ISSUE BRIEF HBV & HCV: America’s Hidden Epidemics EXECUTIVE SUMMARY H epatitis B and hepatitis C are silent epidemics in the United States. Nearly two percent of the U.S. population may have some form of the disease -- and approximately five million of these individuals will develop a chronic form of the diseases, but many of them will not even know they have a hepatitis infection for years or decades, until it has caused significant, irre- versible damage to their livers.1 Right now, thanks to health reform and new But, if the country acts now to take advantage scientific advancements, we have an oppor- of the new options provided by the Patient tunity to transform how the country deals Protection and Affordable Care Act (ACA) with viral hepatitis -- to help identify millions and new treatment possibilities, we could of Americans who are unaware they are liv- identify earlier and treat the millions of Amer- ing with hepatitis B or C before they develop icans who are already infected -- sparing them late-stage liver problems, to more effectively needless suffering, reducing health care costs treat the more than five million Americans and lowering the number of new infections. who have hepatitis B or C, and to prevent In the next decade, the Institute of Medicine even more Americans from becoming in- (IOM) estimates that 150,000 Americans fected. If we do not take this opportunity, could die from liver cancer or end-stage liver we will all pay the price, as people with undi- disease associated with HBV or HCV, and an agnosed HBV and HCV infections -- includ- independent analysis found total medical ing large numbers of Baby Boomers with costs for HCV patients could more than dou- HCV infection -- may develop cirrhosis, liver ble over the next 20 years -- from $30 billion cancer, or other major liver complications as to $80 billion per year. they age, and Medicare and Medicaid will have to pick up the tab for much of the care. Of the more than five million Americans with HBV or HCV: n Baby Boomers account for two-thirds of HCV cases -- and if left untreated this could lead to a major increase in upcoming Medicare spending; n African Americans account for 22 percent of HCV cases; n Asian and Pacific Islander Americans account for 50 percent of HBV cases; and SEPTEMBER 2010 n Gay and bisexual men account for 15 percent to 25 percent of new HBV cases and are at in- PREVENTING EPIDEMICS. creased risk for HCV infection. PROTECTING PEOPLE. The Trust for America’s Health (TFAH) and the sexual minorities; and infectious disease preven- American Association for the Study of Liver Dis- tion strategies have traditionally been siloed. eases (AASLD) developed the following recom- Health reform provides new opportunities mendations for new strategies and policies to through changes in the law, but also provides the help ensure individuals can receive treatment be- impetus to act on existing mechanisms and strate- fore they develop serious liver diseases and to act gies that have been untapped or not fully en- to prevent the future spread of the viruses. There gaged in the past. Some of the recommendations are a number of unique challenges that must be could be achieved through immediate policy addressed when combating HBV and HCV, in- changes, some would require modest levels of cluding: the health complications often take new resources and some would require a longer decades to develop; there are significant social term significant investment. The following is a stigmas connected to the viruses since they are summary overview of recommendations from the spread through blood and sexual contact; the dis- full report. To effectively combat viral hepatitis in eases disproportionately impact racial, ethnic and the United States, the nation needs to: Develop a Better Understanding of the Impact of HBV and HCV: n Improve Surveillance: The scope of the diseases isting, more robust HIV and other infectious dis- have long been under-reported, which has ham- ease systems to leverage resources and create an pered the nation’s ability to reduce the spread integrated approach; 2) be part of any health in- of the diseases, identify those with the diseases, formation technology (HIT) infrastructure; and target treatment, and generate support for 3) include enough support for public health de- needed research. A comprehensive surveillance partments around the country to conduct and system is needed which should: 1) build on ex- follow up on surveillance activities. Identify the Millions of Americans With HBV and HCV: n Make Hepatitis B and C Screening Routine other late-stage liver complications, and stop under the Reformed Health System. As part inadvertently infecting others. Medicaid and of a reformed system, the U.S. Secretary of community health centers should also move Health and Human Services (HHS) can now toward making screenings routine. Systems designate HBV and HCV screening as an “es- should be in place to support screenings in al- sential health benefit,” which would help iden- ternative care settings, such as family planning tify millions of Americans who are infected but clinics, since even in a reformed health care do not know it so they could receive treatment system, millions of Americans will still not have and avoid developing liver cancer, cirrhosis, or regular access to care. Improve Care and Research: n Ensure Everyone Who is Diagnosed Receives n Invest in Biomedical, Behavioral and Health Appropriate Care: All individuals who are di- Services Research and Development: Viral agnosed should receive the determined stan- hepatitis research has been held back due to dard of care regardless of ability to pay and lack of resources, leaving many key questions should receive support services to assure they unanswered, including the differential re- can complete the needed care. In addition, sponse to treatment among certain popula- new treatments are on the horizon, which tions, improved screening and diagnostic tools, promise to make treatment more effective. and new and better vaccines. Support should These should be made available as quickly as be increased to continue to advance the recent possible to all diagnosed individuals. scientific breakthroughs around the diseases. 2 Prevent New Infections: n Develop an Integrated Approach to Reducing with increased infection control practices Risk for Infectious Diseases: The United and standards. States should take an integrated approach to n Promote Universal HBV Vaccination: The preventing infectious diseases, particularly in- HBV vaccine has helped cut infection rates by tegrating efforts around HIV, viral hepatitis around 80 percent, but approximately 10 per- and other sexually transmitted disease (STD) cent of infants are not vaccinated and millions prevention, for those with overlapping risk be- of adults are not vaccinated, since they came haviors for more efficient and effective use of of age before the vaccine was widely available scarce federal resources. in 1992. Universal vaccination would reduce n Eliminate Newborn HBV Infections: An esti- rates of HBV infection. mated 800 to 1,000 newborns are infected n Bolster Prevention Campaigns and Public Aware- with HBV from their mothers through birth ness: HBV and HCV rates could be reduced by each year in the United States. These infec- targeting prevention campaigns for at-risk pop- tions could be virtually eliminated through ulations, including promoting vaccination, safe proper screening and care actions. sex campaigns and expanding access to drug n Eliminate Health Care-Associated HBV and treatment, syringe exchange programs and edu- HCV Infections: The number of HBV and cation about the dangers of sharing needles. HCV infections spread to patients when General public education campaigns should also they are receiving health care due to poor be increased to inform the public about ways to infection control practices has risen in re- reduce risk while reducing the stigma associated cent years, but could be virtually eliminated with the diseases 3 Introduction H epatitis B and hepatitis C are silent epidemics in the United States. Nearly two percent of the U.S. population may have some form of the diseases -- and approximately five million of these individuals will develop a chronic form of the diseases, but many of them will not even know they have a hepatitis infection for years or decades, until it has caused significant, irreversible damage to their livers.2 More than two million Americans live with Health reform provides new opportunities chronic hepatitis B and 2.7 million to 3.9 million through changes in the law, but also provides more live with chronic hepatitis C — but around the impetus to act on existing mechanisms and 65 percent of people with the hepatitis B virus strategies that have been untapped or not fully (HBV) and 75 percent of people with the hepati- engaged in the past to: tis C virus (HCV) are unaware that they are in- n Increase Screening to Help Prevent Cancer, Cir- fected with an infectious disease.3 These rhosis and Other Liver Diseases for Approxi- individuals miss out on treatments that could mately Five Million Americans Estimated To Be spare them from serious liver diseases in the fu- Living with Undiagnosed HBV and HCV: The ture while they also inadvertently may be spread- Patient Protection and Affordable Care Act (Af- ing it to others. Two-thirds of the people with fordable Care Act) provides the opportunity to HCV are Baby Boomers who may have been in- expand preventive health services, which could fected decades ago but do not know they have it. include screenings for HBV and HCV if the U.S. Right now, thanks to health reform and new sci- Department of Health and Human Services entific advancements, we have a new opportunity (HHS) takes action to define these screenings as to transform how the country deals with viral a benefit under Medicare and as a general “es- hepatitis -- to help identify millions of Americans sential health benefit.” Routine screening for who are unaware they are living with hepatitis B HBV and HCV, particularly among high-risk or C before they develop late-stage liver prob- populations like the Baby Boomers, people who lems, to more effectively treat the more than five have injected drugs in the past, African Ameri- million Americans who have hepatitis B or C and cans and Asian and Pacific Islander Americans, to prevent even more Americans from becoming could help identify millions of Americans who infected. If we do not take this opportunity, we are infected and help treat them at earlier stages will all pay the price, as people with undiagnosed of the disease. In addition, 32 million Americans HBV and HCV infections — including the large who were previously uninsured will soon have numbers of Baby Boomers with HCV infection health insurance options and increased access to — may develop cirrhosis, liver cancer or other screenings and care. If people receive earlier major liver complications as they age, and treatment for their HBV and HCV, their chances Medicare and Medicaid will have to pick up the of developing liver cancer, cirrhosis or other tab for much of the care. forms of liver disease decrease dramatically. In the next decade, the Institute of Medicine n Eliminate the Transmission of HBV from (IOM) estimates that 150,000 Americans could Mothers to Newborns: Currently, an esti- die from liver cancer or end-stage liver disease as- mated 800 to 1,000 newborns are infected at sociated with HBV or HCV, and an independent birth each year. Newborns are at the highest analysis found total medical costs for HCV pa- risk of developing chronic hepatitis B and of tients could more than double over the next 20 having greatly increased risk of serious liver years -- from $30 billion to $80 billion per year. disease as they get older. If recommended However, we would reduce the number of deaths screening and treatment actions were taken, and lower costs if we act now to screen at-risk in- the country has the chance to put an end to dividuals so they can receive treatment earlier and maternal-child hepatitis transmission. work to prevent new cases of HBV and HCV.4, 5 5 n Reduce the Number of New Cases of HBV and this could be a critical means for immediate HCV: The U.S. Centers for Disease Control access to care for people living with hepatitis. and Prevention (CDC) estimated that there This means millions of additional Americans were more than 43,000 new HBV infections will have greater access to care. And, new drug and 17,000 HCV infections in 2007, but experts treatments on the horizon mean that HBV believe these estimate are very low due to lim- and HCV care will likely be much more effec- ited surveillance.6 Focused efforts to reach tive in the near future. Researchers are on the high-risk populations and increase public and cusp of new breakthroughs in research, in- provider education could significantly reduce cluding new therapies that could potentially the numbers of individuals who become in- cut treatment cycles for HCV from 48 weeks to fected. New transmissions of HCV occur most 24 weeks and improve cure rates from around frequently among injection drug users, and 40 percent to 75 percent. Therapies for hepa- there has been a rise in health care related in- titis B have also improved dramatically in the fections in recent years. Beginning in fiscal past few years so that one pill per day can pre- year 2010, federal funds can now be used for vent disease progression, reduce risk of trans- syringe exchange programs (SEPs), a proven mission to others and lead to a lower rate of structural intervention to prevent HCV trans- long-term complications, such as liver cancer. mission among injection drug users. A vaccine To help make sure the country takes advantage is available for HBV, which has significantly re- of this moment in time, in this issue brief, the duced the rate of infection in the United Trust for America’s Health (TFAH) and the States, but could reduce rates further if we in- American Association for the Study of Liver Dis- creased vaccination rates -- including the five eases (AASLD) examine an overview of HBV percent of children who go unvaccinated and and HCV policy concerns and examine policy at-risk adults who came of age before the vac- considerations for: cine became available. There is no vaccine available for HCV, but work needs to be fo- n Meeting the challenges of creating an inte- cused on developing an effective vaccine to grated approach to viral hepatitis; prevent hepatitis C infections. In addition, the n