-1. All infants weighing at least 2,000 grams and born to hepatitis
B surface antigen-positive women should receive single-
antigen
hepatitis B vaccine and hepatitis B immune globulin in
the delivery room as soon as they are stable and washed. The
recommendations of the Advisory Committee on Immunization
Practices should remain in effect for all other infants.
• 4-2. All states should mandate that the hepatitis B vaccine series
be completed or in progress as a requirement for school
attendance.
• 4-3. Additional federal and state resources should be devoted to
increasing hepatitis B vaccination of at-risk adults.
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SUMMARY
• 4-4. States should be encouraged to expand immunization-information
systems to include adolescents and adults.
• 4-5. Private and public insurance coverage for hepatitis B vaccination
should be expanded.
• 4-6. The federal government should work to ensure an adequate,
accessible, and sustainable hepatitis B vaccine supply.
• 4-7. Studies to develop a vaccine to prevent chronic hepatitis C virus
infection should continue.
Chapter 5: Viral Hepatitis Services
• 5-1. Federally funded health-insurance programs—such as Medicare,
Medicaid, and the Federal Employees Health Benefits
Program—should incorporate guidelines for risk-factor screening
for hepatitis B and hepatitis C as a required core component
of preventive care so that at-risk people receive serologic
testing for hepatitis B virus and hepatitis C virus and chronically
infected patients receive appropriate medical management.
• 5-2. The Centers for Disease Control and Prevention, in conjunction
with other federal agencies and state agencies, should provide
resources for the expansion of community-based programs that
provide hepatitis B screening, testing, and vaccination services
that target foreign-born populations.
• 5-3. Federal, state, and local agencies should expand programs to
reduce the risk of hepatitis C virus infection through injectiondrug
use by providing comprehensive hepatitis C virus prevention
programs. At a minimum, the programs should include
access to sterile needle syringes and drug-preparation equipment
because the shared use of these materials has been
shown to lead to transmission of hepatitis C virus.
• 5-4. Federal and state governments should expand services to
reduce the harm caused by chronic hepatitis B and hepatitis
C. The services should include testing to detect infection,
counseling to reduce alcohol use and secondary transmission,
hepatitis B vaccination, and referral for or provision of medical
management.
• 5-5. Innovative, effective, multicomponent hepatitis C virus prevention
strategies for injection-drug users and non-injection-drug
users should be developed and evaluated to achieve greater
control of hepatitis C virus transmission.
• 5-6. The Centers for Disease Control and Prevention should provide
additional resources and guidance to perinatal hepatitis B
continued
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HEPATITIS AND LIVER CANCER
Recommendation 2-1. The Centers for Disease Control and Prevention
should conduct a comprehensive evaluation of the national hepatitis B
and hepatitis C public-health surveillance system.
The evaluation should, at a minimum,
• Include assessment of the system’s attributes, including completeness,
data quality and accuracy, timeliness, sensitivity, specificity,
predictive value positive, representativeness, and stability.
• Be consistent with CDC’s Updated Guidelines for Evaluating Public
Health Surveillance Systems.
• Be used to guide the development of detailed technical guidance
and standards for viral hepatitis surveillance.
• Be published in a report.
prevention program coordinators to expand and enhance the
capacity to identify chronically infected pregnant women and
provide case-management services, including referral for appropriate
medical management.
• 5-7. The National Institutes of Health should support a study of
he effectiveness and safety of peripartum antiviral therapy to
reduce and possibly eliminate perinatal hepatitis B virus transmission
from women at high risk for perinatal transmission.
• 5-8. The Centers for Disease Control and Prevention and the Department
of Justice should create an initiative to foster partnerships
between health departments and corrections systems to
ensure the availability of comprehensive viral hepatitis services
for incarcerated people.
• 5-9. The Health Resources and Services Administration should
provide adequate resources to federally funded community
health facilities for provision of comprehensive viral-hepatitis
services.
• 5-10. The Health Resources and Services Administration and the
Centers for Disease Control and Prevention should provide resources
and guidance to integrate comprehensive viral hepatitis
services into settings that serve high-risk populations such as
STD clinics, sites for HIV services and care, homeless shelters,
and mobile health units.
BOX S-1 Continued
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SUMMARY
The committee offers the following recommendations aimed at making
viral hepatitis surveillance systems more consistent among jurisdictions
and improving their ability to collect and report data on acute and chronic
hepatitis B and hepatitis C more accurately:
Recommendation 2-2. The Centers for Disease Control and Prevention
should develop specific cooperative viral-hepatitis agreements with all
state and territorial health departments to support core surveillance for
acute and chronic hepatitis B and hepatitis C.
The agreements should include
• A funding mechanism and guidance for core surveillance
activities.
• Implementation of performance standards regarding revised and
standardized case definitions, specifically through the use of
o Revised case-reporting forms with required, standardized
components.
o Case evaluation and followup.
• Support for developing and implementing automated data-collection
systems, including
o Electronic laboratory reporting.
o Electronic medical-record extraction systems.
o Web-based, Public Health Information Network-compliant reporting
systems.
