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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C 5 Viral Hepatitis Services Hepatitis B virus (HBV) and hepatitis C virus (HCV) infections cause substantial morbidity and mortality despite being preventable and treatable. Deficiencies in the implementation of established guidelines for the prevention, diagnosis, and medical management of chronic HBV and HCV infections perpetuate personal and economic burdens. This chapter reviews the current status of services to prevent and manage chronic hepatitis B and chronic hepatitis C. It then discusses the general components of viral hepatitis services. The chapter ends with an assessment of gaps in existing services, including a description of some models for services and committee recommendations to improve viral hepatitis prevention and management and to fill research needs. Services for the general US population are considered first and then services for special populations and service venues that have unique opportunities for interventions. Hepatitis B immunization is covered in Chapter 4 and so is not discussed in detail here. The recommendations offered by the committee here are presented in the context of the current health-care system in the United States. The committee believes strongly that if the system changes as a result of health-care reform efforts, viral hepatitis services should have high priority in components of the reformed system that deal with prevention, chronic disease, and primary-care delivery. The committee’s recommendations regarding viral hepatitis services are summarized in Box 5-1.
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C BOX 5-1 Summary of Recommendations Regarding Viral Hepatitis Services General Population 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 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 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. 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. CURRENT STATUS Health services related to viral hepatitis prevention, screening, and medical management are both limited and fragmented among entities at the federal, state, and local levels. Numerous federal agencies administer or fund some viral hepatitis–related services, including the Centers for Disease Control and Prevention (CDC), the Health Resources and Services
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C 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. Pregnant Women 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. 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. Incarcerated Populations 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 Facilities 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. High Impact Settings 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. Administration (HRSA), the Office of Minority Health, the Agency for Healthcare Quality and Research, the Centers for Medicare and Medicaid Services (CMS), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Institutes of Health. Because there is no coordinated federal strategy for HBV and HCV prevention and control, those efforts are uneven in their application and funding. States, communi-
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C ties, and nongovernment organizations (NGOs) also provide viral hepatitis services, often with funding from federal agencies. Most viral hepatitis–related activities in CDC are administered by the Division of Viral Hepatitis (DVH), which is part of the National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Prevention (NCHHSTP). The activities of the DVH, shown in Box 5-2, include surveillance and epidemiologic studies and clinical and laboratory research related to viral hepatitis. It supports viral hepatitis programs at the national, state, and community levels; disseminates hepatitis-related information to the public; and develops guidelines for prevention and control. In FY 2008, the DVH received $17.6 million, 2% of the NCHHSTP BOX 5-2 Mission Statement of Centers for Disease Control and Prevention Division of Viral Hepatitis The Division of Viral Hepatitis (DVH) is the Public Health Service component that provides the scientific and programmatic foundation for the prevention, control, and elimination of hepatitis virus infections in the United States, and assists the international public health community in these activities. To achieve its mission, DVH: conducts surveillance and special studies to determine the epidemiology and disease burden associated with acute and chronic infections and liver disease associated with hepatitis viruses; conducts epidemiologic and laboratory studies, including outbreak investigations, to determine risk factors for transmission of infections with hepatitis viruses, define the natural history and pathogenesis of these infections, and determine their health impact; conducts epidemiologic, clinical, laboratory, behavioral, and health communications research to develop and evaluate methods and strategies for the prevention of infections with hepatitis viruses and their acute and chronic disease consequences; develops, implements, communicates and evaluates recommendations and standards for the prevention and control of infections and liver disease associated with hepatitis viruses; provides technical and programmatic leadership and assistance to state and local health departments, non-governmental organizations and the international community to develop, implement and evaluate programs to prevent infections with hepatitis viruses and their consequences, including immunization to prevent hepatitis A
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C budget (Ward, 2008a). In contrast, domestic HIV activities received 69%, sexually transmitted diseases (STDs) received 15%, and tuberculosis received 14% of the NCHHSTP FY 2008 budget. In FY 2009, the amount of NCHHSTP funding received by the DVH was not much greater, at $18.3 million (NASTAD, 2009) (personal communication, J. Efird, CDC, July 9, 2009). That low level of funding for the DVH has been relatively flat for the last 5 years. HRSA, part of the US Department of Health and Human Services (HHS), is charged with increasing access to health care for people who are medically underserved. Several HRSA programs provide some direct services for viral hepatitis, including the Bureau of Primary Health Care, the and eliminate transmission of hepatitis B virus infection, the prevention and control of hepatitis C virus infection through counseling and testing and the prevention of transmission of bloodborne virus infections, including hepatitis viruses, through improved medical practices to reduce the frequency of unsafe injections and the improvement of the safety of blood transfusions; provides the leadership and coordination required to integrate viral hepatitis prevention and control activities into other prevention programs conducted by CDC, other Federal agencies and health care providers; conducts laboratory, clinical and epidemiologic studies to develop and evaluate methods for the diagnosis of infections with hepatitis viruses; identifies and characterizes agents and host factors associated with hepatitis and acute and chronic liver disease; provides epidemic aid, epidemiologic and laboratory consultation, reference diagnostic services and technical assistance to state and local health departments, other Federal agencies, other components of CDC, and national and international health organizations; disseminates information through health communications materials, tools and programs, scientific publications and presentations; provides training opportunities for Epidemic Intelligence Service Officers and others in CDC sponsored programs, including post-graduate students, post-doctoral fellows, and other public health and laboratory scientists; and serves as a WHO Collaborating Center for Reference and Research on Viral Hepatitis. SOURCE: CDC, 2009a.
