For Patients Caregiver Tips and Advice For Medical Professionals

Advocacy

In total, over 30 million Americans have some form of liver disease. Over 5.5 million people are living with chronic liver disease or cirrhosis, and approximately 20-30% of adults and 3-10% of children have non-alcoholic fatty liver disease (NAFLD), which can lead to a more serious liver disease called non-alcoholic steatohepatitis (NASH). Unnervingly, approximately 4.4 million Americans are living with Hepatitis B or C and many of these individuals do not know they are infected. With the prevalence of liver disease in the U.S. alarmingly increasing, we need to work together to take action now!

ALF takes a leadership role in advocating on behalf of the millions of Americans living with liver disease and their families.

  • ALF testifies before Congress and state legislatures on important issues related to liver disease to help effect change in public health policy.
  • We actively lobby Congress and state legislatures for legislation to support increases in organ donations.
  • We have been a moving force behind the acceptance of an agreement on a comprehensive “Research Agenda” for liver disease.
  • The Foundation’s “Annual Day on the Hill” engages staff and volunteers in a full day of lobbying for legislation on critical issues including increased funding for research, public health education and organ donor awareness.
  • The Foundation participates in numerous coalitions and works in partnership with other organizations to support public policy and funding into research, education and advocacy for liver disease and wellness initiatives.
  • ALF has been active in obtaining cosponsors for the Liver Research Enhancement Act (HR1743) to create a center within the National Institutes for Health that will focus solely on research into liver-related diseases.

Our Positions and Policies

Regarding organ donation benefits, the American Liver Foundation resolves that:

  • Organs should not be bought or sold;
  • Donation of organs should not be a financial burden to family or donors;
  • Financial or logistical obstacles should be minimized to the extent possible for organ donations made voluntarily by families or donors;
  • Accommodations to achieve the above should be referred to as “Donation Benefits,” rather than termed as “inducements” or “incentives;”
  • Policy makers should focus attention to considerations or benefits to donors that will increase the rates of donation and be equitable across society; and
  • The Secretary of the Department of Health and Human Services (HHS) should define by regulation the meaning of “valuable consideration” per the National Organ Transplant Act and be empowered to authorize demonstration projects aimed at increasing organ donation rates applying the concept of valuable consideration but not the trafficking of human organs.

Regarding organ donation consent, the American Liver Foundation resolves that:

  • Policy makers need to actively explore different models of consent for organ donation, including presumed consent, and determine what model more effectively increases the level of donation consistent with societal values;
  • In making such a determination, due regard should be given to the medical, legal, ethical and psycho-social implications of the different models;
  • Education and outreach requirements of these different models need to be considered; and physicians seeking consent of family members of individuals who have not made their organ decisions become familiar with
    • The need for donated organs
    • The care of grieving families
    • The proper medical/social screening of potential donors
    • The decision making process and the tools to influence it;
  • Demonstration projects evaluating the potential impact of different consent models on organ donation need to be supported by the private and/or public sectors; and
  • The American Liver Foundation will identify steps to promote this resolution.

Executive Statement

The American Liver Foundation recognizes the significant burden of hepatitis A infection for U.S. families and communities. Each year, more than 180,000 children and adults are infected with this virus, making it the sixth most commonly reported infectious disease in the United States.1,2 In 1999, public health costs for hepatitis A control and management exceeded $500 million.3 There is no treatment for hepatitis A disease, but prevention is available with immunization. The American Liver Foundation endorses the position of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) that routine childhood vaccination is the most effective way to reduce hepatitis A incidence nationwide over time.4 In addition, American Liver Foundation supports a comprehensive plan for vaccination of at risk adults and public health action that includes outreach to families and communities, professional education, and nation-wide coalition building for expanded immunization services and research.


Hepatitis A Impact

By some estimates, 10 million people worldwide acquire the hepatitis A virus (HAV) every year.5 In the United States, hepatitis A is one of the most frequently reported vaccine-preventable diseases, ranking sixth among the top ten causes of food-borne illness.6 The Centers for Disease Control and Prevention (CDC) estimates that more than 180,000 asymptomatic and symptomatic hepatitis A infections occur each year, with approximately one-third involving children < 15 years of age.7 Each year, hepatitis A disease causes approximately 100 deaths.

Hepatitis A often occurs in community-wide epidemics, as occurred in five states in March 1997.9 Cyclic increases of hepatitis A occur approximately every decade in the U.S., but relatively high rates for the disease continue between epidemics. Within the United States; states, counties and communities can be considered to have high, intermediate, or low rates of hepatitis A on the basis of epidemiological characteristics.10

Over the past several decades, areas in the western U.S. have had substantially higher rates of hepatitis A disease than the rest of the country. According to the CDC, most hepatitis A cases result from person-to-person transmission during community-wide outbreaks in these regions. During the period 1987-1997, 68% of U.S. cases occurred in these endemic western states.11

  • High rate states are those with the average annual hepatitis A rate during 1987-1997 greater than 20 cases per 100,000 population (approximately twice the national average). These states include: Arizona, Alaska, Oregon, New Mexico, Utah, Washington, Oklahoma, South Dakota, Idaho, Nevada, and California.12
  • Intermediate rate states are those with the average annual rate of hepatitis A during 1987-1997 was greater than 10 cases per 100,000 population (approximately the national average) but less than 20 cases per 100,000. These states include: Missouri, Texas, Colorado, Arkansas, Montana and Wyoming.3