Recommendation 2-3. The Centers for Disease Control and Prevention
should support and conduct targeted active surveillance, including
serologic testing, to monitor incidence and prevalence of hepatitis B
virus and hepatitis C virus infections in populations not fully captured
by core surveillance.
• Active surveillance should be conducted in specific (sentinel) geographic
regions and populations.
• Appropriate serology, molecular biology, and followup will allow
for
distinction between acute and chronic hepatitis B and hepatitis C.
Incidence refers to the number of new cases within a specified period of time. Prevalence
refers to the number of existing cases in a specified population at a designated time.
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HEPATITIS AND LIVER CANCER
Knowledge and Awareness
The committee found that there is relatively poor awareness about
hepatitis B and hepatitis C among health-care providers, social-service
providers (such as staff of drug-treatment facilities and immigrant-services
centers), and the public, especially important, among members of specific
at-risk populations. Lack of awareness about the prevalence of chronic viral
hepatitis in the United States and the target populations and appropriate
methodology for screening, testing, and medical management of chronic
hepatitis B and hepatitis C probably contributes to continuing transmission;
missing of opportunities for prevention, including vaccination; missing of
opportunities for early diagnosis and medical care; and poor health outcomes
in infected people.
To improve knowledge and awareness among health-care providers
and social-service providers, the committee offers the following
recommendation:
Recommendation 3-1. The Centers for Disease Control and Prevention
should work with key stakeholders (other federal agencies, state and
local governments, professional organizations, health-care organizations,
and educational institutions) to develop hepatitis B and hepatitis
C educational programs for health-care and social-service providers.
The educational programs should include at least the following
components:
• Information about the prevalence and incidence of acute and chronic
hepatitis B and hepatitis C both in the general US population and
in at-risk populations, particularly foreign-born populations in the
case of hepatitis B, and IDUs and incarcerated populations in the
case of hepatitis C.
• Guidance on screening for risk factors associated with hepatitis B
and hepatitis C.
• Information about hepatitis B and hepatitis C prevention, hepatitis
B immunization, and medical monitoring of chronically infected
patients.
• Information about prevention of HBV and HCV transmission in
hospital and nonhospital health-care settings.
• Information about discrimination and stigma associated with hepatitis
B and hepatitis C and guidance on reducing them.
• Information about health disparities related to hepatitis B and
hepatitis C.
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SUMMARY
To increase knowledge and awareness about hepatitis B and hepatitis
C in at-risk populations and the general population, the committee offers
the following recommendation:
Recommendation 3-2. The Centers for Disease Control and Prevention
should work with key stakeholders to develop, coordinate, and evaluate
innovative and effective outreach and education programs to target
at-risk populations and to increase awareness in the general population
about hepatitis B and hepatitis C.
The programs should be linguistically and culturally appropriate and
should advance integration of viral hepatitis and liver-health education into
other health programs that serve at-risk populations. They should incorporate
interventions that meet the following goals:
• Promote better understanding of HBV and HCV infections, transmission,
prevention, and treatment in the at-risk and general
populations.
• Promote increased hepatitis B vaccination rates among children
and at-risk adults.
• Educate pregnant women and women of childbearing age about
hepatitis B prevention.
• Reduce perinatal HBV infections and improve at-birth immunization
rates.
• Increase testing rates in at-risk populations.
• Reduce stigmatization of chronically infected people.
• Promote safe injections among IDUs and safe drug use among noninjection-
drug users (NIDUs).
• Provide culturally and linguistically appropriate educational information
for all persons who have tested positive for chronic HBV
or HCV infections and those who are receiving treatment.
• Encourage notification of close household and sexual contacts of
infected people to be tested for HBV and HCV and encourage
hepatitis B vaccination of close contacts.
Immunization
The longstanding availability of effective hepatitis B vaccines makes
the elimination of new HBV infections possible, particularly in children.
As noted above, about 1,000 newborns are infected by their HBV-positive
mothers at birth each year in the United States, and that number has not
declined in the last decade. To prevent transmission of HBV from mothers
to their newborns, the Advisory Committee on Immunization Practices
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10 HEPATITIS AND LIVER CANCER
(ACIP) recommends that infants born to mothers who are positive for
hepatitis B surface antigen (HBsAg) receive hepatitis B immune globulin
and a first dose of the hepatitis B vaccine within 12 hours of birth. To
improve adherence to that guideline, the committee offers the following
recommendation:
Recommendation 4-1. All infants weighing at least 2,000 grams and
born to hepatitis B surface antigen-positive women should receive
single-antigen hepatitis B vaccine and hepatitis B immune globulin in
the delivery room as soon as they are stable and washed. The recommendations
of the Advisory Committee on Immunization Practices
should remain in effect for all other infants.
The ACIP recommends administration of the hepatitis B vaccine series
to unvaccinated children and young adults under 19 years old. School-entry
mandates have been shown to increase hepatitis B vaccination rates and to
reduce disparities in vaccination rates. Overall, hepatitis B vaccination rates
in school-age children are high (for example, about 80% of states reported
at least 95% hepatitis B vaccine coverage of children in kindergarten in
2006–2007), but there is variability in coverage among states. Additionally,
there are racial and ethnic disparities in childhood vaccination rates—Asian
and Pacific Islander (API), Hispanic, and African American children have
lower vaccination rates than non-Hispanic white children. Regarding vaccination
of children and adults under 19 years old, the committee offers the
following recommendation:
Recommendation 4-2. All states should mandate that the hepatitis B
vaccine series be completed or in progress as a requirement for school
attendance.