Identifying millions of infected Americans -- 2009 stimulus act provided increased funding many of whom do not know they have chronic for health information technology (HIT), HBV or HCV; which provides new, improved tools for public health professionals to target prevention ef- n Treating the more than five million Ameri- forts and track results. cans who currently have chronic HBV or HCV; n Leverage New Opportunities for Treating HBV and HCV: Under the Affordable Care n Preventing new infections, including: Act, in addition to expanding coverage op- s Eliminating the transmission of HBV to tions to 32 million additional Americans, in- newborns; surers will no longer be able to deny coverage s Eliminating the health care transmission of based on pre-existing medical conditions, in- HBV and HCV; cluding HBV and HCV, or revoke coverage once a medical condition is identified. While s Eliminating new HBV and HCV infections most coverage expansion will occur in 2014, among high-risk groups; and the new Pre-existing Condition Insurance Pool n Recommending a strategic approach to ad- provides insurance for those with pre-existing dress HBV and HCV in the United States. conditions who have been denied coverage; 6 Overview of HBV and HCV Policy Concerns 1 SECTION “ MOST PEOPLE [WITH HBV AND HCV] DON’T KNOW THEY’RE INFECTED. THEY CAN TRANSMIT THE VIRUS TO OTHERS, AND CAN’T PROTECT THEIR OWN HEALTH BY SEEKING CARE. VIRAL HEPATITIS IS LIKE HIGH BLOOD PRESSURE. IT SILENTLY ATTACKS THE BODY TO CAUSE DISEASE IN LATER LIFE. THE LIVER IS A VERY STOIC ORGAN. EVEN THOUGH IT’S DISEASED, IT DOESN’T CRY OUT FOR HELP UNTIL VERY, VERY LATE. ” 7 —JOHN W. WARD, MD DIRECTOR, DIVISION OF VIRAL HEPATITIS, NATIONAL CENTER FOR HIV/AIDS, VIRAL HEPATITIS, STD AND TB PREVENTION, CENTERS FOR DISEASE CONTROL AND PREVENTION. The silent epidemics of HBV and HCV take a years, that in the next 10 years commercial and toll on the health and economy of the United Medicare costs will more than double, and that States, and the problem is expected to get ex- in 20 years, Medicare costs will increase from $5 ponentially worse in the coming decades as billion to $30 billion per year. more people who do not even know they have Treatment is also costly to the individual. For the disease -- particularly Baby Boomers -- reach people who do not receive antiviral treatment, an age where they begin to experience the con- lifetime undiscounted costs for treating individ- sequences of their infections. uals with HCV costs range from an estimated Globally HBV or HCV account for more than $30,000 to $50,000 (year 2000 and 2003 values), three-quarters of liver cancer cases and 57 per- according to a review by John B. Wong.15 The cent of cirrhosis (permanent scarring of the Milliman Report modeling analysis used esti- liver) cases.8 In the United States almost half of mates that the cost of treating liver cancer (he- the 6,500 annual liver transplants are related to patocellular carcinoma) can be more than HBV or HCV, and HBV alone is responsible for $62,000 for the first year and the first year cost of tripling the waiting list for liver transplants in the a liver transplant can be $267,000 (based on past five years.9, 10 According to the 2010 IOM re- commercial reimbursement rate estimates).16 port, Hepatitis and Liver Cancer: A National Strategy While the seriousness of the diseases is clear, a for Prevention and Control of Hepatitis B and C, HBV number of major issues exist that make devel- leads to around 3,000 to 4,000 deaths each year oping HBV and HCV prevention, control and from liver cancer or severe liver disease and HCV treatment policies particularly challenging: contributes to an estimated 8,000 to 13,000 deaths each year.11 Many experts believe these n Approximately five million Americans have estimates are low. The death rate from HCV is HBV or HCV, but the vast majority do not expected to triple in the next 10 to 20 years.12 know they have it and often live with the dis- eases for decades before having any symp- Although it is difficult to determine with exist- toms. It is difficult to create urgency for ing data, the direct annual medical costs associ- screenings, despite the seriousness of these ated with HBV and HCV infections are diseases when they reach late stages, when estimated to be $7.6 billion.13 A Milliman Re- people do not know they are at risk or feel the port analysis found that HCV could actually cost immediate impact in their daily lives. There the country approximately $30 billion a year, has never been a concerted effort to try to and these costs are expected to more than dou- screen Americans, even at-risk groups. In ad- ble over the next 20 years to $80 billion per dition, many health care providers may not be year.14 This growth is largely due to the number aware their patients could be at risk and of Baby Boomers who will develop liver prob- health insurance has not regularly covered lems as they age. The Milliman researchers es- routine screenings. timate the per-patient cost of people with chronic HCV will increase 3.5 times over 20 7 n Social stigmas exist around addressing sexual Prevention, while HIV received nearly 70 per- practices and illegal injection drug use, which cent.21 HBV and HCV policies and programs are two of the main ways HBV and HCV are have been hindered by a siloed approach to spread. Stigma also complicates outreach to disease prevention in the United States, where individuals in other at-risk categories — such efforts to address diseases with overlapping as individuals born in other countries or those risk patterns, such as HIV, tuberculosis, or who may have contracted the disease from other sexually transmitted diseases (STDs) birth or blood transfusion — who may be con- have not been effectively integrated with HBV cerned with being associated with these stig- and HCV efforts -- and the programs end up mas. Additionally, there may be stigma for competing for scarce resources. An estimated those at risk for or infected with HBV due to 25 percent of people with HIV also have cultural issues in endemic countries. HCV.22 There is inadequate surveillance and information about the scope and impact of n Hepatitis disproportionately affects racial, HBV and HCV in the United States, which has ethnic, and sexual minorities which makes created a cycle where there is inadequate evi- prevention, control, and treatment strategies dence to show the need for greater resources challenging due to cultural barriers. to combat the diseases. The result is that pre- n African Americans — who make up 14 per- vention efforts and biomedical research to im- cent of the U.S. population — account for 22 prove treatments have been severely limited. percent of HCV cases in the United States.17 n The number of health care associated infec- s Although Asian and Pacific Islander Amer- tions has risen in recent years, putting all icans make up only 4.5 percent of the U.S. Americans at increased risk for infection. In- population, they account for more than 50 dividuals who received blood transfusions or percent of chronic HBV cases.18 One in 10 other types of medical care that may have ex- Asian and Pacific Islander Americans has posed them to blood or bodily fluids before chronic HBV infection, which is signifi- 1992 may have been infected with HCV. Since cantly higher compared with Whites, then, measures have been taken to screen African Americans and Latinos.19 blood donations and to improve safety prac- tices, including a “one needle, one syringe, s An estimated 15 percent to 25 percent of only one time” practice. However, serious new HBV infections in the United States challenges remain in terms of health care set- occur in gay and bisexual men.20 Accord- ting safety. Since 1998, an estimated 100,000 ing to CDC, gay and bisexual men are also patients were notified of potential exposure considered to be at increased risk for HCV to HBV, HCV, and/or HIV due to lapses in if they engage in high risk behaviors. health care safety.23 Between 1998 and 2008, n Efforts to combat HBV and HCV have been CDC identified 33 outbreaks of HBV and hampered by siloed policies, inadequate sur- HCV in hospital settings, 12 in outpatient clin- veillance and insufficient resources. HBV and ics, six in hemodialysis centers and 15 in long- HCV kill far more Americans than HIV every term care facilities. Due to limited funding year, but hepatitis received less than two per- for disease surveillance to detect these out- cent of the budget from the National Center breaks, this may under-represent the extent of for HIV/AIDS, Viral Hepatitis, STD and TB the problem in the United States. 8 WHAT IS HEPATITIS? Hepatitis is an inflammation of the liver. HBV and HCV are both blood-borne diseases caused by viral infections that lead to inflammation of the liver. The symptoms of acute viral hepatitis can include one or more of the following: fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, clay-colored bowel movements, joint pain and jaundice (yellowing of the skin and eyes). Individuals with acute or chronic hepatitis do not always show symptoms. Hepatitis B (HBV) Fast Facts: Cases of Chronic Hepatitis B in the United States: At least two million Percent of HBV infected individuals unaware of infection: 65 percent New infection rate: There is limited accurate data about new infection rates due to limited surveil- lance. According to CDC, in 2007, there were at least 43,000 new infections, but this number is con- sidered to be a very low estimate. How is it spread? T ypically through sexual activity, from a mother to a baby during childbirth, or direct contact with infected blood, such as during household sharing of razors or contact with cuts or wounds, through sharing needles, or exposure in a health care setting resulting from poor infection control practices. How often does HBV lead to a chronic infection? Around 90 percent of newborns who are infected with HBV during childbirth will develop a chronic infection unless they receive proper preventive care measures. For healthy young adults, around five percent of HBV infections develop into chronic HBV. What are the medical complications? Cirrhosis (scarring of the liver), liver cancer, other liver problems. Some patients need liver transplants. Is there a vaccine available? Yes, since 1982 an HBV vaccine has been available. Since 1991 an in- creasing percentage of American children have received hepatitis B vaccine; now more than 90 percent of American children have been vaccinated for HBV.24 Americans who came of age before the vaccine was widely available or are born to mothers who have the disease are still at risk for exposure. What is the treatment? Seven medications are approved for treating HBV. They often do not result in a full cure, but can significantly reduce liver damage particularly if treatment is started early. However, successful therapy of patients with advanced disease can prevent liver cancer, reduce the need for liver transplantation and save lives. Hepatitis C (HCV) Fast Facts: Cases in the United States: 2.7 million to 3.9 million Percent of HCV infected individuals unaware of infection: 75 percent New infections each year: There is limited accurate data about new infection rates due to limited surveillance. According to CDC, in 2007, there were at least 17,000 new infections, but this number is considered to be a very low estimate. How is it spread? Typically through blood-to-blood contact, such as the reuse of contaminated drug in- jection equipment (needles, cookers, etc.) or through exposure in a health care setting resulting from poor infection control practices, or occasionally through sexual contact. Individuals who received blood transfu- sions or procedures before 1992, when blood started to be screened, may be at risk. How often does HCV become chronic? 70 percent to 80 percent of people who contract an HCV infection develop chronic HCV. What are the medical complications? Cirrhosis (scarring of the liver), liver cancer, other liver problems. Some patients need liver transplants. HCV is the most common cause of adult liver trans- plantation in the United States and the world today. Is there a vaccine available? No. What is the treatment? A combination of antiviral medications. Approximately 50 percent to 60 per- cent of patients respond to treatments initially. African Americans only have a 28 percent success rate. 9 DRAMATIC REDUCTION IN HEPATITIS INFECTIONS OVER TIME: A PUBLIC HEALTH SUCCESS Dramatic reductions in hepatitis rates in the United States These reductions reflect the successes of existing public health show how effective public health can be at improving the prevention efforts. Increasing efforts now could result in even health of Americans. lower rates and earlier identification and treatment of people who are currently infected but may not be aware they have HBV or Acute HBV rates declined 81 percent between 1990 and 2006 HCV. However, given the recent increases of cases of HCV infec- due to Hepatitis B vaccine, safer sex practices, a decline in nee- tion among young people who are injecting drugs and HIV in- dle-sharing among injection drug users, and improved blood fected men who have sex with men, there is indication of a new screening.25 Acute HCV infections have fallen from a peak of wave of the epidemic that current prevention efforts have not 230,000 new cases per year in the 1980s to an estimated managed to control. 