Hepatitis A Risk Groups

Historically in the United States, certain populations are at increased risk for hepatitis A disease. Native Americans, Hispanic Americans, Alaskan Natives, migrant populations and certain religious groups have had a higher incidence of hepatitis A in past decades. Some of these rates are now changing as a result of hepatitis A vaccination programs, but without immunization these communities continue at increased risk for the disease.14

According to the CDC, other persons are also at increased risk for HAV infection:

  • Persons traveling to or working in countries that have high or intermediate rates of infection, especially frequent short-term travelers and persons staying for extended periods of time. Geographic areas with increased risk include: Asia, Africa, South America, Latin America, the Middle East, European countries bordering the Mediterranean, and Eastern European countries. Risk for HAV infection in these regions increases with duration of travel.
  • Men who have sex with men.
  • Persons who use injection and non-injection illegal drugs
  • Persons who have an occupational risk for infection including persons working with HAV-infected primates and with the HAV in a research laboratory setting.
  • Persons who have clotting-factor disorders, especially those administered solvent-detergent-treated preparations.15
  • In addition, the CDC considers persons with chronic liver disease at increased risk for the serious sequela of hepatitis A infection, including acute liver failure.16

The American Liver Foundation recognizes other groups for which HAV infection may pose a special risk. These include groups historically associated with common source outbreaks and persons with regular or increased risk for exposure to fecal material:

  • Food handlers17
  • Military personnel18
  • Day care personnel and children attending day care, as well as their parents, siblings and close contacts19
  • Health care workers20
  • Staff of institutions for the developmentally disabled21
  • Consumers of certain high risk foods (e.g. raw shellfish)22

Hepatitis A Disease

Hepatitis A is a serious viral infection of the liver with a variable incubation period of 15 to 50 days.23 It is a systemic disease characterized by an abrupt onset of symptoms that can include fever, fatigue, malaise, anorexia, nausea, abdominal pain, dark urine, and jaundice.24 Hepatitis A symptoms are age-related. Most cases (70%) in children less than 6 years are asymptomatic, while greater than 70% of older children and adult patients develop jaundice.25,26 Older children and adults can experience debilitating symptoms that persist for 2 to 8 weeks. For most of these patients, the illness usually resolves within 2 months, but 10-15% of symptomatic cases can persist or relapse for up to 6 months.27 Persons older than 50 years of age and those with chronic liver disease are at increased risk of acute liver failure due to hepatitis A, a life-threatening event. The mortality rate for adults over age 50 is 27 per 1000 cases. Each year an estimated 100 persons die in the U.S. due to acute liver failure from Hepatitis A.28


Hepatitis A Transmission

The hepatitis A virus (HAV) is highly contagious and is primarily transmitted by the fecal-oral route, through person-to-person contact, or through the ingestion of contaminated food or water. HAV transmission has been linked to uncooked fruits and vegetables, shellfish, and contaminated ice.29 The virus can survive on a surface (e.g. toys, cutting boards) for up to one month.30 CDC documents that approximately 25% of infection with hepatitis A is through household/personal contact; 15% though daycare settings; 7% from international travel and 7% of the cases are outbreak-related. In almost 50% of hepatitis A cases the source of infection is unknown.31

Hepatitis A in young children is often a mild or asymptomatic infection, but young children with unrecognized infections play an important role in HAV transmission. Children infected with the virus have a longer incubation period than adults and can continue to shed virus in their stool for as long as 180 days. They can serve as a significant “invisible” source of infection for others, especially in highly endemic states and in outbreak communities. Care givers in the household and at day care centers risk hepatitis A exposure when changing diapers of infected, asymptomatic children.32,33 Several studies document the role of children < 6 years with HAV transmission within households. In one study of adults without an identifiable source of transmission, over 50% of their households included a child under age 6 associated with the transmission of the disease to family members.34


Economic Impact on Families, Communities, and Business

The economic costs of hepatitis A are significant. Between 11% and 22% of persons who have the disease are hospitalized. A typical adult case of hepatitis A will result in 27 lost days of work.35 Average costs (direct and indirect) of hepatitis A range from $1,817 to $2,459 per case for adults and from $433 to $1492 per case for children less than 18 years of age.36 Health departments incur substantial costs responding to outbreaks. A 1996 Denver, Colorado food-borne outbreak affected 43 persons and cost the community $800,000.37 Restaurants with hepatitis infected food workers also risk economic consequences. Recently, a Seattle law firm won a $1.06 million settlement on behalf of 29 hepatitis A outbreak victims at a local fast food franchise.38

The total economic burden of hepatitis A disease is significant and growing. In 1989 the annual cost of this disease was estimated at $200 million.39 A 1999 analysis estimated that the annual cost of hepatitis A among adolescents and adults now approximated $500 million.40


Hepatitis A Prevention, Treatment, and Outbreak Response

Good personal hygiene, including hand washing, is recommended for the prevention of any food-borne illness. Other preventive public health measures include good sanitation, a safe water supply, and careful food preparation. HAV can be inactivated by boiling or cooking to greater than 185 degrees F or chlorinating the water supply.41

Longer-term prevention against hepatitis A is available with immunization. Currently, there are 2 inactivated single antigen virus vaccines available for protection against hepatitis A in the United States: Havrix and Vaqta. Clinical studies for both have demonstrated excellent protective efficacy, immunogenicity, and safety.42,43 The CDC and others have documented the ability of routine childhood immunization with these vaccines to effectively interrupt and prevent community outbreaks of hepatitis A disease in highly endemic areas.44 Recently the FDA has approved Twinrix, another inactivated vaccine for hepatitis A protection. For use in adults only, Twinrix is a combination vaccine against hepatitis A and B.