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C Healthcare Systems Bureau, the HIV/AIDS Bureau, the Maternal and Child Health Bureau, the Office of Minority Health and Health Disparities, the Office of Planning and Evaluation, the Office of Rural Health Policy, and the Center for Quality (Raggio Ashley, 2009). In addition, viral hepatitis education and training activities are administered by the Bureau of Health Professions. HRSA funding supports federally qualified health centers that serve migrant, rural, tribal, and homeless populations. It also provides funding for Ryan White Care Act services and maternal and child health programs, such as Title V and Healthy Start, which provides some hepatitis B vaccination, testing, and counseling for HBV and HCV infections. Many people in HRSA-funded programs are foreign-born, including people from countries that have a high prevalence of hepatitis B or have behavior risk factors for HBV and HCV infection. CMS, also a part of DHHS, provides health insurance through Medicare and Medicaid programs. Medicare covers people 65 years old or older, people under 65 years old who have specified disabilities, and people who have end-stage renal disease. Hepatitis B vaccination and its administration costs are covered by Part B of Medicare for people at high or intermediate risk for HBV infection (Rogers, 2009). People at low risk for HBV infection can receive the vaccine under Part D with a copayment that depends on their income level. Medicare will cover laboratory testing for HBV and HCV and treatment for chronic hepatitis B or hepatitis C. Medicaid is a state-administered program available to low-income individuals and families who fit into an eligibility group that is recognized by federal and state law. Eligibility for Medicaid and coverage for viral hepatitis services vary from state to state. State and local (county and city) health departments obtain funds for viral hepatitis prevention and control activities from a variety of sources, including CDC, HRSA, SAMHSA, states, counties, cities, and private foundations. CDC funding supports adult viral hepatitis prevention coordinator (AVHPC) positions in 49 states and five cities (Ward, 2008a). The total funding level is about $5 million per year, and the average award is $90,000. CDC also funds perinatal hepatitis B coordinators in 64 states, cities, and territories at a total program cost of $7.5 million per year (CDC, 2009d). Funding for the AVHPC and perinatal hepatitis B coordinator positions covers only the coordinators’ salaries but not programmatic activities. CDC provides viral hepatitis program support—about $900,000 per year—in the form of grants for viral hepatitis training and education at the state and local levels. A number of states have developed viral hepatitis prevention plans. At the committee’s request, the Institute of Medicine asked CDC to survey the 55 AVHPCs about the status of their jurisdiction’s plans (CDC, 2009g). All coordinators responded to the questionnaire. Of the 55, 32 (58.2%) indi-
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C cated that their states had a viral hepatitis prevention plan in place, half of which were completed in the last 5 years. Just over half of the plans include all the components in Table 5-1. All plans address hepatitis C prevention, and two-thirds (65.6%) address hepatitis B prevention. About 78% of the plans include hepatitis B vaccinations whether or not other hepatitis B prevention services are included. Some coordinators indicated that the CDC Section 317 vaccination initiative resulted in substantial progress toward implementing hepatitis B vaccination services in their jurisdictions. The medical management component is included in the smallest percentage of plans (62.5%) and just one-quarter of those plans have acted on this component. Overall, the coordinator survey revealed that over 40% of jurisdictions do not have plans; of the states that do have plans, only half have all the components, and only 20.7% of these reported that they had made progress in all the components. The primary barrier to plan implementation was financial constraints on overall funding and staffing (96.9%). A number of NGOs have been established to address the prevention and control of HBV and HCV infections. Most of them focus on advocacy efforts, such as raising public awareness about viral hepatitis and encouraging people, especially in high-risk populations, to be vaccinated for hepatitis B, to undergo risk-factor screening for hepatitis B and hepatitis C, and to determine whether laboratory testing and medical management are needed. Many organizations target specific populations. For example, the Jade Ribbon Campaign targets Asians and Pacific Islanders to reduce the TABLE 5-1 Summary of Adult Viral Hepatitis Prevention Coordinators Survey Jurisdiction Plan’s Program Components Percentage of Jurisdictions with Plans That Included Component Percentage of Jurisdictions with Plan Components That Have Been Acted On Public education 96.6% 83.9% Surveillance 90.6% 64.5% Training for health-service, human-service providers 87.5% 90.3% Advocacy, community planning 84.4% Not reported Counseling, testing, referral 81.3% 83.9% Vaccination 78.1% 90.3% Medical management 62.5% 25.8% NOTES: All 55 adult viral hepatitis prevention coordinators completed the survey; 23 of the 55 jurisdictions do not have a viral hepatitis plan. SOURCE: CDC, 2009f.