17,000 in 2007.26 HBV AND HCV AROUND THE WORLD Worldwide, about one in 12 persons -- 480 million to 520 mil- and continue through early childhood. In other countries, such lion people -- are chronically infected with HBV or HCV.27 as Panama, Papua New Guinea, Solomon Islands and Green- land, infection rates among infants are low, but increase rap- HBV: Approximately two billion people worldwide have been idly during early childhood. Infection rates are much lower in infected by HBV and about 350 million live with chronic infec- Western and Northern Europe, Australia and parts of South tion.28 An estimated 600,000 persons die each year due to the America. The carrier rate is less than two percent and less acute or chronic consequences of HBV.29 than 20 percent of the population has been infected with HBV. HBV is endemic to Southeast Asia and the Pacific Basin (ex- HCV: An estimated 200 million or more individuals (about cept for Japan, Australia and New Zealand), sub-Saharan three percent of the world’s population) are believed to be in- Africa, the Amazon Basin, parts of the Middle East, the central fected with HCV.31 There are about four million carriers in Eu- Asian Republics and in some Eastern European countries. In rope alone.32 HCV is a particular problem in Egypt, where the most of these areas, about 70 percent to 90 percent of the virus spread over decades through contaminated needles used population becomes HBV-infected before age 40 and up to 20 to treat widespread parasitic infections and in the former Soviet percent are HBV carriers.30 In countries such as China, Sene- Union through poor infection control or injection drug use.33 gal and Thailand, infection rates are extremely high in infants CONGRESSMAN LIVING WITH HCV SPEAKS OUT On December 7, 2009, Rep. Hank Johnson (D-GA), an- many millions of others, I was infected many years without nounced that he has been battling chronic HCV for more than ever knowing how I contracted it.” a year with a course of drug therapy his physician hopes will He said he plans to use his position to help raise awareness of eradicate the virus.34 the disease and show that it is possible to be successful de- Maria Sjogren, MD, of Walter Reed Army Medical Center, spite it. “Though this infection has caused me some discom- praised her patient’s diligence in fighting the infection, saying fort and frustration, it has in no way affected my ability to he should serve as “an inspiration to thousands of people who legislate and serve my constituents,” he said. suffer from this illness. He has been a model patient, sticking He is co-sponsor of a bill introduced by Representative Mike with his course of treatment even when it was most difficult.” Honda (D-CA), H.R.3974 and by Senator John Kerry (D-MA), Johnson said he hopes his disclosure will comfort others with S.3711 -- Viral Hepatitis and Liver Cancer Control and Pre- this illness and give them the confidence to speak out. “The vention Act of 2009, which would establish a comprehensive causes of this disease are many, but in the end it does not mat- prevention, education, research and medical referral program ter how someone contracted the virus,” he said. “Like so for viral hepatitis. 10 Meeting the Challenges of Creating an Integrated Approach to Viral Hepatitis 2 SECTION R esources and programs for HBV and HCV have been hampered by a siloed approach to disease management, a lack of understanding about the impact of the disease in the country and limited funding. Traditionally, disease prevention policies in the A strategic, integrated approach to address HBV Unites States focus on a disease-by-disease ap- and HCV in concert with HIV and other STDs proach. This means that many diseases that could create synergies for improving surveillance, have overlapping risk patterns and overlapping screening, prevention and treatment for all of the prevention and treatment strategies are not well diseases. CDC has recognized the need to de- integrated -- and policies and programs end up velop a more integrated approach to hepatitis competing for resources and often duplicating with the addition of hepatitis in 2006 to the Na- efforts. This is particularly true for viral hepa- tional Center for HIV/AIDS, STD and Tubercu- titis, which has been chronically underfunded losis Prevention (NCHSTP), now the National compared to its impact on the public’s health. Center for HIV/AIDS, Viral Hepatitis, STD and For example, CDC provides cooperative agree- TB Prevention (NCHHSTP). In addition, ments to 49 states, the District of Columbia and NCHHSTP has begun a Program Collaboration five cities to fund the salaries of adult viral hep- and Service Integration (PCSI) initiative to foster atitis prevention coordinators (AVHPC) who a client-centered integrated approach to HIV, are tasked with integrating viral hepatitis serv- STD, hepatitis and TB services at the state and ices with other local efforts to reach popula- local level. The new National Prevention and tions at-risk. However, CDC only has resources Public Health Promotion Strategy, mandated as to fund a small number of jurisdictions for hep- part of health reform, offers an additional op- atitis surveillance or for other activities. As a re- portunity to make HBV and HCV prevention a sult, CDC estimates that only 10 percent of new much higher national priority across the federal HCV cases are reported each year and only two- government -- not just within CDC -- and to find thirds of states currently report cases of chronic ways to integrate approaches to related diseases HCV.35 for greater effectiveness and efficiency. A. UPGRADING SURVEILLANCE Challenge: The United States lacks a comprehensive surveillance system for hepatitis, resulting in partial understanding of the scope of the problem and, therefore, diminished capacity to constrain transmission, target prevention activities, and plan for treatment service needs. According to the IOM, current surveillance for As all systems are under review as part of health HBV and HCV is fragmented, poorly developed, reform implementation, upgrading and inte- and inconsistent across jurisdictions due to CDC grating how HBV and HCV are monitored could having very limited resources to develop guidance be reconsidered. For instance, many experts rec- or fund state health departments’ activities.36 ommend that HBV and HCV surveillance could be built on existing surveillance systems for HIV Without better situational awareness and surveil- or other infectious diseases, which are more ro- lance, the country will continue to lack sufficient bust. While the diseases are different, many of data to determine the scope of the problem and the risk behaviors and affected populations over- who is affected. This influences not only the abil- lap enough to make this expansion feasible. To ity to prevent and treat disease, but it also creates be effective, a new system would also need to in- a vicious cycle of inadequate evidence to support clude expanded sentinel surveillance, where se- greater public resources to address the problem. 11 lected facilities report infection rates, so new treatment of these diseases. As a result of pas- pockets of infection can be identified quickly to sage of the 2009 stimulus (American Recovery target new primary prevention efforts. Serosur- and Reinvestment Act), Medicare and Medicaid veillance among at-risk populations that have lim- eligible providers will have to follow certain stan- ited access to health care, such as injection drug dards, known as “meaningful use” of electronic users and immigrants from HBV endemic coun- health records (EHRs), in order to qualify for tries, would also be useful in measuring incidence federal incentive payments and avoid penalties. and determining the extent of the epidemic in The publication of HHS’s final rule on mean- those communities that standard surveillance will ingful use of EHRs in July may help with track- not be able to detect. The IOM recommends sur- ing childhood immunizations against HBV and veillance could be improved if CDC could pro- lays the groundwork for better surveillance vide cooperative agreements to states to enhance through requiring the capability to report data, their surveillance of viral hepatitis similar to how but the rule does not require other measures HIV/AIDS surveillance is supported.37 that could improve hepatitis tracking and treat- ment, such as screening of pregnant women, In addition, changes in health information tech- adult immunization and recording risk factors.38 nology (HIT) systems provide new opportuni- ties for improving surveillance, control and “ MASSACHUSETTS DOES NOT HAVE FUNDING FROM THE CDC FOR VIRAL HEPATITIS SURVEILLANCE. OUR VIRAL HEPATITIS SURVEILLANCE HAS BEEN FUNDED, IN THE PAST, WITH STATE APPROPRIATIONS. CURRENTLY, ALL OF OUR STATE FUNDING FOR THESE PROGRAMS, INCLUDING SURVEILLANCE, HAS BEEN ELIMINATED….FUNDING FROM THE STATE TENDS TO FLUCTUATE GREATLY FROM YEAR TO YEAR…SO HEALTH DEPARTMENTS REALLY NEED TO RECEIVE FUNDING AND SUPPORT FROM CDC TO CREATE AND MAINTAIN SYSTEMS APPROPRIATELY. ” 39 -- DANIEL CHURCH, EPIDEMIOLOGIST/VIRAL HEPATITIS COORDINATOR, MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH IOM RECOMMENDATIONS FOR AN HBV AND HCV SURVEILLANCE SYSTEM n A federal funding mechanism and guidance for core surveillance activities. n Viral hepatitis specific cooperative agreements with all state and territorial health departments. n Implementation of performance standards regarding revised and standardized case definitions, specifically through the use of: s Revised case-reporting forms with required, standardized components; and s Case evaluation and follow up. n Support for developing and implementing automated data-collection systems, including: s Electronic laboratory reporting; s Electronic medical-record extraction systems; s Web-based, Public Health Information Network-compliant reporting systems; and s Federal funding for targeted supplemental surveillance. Improved surveillance would make it possible for CDC to implement a national collaborative network inclusive of other programs, community partners to deliver comprehensive outreach, education, in- tervention and management services to populations at risk. 12 Increasing Screening and Testing To Help Prevent Cancer, Cirrhosis and Other Liver Diseases for Millions of Infected Americans Who Do 3 SECTION Not Know They Have HBV or HCV Challenge: All who are at risk for hepatitis should be screened, so they know their status and are linked to appropriate prevention (including vaccination) and treatment services. Identifying the millions of Americans who have lion to 2.5 million individuals). The high num- HBV or HCV infections and who are unaware of ber of Baby Boomers who have HCV and are their conditions is challenging, but routine screen- not aware of it represents a particularly difficult ing and testing could get people into treatment be- public policy challenge. Many of them may fore they develop late-stage liver complications, have been exposed through blood transfusions sparing needless suffering and significantly reduc- or other medical procedures prior to 1992 ing health care costs while also improving sur- when blood screening and other safety meas- vival.40 Universal screening would also help reduce ures were not in place, or through at-risk be- the stigmas associated with the diseases and pro- haviors, like injection drug use in the 1960s and vide a real basis of knowledge about the true scope 1970s, before there was knowledge about the and impact of the disease in the United States. dangers of sharing drug injection equipment. Because many of this generation do not iden- Rapid, reliable and relatively inexpensive diag- tify with the behavioral risk factors for hepati- nostic blood tests exist for both HBV and HCV, tis, many have suggested that an age-based but most Americans have never been tested due approach to screening and testing is needed in to lack of access to preventive services, lack of addition to a risk-based screening mechanism;41 information, or stigmas around the diseases: n A significant portion of Americans have not n African Americans: 22 percent of HCV cases had access to preventive care services; are African Americans (an estimated 540,000 to 858,000 individuals);42 n The U.S. Preventive Services Task Force (USP- STF) guidelines recommend against wide- n Asian and Pacific Islander Americans: One in spread screening for HBV and HCV, in 10 Asian and Pacific Islander Americans are contradiction to the view of CDC and other estimated to have a chronic HBV infection.43 experts who believe there is sufficient evi- More than 50 percent of chronic HBV cases dence to support broader screening; are Asian and Pacific Islander Americans;44 n Many health care providers are not aware of n Gay and Bisexual Men: An estimated 15 percent the risk groups for viral hepatitis, what tests to to 25 percent of new HBV infections in the order for those at risk or how to interpret lab United States occur in gay and bisexual men and results and educate patients on prevention men who have sex with men.45 Gay and bisexual and medical management; men are also considered to be at increased risk n Providers may be reluctant to ask patients about for HCV if they engage in high risk behaviors; whether they engage in high-risk behaviors or n Injection Drug Users: Injection drug users are previously did so; and at particularly high risk for infection from both n Individuals may be reluctant to ask for testing diseases. Supporting screenings outside of tra- due to fear of being associated with high-risk ditional medical settings for individuals, such as behaviors. injection drug users -- who may remain outside With an approach that combines both risk fac- of the mainstream medical system even after tors and demographic factors (including age) health reform -- will be important. Alternative targeted testing could help identify a significant testing sites could include: HIV, STD and TB number of people living with the diseases. clinics; substance abuse and mental health pro- grams; harm reduction services including sy- n Baby Boomers: Currently, two-thirds of HCV ringe exchange programs; federal and state and cases are Baby Boomers (an estimated 1.8 mil- 13 juvenile correctional facilities; college cam- centers (CHC) and require that all CHC patients puses; and family planning clinics; and have a record of HBV vaccinations. n The Incarcerated: Chronic HCV can affect as In the near-term, HHS should work with USP- many as 12 percent to 35 percent of prison STF in an expedited way to add routine HBV populations.46 Although some HCV transmis- and HCV screening to the Task Force list of rec- sion occurs within correctional settings, the ommended services. CDC and other public vast majority of HCV-infected inmates were in- health organizations, which have already rec- fected through injection drug use outside of ommended this addition, can continue to re- prison, not during their incarceration.47, 48, 49 search the value of routine HBV and HCV The number of incarcerated adults living with screenings and provide this data to the USPSTF. chronic HBV is estimated to be between one If the USPSTF were to recommend a screening, percent and 3.7 percent.50 Viral hepatitis spe- under the new health reform law, it would be- cific cooperative grants should be established come a mandated benefit with no cost sharing with state and territorial health departments. for most private plans and Medicare. Health reform creates some new authorities that n Opportunities for strategic integration with HIV could greatly expand the number of individuals and other STD screening: HIV screening