Hepatitis B vaccination for adults is directed at high-risk groups—
people at risk for HBV infection from infected household contact and sex
partners, from injection-drug use, from occupational exposure to infected
blood or body fluids, and from travel to regions that have high or intermediate
HBV endemicity. Only about half the adults who are at high risk for
HBV infection receive the hepatitis B vaccine. Low coverage of high-risk
adults is attributed to the lack of dedicated vaccine programs; limitations
of funding, insurance coverage, and cost-sharing; and noncompliance of
the involved populations. To increase the rate of hepatitis B vaccination of
at-risk adults, the committee offers the following recommendation:
Recommendation 4-3. Additional federal and state resources should be
devoted to increasing hepatitis B vaccination of at-risk adults.
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SUMMARY 11
• Correctional institutions should offer hepatitis B vaccination to all
incarcerated persons. Accelerated schedules for vaccine administration
should be considered for jail inmates.
• Organizations that serve high-risk populations should offer the
hepatitis B vaccination series.
• Efforts should be made to improve identification of at-risk
adults. Health-care providers should routinely seek risk behavior
histories from adult patients through direct questioning and
self-assessment.
• Efforts should be made to increase rates of completion of the vaccine
series in adults.
• Federal and state agencies should annually determine gaps in hepatitis
B vaccine coverage among at-risk adults and estimate the
resources needed to fill those gaps.
Immunization-information systems are used for collection and consolidation
of vaccination data from multiple health-care providers, vaccine
management, adverse-event reporting, and tracking lifespan vaccination
histories. States have made progress on developing and implementing immunization-
information systems, particularly with regard to collecting vaccination
data on children. The committee believes that it is also important
to include vaccination data on adolescents and adults in immunization
information systems and offers the following recommendation:
Recommendation 4-4. States should be encouraged to expand
immunization-
information systems to include adolescents and adults.
Coverage for hepatitis B vaccination is greater for children and youths
than for adults. Except for Medicaid’s Early Periodic Screening, Diagnosis,
and Treatment entitlement, public-health insurance often contains
cost-sharing, which may create a barrier to vaccination for some people.
Private health insurance has gaps for vaccination coverage because it does
not universally cover all ACIP-recommended vaccinations for children and
adults. Furthermore, most privately insured persons are required to pay to
receive vaccinations. To reduce barriers to children and adults for hepatitis
B vaccination, the committee offers the following recommendation:
Recommendation 4-5. Private and public insurance coverage for hepatitis
B vaccination should be expanded.
• Public Health Section 317 should be expanded with sufficient funding
to become the public safety net for underinsured and uninsured
adults to receive the hepatitis B vaccination.
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12 HEPATITIS AND LIVER CANCER
• All private insurance plans should include coverage for all ACIPrecommended
vaccinations. Hepatitis B vaccination should be free
of any deductible so that first-dollar coverage exists for this preventive
service.
There has not been a national shortage of the hepatitis B vaccine, however,
temporary supply problems occurred with this vaccine in 2008 (adult
and dialysis formulations of Recombivax HB) and 2009 (pediatric formulations
of Recombivax HB and Pediatric Engerix-B). A shortage was avoided
because other manufacturers were able to provide an adequate supply of the
vaccine in adult and dialysis formulations, and CDC released doses of pediatric
vaccine from its stockpile. To prevent future supply problems of the
hepatitis B vaccine, the committee offers the following recommendation:
Recommendation 4-6. The federal government should work to ensure
an adequate, accessible, and sustainable hepatitis B vaccine supply.
Efforts are going on to develop a vaccine for hepatitis C, which could
substantially enhance hepatitis C prevention efforts. The committee recognizes
the need for a safe, effective, and affordable hepatitis C vaccine and
offers the following recommendation:
Recommendation 4-7. Studies to develop a vaccine to prevent chronic
hepatitis C virus infection should continue.
Viral Hepatitis Services
Health services related to viral hepatitis prevention, risk-factor screening
and serologic testing, and medical management are both sparse and
fragmented among entities at the federal, state, and local levels. The committee
believes that a coordinated approach is necessary to reduce the
numbers of new HBV and HCV infections, illnesses, and deaths associated
with these infections. Comprehensive viral hepatitis services should have
five core components: outreach and awareness, prevention of new infections,
identification of infected people, social and peer support, and medical
management of infected people.
The committee identified major gaps in viral hepatitis services for
the general population and specific groups that are heavily affected by
HBV and HCV infections: foreign-born populations, illicit-drug users, and
Risk-factor screening is the process of determining whether a person is at risk for being
chronically infected or becoming infected with HBV or HCV. Serologic testing is laboratory
testing of blood specimens for biomarker confirmation of HBV or HCV infection.
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SUMMARY 13
pregnant women. It also examined venues that provide services to at-risk
groups: correctional facilities, community health facilities, STD and HIV
clinics, shelter-based programs, and mobile health units. The committee
offers recommendations to address major deficiencies for each group and
health-care venue.
