IOM Recommends National Strategy for Hepatitis B and C

IOM Recommends National Strategy for Hepatitis B and C

Medscape Medical News
Laurie Barclay, MD
Freelance writer and reviewer, MedscapeCME

January 11, 2010 — The Institute of Medicine (IOM) issued a report today recommending a national strategy for the prevention and control of hepatitis B and C virus infection, which disproportionately affect minorities and often lead to liver cancer and death. The IOM held a telephone briefing today to discuss the report, which is posted online at http://books.nap.edu/openbook.php?record_id=12793&page=R1.

"Although hepatitis B and C are preventable, the rates of infection have not declined over the past several years, underscoring the conclusion that we have allowed gaps in screening, prevention, and treatment to go unchecked," committee chair R. Palmer Beasley, MD, professor of epidemiology and disease control at the University of Texas School of Public Health in Houston, said in a news release. "This report outlines the additional resources and actions needed to reduce the unacceptably high burden of liver disease and cancer associated with these viruses."

Public Health Burden of Hepatitis B and C

Chronic hepatitis B and C virus infection are among the leading causes of preventable deaths worldwide. Up to 1 in 50 Americans has chronic viral hepatitis, with estimated US prevalence of chronic hepatitis B at 800,000 to 1.4 million, and of chronic hepatitis C at 2.7 million to 3.9 million. However, about half of infected individuals are unaware of their diagnosis until they become symptomatic with liver cancer or liver disease. Among high-risk populations, rates of testing for hepatitis infection, or even of receiving information on reducing risk for infection, are very low.

Groups at high risk for hepatitis B virus infection are infants born to women with the disease, sexual contacts of infected persons, injection drug users, and immigrants from countries in which hepatitis B and C are endemic, particularly East and Southeast Asia and sub-Saharan Africa. Although Asians and Pacific Islanders constitute only 4.5% of the US population, they account for more than half of chronic hepatitis B cases.

Persons at highest risk for hepatitis C virus infection are those who received a blood transfusion before 1992 and past or current users of injection drugs, with prevalence approaching 90% among long-term users. Hepatitis C mortality is increasing and is greatest among middle-aged men, non-Hispanic blacks, and American Indians.

Further compounding the problem of undiagnosed hepatitis B and C infection is the generally low level of knowledge about these infections among healthcare workers and social service providers. Many providers do not comply with guideline recommendations for hepatitis B and C screening, prevention, treatment, and follow-up services.

Each year, thousands of cases of liver cancer, liver disease, and mortality, and nearly half of liver transplantations, are attributable to chronic hepatitis B and C, particularly among Asians, Pacific Islanders, and blacks in the United States. Although chronic viral hepatitis B is preventable through a vaccine, chronic hepatitis B or C infection accounts for 78% of cases of primary liver cancer (hepatocellular carcinoma) and 57% of cases of cirrhosis.

Healthcare Funding Insufficient for Hepatitis B and C

Despite the significant public health burden posed by hepatitis B and C, current resources and efforts to curb this problem are inadequate for chronic viral hepatitis prevention, control, and surveillance programs and are notably less than those targeting other infectious diseases that have a similar effect on public health, according to the IOM report.

The Centers for Disease Control and Prevention's (CDC's) Division of Viral Hepatitis, a division of the National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Disease (STD), and Tuberculosis Prevention (NCHHSTP), administers most programs related to chronic viral hepatitis. These programs include surveillance and epidemiologic studies, clinical and laboratory research, national and local viral hepatitis programs, public dissemination of hepatitis-related information, and development of guidelines for prevention and control.

In fiscal year 2008, the Division of Viral Hepatitis' budget allocation was $17.6 million, or 2% of the entire NCHHSTP budget, whereas domestic HIV activities received 69%, STDs received 15%, and tuberculosis received 14% of the NCHHSTP 2008 budget. These discrepancies are particularly striking in light of the observation that HIV/AIDS affects 3 to 5 times fewer Americans than viral hepatitis.

In the United Kingdom, the National Health Service (NHS) has considered the use of hepatitis B vaccine in newborns to prevent liver cancer but decided that this strategy was not cost-effective, according to Professor Sir Michael Richards, National Cancer Director for the NHS. He spoke at the 2010 School of Pharmacy lecture in London on January 7, and he contrasted this decision with that made more recently for the use of the human papillomavirus (HPV) vaccine for preventing cervical cancer, which was judged to be cost-effective; a national HPV immunization program is now in place in the United Kingdom.