pro- screened for HBV and HCV and could provide the grams are more robust and well developed than impetus for acting on existing authorities to ex- HBV and HCV screening efforts. CDC estimates pand screening. The HHS Secretary has the au- that only 20 percent of people with HIV infec- thority to consider HBV and HCV screening an tion do not know their status -- compared to the “essential health benefit” for most private plans, 65 percent of people infected with HBV and 75 which would mandate coverage and limit cost shar- percent of people with HCV who do not know ing, starting in 2014. The Centers for Medicare they are infected.51 HIV screening programs and Medicaid Services (CMS) should take imme- have a history of conducting public education diate steps to cover routine screening for Medicare campaigns that encourage testing in de-stigma- beneficiaries. The Health Resources and Services tizing ways and reaching targeted at-risk groups Administration (HRSA) could also make screen- based on behavior patterns, including hard-to- ing a mandated protocol for community health reach groups, like injection drug users. TARGETED SCREENING AT WORK: ASIAN AND PACIFIC ISLANDER AMERICANS A 2005 HBV screening program in New York City of Asian ing in the United States for more than 10 years and likely ac- and Pacific Islanders, mostly Chinese and South Korean, found quired their infections in their countries of origin. Screening that about 15 percent tested positive for chronic HBV infec- programs in Atlanta, Chicago, Philadelphia and California pro- tion.52 Half of those with chronic HBV infection had been liv- duced similar results. ONE PROGRAM IN ACTION: CHARLES B. WANG COMMUNITY HEALTH CENTER, NEW YORK CITY The Charles B. Wang Community Health Center (CBWCHC) difficulty navigating the medical system, including treatment in New York City extensively, and successfully, serves the city’s protocols and payment procedures; widespread use of large Asian population with affordable, high quality health serv- herbal medications and complementary and alternative ices. According to CBWCHC, one in 10 New York City resi- medicines (CAM); and diverse health beliefs which may pri- dents are Asian, and of the population they serve 98 percent oritize different aspects of personal and social health. CBW- do not speak English as their first language. CBWCHC’s initial CHC has the resources to appropriately address these step in improving health services to this population was to barriers and they have. For example, through HBV out- provide services in at least five languages other than English, reach campaigns in various languages, using culturally com- allowing staff to communicate and reach-out to the various petent terminology. Additionally, CBWCHC has successfully Asian communities throughout the city.53 CBWCHC is a gen- implemented an electronic HBV registry and HBV history eral health clinic -- not just a hepatitis screening program -- form, allowing them to better track and treat all of their but screening and treatment for hepatitis is considered an im- HBV cases. The “patient tracker” for hepatitis patients is a portant component of care for this patient population. With portable record that contains important hepatitis and liver the knowledge that HBV is affecting a large proportion of the health information about individuals. population they serve, CBWCHC has developed the tools to Between 2004 and 2008, CBWCHC was able to screen more adequately screen and treat HBV. more than 4,000 individuals for HBV. Twenty-two percent Language and cultural barriers to HBV care are apparent of the individuals tested were found to be positive and are within the New York City Asian population. These include: now in their system for treatment. 14 Treating More than Five Million Americans with HBV or HCV 4 SECTION “ WE ARE TALKING ABOUT A CURE FOR HEPATITIS C. WE ARE ON THE THRESHOLD OF AN ERA OF MORE EFFECTIVE TREATMENT. WE ARE WHERE WE WERE IN THE EARLY 1990S WITH HIV AND HAART [HIGHLY ACTIVE ANTIRETROVIRAL THERAPY]. WE ARE ABOUT TO HAVE A GAME-CHANGER IN THERAPY FOR HEPATITIS C. WITH CURRENT TREATMENTS, ABOUT 35 PERCENT TO 40 PERCENT OF PEOPLE CLEAR HCV FROM THEIR SYSTEM. THEY HAVE TO TAKE THE DRUGS FOR 48 WEEKS. WE THINK THE NEW THERAPIES WILL REDUCE THAT TO A24-WEEK THERAPY PERIOD AND THAT THE CHANCE FOR A CURE WILL GO UP TO ABOUT 75 PERCENT. SO, THE STUDIES INDICATE THAT THE THERAPIES WILL BE MORE EFFECTIVE, PEOPLE CAN TAKE THEM FOR A SHORTER PERIOD OF TIME, AND THEY WILL HAVE A GREATLY INCREASED CHANCE OF A CURE. ” 54 -- JOHN W. WARD, MD Challenge: To assure that all individuals diagnosed with hepatitis receive the standard of care regardless of ability to pay and receive the support services needed to assure completion of treatment. Today, millions of Americans with hepatitis are not getting the potentially life-saving treatment they need. With the incredible promise of new treat- ments that could become available in the next few years, the importance of accessing treatments will become even greater as new therapies offer the hope of shorter treatment courses, with fewer side effects and higher rates of cure. While the United States has made an appropriate and very strong commitment to assuring access to non-curative treatment for HIV, which has dramatically changed the course of the epidemic for Americans living with HIV, we have not made a similar commitment to the more than five million people in the United State living with hepatitis -- even with a time-limited treatment course that can provide a cure. Health reform offers the potential to change this equation. The Affordable Care Act means 32 mil- lion previously uninsured Americans will now have health insurance options and individuals who were denied coverage for preexisting med- ical conditions, including HBV and HCV, will no longer be denied coverage or have their cover- age revoked once a medical condition is found. 15 A. NAVIGATING TREATMENT AND COVERAGE Treating chronic HBV and HCV is not cheap or range or scope of possible treatment options. In easy. The earlier the diseases are found, how- addition, insurance providers may also require ever, there is greater chance for treatment to copayments or not cover all of the necessary test- help lessen the long-term damage done to a pa- ing and medications. tient’s liver. And earlier treatment costs are sig- Proper treatment requires a continuum of care nificantly less than the costs associated with and a patient who is fully committed to the treatment for cirrhosis, liver cancer, or liver process. Receiving support to help stay in treat- transplants. For people who do not receive an- ment, including social support, mental health tiviral treatment, lifetime undiscounted costs for care, nutrition services, and other types of sup- treating individuals with hepatitis C range from port, increases the likelihood a patient will finish an estimated $30,000 to $50,000 (year 2000 and the process. 2003 values), according to a review by John B. Wong.55 Costs can reach more than $267,000 n Opportunities for integrating with treatment in- for the first year costs of a liver transplant.56 frastructure for HIV and other STDs: One model for providing a complete continuum of Right now, some individuals who are identified care, which includes coordination of services, as having HBV or HCV do not get into treat- is the Ryan White program for people living ment programs due to lack of insurance cover- with HIV/AIDS. Like HIV, HBV and HCV re- age or they are not referred to providers who are quire complex treatment cycles. Successful equipped to provide full diagnostic exams and treatment strategies could be integrated with or, help the patient make treatment decisions. The at a minimum, be informed by the Ryan White lack of a good follow up and referral system Care program. A number of states have already means some patients fall through the cracks and started to integrate viral hepatitis services into do not receive care. Even with the Affordable their existing public health infrastructure. For Care Act, there are likely to be many HBV and instance, Massachusetts has used state resources HCV infected individuals who will remain unin- in the past to build upon its Ryan White Care sured or otherwise not have access to care. program infrastructure to provide medical In addition, there are hurdles to many patients management services for viral hepatitis.57 getting proper care and ongoing support. Even for patients receiving care, the current Treatment can take a long time and requires lots drug treatments for HBV and HCV are limited of testing, follow up appointments and medica- and are not effective for clearing the infection tions. Currently, there are not clear standards for all patients. Because successful treatment is and guidelines for care, so providers may vary in not guaranteed, an emphasis on preventing peo- how they treat the disease and may not use the ple from getting the diseases in the first place is most up-to-date treatments. Without these stan- particularly important. dards, insurers may also decide not to cover the 16 THE AFFORDABLE CARE ACT AND HEPATITIS The new health reform law provides a number of reforms that could dramatically improve prevention, screening and treatment of viral hepatitis -- some are immediate and others are required to take effect by 2014. Immediate reforms include: n Pre-existing Condition Insurance Plans (PCIPs) provide coverage for people who have been uninsured for six months and have been denied coverage for a pre-existing condition. Most uninsured people with hepatitis would fall in this category. n Extended coverage for young adults who can remain on their parents’ plans. n USPSTF recommended preventive services and ACIP recommended vaccines and screenings are mandated to be covered without cost sharing for any new plans or existing plans that are significantly changed. n Prohibition of rescission of coverage based on a newly identified condition. n Prohibition of lifetime caps on payments. n Regulation on annual limits on coverage. n Optional expansion of Medicaid to include all persons who live below 133 percent of federal poverty level (FPL). Reforms effective by 2014 include: n Elimination of pre-existing condition exclusions, with insurance available for individuals and small businesses through exchanges that assure lower premiums. n Expansion of the Medicaid program to cover all who live below 133 percent of FPL. n Premium subsidies for those purchasing private insurance with incomes between 133 percent and 400 percent of FPL. n Premiums adjusted for age and geography only, not medical condition. n Essential health benefits requirements that include preventive services with reduced cost sharing (for those benefits not recommended by the USPSTF). B. PROMISING NEW MEDICATIONS ON THE HORIZON -- BUT RESEARCH FUNDING IS LIMITED Challenge: Key biomedical, behavioral, and other health services research questions impede our ability to better prevent and treat various forms of hepatitis. Seven medications have been approved by the For chronic HCV, antiviral medications are used U.S. Food and Drug Administration (FDA) for for treatment. Fifty percent to 60 percent of pa- treating chronic HBV. The drugs often do not tients respond to treatment initially.59 African result in a full cure, but they can significantly re- Americans do not respond as well to HCV treat- duce the risk of liver damage by slowing or stop- ment compared with the general population, ping the virus from reproducing. This in turn with a 28 percent success rate compared to 50 leads to improved outcome, less need for trans- percent to 60 percent success rates among the plant and improved survival in patients with ad- overall population.60 Researchers are continu- vanced disease. Studies are underway looking ing to investigate the reasons for this difference. at the impact of various drug combinations for Scientists are optimistic about research into new HBV. It appears that earlier treatment of therapies currently underway to treat HCV. chronic HBV increases the efficacy of treatment, Some experts compare the current state to the underscoring the need for early identification late 1980s and 1990s when combinations of of those who are infected.58 17 novel antiviral medications were introduced, The investment into research for HBV and HCV changing HIV/AIDS from a uniformly fatal dis- is particularly disproportionate to the threat of ease to a highly treatable chronic illness. Unlike the diseases -- with one percent to two percent HIV/AIDS, however, which cannot be eradi- of Americans infected with chronic HBV or cated but only suppressed, researchers hope HCV. Combined, HBV and HCV research re- that emerging HCV medications will result in ceive approximately five percent of the funds de- significantly higher rates of sustained HCV voted to HIV research -- $152 million compared clearance, that represent true cures and with to more than $3 billion. Although making per fewer side effects. capita assessments is not appropriate for re- search funding, this level of difference does Despite the advances in treatment research, demonstrate a serious disconnect. progress has been hampered by limited funds. National Institutes of Health (NIH) Hepatitis Research Dollars FY 2009 FY 2010 FY 2011 HBV $51 million $52 million $54 million HCV $97 million $100 million $102 million HIV $3,019 million $3,086 million $3,184 million Source: U.S. Department of Health and Human Services.61 Note: FY 2009 dollars exclude American Recovery and Reinvestment Act funding. With more funding, the National Institutes of active infections and permit fast referral to Health (NIH) could better address some key is- care; and sues, a number of which were identified during n Developing screening tests that can be per- a May 2010 consensus building meeting con- formed at the point of care. vened by TFAH and AASLD including: In addition, an IOM panel included research to n Developing a single dose HBV vaccine, which compare the effectiveness of alternative clinical could dramatically improve the chances of management strategies for HCV (including du- reaching universal vaccination; ration of therapy) for patients based on viral ge- n Continuing to study combination therapy for nomic profile and patient risk factors (such as HCV, which will be critical for the better use behavior-related risk factors) among their top of new treatments and for which there is little 100 priorities for comparative effectiveness re- private sector incentive; search. It remains to be seen if this will be adopted as an objective of the new comparative n Developing a preventive vaccine for hepatitis C; effectiveness research program established with n Studying racial and ethnic differences in re- initial funding as part of American Recovery sponse to hepatitis treatment. For instance, and Reinvestment Act.63 reports that African Americans only have a 28 In addition, NIH, HRSA, the Agency for Health- percent success rate, compared to approxi- care Research and Quality (AHRQ) and CDC mately 50 percent to 60 percent overall, re- could develop a research agenda to determine quires a deeper scientific understanding that the best mechanisms for delivering care, in- addresses this question during the research cluding resolving questions about types of social phase, not after a treatment is already in use;62 service supports needed and whether integrat- n Developing a rapid polymerase chain reaction ing HIV and hepatitis systems of care meet the (PCR) test for HCV, could identify those with needs of both affected populations. 