General Population
Most people who are chronically infected with HBV or HCV are unaware
of their infection status. As treatments for chronic hepatitis B and C
improve, it becomes critical to identify chronically infected people. Therefore,
it is important that the general population have access to screening
and testing services so that people who are at risk for viral hepatitis can
be identified. The federal government is the largest purchaser of health
insurance nationally and is well positioned to be the leader in the development
and enforcement of guidelines to ensure that the people for whom it
provides health care have access to risk-factor screening, serologic testing
for HBV and HCV, and appropriate medical management.
Recommendation 5-1. Federally funded health-insurance programs—
such as Medicare, Medicaid, and the Federal Employees Health Benefits
Program—should incorporate guidelines for risk-factor screening
for hepatitis B and hepatitis C as a required core component of preventive
care so that at-risk people receive serologic testing for hepatitis
B virus and hepatitis C virus and chronically infected patients receive
appropriate medical management.
Foreign-Born Populations
Nearly half of US foreign-born people, or 6% of the total US population,
originate in HBV-endemic countries. Thus, there is a growing urgency
for culturally appropriate programs to provide hepatitis B screening and
related services to this high-risk population. There is a pervasive lack of
knowledge about hepatitis B among Asians and Pacific Islanders, and this
is probably also the case for other foreign-born people in the United States.
The lack of awareness in foreign-born populations from HBV-endemic
countries is compounded by the gaps in knowledge and preventive practice
among health-care and social-service providers, particularly those who
serve a large number of foreign-born, high-risk patients. The committee believes
that the needs of foreign-born people are best met with the approach
outlined in Recommendations 3-1 and 3-2. The community-based approach
as outlined in Recommendation 3-2 would be strengthened by additional
resources to provide screening, testing, and vaccination services.
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14 HEPATITIS AND LIVER CANCER
Recommendation 5-2. The Centers for Disease Control and Prevention,
in conjunction with other federal agencies and state agencies, should
provide resources for the expansion of community-based programs
that provide hepatitis B screening, testing, and vaccination services that
target foreign-born populations.
Illicit-Drug Users
HBV and HCV infection rates in illicit-drug users are high, particularly
in IDUs. HCV is easily transmitted among IDUs, and methods to promote
safe injection can be considered essential for HCV control. However, safeinjection
strategies alone are insufficient to control HCV transmission.
Prevention of HCV infection is a function of multiple factors—safe-injection
strategies, education, testing, and drug treatment—so an integrated
approach that includes all these elements is more likely to be effective in
preventing hepatitis C.
Recommendation 5-3. Federal, state, and local agencies should expand
programs to reduce the risk of hepatitis C virus infection through
injection-
drug use by providing comprehensive hepatitis C virus prevention
programs. At a minimum, the programs should include access
to sterile needle syringes and drug-preparation equipment because the
shared use of these materials has been shown to lead to transmission
of hepatitis C virus.
Although illicit-drug use is associated with many serious acute and
chronic medical conditions, health-care use among drug users is lower than
among persons who do not use illicit drugs. Health care for both IDUs and
NIDUs is sporadic and typically received in hospital emergency rooms,
corrections facilities, and STD clinics. Given that population’s poor access
to health care and services, it is important to have prevention and care services
in settings that IDUs and NIDUs are likely to frequent or to develop
programs that will draw them into care.
Recommendation 5-4. Federal and state governments should expand
services to reduce the harm caused by chronic hepatitis B and hepatitis
C. The services should include testing to detect infection, counseling to
reduce alcohol use and secondary transmission, hepatitis B vaccination,
and referral for or provision of medical management.
Studies have shown that the first few years after onset of injectiondrug
use constitute a high-risk period in which the rate of HCV infection
can exceed 40%. Preventing the transition from non-injection-drug use
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SUMMARY 15
to injection-
drug use will probably avert many HCV infections. The committee
therefore offers the following research recommendation:
Recommendation 5-5. Innovative, effective, multicomponent hepatitis
C virus prevention strategies for injection-drug users and non-injectiondrug
users should be developed and evaluated to achieve greater control
of hepatitis C virus transmission. In particular,
• Hepatitis C prevention programs for persons who smoke or sniff
heroin, cocaine, and other drugs should be developed and tested.
• Programs to prevent the transition from noninjection use of illicit
drugs to injection should be developed and implemented.
Pregnant Women
States and large metropolitan areas are eligible to receive federal funding
to support perinatal hepatitis B prevention programs through CDC’s
National Center for Immunization and Respiratory Diseases. Comprehensive
programs have been shown to be effective not only in identifying HBVinfected
pregnant women but in providing other case-management services
(for example, testing of household and sexual contacts and referral to
medical care). However, most programs are understaffed and underfunded
and cannot offer adequate case-management services.
Recommendation 5-6. The Centers for Disease Control and Prevention
should provide additional resources and guidance to perinatal hepatitis
B prevention program coordinators to expand and enhance the
capacity to identify chronically infected pregnant women and provide
case-management services, including referral for appropriate medical
management.