In the World Health Organization Western Pacific region, where hepatitis B is highly endemic in many countries, 23 of 26 countries have introduced hepatitis B vaccine starting at birth.

Hepatitis B and C Strategies Recommended by IOM

Strategies recommended by the new IOM report to address discrepancies in healthcare allocation and to reduce the substantial public health burden associated with hepatitis B and C are more inclusive vaccination requirements, increased provision of resources for prevention and treatment, and a public awareness campaign similar to that implemented for HIV/AIDS.

Despite the availability of an effective hepatitis B vaccine that has significantly reduced transmission, approximately 1000 infants born to infected mothers develop chronic hepatitis each year, and this incidence has not declined during the past decade. A new recommendation is that all full-term newborns born to hepatitis B–positive mothers be vaccinated once they are stable and before leaving the delivery room, rather than up to 12 hours after birth.

Although most states mandate hepatitis B vaccination for children entering daycare or school, Alabama, Montana, and South Dakota still do not. The IOM report therefore recommends that all states require hepatitis B vaccination for school attendance and that health plans fully cover the costs of vaccination. Each year, approximately 40,000 to 45,000 people legally immigrate to the United States from hepatitis B–endemic countries, and children in these groups should be highlighted for screening and vaccination campaigns.

Because healthcare and social services targeting viral hepatitis are sparse and spread out among providers and organizations, opportunities are often missed to prevent transmission and to reduce the effect of chronic infections. The IOM report therefore recommends better coordination of hepatitis-related healthcare through strategies to identify more infected individuals, to reduce the stigma of infection via social and peer support, and to provide medical management for patients with chronic hepatitis B or C. These recommendations target groups that provide services to at-risk populations, including prisons and jails, HIV and STD clinics, shelter-based programs, and mobile health units, as well as health professionals based in hospitals and physician's offices.

Following the model of the HIV/AIDS public awareness initiative, the IOM report recommends developing and disseminating to all health professionals and social service providers educational programs and materials describing risk factors for viral hepatitis and recommendations for vaccination, prevention, and proper monitoring of infected persons.

A significant barrier to overcome through this public awareness initiative is the stigma associated with viral hepatitis, which may foster reluctance to seek testing and treatment, particularly among immigrants from countries with negative perceptions about hepatitis B. For example, chronic hepatitis B in persons living in China may be associated with discrimination both in the work force and socially. Negative attitudes about illicit drug users, who make up the highest proportion of those infected with hepatitis C, may affect their access to quality healthcare or their willingness to seek care.

Specific recommendations in the IOM report include the following:

* The CDC should perform a comprehensive evaluation of the national hepatitis B and hepatitis C public health surveillance system and 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 CDC should support and perform serologic testing and other targeted active surveillance to monitor incidence and prevalence of hepatitis B and C virus infections in populations not fully captured by core surveillance.
* The CDC should work with key stakeholders (other federal agencies, state and local governments, professional organizations, healthcare organizations, and educational institutions) to develop hepatitis B and C educational programs for healthcare and social service providers. These programs should also target at-risk populations and increase awareness in the general population about hepatitis B and C.
* All infants weighing at least 2000 g 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. All other infants should be vaccinated in accordance with the recommendations of the Advisory Committee on Immunization Practices.
* All states should require that the hepatitis B vaccine series be completed or in progress before school attendance.
* Additional federal and state resources should be allocated to increasing hepatitis B vaccination of at-risk adults. States should be encouraged to expand immunization information systems to include adolescents and adults. Private and public insurance coverage for hepatitis B vaccination should be expanded.
* The federal government should work to ensure an adequate, accessible, and sustainable supply of hepatitis B vaccine, and research should continue to develop a hepatitis C vaccine.
* Federally funded health insurance programs should incorporate guidelines for risk-factor screening for hepatitis B and C as a required core component of preventive care.
* The CDC, in conjunction with other federal and state agencies, should provide resources to expand community-based programs providing hepatitis B screening, testing, and vaccination services targeting foreign-born populations.
* Federal, state, and local agencies should expand prevention programs to reduce the risk for hepatitis C virus infection through injection drug use. These programs should include access to sterile needle syringes and drug preparation equipment.
* Federal and state governments should expand testing, counseling, vaccination, and management services to reduce the harm caused by chronic hepatitis B and hepatitis C.
* Innovative, effective, multicomponent hepatitis C virus prevention strategies for injection and noninjection drug users should be developed and assessed to achieve greater control of hepatitis C virus transmission.
* The CDC should provide additional resources and guidance to perinatal hepatitis B prevention program coordinators to improve the identification of chronically infected pregnant women and to provide case management services.
* The National Institutes of Health should support a study of the effectiveness and safety of peripartum antiviral therapy to reduce or possibly eliminate perinatal hepatitis B virus transmission from women at high risk.
* The CDC 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 people in prison.
* The Health Resources and Services Administration should provide federally funded community health facilities with adequate resources to provide comprehensive viral hepatitis services.
* The Health Resources and Services Administration and the CDC should provide resources and guidance to integrate comprehensive viral hepatitis services into settings that serve high-risk populations (eg, STD clinics, sites for HIV services and care, homeless shelters, and mobile health units).