18 Preventing New Cases of HBV and HCV Challenge: The United States does not take an integrated approach to reducing risk for related infectious diseases. Even though it is well known that risky sexual behaviors are associated with HIV, hepatitis, and STD transmission, and that injection drug use is often associated with HIV and hepatitis transmission, federal programming continues to take a categorical, 5 SECTION stovepiped approach by disease. Since HBV can be transmitted by an infected infected person, or use of unsterilized needles mother to her newborn at birth, and both HBV (including tattoo or piercing needles) -- strate- and HCV can be spread through medical care gies to prevent new cases should focus on limit- or through unprotected sex, sharing injection ing exposure to other people’s blood and bodily drug equipment, living in a household (or shar- fluids, and for HBV, encouraging individuals to ing nail clippers/razors/toothbrushes) with an get the available vaccine.64 A. ELIMINATING TRANSMISSION OF HBV TO NEWBORNS Challenge: To set a goal of eliminating mother-to-child transmission in the United States, simi- lar to the effort undertaken to eliminate such transmission of HIV. An estimated 800 to 1,000 infants are infected Pennsylvania, Tennessee, Texas, Utah and Vir- each year by HBV from their mothers at birth. If ginia have screening requirements.) preventive measures are not taken, children n Only 26 states and Washington, DC have specific born to women with chronic HBV have a greater HBV-positive maternal reporting mandates. than 90 percent chance of also developing (Arkansas, California, Connecticut, DC, Florida, chronic HBV. In 2004, according to National Georgia, Hawaii, Illinois, Indiana, Kansas, Ken- Center for Health Statistics birth data, approxi- tucky, Louisiana, Minnesota, Missouri, Montana, mately 24 percent of all births in the United Nevada, New Hampshire, New Jersey, New York, States were to foreign-born women, who account North Carolina, Rhode Island, South Carolina, for a high proportion of HBV-positive pregnan- Tennessee, Texas, Utah, Vermont and Washing- cies.65 USPSTF and CDC have recommended ton have reporting requirements.)68 screening all pregnant women for HBV.66 If a mother is identified as having HBV, steps can be In the mid-1990s, the United States undertook taken to reduce the risk of transmission to the an effort to eliminate mother-to-child transmis- baby through the co-administration of a hepati- sion of HIV. Because most of the mothers with tis B immunogloblin (HBIG), allowing time for HIV infection giving birth were already on the the infant to receive the HBV vaccination to try Medicaid program, federal officials worked with to build up immunity to the disease. state Medicaid program officials to assure that appropriate prevention protocols were adopted Currently, however, despite the recommenda- during pre-natal visits and during labor and de- tions by USPSTF and CDC, many pregnant livery. New HIV cases in U.S. children have women are not screened for HBV, and even in steadily declined over the years -- from 855 in cases where HBV is identified in the mother, a 1992 to 57 in 2005.69 The dramatic reduction in 2006 CDC study found 33 percent of pregnant cases was associated with increased HIV testing women and their babies testing positive did not among pregnant women and the use of anti- receive treatment that could help the baby retrovial drugs to prevent mother-to-child trans- from* being infected with HBV.67 mission. Thus, a targeted effort involving the n Only 26 states and Washington, DC have HBV Medicaid programs might achieve similar results prenatal screening mandates. (Alabama, for HBV in a larger portion of the women. Ac- Alaska, Arkansas, California, Colorado, DC, cording to experts, if the recommended screen- Florida, Hawaii, Illinois, Kansas, Kentucky, ing and early treatment measures were taken, Massachusetts, Michigan, Missouri, Montana, the transmission of HBV from mothers to their Nevada, New Hampshire, New Jersey, New newborns could be virtually eliminated in the York, North Carolina, Oklahoma, Oregon, United States. 19 Hepatitis B Prevention Mandates State Hep B Prenatal Specific Hep B Perinatal Hep Hep B Childhood Screening Mandate Positive Maternal Cooridinator Vaccination Mandate Reporting Mandate Alabama 3 3 Alaska 3 3 3 Arizona 3 3 Arkansas 3 3 3 3 California 3 3 3 3 Colorado 3 3 3 Connecticut 3 3 3 Delaware 3 3 DC 3 3 3 3 Florida 3 3 3 3 Georgia 3 3 3 Hawaii 3 3 3 3 Idaho 3 3 Illinois 3 3 3 3 Indiana 3 3 3 Iowa 3 3 Kansas 3 3 3 3 Kentucky 3 3 3 3 Louisiana 3 3 3 Maine 3 3 Maryland 3 3 Massachusetts 3 3 3 Michigan 3 3 3 Minnesota 3 3 3 Mississippi 3 3 Missouri 3 3 3 3 Montana 3 3 3 Nebraska 3 3 Nevada 3 3 3 3 New Hampshire 3 3 3 3 New Jersey 3 3 3 3 New Mexico 3 3 New York 3 3 3 3 North Carolina 3 3 3 3 North Dakota 3 3 Ohio 3 3 Oklahoma 3 3 3 Oregon 3 3 3 Pennsylvania 3 3 3 Rhode Island 3 3 3 South Carolina 3 3 3 South Dakota 3 Tennessee 3 3 3 3 Texas 3 3 3 3 Utah 3 3 3 3 Vermont 3 3 3 Virginia 3 3 3 Washington 3 3 3 West Virginia 3 3 Wisconsin 3 3 Wyoming 3 3 Total 26 + DC 26 + DC 50 + DC 47 + DC Sources: 1) Immunization Action Coalition. “State Information: Hepatitis B Prevention Mandates: Prenatal, Daycare and K-12.” http://www.immunize.org/laws/hepb.asp (accessed May 24, 2010). 2) Centers for Disease Control and Prevention. “Maternal Hepatitis B Screening and Reporting Requirements.” National Center for Immunizations and Respiratory Diseases http://www2a.cdc.gov/nip/StateVac- cApp/statevaccsApp/HepatitisScreenandReport.asp (accessed May 24, 2010). 3) Centers for Disease Control and Prevention. “Perinatal Hep- atitis B Coordinator List.” http://www.cdc.gov/vaccines/vpd-vac/hepb/perinatal-contacts.htm (accessed May 24, 2010) 20 B. ELIMINATING HEALTH CARE TRANSMISSION OF HBV AND HCV Since 1992, measures were taken to improve n Syringe reuse and medical vial containment safety precautions and screen blood donations, in a diverse array of outpatient clinics (en- which helped reduce the transmission of HCV in- doscopy, surgical settings, cardiology); fections in health care settings. However, experts n Improper use and handling of blood glucose are concerned that health care transmissions are monitoring equipment in long-term care set- increasing again due to lapses in infection con- tings. The prevention and containment of trol practices. In addition, there are also con- viral hepatitis in long-term residential care fa- cerns about maintaining high standards of cilities is of growing concern as the number infection control in non-hospital facilities. of Americans ages 65 and older will double to Meanwhile, limited surveillance means that data more than 70 million by the year 2030; and about the rates of health care acquired infec- n Lapses in cleaning and disinfection of equip- tions is lacking. At least 100,000 patients have ment, supplies and hands of health care been notified about potential exposure to HBV, providers in hemodialysis settings. Reducing HCV and/or HIV while receiving care since the risk of transmission in these settings re- 1998.70 Between 1998 and 2008, CDC identified quires aggressive practice and enforcement of 33 outbreaks of HBV and HCV in hospital set- standards of care including vaccination of tings, 12 in outpatient clinics, six in hemodialy- staff and patients against HBV, segregation of sis centers and 15 in long-term care facilities. patients with chronic viral hepatitis, careful Some examples of health care settings and un- sterilization of all equipment and machines, safe practices where transmissions are being and preparing injection medications in a sep- identified with some frequency include: arate room from where dialysis occurs. 21 C. ELIMINATING NEW INFECTIONS AMONG HIGH-RISK POPULATIONS Major opportunities for increased prevention in- communities -- including through better inte- clude increasing HBV vaccination rates and bol- gration with HIV and STD prevention efforts. stering prevention campaigns targeting at-risk 1. Increasing HBV Vaccination Rates The most effective approach to preventing HBV sexually transmitted disease, persons with HIV is a vaccine that has been available in the United infection, sex partners of people living with an States since 1982. Since 1991, an increasing per- infected person, injection-drug users, travelers centage of children born in the United States to countries with high rates of HBV, patients have been vaccinated for HBV, which has been with kidney disease or undergoing dialysis, per- shown to be an extremely safe vaccination.71 sons with HIV, persons with HCV and residents Now, more than 90 percent of infants receive and staff of correctional facilities and facilities the hepatitis B vaccine. Most infants receive the for developmentally disabled persons. While first of three needed vaccination shots within more than 90 percent of U.S.-born children three days of birth, though there is significant have been vaccinated for HBV, HBV infections state-by-state variability in the number of chil- could be reduced if more of the remaining chil- dren who receive their first shot within three dren were vaccinated and if more adults who days of birth -- in 2008, the rates ranged from a came of age before the vaccine became widely high of 81.4 percent in Arizona to a low of 19.1 available were vaccinated.73 Some barriers to in- percent in Vermont. Experts recommend that creasing vaccine rates involve misperceptions all infants should be given their first vaccination about the safety of vaccines and lack of knowl- before they are discharged from the birthing edge about the availability of the vaccine for sex- hospital, ideally within 12 hours of birth. ually active adults. While the vaccine has contributed to an 81 per- The HBV vaccination gap could be decreased cent drop in the HBV infection rate, at least with 1) additional funding from CDC to support 43,000 individuals were newly infected by HBV the efforts of state and local health departments in 2007, although experts believe this is a low es- to vaccinate individuals for HBV and 2) an in- timate due to limited surveillance.72 crease in public education campaigns to educate parents, at-risk individuals and health care To further reduce cases of HBV, CDC recom- providers about the importance of the vaccine mends all infants and children get vaccinated for the health and the safety of individuals at against HBV as well as any other persons seek- risk. Policies requiring proof of vaccinations for ing protection from HBV infection. In addition, elementary school admittance have also proven CDC recommends hepatitis B vaccination for to be an effective way to increase immunization health care professionals and public safety work- rates. Under health reform, hepatitis B vacci- ers, all teens and adults (who have had more nations will be covered without cost sharing, than one sex partner within the past six which should remove one barrier to reach a uni- months), persons with chronic liver disease, gay versal vaccination goal. and bisexual men, persons being evaluated for a 22 Estimated Vaccination Coverage for Hepatitis B Vaccine Among Children* from Birth to 3 Days of Age by State (National Immunization Survey, 2008) [This data represents the first of three shots that children need.] State 1 or more HepB dose w/in 3 days of birth Rank (Percent and 95% confidence interval) Alabama 66.5 (+/- 5.8) 19 Alaska 64.6 (+/- 6.9) 24 Arizona 81.4 (+/- 4.9) 1 Arkansas 73.8 (+/- 6.6) 5 California 36.3 (+/- 5.0) 45 Colorado 48.7 (+/- 8.9) 39 Connecticut 63.2 (+/- 7.2) 28 Delaware 58.6 (+/- 7.2) 33 DC 61.7 (+/- 7.1) 31 Florida 40.7 (+/- 6.7) 43 Georgia 65.8 (+/- 7.0) 21 Hawaii 68.3 (+/- 7.2) 11 Idaho 64.0 (+/- 6.6) 26 Illinois 56.4 (+/- 5.1) 34 Indiana 64.5 (+/- 7.3) 25 Iowa 31.4 (+/- 6.1) 48 Kansas 68.1 (+/- 6.7) 12 Kentucky 74.4 (+/- 6.2) 4 Louisiana 62.3 (+/- 6.2) 30 Maine 66.8 (+/- 6.1) 16 Maryland 67.8 (+/- 5.7) 13 Massachusetts 66.8 (+/- 7.3) 16 Michigan 75.7 (+/- 6.2) 3 Minnesota 21.7 (+/- 5.5) 50 Mississippi 67.3 (+/- 5.9) 14 Missouri 56.2 (+/- 6.6) 35 Montana 66.4 (+/- 6.6) 20 Nebraska 31.0 (+/- 6.0) 49 Nevada 65.5 (+/- 6.6) 22 New Hampshire 69.0 (+/- 6.0) 10 New Jersey 44.9 (+/- 7.1) 40 New Mexico 52.3 (+/- 7.6) 38 New York 34.4 (+/- 4.8) 47 North Carolina 72.2 (+/- 6.3) 7 North Dakota 72.0 (+/- 5.9) 8 Ohio 64.7 (+/- 7.0) 23 Oklahoma 61.4 (+/- 6.8) 32 Oregon 41.8 (+/- 7.7) 42 Pennsylvania 67.0 (+/- 5.5) 15 Rhode Island 69.4 (+/- 7.1) 9 South Carolina 62.8 (+/- 6.8) 29 South Dakota 40.5 (+/- 6.6) 44 Tennessee 35.8 (+/- 6.4) 46 Texas 66.6 (+/- 5.5) 18 Utah 78.6 (+/- 6.7) 2 Vermont 19.1 (+/- 6.3) 51 Virginia 42.2 (+/- 8.7) 41 Washington 72.6 (+/- 5.3) 6 West Virginia 55.3 (+/- 7.2) 37 Wisconsin 55.8 (+/- 7.6) 36 Wyoming 63.5 (+/- 6.4) 27 United States 55.3 (+/- 1.3) N/A Centers for Disease Control and Prevention. “Estimated Vaccination Coverage for Hepatitis B Vaccine Among Children from Birth to 3 Days of Age by State and Immunization Action Plan Area National Immunization Survey, 2008.” http://www.cdc.gov/hepatitis/Partners/PeriHepB- Coord.htm (accessed May 24, 2010). * Information from children born between January 2005 and June 2007. 