To prevent hepatitis A during international travel, persons over age two going to endemic areas can receive hepatitis A vaccine and education about personal hygiene and food and beverage safety. Accompanying children under age two and persons departing in less than four weeks can receive immune globulin for short-term protection against HAV.

In the event of a community-wide outbreak, immune globulin can be offered as post-exposure prophylaxis to persons with close contact to identified cases. At this time, hepatitis A vaccine can also be offered concomitantly for longer-term protection.

There is no curative treatment for hepatitis A disease and clinical management for symptomatic cases is supportive care.


American Liver Foundation Call For Action

I. Public Health Recommendations

The American Liver Foundation endorses the recommendations of the Advisory Committee on Immunization Practices (ACIP) for the immunization of children and adults at increased risk for hepatitis A infection and for any person wishing to obtain immunity.45

A. Recommendations for Children at Increased Risk for Hepatitis A Infection

1. Routine vaccination for pre-exposure prevention is recommended for children living in areas where the rates of hepatitis A are at least twice the national average or greater than 20 cases per 100,000 population during 1987-1997. Beginning at age 2, these children should be routinely immunized against hepatitis A and catch-up vaccination of pre-school children should be a highest priority. These states and communities include:

  • Arizona, Alaska, Oregon, New Mexico, Utah, Washington, Oklahoma, South Dakota, Idaho, Nevada, and California.
  • American Indian, Alaskan Native, and selected Hispanic, migrant, and religious communities.

The American Academy of Pediatrics also recommends that children 2 years and older who live in defined and circumscribed communities with high endemic rates should be vaccinated against hepatitis A.46

2. Routine vaccination for pre-exposure prevention should be considered for children who live in areas where the annual rates of hepatitis A are greater than the national average, but lower than twice the national average (e.g. children who lives in intermediate-rate states where the average annual rate of hepatitis A during 1987-1997 was greater than 10 cases per 100,000 population but less than 20 cases per 100,000). These states and counties include:

  • Missouri, Texas, Colorado, Arkansas, Montana and Wyoming.
  • Children who live in select counties or communities where rates are greater than the national average but lower than twice the national average.

The American Academy of Pediatrics also recommends that children 2 years and older residing in defined communities with periodic outbreaks of hepatitis A be vaccinated.47

B. Recommendations for Persons at Increased Risk for Hepatitis A Infection

1. Routine vaccination is recommended for persons traveling to or working in countries that have high or intermediate rates of infection. These areas include: Asia, Africa, South America, Latin America, the Middle East, European countries bordering the Mediterranean, and Eastern European countries and for;

  • Children greater than 2 years of age, adolescents and adults who plan frequent travel or who reside for long periods in high-risk areas should receive the age appropriate dose of the hepatitis A vaccination.
  • Children less than 2 years of age who should receive immune globulin because the vaccine is currently not licensed for this age group.
  • Persons traveling to a high-risk area <4 weeks after the initial hepatitis A vaccine dose also should be administered IG for protection.

2. Men who have sex with men;

3. Persons who use injection and non-injection illegal drugs;

4. Persons who have an occupational risk for infection including persons working with HAV-infected primates and with the HAV in a research laboratory setting;

5. Persons who have clotting-factor disorders, especially those administered solvent-detergent-treated preparations.

C. Recommendations for Persons with Chronic Liver Disease

1. Routine vaccination is recommended for persons with evidence of chronic liver disease who are at increased risk for acquiring hepatitis A and for;

2. Susceptible persons who are either awaiting or have received liver transplants.

D. Recommendations for Hepatitis A Vaccination During Outbreaks

1. In communities with high rates of hepatitis A, vaccination efforts among preschool and school-age children should be intensified during an outbreak to achieve at least a 70% vaccination coverage level.

2. In communities with intermediate rates of hepatitis A, outbreak recommendations include:

  • Routine childhood vaccination should be initiated during the outbreak, if this recommendation has not yet been implemented.
  • Accelerated vaccination can be considered using local surveillance and epidemiological data to define populations and community areas at highest risk for hepatitis A infection.
  • Evaluation of the effectiveness of vaccination programs to control outbreaks in these communities should be an essential element of programs in these settings.

3. In communities with low rates of hepatitis A, community-wide outbreaks are uncommon. However, if outbreaks do occur, vaccination programs should focus on identified risk groups of adults or children.