Although an increasing number of effective HBV antiviral suppressive
medications have become available for the management of chronic HBV
infection, very little research has been done on the use of these medications
during the last trimester of pregnancy to eliminate the risk of perinatal
transmission. The committee believes that there is a need to fund research
to guide the effective use of antiviral medications late in pregnancy to
prevent maternofetal HBV transmission, and offers the following research
recommendation:
Recommendation 5-7. The National Institutes of Health should support
a study of the effectiveness and safety of peripartum antiviral
therapy to reduce and possibly eliminate perinatal hepatitis B virus
transmission from women at high risk for perinatal transmission.
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16 HEPATITIS AND LIVER CANCER
Correctional Facilities
Incarcerated populations have higher rates of HBV and HCV infections
than the general population. Screening of all incarcerated people for
risk factors can identify those who need blood tests for infection and, if
appropriate, treatment.
Recommendation 5-8. The Centers for Disease Control and Prevention
and the Department of Justice should create an initiative to foster
partnerships between health departments and corrections systems to
ensure the availability of comprehensive viral hepatitis services for
incarcerated people.
Community Health Centers
The Health Resources and Services Administration administers grant
programs across the country to deliver primary care to uninsured and
underinsured people in community health centers, migrant health centers,
homeless programs, and public-housing primary-care programs. In general,
funding of viral hepatitis services at community health centers is inadequate.
Because community health centers provide primary health care for
many people who are at risk for hepatitis B and hepatitis C, it is important
for them to offer comprehensive viral hepatitis services.
Recommendation 5-9. The Health Resources and Services Administration
should provide adequate resources to federally funded community
health facilities for provision of comprehensive viral-hepatitis
services.
Other Settings That Target At-Risk Populations
STD and HIV clinics, shelter-based programs, and mobile health units
are settings that serve populations that are at risk for hepatitis B and hepatitis
C. The populations that use the settings may not have access to care
through traditional health-care venues. Integration of viral hepatitis services
into those settings creates opportunities to identify at-risk clients and to get
them other services that they need.
Recommendation 5-10. The Health Resources and Services Administration
and the Centers for Disease Control and Prevention should
provide resources and guidance to integrate comprehensive viral hepatitis
services into settings that serve high-risk populations such as STD
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SUMMARY 17
clinics, sites for HIV services and care, homeless shelters, and mobile
health units.
Recommendation Outcomes
The committee believes that implementation of its recommendations
would lead to reductions in new HBV and HCV infections, in medical
complications and deaths that result from these viral infections of the liver,
and in total health costs. Advances in three major categories will be needed:
in knowledge and awareness about chronic viral hepatitis among healthcare
and social-service providers, the general public, and policy-makers; in
improvement and better integration of viral hepatitis services, including expanded
hepatitis B vaccination coverage; and in improvement of estimates
of the burden of disease for resource-allocation purposes.
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Heather M. Colvin and Abigail E. Mitchell, Editors
Committee on the Prevention and Control of Viral Hepatitis Infections
Board on Population Health and Public Health Practice
H E PAT I T I S A N D
L I V E R CA N C E R
A National Strategy for Prevention and
Control of Hepatitis B and C
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Library of Congress Cataloging-in-Publication Data
Hepatitis and liver cancer : a national strategy for prevention and control of hepatitis B
and C / Heather M. Colvin and Abigail E. Mitchell, editors ; Committee on the Prevention
and Control of Viral Hepatitis Infections, Board on Population Health and Public Health
Practice.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-309-14628-9
1. Hepatitis B—United States. 2. Hepatitis C—United States. 3. Liver—Cancer—United
States. I. Colvin, Heather M. II. Mitchell, Abigail E. III. Institute of Medicine (U.S.).
Committee on the Prevention and Control of Viral Hepatitis Infections. IV. Institute of
Medicine (U.S.). Board on Population Health and Public Health Practice. V. National
Academies Press (U.S.)