23 THE ADULT HEPATITIS VACCINE PROJECT -- CALIFORNIA, 2007-200874 HBV vaccination rates for high-risk adults traditionally have been low. In 2006, ACIP recommended that HBV vaccination be offered to all adults as part of routine prevention services in settings where a high proportion of those served are at increased risk. CDC provided approximately $20 million to en- courage states to purchase adult HBV vaccine. In response, the California Department of Public Health established the Adult Hepatitis Vaccine Proj- ect to expand HBV vaccination in sites serving at-risk adults.75 Between 2007 and 2008, 28,824 doses of HBV vaccine were administered at 29 participating sites during the first 19 months of the campaign; 13 sites administered HBV vaccine for the first time. Because the federal government was able to provide vaccine, many adults were vaccinated who otherwise might not have received it. The California sites included 11 STD clinics, four correctional facilities, four community health cen- ters, four substance abuse treatment programs, four syringe exchange programs and two HIV coun- seling, testing and treatment sites. At the national level, between June 2007 and December 2008, the CDC initiative, in collaboration with 51 state and local vaccination programs and viral hepatitis prevention coordinators, administered 275,445 doses of HBV vaccine in 1,065 sites. Most were administered by local health departments (37 percent) and STD clinics (30 percent), followed by correctional facilities (22 percent). California administered 10.5 percent of the national doses available through the CDC initiative, a majority of which were administered in local STD clinics. California administered the second largest number of HBV vaccine doses in STD clinics of any state. In 2008 and 2009, CDC distributed an additional $16 million each year to states and localities to buy adult HBV vaccine. The IOM report estimates that approximately $80 million would be needed to vaccinate just 75 percent of adults in STD/HIV and drug treatment centers alone. In August 2010 CDC Immunization Services Division terminated this initiative and will not be provid- ing funding to continue the adult hepatitis B vaccination initiative. 2. Bolstering Prevention Campaigns Targeting At-Risk Groups New cases of hepatitis B and C could also be fur- n Health care workers and emergency response ther reduced by strategically targeting programs personnel, who can become exposed through and efforts around groups at the greatest risk for blood or bodily fluids of patients; spreading the diseases. This is challenging since n Injection drug users who share needles and many individuals at high risk do not even know other drug using equipment; and they are at risk. n Institutionalized individuals. Non-vaccinated individuals who are at the great- est risk for HBV include: There is no vaccine available for HCV, so other prevention efforts are essential to help reduce the n Sexually active adults who have been with spread of the disease. While rates have signifi- more than one partner in their lifetime and cantly decreased since the 1980s due to increased came of age before the vaccine was widely knowledge about safe sex practices, changes in available in 1992; safety in medical practices (such as screening n People who are exposed to HBV through rela- blood transfusions) and practices to decrease the tives or friends who were born abroad and who use of sharing needles, there are still at least an es- are more likely to carry the disease than Amer- timated 17,000 new cases of HCV each year, al- icans. Estimates are that every year 40,000 to though experts believe this estimate is extremely 45,000 people enter the United States legally low due to limited surveillance.77 from HBV-endemic countries. Currently, these Individuals at the greatest risk for HCV include: people do not undergo mandatory screening for HBV unlike HIV;76 n Injection drug users who share needles and other drug using equipment; n People who live with children adopted inter- nationally, especially if they come from areas n Health care workers and emergency response where the disease is endemic, such as East or personnel, who can become exposed through Southeast Asia and Eastern Europe; blood or bodily fluids of patients; 24 n People who have been pierced, tattooed, or plicated in the transmission of HCV.79 Indi- received acupuncture in facilities that do not viduals are particularly vulnerable during the take careful measures not to reuse needles; first few years of drug use, when HCV infec- tion rates can exceed 40 percent.80 n Patients who receive health care in facilities where adherence to infection control prac- Public health officials have designed syringe tices is inadequate; exchange programs (SEPs), where drug users can exchange used needles for clean n People who received medical care in coun- ones so the diseases are not passed on from tries where they do not regularly screen blood one drug user to another to help control the or take measures to protect against HCV spread of these diseases. Prominent scientific transmission; and public health organizations and leaders, n Sexually active adults who have been with more including the IOM and officials from NIH than one partner in their lifetime, although this and CDC have endorsed the effectiveness of is a less common way for HCV to be spread; and these programs. Hundreds of scientific stud- ies have been conducted that have found sy- n Institutionalized individuals. ring exchange programs can help to reduce Targeted public education campaigns, as well as hepatitis and HIV transmission and do not enhanced efforts to educate medical providers promote illegal drug use.81, 82 There is also ev- that their patients are at risk, could help reduce idence that syringe exchange programs do the spread of HBV and HCV. not increase unsafe disposal of unused sy- ringes among participants in these programs. Campaigns to encourage safe sex and warn about Syringe exchange programs are often effec- the dangers of injection drug use are major strate- tive ways to find hard-to-reach drug users to gies to fight HBV and HCV. However, it is also im- connect them with a wide range of important portant to develop strategies and public education health and social services, including sub- initiatives designed to reach other at-risk groups, stance abuse treatment and on-site testing for including ones for communities where exposure HIV, HBV and HCV. rates are high, such as among Asian and Pacific Is- lander Americans; patients who receive care in fa- In December 2009, Congress lifted a long- cilities where adherence to infection control standing ban on the use of federal funds for practices is inadequate; medical providers who syringe exchange programs. In July 2010, may be at risk through exposure to patients; and HHS released interim guidance for the use for individuals who may be at risk through other of federal funds for syringe exchange pro- activities, such as tattoos and piercings. grams. State and local health departments now have the option of using federal funds n Opportunities for integrating HBV and HCV to create and/or expand syringe exchange prevention strategies with HIV and other STDs: programs in their communities. Practices to prevent and limit the spread of HBV and HCV are consistent with those used to pre- Many injection drug users do not have reg- vent HIV and other STDs. Currently, the United ular access to health care, making them States does not have an integrated approach to hard to reach through standard care. reducing risk for HIV, hepatitis and STDs for Other ways to reach these individuals can those with overlapping risk behaviors, including be utilized, such as through drug treat- unprotected sexual activity and needle sharing. ment programs and health clinics. s Curbing Transmission through Drug Use -- s Safe Sex Education: There are a lot of social Expanding Access to Drug Treatment, Sy- stigmas around addressing sexual behavior in ringe Exchange Programs and Education the United States, including worries about about the Dangers of Sharing Contaminated unintentionally encouraging teens’ interest Drug Use Equipment: Sharing dirty needles in sex. However, education about the dan- and other injection drug use equipment is a gers of unprotected sex and how diseases can major source of new infections of HCV in the be spread through sex are essential for pre- United States; injection drug users are also at vention of a range of STDs, including HIV increased risk of contracting HBV and HIV. and HBV. For HBV, in particular, adults who came of age before 1982 are actually the most Injection drug users often end up sharing likely to contract the disease through sexual needles when clean ones are not available -- relations, since a vast majority of children and nearly 32 percent of injecting-drug users re- teens have received the vaccination, so adult port sharing needles.78 Shared use of other education about safe sex practices is essential. drug injection equipment has also been im- 25 RISE OF HCV IN YOUNG INJECTION DRUG USERS “ HEPATITIS C IS A LARGELY UNRECOGNIZED PUBLIC HEALTH CRISIS. WE ARE SEEING A REEMERGENCE OF THE DISEASE IN YOUNG ADULTS AND INJECTION DRUG USERS. BECAUSE OF INADEQUATE PREVENTION AND SURVEILLANCE FUNDING, THERE IS ONLY SO MUCH WE CAN DO. ” 83 -- DANIEL CHURCH, EPIDEMIOLOGIST/VIRAL HEPATITIS COORDINATOR, MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH New York State Department of Health (NYSDOH): In 2007, using targeted enhanced surveil- lance, NYSDOH staff noticed a high number of newly identified HCV infections among individuals under the age of 30, all of whom resided in the same postal code in suburban Buffalo, New York. The median age of these individuals was 19 (17-29 years), all of the new cases identified as White, and 75 percent were male. Over half of these young people reported injecting heroin and sharing drug equipment. While a relatively small number of youth were identified in total, there is no way of know- ing how many additional young people may have become infected through the broader social net- work of youths and injection drug users in the greater Buffalo area.84 Massachusetts Department of Public Health (MDPH): In 2005, the state of Massachusetts began noticing an increasing proportion of young people being admitted to drug treatment programs and a rising proportion of young persons reporting injection drug use. After further investigation, using statewide disease surveillance data, the MDPH confirmed that since 2007 there have been more than 1,000 probable and confirmed new cases of HCV infection reported annually in persons under the age of 25, statewide. This is 13 percent of the total number of new cases in the state each year. Unlike with older cohorts both in Massachusetts and nationwide, which are overwhelmingly male, there are an approximate equal number of male and female youth being reported.85 26 Policy Recommendations “ VIRAL HEPATITIS IS A SILENT BUT DEADLY THREAT TO PUBLIC HEALTH. THE DANGER FOR THE AMERICAN PEOPLE IS COMPOUNDED BY WIDESPREAD IGNORANCE ABOUT IT AMONGST HEALTH CARE PROVIDERS ESPECIALLY THOSE INVOLVED IN PRIMARY CARE. THE 6 SECTION TFAH REPORT BUILDS ON THE IOM REPORT BY PROVIDING SPECIFIC RECOMMENDATIONS TO INCREASE AWARENESS, ESTABLISH WIDESPREAD SCREENING SURVEILLANCE AND PRIMARY PREVENTIVE STRATEGIES. IMPORTANTLY, IT PROVIDES SPECIFIC MECHANISMS TO INCREASE ACCESS TO CARE FOR AFFLICTED INDIVIDUALS. IF IMPLEMENTED, THESE WILL GO A LONG WAY TO REDUCE THE BURDEN OF CHRONIC LIVER DISEASE AND LIVER CANCER. ” 86 -- ARUN J. SANYAL, MD, PRESIDENT OF AASLD AND PROFESSOR OF MEDICINE AND CHAIRMAN, DIVISION OF GASTROENTEROLOGY, VIRGINIA COMMONWEALTH UNIVERSITY MEDICAL CENTER H ealth reform combined with new scientific advances offers the chance to dramatically improve hepatitis prevention, control and treatment in the United States. The following are recommendations for actions to take advantage of this opportunity -- to prevent new infections, to identify and provide earlier treat- ment to people who do not know they have the disease and to treat people in the most effective ways possible. If we invest in prevention and early treatment now, we could avoid new infections and spare millions of individuals the pain and financial burden of untreated liver disease -- or we could delay the investment, and incur far greater costs and cause avoidable disease, disability and suffering for millions of Americans and their families. The following recommendations offer a compre- and (3) reducing the financial impact of hepatitis hensive policy response to the problem and con- on our health care delivery system, much of which tinuous threat of viral hepatitis. Together, these will be borne by Medicare and Medicaid. recommendations can address three related pub- Some of the recommendations could be achieved lic health goals: (1) assuring that our public through immediate policy changes, some would health and health care delivery systems are ready require modest levels of new resources and some for the new, more effective treatments for hepati- would require a longer term significant invest- tis that are on the horizon -- to ensure that all in- ment. Some of the funding for these initiatives dividuals in the United States with viral hepatitis could come from the Prevention and Public can benefit from improved health outcomes; (2) Health Fund created by the Affordable Care Act. assuring that the current racial and ethnic dis- parities associated with hepatitis are addressed; 27 A. SURVEILLANCE Challenge: The United States lacks a comprehensive surveillance system for viral hepatitis, resulting in a partial understanding of the scope of the problem and, therefore, diminishing the capacity to target prevention activities and plan for treatment service needs. It is important to have a clear and accurate understanding of both the prevalence of hepatitis in the United States as well as inci- dence levels -- with the ability to rapidly identify new outbreaks of viral hepatitis that can lead to successful targeted interventions. Viral hepatitis surveillance should build on the ex- approaches are more informative of the cumu- isting, more robust HIV and other infectious dis- lative burden of hepatitis, without giving public ease surveillance systems, creating an integrated health officials timely accessible data on new infrastructure for surveillance. Appropriate adap- acute cases of hepatitis. tation of infectious disease surveillance systems n CDC should support viral hepatitis specific co- in an era of electronic health records may free up operative agreements with all state and terri- resources to create this integrated capacity. torial health departments. n Given limited resources and the availability of n CDC should explore expanding the network already developed surveillance systems for of sentinel reporting sites across