4. For outbreaks in other settings, including day care center, hospitals, institutions for the developmentally disabled, prisons, and schools, recommendations include:

  • Post-exposure prophylaxis with immune globulin is for individuals who had close contact with the infected person(s)
  • However, the following issues should be noted:
  • The frequency of outbreaks in these settings is not high enough to warrant routine hepatitis A vaccination of persons specifically because they are in these settings.
  • Few data exist regarding the role of hepatitis A vaccine in controlling outbreaks in these settings.

II. Other ALF Recommendations

In addition to the CDC guidelines for the prevention and eradication of hepatitis A in the U.S., ALF recommends:

A. Administration of hepatitis A vaccine to food handlers. Food handlers have a critical role in common-source food-borne HAV transmission. This group should be vaccinated to reduce the frequency of medical evaluations of food handlers with hepatitis A and to eliminate the need for post-exposure prophylaxis for patrons. 48

B. Expanded vaccine use should be considered for groups often associated with common source outbreaks including: military personnel, day care personnel, health care workers, staff of institutions for the developmentally disabled, children at day care centers, as well as their parents, siblings and other close contacts, persons who repeatedly contract sexually transmitted diseases, and consumers of high risk foods (e.g. raw shellfish).

C. Administration of hepatitis A vaccine to persons who test positive for hepatitis C, with or without evidence of chronic liver disease.49

D. Educational outreach to individuals, families and communities: The American public continues to be largely unaware of its risk for this disease. There is a need for ongoing education about hepatitis A transmission, its economic impact and the availability of a safe and effective vaccine.

E. Endemic communities and persons at high risk should receive customized educational messages.

F. Enhanced Professional Education: Health professionals can benefit from updated information on the epidemiology of hepatitis A within the U.S., the efficacy and safety of hepatitis A vaccines, and the revised ACIP vaccination recommendations. AS well, updated patient educational materials, available in multiple languages and different literacy levels, should be readily available to help clinicians meet their hepatitis A vaccination goals with targeted ethnic and cultural populations.

G. Coalition-Building in Endemic States: ALF chapters will work to gain the support of critical partners in this public health effort. Potential partners include state and community health departments, school boards and parent-teacher associations, school nurses, day care organizations, parent advocacy groups, pediatricians, hepatologists and gastroenterologists, restaurant associations, and organizations with high-risk group members. ALF chapters will work with state and local legislative groups to fully implement this action plan.

H. Support for Ongoing Research to Eliminate HAV Transmission: Vaccine research is needed to address the issue of infant immunogenicity and develop vaccines that protect children < 2 years of age. Research is needed to test the value of hepatitis A vaccine as post-exposure prophylaxis. As well, outreach techniques must be refined to effectively reach target groups with the hepatitis A prevention message, especially in endemic areas.


1, 2 CDC. Summary of notifiable diseases, United States, 1997. MMWR 1998; 46:1-87..CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999;48 (No. RR-12): 5.

3 Jacobs J. “The cost effectiveness of childhood hepatitis A vaccination.” Presentation at American Liver Foundation Meeting “Strategic Directions for Reducing Hepatitis A in High Endemic States”, St Louis, MO, June 10, 2000.

4 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48 (No. RR-12): 1

5 de Vincent-Hayes N. Hepatitis. Current Health 1995; 22(4): 20.

6 CDC. Summary of notifiable diseases, United States, 1997. MMWR 1998; 46:1-87.

7 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 5

8 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 4

9 Hutin YJ, et al. A multistate, food borne outbreak of hepatitis A. N Engl J Med 1999; 340(8): 595-602.

10 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 9

11 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 7

12 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 8

13 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 9

14 Koff RS. Seroepidemiology of hepatitis A in the United States. J Infect Dis. 1995; 171 (suppl 1): S19-S23.

15 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 11-12

16 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 12

17 Carl M, Francis DP, Maynard JE. Food-borne hepatitis: recommendations for control. J Infect Dis 1983; 148:1133-5.

18 Jefferson TO, et al. Should British soldiers be vaccinated against hepatitis A? An economic analysis. Vaccine 1994; 12: 1379-83

19 Hadler SC, et al. Hepatitis A in day-care centers: a community wide assessment. N Engl J Med 1980; 302:1222-7.

20 Rosenblum LS et al. Hepatitis A outbreak in a neonatal intensive care unit: risk factors for transmission and evidence of prolonged viral excretion among preterm infants. J Infect Dis 1991; 164:476-82.

21 Szmuness W, Purcell RH, Dienstag JL, Stevens CE. Antibody to hepatitis A antigen in institutionalized mentally retarded patients. JAMA 1977; 237:1702-5.

22 Desenclos JA et al. A multistate outbreak of hepatitis A caused by the consumption of raw oysters. Am J Public Health 1991; 81

23 Krugman S, Giles JP. Viral hepatitis: new light on an old disease. JAMA 1970; 212:1019-29.

24 Koff RS. Clinical manifestations and diagnosis of hepatitis A virus infection. Vaccine. 1992; 10 (suppl 1): S15-S17.

25,26 Hadler SC, et al. Hepatitis A in day-care centers: a community wide assessment. N Engl J Med 1980; 302:1222-7. Lednar WM et al. Frequency of illness associated with hepatitis A virus infection in adults. Am J Epidemiol 1985; 122:226-33.