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C prevalence of chronic HBV infection and HBV-related liver cancer (Asian Liver Center, 2009). The Harm Reduction Coalition is an example of an organization that develops and disseminates hepatitis C information among illicit-drug users (Harm Reduction Coalition, 2009). Information regarding the activities and programs supported by NGOs are presented primarily in Chapter 3. Health services provided by federal agencies, state and local governments, and NGOs do not form part of a coordinated national campaign. Existing efforts at interagency information exchange, intermittent meetings to share plans and results, and joint administration of funds for some grants are not sufficient for the scale of the health burden presented by hepatitis B and hepatitis C. The lack of an accountable entity to lead a coordinated national effort has led to missed opportunities for prevention and identification of and treatment for chronic HBV and HCV infections. COMPONENTS OF VIRAL HEPATITIS SERVICES The committee has identified five core functions for comprehensive viral hepatitis services—(1) community outreach, (2) prevention, (3) identification of infected persons, (4) social and peer support, and (5) medical management (Box 5-3). Community outreach and immunization for primary prevention are discussed in depth in Chapters 3 and 4, respectively. Identification of infected persons, harm reduction, and medical management are reviewed below. Identification of Infected Persons There are two goals for identifying people chronically infected with HBV and HCV: to prevent transmission to close contacts (for example, through sharing of needles and other paraphernalia and through household and sexual contacts) and to reduce the risk of chronic liver disease through medical treatment and support. The identification of HBV-infected and HCV-infected people requires engagement of at-risk people and activism by the health-care–provider community. As discussed in Chapter 3, culturally relevant, accessible, and trusted sources of communication are required to increase awareness and promote use of appropriate services. Health-care and social-service providers, particularly primary-care providers, should be knowledgeable about chronic HBV and HCV infection and identify patients who are at risk because of their behavior or previous potential exposure to HBV or HCV. Programs and venues that serve at-risk populations—such as foreign-born people from HBV-endemic countries, the uninsured and underinsured, illicit-drug users, and homeless people—should also be knowl-
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C BOX 5-3 Components of Comprehensive Viral Hepatitis Services Community Outreach Community-awareness programs Provider-awareness programs Prevention Vaccination Harm reduction Needle-exchange programs Drug and alcohol treatment services Vaccination of hepatitis B virus-susceptible contacts Identification of Infected Persons Risk-factor screening Laboratory testing Social and Peer Support Positive prevention services Education and referral to other related services and care Medical Management Assessment for and provision of long-term monitoring for viral hepatitis and selection of appropriate persons for treatment (in accordance with American Association for the Study of Liver Diseases guidelines) Psychiatric and other mental-health care Adherence support edgeable about viral hepatitis and should have mechanisms for identifying infected people and referring them to followup medical management. The committee has defined a two-step process for identifying infected people: Risk-factor screening. 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. Risk factors include being born in a country where the disease is prevalent, and behavior such as illicit-drug use and having multiple sexual partners.
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C Serologic testing. Serologic testing is laboratory testing of blood specimens for biomarker confirmation of HBV or HCV infection. Risk-Factor Screening Hepatitis B Risk-Factor Screening CDC has identified risk factors for becoming infected or chronically infected with HBV (see Box 5-4). As discussed in Chapter 3, improved provider awareness about risk factors is critical for ensuring that people at risk for chronic HBV infection are identified and that those at risk for becoming infected with HBV are vaccinated. Providers should review patients’ backgrounds (for example, country of birth) and discuss relevant behaviors to determine what services they need. Figure 5-1 illustrates the pathway of services and care for people depending on their risk factors identified. People who have HIV infection or other sexually transmitted infections, men who have sex with men, injection-drug users (IDUs), and institutionalized and incarcerated persons BOX 5-4 Summary of CDC At-Risk Populations for Hepatitis B Virus Infection Persons born in geographic regions that have HBsAg prevalence of at least 2% Infants born to infected mothers Household contacts of persons who have chronic HBV infection Sex partners of infected persons Injection-drug users Sexually active persons who are not in long-term, mutually monogamous relationships (for example, more than one sex partner during previous 6 months) Men who have sex with men Health-care and public-safety workers at risk for occupational exposure to blood or blood-contaminated body fluids Residents and staff of facilities for developmentally disabled persons Persons who have chronic liver disease Hemodialysis patients Travelers to countries that have intermediate or high prevalence of HBV infection SOURCE: Mast et al., 2005, 2006.
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Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C FIGURE 5-1 Hepatitis B services model. Abbreviations: HBV, hepatitis B virus; HBsAg, hepatitis B surface antigen; anti-HBs, antibody to hepatitis B surface antigen. are at increased risk for HBV infection. CDC recommends that all those populations be tested and given a first dose of vaccine at the time of testing. However, the committee believes that an acceptable alternative is hepatitis B vaccination without testing for all the populations except HIV-infected persons. This approach may facilitate increased vaccination rates. All persons found to have risk factors for HBV infection should receive counseling about prevention. Hepatitis C Risk-Factor Screening CDC has identified risk factors for people at risk for being infected with HCV or becoming infected with HCV (see Box 5-5). Risk-factor screening has been tested by using question-
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