the country HIV, STDs or other infectious diseases, it is ap- that can become the early warning system for propriate -- both programmatically and fiscally new outbreaks of hepatitis, especially HCV. -- to integrate viral hepatitis surveillance These sentinel sites would collect the infor- where most appropriate. It is consistent with mation needed to monitor the on-going trans- the policy decision to include viral hepatitis as mission of hepatitis and assess the impact of part of the NCHHSTP and also in keeping primary prevention approaches. with the Center’s 2010-2015 strategic plan. Congress should appropriate additional funding n CDC should work with HHS’s Office of the for public health agencies to support their sur- National Coordinator for Health Information veillance and related hepatitis prevention work. Technology (ONC) to assure that relevant hepatitis data are part of the developing n State and local health departments have faced HIT infrastructure, including infectious dis- serious cutbacks in their funding for core ease reporting and health care acquired in- public health programs. CDC’s hepatitis sur- fection reporting. This has the potential veillance grants are currently insufficient to to dramatically increase data available while assure the comprehensive approach needed. reducing the burden on surveillance pro- n CDC’s surveillance programs (or other popu- grams in state and local health departments. lation-level studies that help determine hepa- Training for state surveillance officials will be titis prevalence) need to be robust enough to needed to take advantage of the new data determined prevalence levels among key available through HIT. high-risk populations such as Asian and Pa- CDC must create the capacity to better identify cific Islander Americans. the number of new cases of hepatitis. Current B. SCREENING AND TESTING FOR HBV AND HCV Challenge: All who are at risk should be screened and tested so they know their status. In the case of HBV, those who are not infected should be vaccinated. If infected, individuals can be re- ferred for immediate treatment, counseled about reducing the risk of transmission and how to manage the disease and educated about the progression of the disease. HBV and HCV screening and HBV vaccination they age into Medicare. Hepatitis screening should be the standard of care in the reformed could be part of every initial Medicare health health care system. care encounter. This intervention could ulti- mately be a cost saving to the Medicare system if n The HHS Secretary should move toward routine more serious liver disease is avoided. screening in the Medicare population under the Secretary’s authority to define preventive bene- n CDC should work with the USPSTF to assess fits for Medicare beneficiaries. Given the high the value of routine HBV and/or HCV screen- prevalence of HCV among aging “boomers,” (46 ing. If supported by the USPSTF, screening -- 64 years of age) this is a critically important would become a mandated benefit with no co- population to target for testing and treatment as payments under new health plans. 28 n While the USPSTF considers a screening rec- propriately screened upon entry to the United ommendation, the HHS Secretary should ex- States, as recommended by CDC and an NIH ercise her authority under the new law to 2008 consensus conference on HBV.87 consider HBV and HCV screening an “essen- Other care settings include: tial health benefit.” This will require cover- age by public and new small and individual n HIV, STD and TB clinics; private plans with limited cost sharing. n Substance abuse and mental health programs; n Medicaid should take all necessary steps to as- n Syringe exchange and other harm reduction sure that routine screening is covered and en- programs; couraged. For children, this should be an Early and Periodic Screening, Diagnosis, and n Federal, state and adult and juvenile correc- Treatment Program (EPSDT) benefit. tional facilities; and n HRSA should make routine screening a man- n Family planning clinics. dated protocol for community health centers. Programs and policies will be needed to help in- n HRSA should mandate that all community dividuals overcome their reluctance and limited health centers’ patients have a record of HBV understanding of the need to be screened, ei- vaccination. ther because they do not perceive themselves to be at risk or because of the stigma associated n CDC should undertake a policy initiative and with the hepatitis infection. These approaches national campaign to assure that all states re- must be carefully and creatively designed to re- quire proof of hepatitis B vaccination for all flect cultural and linguistic competencies and be students entering elementary schools. implemented in places where high-risk popula- n As CDC moves toward an integrated approach tions reside. Public education campaigns will be to supporting HIV, STD, TB and viral hepati- needed to raise awareness about HBV and HCV tis funding for all states, sufficient funds in ways that reduce the stigma associated with should be made available to assure that each the diseases and inform people about their need state has an individual with responsibilities for to be screened and ways to avoid infection. viral hepatitis coordination and perinatal hep- n A special focus on hepatitis should be part of atitis coordination. All states should have a the outreach and national education program comprehensive viral hepatitis plan in place by for consumers regarding preventive services 2014, with sufficient federal funding to sup- benefits authorized under health reform. port its implementation. This should include the value of screening Since not all individuals at risk for hepatitis are and the potential of new treatments to eradi- part of the health care system (even if they will cate infection. Such outreach efforts could in- be eligible for coverage with the implementation clude the spectrum of technological devices, of health reform), alternative methods for social networking sites, public service an- reaching those at risk will be needed. The fed- nouncements (PSAs) and celebrities to cham- eral government should assure (through policy pion the cause. At the same time, these efforts and funding) that screening for hepatitis occurs can be combined with existing health promo- within programs more likely to encounter those tion work already underway with CDC. with hepatitis. CMS should direct states to co- n CDC should consider a social marketing cam- ordinate services within above listed programs paign that promotes HBV vaccination, testing to determine Medicaid (and other insurance) el- for hepatitis and addresses the stigma and igibility of clients and give enrollment guidance knowledge gaps associated with hepatitis. on-site. CDC should work with non-govern- Such a program could include other infec- mental organizations that work with immigrant tious diseases and could be funded through populations to assure that all immigrants arriv- the Prevention and Public Health Fund cre- ing from countries where the prevalence of HBV ated under health reform. is greater than two percent are routinely and ap- 29 C. PRIMARY PREVENTION OF HEPATITIS Challenge: The United States does not take an integrated approach to reducing risk for related infectious diseases. Even though it is well known that risky sexual behaviors are associated with HIV, hepatitis, and STD transmission, and that injection drug use is often associated with HIV and hepatitis transmission, federal programming continues to take a categorical, stovepiped approach by disease. CDC should require an integrated approach to CDC should support state and local health de- HIV, hepatitis and STD prevention for those partment efforts to vaccinate individuals for with overlapping risk behaviors. This would HBV to close gaps in vaccination coverage. lead to more efficient and effective use of scarce n This should include a targeted effort among federal resources. the incarcerated, people in drug treatment n Prevention programs that address hepatitis programs and immigrants, who are at highest must be cognizant of the fact that a large risk, and to fill any gaps in vaccination cover- number of individuals with hepatitis do not age among individuals who may not have know their status. Therefore, prevention been vaccinated as infants before the vaccine must focus on changing risky behaviors of all became available in 1982. people, not just the individuals already iden- n The ONC, as part of the meaningful use HIT tified as infected with hepatitis. regulations, should mandate that hepatitis B n New funding for prevention across the Na- vaccination information be part of each med- tional Center for HIV/AIDS, Viral Hepatitis, ical record, with clinical reminders for all in- STD and TB Prevention should emphasize dividuals at risk who have not been vaccinated viral hepatitis activities within the Program and for follow-up doses. Hepatitis B vaccina- Collaboration and Service Integration (PCSI) tion is now recommended by ACIP for all in- initiative, which is designed to break down the dividuals seen in settings that care for stovepipes among prevention efforts targeting individuals at increased risk of HBV infection, those with overlapping risk. all children and adolescents, and can be given to any individual who wishes to be protected. n States and localities should be encouraged to use their prevention funds for syringe exchange CDC, in developing the community transforma- programs as a proven structural intervention to tion grants authorized in health reform, should reduce transmission of HIV and hepatitis. assure grantees can develop interventions that address the policy and structural factors related n Substance abuse prevention and treatment to hepatitis transmission. should be seen as part of hepatitis prevention. D. PREVENTION OF HEPATITIS TRANSMISSION DURING HEALTH CARE CDC, CMS, FDA, and AHRQ should develop n Capacity should be strengthened in state policies to assure that health care associated hep- health departments to identify and respond atitis infections are treated as a “never” event in to outbreaks in health care settings. infection control and reimbursement policy. n Systems should be developed and imple- n Federal, state, and local governments and the mented for gathering data on adherence to health care community should work to increase CDC’s recommendations for infection control education requirements and certification re- and performance on preventing infection. quirements for health care providers based on n Advances in engineering and technology CDC’s recommendations for infection control. should be supported to prevent reuse of sy- n There should be increased oversight in non- ringes and other injection equipment. hospital health care settings to ensure adher- ence to CDC’s evidence based recommended infection control guidelines. 30 E. REFERRAL SYSTEMS TO CARE Challenge: When testing occurs in a non-clinical setting or in a health setting that does not pro- vide hepatitis treatment, a referral system is needed to identify providers who are equipped to do a full diagnostic examination and help the individual make treatment decisions. The referral sys- tem must assure that both appropriate referral and follow-up appointments are made and kept. Patients, service providers, and primary care should be required to do telephone, elec- providers should have ready access to databases tronic, or other means of communication to of qualified providers of hepatitis care. follow-up with patients to confirm that they have been connected to care. Significant in- n Where public health agencies support screen- creases in funding for state hepatitis programs ing for hepatitis, they should be required and would be required. funded to create databases of clinics or providers (including information on what in- s Alternative: Private plans can be required to surance plans they accept). provide case management that assures fol- low-up after a positive test result. Also, indi- n Health plans should be required and funded to viduals screened at public sites or without have web-based access to specialists or appropri- insurance can receive case management sup- ate providers as part of demonstrating “network port from a public health agency program. sufficiency” to participate in Health Exchanges This could be part of a larger case manage- created by the new health reform law. ment program for those in treatment. n For all patients who are reported to state n Professional education about viral hepatitis health departments as having tested positive should be increased for health care providers. for HBV or HCV, public health agencies F. TREATMENT PROVISION Challenge: To assure that all individuals diagnosed with hepatitis receive the standard of care and that there are a sufficient number of quality health professionals who can provide the standard of care. HHS should create a public-private partnership A safety net system of care delivery will be that articulates and revises treatment guidelines needed for those with hepatitis who do not have on a regular basis, similar to the HHS panel on a regular source of care (including those who re- HIV antiretroviral treatment. main uninsured after reform). n As new treatments come on line, and as more n If the IOM recommendation to make Com- is known about their efficacy, treatment pro- munity Health Centers the safety net provider tocols are likely to change and become more for hepatitis is adopted, additional resources complex (and more individualized). This is will need to be provided by HRSA to create very similar to the HIV experience. Having a the capacity within the health center system, federal agency define the range of options is including training of personnel. critical to assuring appropriate treatment. s Alternative: Provide support for currently The newly created Health Exchanges and Medi- funded Part C programs under the Ryan caid programs should define a minimum stan- White program to provide care for people dard regarding quantity and expertise of allied with hepatitis, regardless of their HIV in- health professionals available to treat people fection status. with hepatitis. Public health agencies should play a “quality as- n To define this standard, HHS should convene a surance” role through monitoring and assisting panel of consumers, hepatitis specialists, public in medical management of hepatitis treatment. health officials, researchers and representatives n As we enter a new treatment era, it will be crit- of