27 Glikson M, et al. Relapsing hepatitis A. Review of 14 cases and literature survey. Medicine 1992; 71:14-23.

28 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 4.

29 Beller M. Hepatitis A outbreak in Anchorage, Alaska traced to ice slush beverages. West J Med 1992; 156:624-627.

30 Hollinger FB and Glombicki AP. Hepatitis A virus. In: Mandell GL et al, eds. Principles and Practice of Infectious Diseases, 3rd ed., New York, NY: Churchill Livingston, 1990: 1383-1396.

31 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 5

32, 33 American Academy of Pediatrics. Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin (RE9646). Pediatrics 1996; 98:1207-1215.

34 Staes C, Schlenker T, Risk I, et al. Source of infection among persons with acute hepatitis A and no identified risk factors, Salt Lake City, Utah, 1996. Clin Infect Dis 1997; 25:411.

35 American Academy of Pediatrics. Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin (RE9646). Pediatrics 1996; 98:1207-1215.

36 CDC. Prevention of hepatitis A through active or passive immunization. MMWR 1999; 48 (RR-12): 4

37 Dalton CB, Haddix A, Hoffman RE, Mast EE. The cost of a food-borne outbreak of hepatitis A in Denver, Colorado. Arch Intern Med 1996; 156:1013-6.

38 Marler Clark, LLP. “Seattle law firm obtains $1.06 million settlement on behalf of hepatitis outbreak victims.” Accessed @ www.marlerclark.com.

39 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 5.

40 Jacobs J. “The cost effectiveness of childhood hepatitis A vaccination.” American Liver Foundation Meeting “Strategic Directions for Reducing Hepatitis A in High Endemic States”, St Louis, MO, June 10, 2000.

41 Favero MS, Bond WW. Disinfection and sterilization. In: Zuckerman AJ, Thomas HC, eds. Viral hepatitis, scientific basis and clinical management. New York, NY: Churchill Livingston, 1993: 565-75.

42, 43 Innis BL, Snitbhan R, Kunasol P, et al. Protection against hepatitis A by an inactivated vaccine. JAMA 1994; 271:1328-1334. Werzberger A, Mensch B, Kuter B, et al. A controlled trial of a formal in-inactivated hepatitis A vaccine in healthy children. N Engl J Med 1992; 327:453-457.

44 Wersberger A, Kuter B, Nalin D. Six years’ follow-up after hepatitis A vaccination (Letter). N Engl J Med 1998; 338:1160.

45 CDC. Prevention of hepatitis A through active and passive immunization. MMWR 1999; 48(No. RR-12): 25-30.

46 American Academy of Pediatrics. Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin (RE9646). Pediatrics 1996; 98:1207-1215.

47 American Academy of Pediatrics. Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin (RE9646). Pediatrics 1996; 98:1207-1215.

48 American Academy of Pediatrics. Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin (RE9646). Pediatrics 1996; 98:1207-1215.

49 NIH. Management of hepatitis C-NIH consensus statement, NIH Consensus Development Conference, March 24-25, 1997, Bethesda, Maryland. Accessed @ http://odp.od.nih.gov/consensus/cons/105.htm

  • WHEREAS, the hepatitis A virus (HAV) is hardy and continuously reintroduced into the US;
  • WHEREAS, that HAV is an important illness, the scope of which has been underestimated;
  • WHEREAS, that outbreaks of HAV are still a threat that take a toll on all Americans;
  • WHEREAS, the incidence of hepatitis A is more common than hepatitis B or hepatitis C;
  • WHEREAS, incidence of hepatitis A goes beyond well-defined risk groups (e.g., people with chronic liver disease, travelers, men who have sex with men);
  • WHEREAS, hepatitis A is estimated to infect some 35,000 people a year;
  • WHEREAS, hepatitis A hospitalizes some 22% of those adults infected, an estimated 100 of whom die annually;
  • WHEREAS, children are a reservoir for hepatitis A infection and represent the single most important point of intervention in the effort to eliminate the transmission of the disease
  • WHEREAS, routine HAV vaccination of children to climinate community-wide HAV is a tactic that both works and is cost effective;

THEREFORE, BE IT RESOLVED BY AMERICAN LIVER FOUNDATION THAT:

  • Education efforts should be increased to underscore the urgency of hepatitis A vaccination to at-risk groups (e.g., people with chronic liver disease, travelers, men who have sex with men);
  • Policy makers should make hepatitis A vaccination universal for children nationwide;
  • Education and advocacy should be pursued at the federal and state level to accomplish this;
  • The American Liver Foundation will identify steps to promote this resolution.

The US Preventive Services Task Force (USPSTF) made recommendations on screening for hepatitis C virus (HCV) infection in the 16 March issue of Annals of Internal Medicine (volume 140). Some of these recommendations are not in line with those of the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) Consensus Panel, as endorsed by the American Liver Foundation.

The Summaries for Patients document, written in Q&A format, reads as follows:

What does the USPSTF suggest that patients and doctors do?

Patients and doctors should be aware that there are no studies that prove that screening for HCV infection during routine health care improves patient outcomes. The USPSTF recommends against testing for HCV infection in patients who have no specific risk factors for HCV infection and no symptoms of liver disease. The USPSTF recommends neither for nor against routine testing for HCV infection for patients with specific risk factors for HCV infection.