Responses of Other Organizations

In response to the IOM report, the CDC Foundation (an independent nonprofit partner of the CDC), in partnership with the CDC's Division of Viral Hepatitis, has launched a Viral Hepatitis Action Coalition. The coalition includes private-sector organizations such as Gilead Sciences, Inc; Merck & Co, Inc; OraSure Technologies, Inc; and Vertex Pharmaceuticals that support and fund high-priority research, education, and program evaluation projects begun by the CDC's Division of Viral Hepatitis.

"The ongoing challenge of preventing and controlling viral hepatitis requires a multifaceted response. CDC cannot do the job alone and is pleased to join with industry partners through the Viral Hepatitis Action Coalition to put forth a collective effort," John Ward, MD, director of the Division of Viral Hepatitis, NCHHSTP, told Medscape Infectious Diseases. "The coalition will help jump start priority viral hepatitis research and programs here at CDC and will use the IOM report to help identify those areas — like building awareness and improving surveillance — where CDC science, combined with resources and expertise from industry, can make the biggest impact."

The first 2 designated priority projects for the coalition are the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) study and a national hepatitis education campaign. Additional goals of the coalition are to share research data and feedback regarding information and tools needed in the field to respond to the IOM recommendations.

The release of the IOM report has prompted the National Viral Hepatitis Roundtable (NVHR) to once more urge the Obama administration, Congress, and the US healthcare system to act quickly and forcefully against the threat posed by hepatitis B and C. The NVHR is a coalition of more than 150 public, private, and voluntary organizations using strategic planning and legislation to reduce the incidence of infection, morbidity, and mortality from viral hepatitis in the United States.

In particular, NVHR is hopeful that the IOM will spur urgent congressional action on the bipartisan Honda-Dent legislation that quickly would help implement many of the IOM report's recommendations," said NVHR Chair Lorren Sandt. "We are in the grips of a public health crisis that cannot be ignored."

The Viral Hepatitis and Liver Cancer Control and Prevention Act, recently introduced in Congress by Representatives Mike Honda (D-Calif.) and Charles Dent (R-Pa.) calls for an initial $90 million in funding in 2011, and additional funding subsequently, for comprehensive prevention, research, and medical management referral programs for chronic viral hepatitis B and C infection.

"The [IOM] report highlights many important issues we see in our clinics," said NVHR Steering Committee Member Andrew Muir, MD, clinical director of hepatology at the Duke University School of Medicine in Durham, North Carolina. "Too many patients are unaware they have viral hepatitis, and this makes it difficult to control the spread of these infections and provide appropriate treatment to those infected. Too many patients present to our clinics in the late stages of cirrhosis or with advanced liver cancer. If we could identify these patients sooner, we have effective treatment strategies to help them avoid these devastating complications. We need coordinated surveillance and educational programs to aid us in these efforts."

The IOM report was sponsored by the US Centers for Disease Control and Prevention, the US Department of Health and Human Services' Office of Minority Health, the US Department of Veterans Affairs, and NVHR