[DNLM: 1. Hepatitis B—complications—United States. 2. Hepatitis B—prevention &
control—United States. 3. Hepatitis C—complications—United States. 4. Hepatitis C—
prevention & control—United States. 5. Liver Neoplasms—prevention & control—United
States. 6. Viral Hepatitis Vaccines—therapeutic use—United States. WC 536 H5322 2010]
RA644.H4H37 2010
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2010003194
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Suggested citation: IOM (Institute of Medicine). 2010. Hepatitis and Liver Cancer: A National
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Committee on the Pre vention and
Control of Viral Hepatitis Infections
R. Palmer Beasley (Chair), Ashbel Smith Professor and Dean Emeritus,
University of Texas, School of Public Health, Houston, Texas
Harvey J. Alter, Chief, Infectious Diseases Section, Department of
Transfusion Medicine, National Institutes of Health, Bethesda, Maryland
Margaret L. Brandeau, Professor, Department of Management Science
and Engineering, Stanford University, Stanford, California
Daniel R. Church, Epidemiologist and Adult Viral Hepatitis Coordinator,
Bureau of Infectious Disease Prevention, Response, and Services,
Massachusetts Department of Health, Jamaica Plain, Massachusetts
Alison A. Evans, Assistant Professor, Department of Epidemiology
and Biostatistics, Drexel University School of Public Health,
Drexel Institute of Biotechnology and Viral Research, Doylestown,
Pennsylvania
Holly Hagan, Senior Research Scientist, College of Nursing, New York
University, New York
Sandral Hullett, CEO and Medical Director, Cooper Green Hospital,
Birmingham, Alabama
Stacene R. Maroushek, Staff Pediatrician, Department of Pediatrics,
Hennepin County Medical Center, Minneapolis, Minnesota
Randall R. Mayer, Chief, Bureau of HIV, STD, and Hepatitis, Iowa
Department of Public Health, Des Moines, Iowa
Brian J. McMahon, Medical Director, Liver Disease and Hepatitis
Program, Alaska Native Tribal Health Consortium, Anchorage, Alaska
Martín Jose Sepúlveda, Vice President, Integrated Health Services,
International Business Machines Corporation, Somers, New York
Samuel So, Lui Hac Minh Professor, Asian Liver Center, Stanford
University School of Medicine, Stanford, California
David L. Thomas, Chief, Division of Infectious Diseases, Department of
Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland
Lester N. Wright, Deputy Commissioner and Chief Medical Officer, New
York Department of Correctional Services, Albany, New York
Study Staff
Abigail E. Mitchell, Study Director
Heather M. Colvin, Program Officer
Kathleen M. McGraw, Senior Program Assistant
Norman Grossblatt, Senior Editor
Rose Marie Martinez, Director, Board on Population Health and Public
Health Practice
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vii
Reviewers
This report has been reviewed in draft form by persons chosen for
their diverse perspectives and technical expertise, in accordance with
procedures approved by the National Research Council’s (NRC’s)
Report Review Committee. The purpose of this independent review is to
provide candid and critical comments that will assist the institution in making
its published report as sound as possible and to ensure that the report
meets institutional standards for objectivity, evidence, and responsiveness
to the study charge. The review comments and draft manuscript remain
confidential to protect the integrity of the deliberative process. We wish to
thank the following individuals for their review of this report:
Scott Allen, Brown University Medical School
Jeffrey Caballero, Association of Asian Pacific Community Health
Organizations
Colleen Flanigan, New York State Department of Health
James Jerry Gibson, South Carolina Department of Health and
Environmental Control
Fernando A. Guerra, San Antonio Metropolitan Health District
Theodore Hammett, Abt Associates Inc.
Jay Hoofnagle, National Institute of Diabetes and Digestive and
Kidney Diseases
Charles D. Howell, University of Maryland School of Medicine
Walter A. Orenstein, Bill & Melinda Gates Foundation
Philip E. Reichert, Florida Department of Health
Charles M. Rice III, The Rockefeller University
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viii REVIEWERS
Tracy Swan, Treatment Action Group
Su Wang, Charles B. Wang Community Health Center
John B. Wong, Tufts Medical Center
Although the reviewers listed above have provided many constructive
comments and suggestions, they were not asked to endorse the conclusions
or recommendations, nor did they see the final draft of the report before
its release. The review of the report was overseen by Bradford H. Gray,
Senior Fellow, The Urban Institute, and Elena O. Nightingale, Scholar-in-
Residence, Institute of Medicine. Appointed by the Institute of Medicine
and the National Research Council, they were responsible for making certain
that an independent examination of the report was carried out in accordance
with institutional procedures and that all review comments were
carefully considered. Responsibility for the final content of the report rests
entirely with the author committee and the institution.
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ix
Acknowledgments
The committee acknowledges the valuable contributions made by the
many persons who shared their experience and knowledge with the
committee. The committee appreciates the time and insight of the presenters
during the public sessions: John Ward, Dale Hu, Cindy Weinbaum,
and David Bell, Centers for Disease Control and Prevention; Chris Taylor
and Martha Saly, National Viral Hepatitis Roundtable; Lorren Sandt, Caring
Ambassadors Program; Joan Block, Hepatitis B Foundation; Gary
Heseltine, Council of State and Territorial Epidemiologists; William Rogers,
Centers for Medicare and Medicaid Services; Tanya Pagán Raggio Ashley,
Health Resources Services Administration; Carol Craig, National Association
of Community Health Centers; Daniel Raymond, Harm Reduction
Coalition; and Mark Kane, formerly of the Children’s Vaccine Program,
PATH. We are also grateful for the thoughtful written and verbal testimony
provided by members of the public affected by hepatitis B or hepatitis C.
Several persons contributed their expertise for this report. The committee
thanks David Hutton, of the Department of Management Science
and Engineering at Stanford University; Victor Toy, Beverly David, and
Kathleen Tarleton, of IBM; Shiela Strauss, of the New York University
College of Nursing; Ellen Chang and Stephanie Chao, of the Asian Liver
Center at Stanford University; Gillian Haney, of the Massachusetts Department
of Public Health; and all the State Adult Viral Hepatitis Prevention
Coordinators that provided information to the committee.
This report would not have been possible without the diligent assistance
of Jeffrey Efird and Daniel Riedford, of the Centers for Disease Control and
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ACKNOWLEDGMENTS
Prevention. We appreciate the assistance of Ronald Valdiserri, of the Department
of Veterans Affairs, for providing literature for the report.