American Liver Foundation Position

The American Liver Foundation believes that, by failing to support the importance of testing those at risk for hepatitis C, the USPSTF trivializes a serious public health problem, for which substantial scientific evidence and FDA-approved tools and therapies demonstrate that diagnosis and treatment are beneficial. The ALF also believes that the USPSTF’s lack of recommendation for testing for HCV in patients who have no specific risk factors may confuse the public and undermine current screening recommendations that are in practice.

The seriousness of USPSTF’s position is underscored by the fact that over 80% of the more than 4 million Americans infected with HCV do not know that they are infected. Identifying those infected through testing is a matter of national health urgency.

The primary concern of the ALF is the USPSTF recommendation that there is insufficient evidence to recommend for or against routine screening of high-risk adults effectively provides a rationale for health care providers to stop HCV testing for highest risk individuals and for third party payers not to reimburse for the testing. This flies in the face of the accumulated expertise and findings of the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) Consensus Conference Panel on the Management of Hepatitis C. CDC and Consensus Conference recommendations are based on the intermediate outcomes regularly curing people of HCV infection.

Most of those with HCV have been infected for more than 15-20 years. For those who are vulnerable to HCV-induced liver damage, this passage of time without therapeutic intervention can lead to serious morbidity, liver transplantation or death.

At this time, there are no long term follow-up studies (10-20 years) comparing outcomes of patients treated with combination therapy vs. those that were not. This length of follow-up is needed for HCV for, when it progresses, it moves very slowly. And there is no data on prognosis of patients at risk identified by screening. Until such data are available, it remains prudent to screen those at risk for this infection and to assess their need for treatment. While more long term data is needed, there is abundant data about intermediate outcomes regarding curing patients of HCV infection.

In addition, the ALF believes that:

  • Hepatitis C awareness must be increased among the general public and within the medical community.
  • Screening and diagnosis should be available to everyone who needs or wants it.
  • Information regarding treatment options should be available to anyone who needs it.
  • Effective hepatitis C treatment must be available to anyone who needs it.

The American Liver Foundation also has grave concerns over the unfortunate recommendation from the USPSTF that interventions designed to reduce liver injury from other causes, such as counseling to avoid alcohol misuse and immunization against hepatitis A and hepatitis B, demonstrate limited evidence of the effectiveness of these interventions. For the millions of Americans with hepatitis C these interventions help maintain the health and stability of an impaired liver. Also of great concern to the American Liver Foundation is the apparent dismissal of liver biopsies by the USPSTF, long the “gold standard” through which to determine levels of liver disease and liver damage.

Current estimates indicate that deaths from hepatitis C will outpace deaths from HIV by the end of this decade. Without screening of those at risk, and the use of directed therapy, we won’t be able to change this. Also, the majority of liver transplants in this country are the result of chronic hepatitis C infection and substantial scientific evidence demonstrates that the burden is projected to increase.


AASLD Position

March 16, 2004
From the President of the American Association for the Study of Liver Diseases (AASLD):

A study was published today in the Annals of Internal Medicine entitled Screening for Hepatitis C Virus Infection: Recommendations from the U.S. Preventive Services Task Force, concluding that it “found no evidence that screening for HCV infection in adults at high risk leads to improved long-term health outcomes”. It is critical that the contents of this study be understood and not misinterpreted.

The report points out that “Antiviral treatment can successfully eradicate HCV, but data on long-term outcomes in the populations likely to be identified by screening are lacking.”

While this statement is true, it would be erroneous and dangerous to conclude from it that screening of high-risk populations, therefore, is not a public health benefit to the American people.

There are no data on long-term studies of the effectiveness of screening and treatment. The reason for this is that the disease can often take 20 or more years before symptoms appear and effective treatments for the disease using combination therapies have only been developed in the past 6 years and further improved in the past two years.

The report is correct when it says in its final paragraph:

Complications from chronic HCV infection present an enormous health burden that is expected to increase 2- to 4-fold over the next 2 to 4 decades. Further research to more accurately determine the benefits and harms of screening is of paramount importance. (p. 475)

Researchers will not be able to determine the “benefits and harms of screening” unless there is screening of high-risk populations. To misinterpret the report to say that such screening should be stopped would be a terrible mistake with grave consequences over the next two decades.

The study correctly points out some key data about infection with the hepatitis C virus that argue strongly in favor of screening of high-risk populations:

  • Hepatitis C is the most common chronic bloodborne pathogen in the United States.(p.465)
  • Approximately 2.3% of adults 20 years or older are positive for anti-HCV and 55% to 84% of these have chronic infection. (p.465)
  • Most of those infected are not aware of it and, therefore, can and do spread the disease. (p.465)
  • In the U.S., HCV is associated with 40% of cases of chronic liver disease and 8,000 to 10,000 deaths per year. (p. 465)

In addition, it should be noted that HCV is a leading cause of cirrhosis, a common cause of hepatocellular carcinoma (HCC) and the leading cause of liver transplantation in the United States. Early and effective treatment of HCV holds the potential to reduce the number of liver transplants needed and to alleviate the current severe shortage of donor organs.