The committee thanks the staff members of the Institute of Medicine,
the National Research Council, and the National Academies Press who
contributed to the development, production, and dissemination of this
report. The committee thanks the study director, Abigail Mitchell, and
program officer Heather Colvin for their work in navigating this complex
topic and Kathleen McGraw for her diligent management of the committee
logistics.
This report was made possible by the support of the Division of Viral
Hepatitis and Division of Cancer Prevention and Control of the Centers
for Disease Control and Prevention, the Department of Health and Human
Services Office of Minority Health, the Department of Veterans Affairs, and
the National Viral Hepatitis Roundtable.
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xi
Contents
Acronyms and Abbreviations xvii
SUMMARY 1
The Charge to the Committee, 2
Findings and Recommendations, 2
Surveillance, 3
Knowledge and Awareness, 8
Immunization, 9
Viral Hepatitis Services, 12
Recommendation Outcomes, 17
1 INTRODUCTION 19
Prevalence and Incidence of Hepatitis B and Hepatitis C
Worldwide, 22
Prevalence and Incidence of Hepatitis B and Hepatitis C
in the United States, 25
Hepatitis B, 25
Hepatitis C, 28
Liver Cancer and Liver Disease from Chronic Hepatitis B Virus and
Hepatitis C Virus Infections, 29
The Committee’s Task, 30
The Committee’s Approach to Its Task, 32
References, 35
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xii CONTENTS
2 SURVEILLANCE 41
Applications of Surveillance Data, 43
Outbreak Detection and Control, 44
Resource Allocation, 45
Programmatic Design and Evaluation, 45
Linking Patients to Care, 45
Disease-Specific Issues Related to Viral-Hepatitis Surveillance, 46
Identifying Acute Infections, 47
Identifying Chronic Infections, 51
Identifying Perinatal Hepatitis B, 54
Other Challenges for Hepatitis B and Hepatitis C Surveillance
Systems, 56
Infrastructure and Process-Specific Issues with Surveillance, 57
Funding Sources, 58
Program Design, 59
Reporting Systems and Requirements, 59
Capturing Data on At-Risk Populations, 61
Case Evaluation, Followup, and Partner Services, 62
Recommendations, 63
Model for Surveillance, 66
Core Surveillance, 67
Targeted Surveillance, 71
References, 72
3 KNOWLEDGE AND AWARENESS ABOUT CHRONIC
HEPATITIS B AND HEPATITIS C 79
Knowledge and Awareness Among Health-Care and Social-Service
Providers, 80
Hepatitis B, 81
Hepatitis C, 83
Recommendation, 85
Community Knowledge and Awareness, 89
Hepatitis B, 89
Hepatitis C, 93
Recommendation, 96
References, 101
4 IMMUNIZATION 109
Hepatitis B Vaccine, 109
Current Vaccination Recommendations, Requirements, and
Rates, 110
Immunization-Information Systems, 126
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CONTENTS xiii
Barriers to Hepatitis B Vaccination, 127
Hepatitis C Vaccine, 136
Feasibility of Preventing Chronic Hepatitis C, 136
Need for a Vaccine to Prevent Chronic Hepatitis C, 137
Cost Effectiveness of a Hepatitis C Vaccine, 137
References, 138
5 VIRAL HEPATITIS SERVICES 147
Current Status, 148
Components of Viral Hepatitis Services, 154
Identification of Infected Persons, 154
Prevention, 166
Medical Management, 166
Major Gaps in Services, 170
General Population, 170
Foreign-Born People, 173
Illicit-Drug Users, 175
Pregnant Women, 181
Correctional Settings, 184
Community Health Facilities, 186
Targeting Settings That Serve At-Risk Populations, 189
References, 192
A COMMITTEE BIOGRAPHIES 209
B PUBLIC MEETING AGENDAS 215
Boxes , Fig ures , and Tables
Boxes
S‑1 Recommendations, 4
2‑1 Role of Disease Surveillance, 42
2‑2 CDC Acute Hepatitis B Case Definition, 48
2‑3 CDC Acute Hepatitis C Case Definition, 49
2‑4 CDC Chronic Hepatitis B Case Definition, 52
2‑5 CDC Hepatitis C Virus Infection Case Definition
(Past or Present), 53
2‑6 CDC Perinatal Hepatitis B Virus Infection Case Definition, 55
3‑1 Geographic Regions That Have Intermediate and High Hepatitis B
Virus Endemicity, 81
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xiv CONTENTS
4‑1 Summary of ACIP Hepatitis B Vaccination Recommendations, 112
5‑1 Summary of Recommendations Regarding Viral Hepatitis
Services, 148
5‑2 Mission Statement of Centers for Disease Control and Prevention
Division of Viral Hepatitis, 150
5‑3 Components of Comprehensive Viral Hepatitis Services, 155
5‑4 Summary of CDC At-Risk Populations for Hepatitis B Virus
Infection, 156
5‑5 Summary of CDC At-Risk Populations for Hepatitis C Virus
Infection, 158
5‑6 Hepatitis B Virus-Specific Antigens and Antibodies Used for
Testing, 160
Figures
1‑1 Approximate global preventable death rate from selected infectious
diseases and other causes, 2003, 20
1‑2 The committee’s approach to its task, 34
2‑1 Natural progression of hepatitis B infection, 46
2‑2 Natural progression of hepatitis C infection, 47
4‑1 Estimated cost of adult hepatitis B vaccination per quality adjusted
life year (QALY) gained for different age groups and different rates
of acute hepatitis B virus (HBV) infection incidence, 119
4‑2 Trends in private health-insurance coverage, 133
5‑1 Hepatitis B services model, 157
5‑2 Essential viral hepatitis services for illicit-drug users, 180
Tables
1‑1 Key Characteristics of Hepatitis B and Hepatitis C, 21
1‑2 Burden of Selected Serious Chronic Viral Infections in the United
States, 26
4‑1 Hepatitis B Vaccine Schedules for Newborns, by Maternal HBsAg
Status—ACIP Recommendations, 114
4‑2 Hepatitis B Immunization Management of Preterm Infants Who
Weigh Less Than 2,000 g, by Maternal HBsAg Status—ACIP
Recommendations, 115
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CONTENTS xv
4‑3 Estimated Chance That an Acute Hepatitis B Infection Becomes
Chronic with Age, 118
4‑4 Studies of Hepatitis B Vaccination Rates in Injection-Drug
Users, 122
4‑5 Public Health-Insurance Plans, 130
5‑1 Summary of Adult Viral Hepatitis Prevention Coordinators
Survey, 153
5‑2 Interpretation of Hepatitis B Serologic Diagnostic Test
Results, 161
5‑3 Interpretation of Hepatitis C Virus Diagnostic Test Results, 164
5‑4 Studies of Association Between Opiate Substitution Treatment and
Hepatitis C Virus Seroconversion, 178
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xvii
Acronyms and Abbreviations
AASLD American Association for the Study of Liver Diseases
ACIP Advisory Committee on Immunization Practices
ACOG American College of Obstetricians and Gynecologists
AHRQ Agency for Healthcare Research and Quality
AIDS acquired immunodeficiency syndrome
ALT alanine aminotransferase
anti-HBc Hepatitis B core antibody
anti-HBs Hepatitis B surface antibody
anti-HCV Hepatitis C antibody
API Asian and Pacific Islander
AST aspartate transaminase
AVHPC adult viral hepatitis prevention coordinators
CDC Centers for Disease Control and Prevention
CHIP Children’s Health Insurance Program
CI confidence interval
CIA enhanced chemiluminescence
CMS Centers for Medicare and Medicaid Services
DIS disease intervention specialist
DTaP diptheria and tetanus toxoids and acellular pertussis
adsorbed vaccine
DUIT drug user intervention trial
DVH Division of Viral Hepatitis
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xviii ACRONYMS AND ABBREVIATIONS
EIA enzyme immunoassay
EIP Emerging Infections Program
EPSDT early periodic screening diagnosis and treatment program
FDA Food and Drug Administration
FEHBP Federal Employee Health Benefit Program
FQHC federally qualified health center
HAV Hepatitis A virus
HBIG Hepatitis B immunoglobulin
HBsAg Hepatitis B surface antigen
HBV Hepatitis B virus
HCC hepatocellular carcinoma
HCV Hepatitis C virus
HCW health-care workers
HDHP high deductable health plan
HIAA Health Insurance Association of America
HIB haemophilus influenzae type B
HIV human immunodeficiency virus
HMO health maintenance organization
HPV human papilloma virus
HRSA Health Resources and Services Administration
IDU injection-drug user
IIS immunization information systems
IOM Institute of Medicine
IPV inactivated polio virus
MMTP methadone maintenance treatment program
NASTAD National Alliance of State and Territorial AIDS Directors
NAT nucleic acid test
NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, Sexually
Transmitted Diseases, and Tuberculosis Prevention
NEDSS National Electronic Disease Surveillance System
NETSS National Electronic Telecommunications System for
Surveillance
NGO nongovernmental organization
NHANES National Health and Nutrition Examination Survey
NIDU non-injection-drug user
NVAC National Vaccine Advisory Committee
Copyright National Academy of Sciences. All rights reserved.
This summary plus thousands more available at http://www.nap.edu
Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C
http://books.nap.edu/catalog/12793.html
ACRONYMS AND ABBREVIATIONS xix
OB/GYN obstetrician/gynecologist
OMH Office of Minority Health
OR odds ratio
PEI peer education intervention
PHIN Public Health Information Network
POS point of service
PPO preferred provider organization
PY person year
QALY quality adjusted life year
RCT randomized clinical trial
RIBA recombinant immunoblot assay
RNA ribonucleic acid
RSV respiratory syncytial virus
SAMHSA Substance Abuse and Mental Health Services
Administration
SARS severe acute respiratory syndrome
SEP syringe exchange program
STD sexually transmitted disease
STRIVE Study To Reduce Intravenous Exposures
TB tuberculosis
TCM traditional Chinese medicine
USPHS US Public Health Service
USPSTF US Preventive Services Task Force
VA Department of Veterans Affairs
vCJD variant Creutzfeldt-Jakob disease
VFC Vaccines for Children
WHO World Health Organization
Copyright National Academy of Sciences. All rights reserved.
This summary plus thousands more available at http://www.nap.edu
Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C
http://books.nap.edu/catalog/12793.html