This study makes a valuable contribution to the public debate about addressing the epidemic of HCV in the United States. Other contributions on the subject include the AASLD practice guidelines for the diagnosis, management and treatment of hepatitis C which are posted on the AASLD web site and published in the April issue of HEPATOLOGY. AASLD looks forward to continuing to participate in the discussion as our members make valuable contributions to the research on this important and deadly disease.

Bruce R. Bacon, MD, President,

American Association for the Study of Liver Diseases (AASLD)

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD’s vision is to prevent and cure liver diseases. The Web site is www.aasld.org.


CDC Position

U.S. Preventive Services Task Force Hepatitis C Screening Recommendations

Q&A FROM THE CDC

Q1. Why has CDC developed this Q and A?

A1. CDC has developed this document to address questions that might arise about how and why the hepatitis C screening recommendations for adults made by the United States Preventive Services Task Force (USPSTF) differ from those previously published by CDC.

The USPSTF is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services. The Task Force and its review of published research are supported by the Agency for Healthcare Research and Quality, Department of Health and Human Services.

The USPSTF makes recommendations based on review of the published literature and a strict set of criteria. The primary basis for their findings are whether there is sufficient evidence (e.g., data on effectiveness) that the intervention (service) improves important long-term, health outcomes (e.g., mortality, morbidity, quality of life) and that benefits outweigh harms.

Q2. What are the USPSTF hepatitis C screening recommendations?

A2. The Task Force:

  • recommended against routine screening for hepatitis C virus (HCV) infection in the general U.S. population because of the low prevalence of infection
  • found insufficient evidence to recommend for or against routine HCV screening in adults at high risk for infection because there is no evidence yet that such screening leads to improved long-term health outcomes.

Q3. Are the USPSTF hepatitis C screening recommendations consistent with CDC hepatitis C screening recommendations?

A3. The Task Force recommendation against routine screening for HCV infection in the general population is the same as CDC’s recommendation. In addition, the Task Force recommendation that health care providers test for HCV infection persons with signs (e.g., elevated ALT) or symptoms of liver disease also support CDC’s recommendation.

The recommendation that there is insufficient evidence for or against HCV testing in adults at high risk for infection differs from current recommendations made by CDC, NIH and other professional organizations because there are criteria other than evidence of improved long-term outcomes that can support recommendations for routine testing.

Q4. Why does CDC recommend HCV testing routinely for persons at increased risk?

A4. About 2.7 million persons are chronically infected with HCV, and most of these are adults 30-59 years old. A major focus of current prevention activities is to reduce progression or severity of chronic disease as this cohort ages. Identification of HCV infected persons provides the opportunity for medical evaluation to determine disease status and possible treatment, and to obtain information on how they can prevent further harm to their liver (e.g., reduce alcohol intake, hepatitis A and hepatitis B immunization, substance abuse treatment). In addition, identification of HCV infected persons provides the opportunity for counseling on how to prevent transmission to others.

Q5. Who is the target audience for CDC’s recommendations?

A5. CDC’s hepatitis C screening recommendations are intended to serve as a resource for health professionals, public health officials, and organizations involved in the development, delivery, and evaluation of prevention and clinical services.

Q6. Who are the persons, most likely to be infected with HCV, that CDC recommends be tested?

A6. Persons most likely to be infected with HCV for whom testing should be offered routinely are:

  • persons who ever injected illegal drugs;
  • persons who received clotting factor concentrates produced before 1987 (e.g., those with hemophilia);
  • persons who were ever on chronic (long-term) hemodialysis;
  • persons with persistently abnormal liver enzymes (i.e., alanine aminotransferase levels); and
  • persons who received a transfusion of blood or blood components or an organ transplant before July 1992.

Persons for whom CDC recommends routine testing based on a recognized exposure are:

  • health care, emergency medical, and public safety workers after needle sticks, sharps, or mucosal exposures to HCV-positive blood; and
  • children born to HCV-positive women.

Q7. How did CDC select these persons for screening routinely?

A7. These recommendations were made based on various considerations, including established epidemiologic relationships between risk factors and acquiring HCV infection, the prevalence of risk behaviors in the population, the prevalence of HCV infection among persons with a risk behavior, and the need for persons with a recognized exposure to be evaluated for infection.

Q8. When and where were CDC’s hepatitis C screening recommendations published?

A8. Hepatitis C screening recommendations were published by CDC in 1998 in: Centers for Disease Control and Prevention. Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease. MMWR 1998;47(No.RR-19). These recommendations are available on the internet at:

http://www.cdc.gov/mmwr/preview/mmwrhtml/00055154.htm

Q9. What was the process used to develop CDC hepatitis C screening recommendations?

A9. These recommendations were developed by CDC based on extensive review of available knowledge and after consultation with a panel of experts, including representatives from federal agencies, state and local public health departments, professional medical organizations, blood banking organizations, and community groups.

Q10. Why did the USPSTF’s conclude that there is insufficient evidence to recommend for or against routine screening of adults at increased risk for hepatitis C?

A10. Currently the data are insufficient to determine whether long term outcomes are improved in HCV infected patients who receive antiviral treatment for chronic hepatitis. However, controlled clinical trials have shown that antiviral therapy for chronic hepatitis C results in the intermediate outcomes of eradication of virus and improved liver histology in an average of 50% of treated patients. These intermediate benefits may be surrogates for long-term benefits. In addition, the Food and Drug Administration has licensed treatment for chronic hepatitis C based on short and intermediate term outcomes and a conclusion that the benefit of treatment outweighs potential harms.

Q11. Are there important gaps in the information needed to determine the health benefits of HCV screening?

A11. There is a need for further research to evaluate the long-term effectiveness of antiviral therapy for chronic hepatitis C. In addition, it is not known whether counseling HCV-infected persons leads to behavior changes that would reduce transmission or reduce liver damage from alcohol and/or drug abuse, and studies are needed to determine the effectiveness of these interventions.

Because of the variability in the progression of HCV infection, it is important to define more precisely the risk of developing clinically important liver disease and factors that accelarate disease progression. In addition, studies are needed to identify HCV infected persons who would most likely benefit from antiviral therapy as measured by decreased mortality and morbidity, and improvement in quality of life.

It is known that patients with chronic hepatitis C are more likely to have fulminant disease if they are infected with hepatitis A virus and the Advisory Committee on Immunization Practices recommends hepatitis A vaccination for persons with chronic hepatitis C. However, the effectiveness of this intervention has not been evaluated.

In addition, research is needed to determine the screening benefit of identification and counseling of uninfected persons who are at increased risk for HCV infection and other bloodborne infections such as hepatitis B and HIV/AIDS.

Q12. Is CDC planning any changes in implementation of the National Hepatitis C Prevention Strategy?

A12. At this time CDC continues to support implementation of hepatitis C prevention activities and evaluation of the effectiveness of these activities.

The National Hepatitis C Prevention Strategy is available on the internet at:

http://www.cdc.gov/ncidod/diseases/hepatitis/c/plan/strategy.pdf

The principal components of this strategy are:

  • education of health care and public health professionals to improve the identification of persons at risk for HCV infection and to ensure appropriate counseling, diagnosis, medical management, and treatment;
  • education of the public and persons at risk for infection about risk factors for HCV transmission, and the need for testing and medical evaluation;
  • clinical and public health activities to identify, counsel, and test persons at risk for HCV infection, and medical evaluation or referral for those found to be infected;
  • outreach and community-based programs to prevent practices that put people at risk for HCV infection, and to identify persons who need to get tested;
  • surveillance to monitor acute and chronic disease trends and to evaluate the effectiveness of prevention and medical care activities; and
  • research to better guide prevention efforts.

American Liver Foundation position on needle exchange

  • WHEREAS injection drug users that share needles are at increased risk of contracting hepatitis B, hepatitis C and HIV; and
  • WHEREAS HIV, hepatitis B and hepatitis C are devastating diseases and can be transmitted to sexual partners and unborn children; and
  • WHEREAS the National Academy of Sciences, through the National Research Council and Institute of Medicine, has stated that needle exchange programs are part of a comprehensive strategy to decrease the transmission of blood-borne pathogens including hepatitis and HIV:
  • THEREFORE BE IT RESOLVED that ALF supports and encourages the development and analysis of needle exchange programs for the express purpose of decreasing transmission of HIV, hepatitis and other blood-borne pathogens and as part of comprehensive hepatitis and HIV prevention activities that include programs directed at preventing and treating drug use

Recommendations for the prevention and control of viral Hepatitis among incarcerated persons

Centers for Disease Control and Prevention (CDC)
Consultants Meeting to Develop Recommendations for the Prevention and Control of Viral Hepatitis Among Incarcerated Persons

All individuals with chronic hepatitis, including those who are incarcerated, need access to immunization, testing and, when appropriate, treatment. Given the high prevalence of chronic hepatitis B and C, and the potential risk for acute hepatitis A and B infection, in incarcerated populations, we support the following principles:

Education and Counseling

Educational programs within correctional systems should permit incarcerated persons to:

  • Assess their risk for viral hepatitis (e.g. utilizing a health risk assessment tool);
  • Learn about the ways in which to prevent infection by avoiding high-risk behaviors;
  • Appreciate the availability of vaccines for hepatitis A and B;
  • Receive information in multiple languages, and in a manner that accommodates different levels of literacy, and is sensitive to cultural and ethnic differences.

Testing

Testing for hepatitis B and C should be available within correctional systems on a routine basis or for persons for whom it is indicated.

Treatment

When it is medically advisable, treatment for chronic hepatitis B or C should be made available within the prison system. Ongoing medical care should be made available for all incarcerated persons who decline or are ineligible for treatment.

Vaccination

Hepatitis A and B vaccines should be provided for all persons with chronic hepatitis C.

Hepatitis A vaccine should be made available for all incarcerated persons with chronic hepatitis B or any other form of chronic liver disease.

Due to the fact that incarcerated persons are at risk for viral hepatitis, vaccination for hepatitis A and B should be encouraged within correctional systems.

The American Liver Foundation supports the responsible and humane use of animals in research. Animal research has yielded crucial advances in the fight against liver disease, and ALF is committed to facilitating current research of exceptional promise. Researchers, funded by ALF, must have their studies approved by their Institutional Animal Care and Use Committee (IACUC), and must conduct all research in compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals.


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