the insurance industry to define the range of ical to assure that funds are available to people who should be eligible to meet the net- state/local viral hepatitis programs so they work sufficiency requirement, including what can monitor treatment in the community and level of specialty is needed for routine treatment provide assistance and care coordination to and more complex cases and the role that mid- providers as needed. level professionals can play in hepatitis care. 31 G. PAYMENT FOR TREATMENT Challenge: To assure that all who need care receive it regardless of ability to pay. All public plans should assure coverage of treat- efit in all plans subject to the Patient Protection ment guidelines for their beneficiaries without and Affordable Care Act. copayments. Congress should expand and adequately fund HHS should assure that all plans participating the Ryan White program (in particular the AIDS in the Pre-existing Condition Insurance Program Drug Assistance Program) to pay for treatment will provide coverage for the protocols in the costs incurred by following the HHS hepatitis treatment guidelines, with no more than stan- guidelines for those with hepatitis who are not dard out-of-pocket costs. HHS should further co-infected with HIV. assure that those eligible for other programs n If community health centers or other safety (e.g., Ryan White) can use resources from those net providers are offering care services to programs to meet coinsurance requirements. those who remain uninsured (or underin- HHS should assure that following the treatment sured), they can only be effective if there is a guidelines is considered an essential health ben- third party able to pay for medications. H. KEEPING PEOPLE IN CARE: SUPPORT SERVICES Challenge: To provide support services to the individual patient to help him/her stay in treat- ment until treatment is completed (or stay in treatment/monitoring if treatment fails). HHS should assure that public plans cover care co- however long treatment or post-treatment care is ordination services for people with HBV or HCV. necessary. This would include providing support services that will assist people to stay in care. HHS should require that some level of care co- ordination be provided by private plans. n This system could be an expansion of the Ryan White program or a separate program. HHS should create an integrated system of care co- ordination as a separate categorical program to as- s Discussion will be needed regarding the sure case management for individuals from point pros and cons of: (1) creating hepatitis-spe- of diagnosis through maintenance in treatment for cific eligibility; and (2) integration with HIV. I. RESEARCH NEEDS Challenge: Key biomedical, behavioral and other health services research questions impede our ability to better prevent and treat various forms of hepatitis. While this is not a comprehensive set of research recommendations, during a TFAH/AASLD consultation meeting held in May 2010, several issues arose that suggest the need for particularly focused research studies, as well as increased investment and better coordination of research efforts. Many of the comprehensive issues associated with hepatitis and biomedical and behavioral research are contained in the NIH Action Plan on Liver Disease. The United States should invest in hepatitis re- hepatitis is four to five times that of HIV. While search at NIH, CDC and AHRQ that is more it is not appropriate to make per capita assess- proportionate to the public health threat associ- ments regarding research funding, the discon- ated with hepatitis. Given that biomedical and nect in this instance is rather stark. behavioral research issues associated with hepa- n With more funding, NIH could better address titis cross many NIH institutes, centers and divi- some key issues raised at the TFAH/AASLD sions, a central coordinating mechanism is consultation meeting, including: needed within NIH. In addition, HHS should assure strategic coordination of the plan. s Developing a single dose HBV vaccine, would dramatically improve the chances of n NIH spending on hepatitis is just over $150 mil- achieving universal HBV vaccination. lion a year; this is about five percent of spend- ing on HIV/AIDS, even though the number of s Developing a preventive vaccine against individuals in the United States infected with HCV, indicated as a need in the IOM report. 32 s Continuing to study combination therapy n An IOM panel convened to identify the top for HCV, which will be critical to better use 100 priorities for comparative effectiveness re- of new treatments and for which there is lit- search, which included calling for comparing tle private sector incentive. the effectiveness of alternative clinical man- agement strategies for HCV (including alter- n FDA, as a condition of approval of new thera- native duration of therapy) for patients based pies for HCV, should require manufacturers on viral genomic profile and patient risk fac- to participate in Phase IV combination trials. tors (e.g., behavior-related risk factors).88 s Studying racial and ethnic differences in Conduct public health and health systems re- response to hepatitis treatment. For in- search to better understand the service needs of stance, reports that African Americans re- people with hepatitis and the best systems of de- spond at lower rates to current treatments livering those services. requires a deeper scientific understanding of this difference and assurance that re- n NIH, HRSA, AHRQ, in collaboration with search for new treatments addresses this CDC should develop an appropriate research question during the research phase, not agenda that can better determine the best after a treatment enters the community. mechanisms for delivering care (e.g., resolv- ing questions regarding the kind of social s Developing a rapid polymerase chain reac- service support needed for hepatitis care; tion (PCR) test for HCV, could identify whether integrating HIV and hepatitis systems those with active infection and assure ap- of care would meet the needs of both affected propriate referral to care. Point-of-care populations; what the most effective methods testing for HBV and HCV would also be ex- of HCV prevention for injection drug users tremely useful (e.g. at STD clinics). are; determining the level of experience or AHRQ should invest in comparative effective- specialty needed to provide hepatitis care). ness research for hepatitis, in accordance with the IOM recommendation. J. SPECIAL POLICY INITIATIVE: ELIMINATING PERINATAL TRANSMISSION OF HBV Challenge: To set a goal in the United States of eliminating perinatal transmission of HBV. The model for this initiative is the very successful effort to virtually eliminate perinatal transmission of HIV. Given that a very substantial portion of pregnant women with HBV are likely to be cov- ered by Medicaid, this is something the federal government can undertake as an initiative in co- operation with the states. CMS should undertake a major education cam- n Enhanced reimbursement should be given to paign among Medicaid providers to assure providers or plans that successfully reduce timely screening and diagnosis for HBV among HBV transmission. pregnant women and appropriate health inter- n Medicaid should provide funding to ventions with the mother and infant and provide state/local health departments and other ma- financial incentives to follow treatment proto- ternal and child health programs to assure cols that will reduce perinatal transmission. outreach and care coordination for women at- n Medicaid should make every effort to ensure risk and their household contacts. that all children are vaccinated at birth and n Case management services should begin with that all infants born to mothers known to identification of the mother having HBV and have chronic HBV also receive the HBIG (im- continue until it is assured that the infant has munoglobulin) at birth. a full series of immunological testing and im- n CMS should establish screening of pregnant munizations, and the mother has been of- women for hepatitis as a quality measure fered and linked to ongoing care. under its new HIT regulations. The proposed n Medicaid benefits for mothers should be ex- regulations call for screening pregnant tended for the duration of her hepatitis treat- women for HIV, but not for hepatitis, chlamy- ment, if this is longer than the standard dia, syphilis or gonorrhea. post-partum period. 33 n CDC and CMS should undertake a policy ini- n CMS should work with the American College tiative and national campaign to require hospi- of Pathologists to direct all Clinical Labora- tals receiving federal funds to have preprinted tory Improvement Amendment (CLIA)-certi- orders in place to adhere to CDC guidelines re- fied laboratories to require pregnancy status garding screenings, vaccines, and treatment. on all HBV test requisitions. All pregnant They should also require discharge planning. women should be screened for HBV. n HRSA should also include appropriate preven- n All states should require routine HBV, HIV tive protocols for HBV as part of Bright Futures, and syphilis screening of pregnant women. to assure appropriate coverage in private plans. State health department follow-up of pregnant women with positive results is of high priority. To assure appropriate and timely intervention Pregnancy status and other patient-specific to prevent perinatal transmission of HBV, preg- data would alert clinical and public health pro- nancy status should be part of any laboratory- fessionals of the need for immediate investi- based reporting of hepatitis tests. gation, and allow appropriate prioritization n Currently, a mechanism does not exist for pub- when resources are scarce. lic health officials to immediately identify HRSA’s Maternal and Child Health Bureau whether positive hepatitis tests reported to them should assure that all prenatal care programs en- are from pregnant women. This requires very courage HBV and HCV screening and preven- time-consuming follow-up that could be elimi- tive intervention. nated with a change in reporting requirements. 34 APPENDIX A: TYPES OF VIRAL HEPATITIS Hepatitis A Hepatitis B Hepatitis C Hepatitis D Hepatitis E Type of Disease Acute, lasting from a Varies in severity from Can result in an acute Serious disease Typically results in an few weeks to several a mild illness that is illness, but typically that relies on the acute infection. Does months. Does not acute and lasts for a results in a chronic Hepatitis B virus not lead to chronic lead to chronic few weeks to a chronic infection that can to replicate. illness. Rare in the infection. disease that is serious lead to cirrhosis of Uncommon in the United States but and long-lasting, the liver and liver United States. common in many leading to liver disease cancer. international or liver cancer. countries. Populations Travelers to international People who live with Injection drug users; Individuals who are Individuals living At Risk countries; those living or or have sexual contact individuals who infected with the in countries with working in areas during with an infected received blood or Hepatitis B virus. poor sanitation outbreaks; men who person; men who have blood products before and contaminated have sex with men; use sex with men; July 1992 when water. of illegal drugs (injected individuals with sensitive tests for or otherwise); persons multiple sex partners; hepatitis C were who reside with injection drug users; introduced; people someone infected with immigrants and who live with or have hepatitis A; individuals children of immigrants sexual contact with who have anal sexual from areas with high an infected person; contact with someone rates of hepatitis B; individuals with who has hepatitis A; and infants born to infected multiple sex partners; those who have a mothers; health care immigrants from areas clotting-factor disorder workers; hemodialysis with high rates of such as hemophilia. patients; individuals hepatitis C; infants who received blood born to infected transfusions or blood mothers; hemodialysis products before 1987 patients; and those when more effective who received clotting screening tests were factors produced developed; international before 1987, when travelers to areas where manufacturing for the virus is endemic; these products were and those who received improved. clotting factors produced before 1987, when manufacturing methods for these products were improved. Transmission Ingestion of fecal matter Contact with infectious Contact with Similar to the spread Like Hepatitis A, -- even in microscopic blood, semen, and infectious blood, of Hepatitis B, spread through the amounts -- from contact other body fluids from primarily through requiring contact ingestion of fecal with objects, food, or having sex with an sharing contaminated with infectious blood. matter, even in drinks contaminated by infected person; equipment used to microscopic amounts; the feces of an sharing contaminated inject drugs. and a contaminated infected person. needles used to inject water supply (in drugs; through birth countries with from an infected poor sanitation) mother to her newborn. Vaccine- Yes Yes No No -- although No Preventable vaccination against HBV will prevent HDV infection 35 APPENDIX B: LIVER CANCER CASES BY SEX, RACE/ETHNICITY (2001-2006) Liver Cancer Average Annual Cases by Sex, Race/Ethnicity, and Age Group 2001-2006 Both Sexes Male Female Ave Annual Ave Rate Ave Annual Ave Rate Ave Annual Ave Rate Cases of Cases* Cases of Cases* Cases of Cases* Overall 8,099 3.0 6,162 5.0 1,938 1.3 Race White 6,032 2.6 4,598 4.4 1,434 1.1 Black 1,136 4.2 872 7.4 265 1.8 American Indian/Alaska Native 58 3.2 40 4.6 17 2.0 Asian/Pacific Islander 804 7.8 597 12.6 207 3.9 Ethnicity Non-Hispanic 6,946 2.8 5,304 4.7 1,642 1.2 Hispanic 1,154 5.7 858 9.0 296 2.9 Age group (yrs) 0-19 38 0.1 21 0.1 18 0.1 20-29 51 0.1 32 0.2 18 0.1 30-39 129 0.4 95 0.5 34 0.2 40-49 861 2.1 716 3.5 145 0.7 50-59 2,184 6.8 1,848 11.8 337 2 60-69 1,912 9.6 1,469 15.7 443 4.2 70-79 1,990 13.7 1,393 22.3 596 7.2 ≥0 935 10.0 587 17.9 347 5.8 Sources: CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Re- sults Surveillance System; data from 45 cancer registries covering 90.4% of the U.S. population *Per 100,000 persons 8 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver Endnotes Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Institute of Medicine. Washington, 1 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver D.C.: The National Academies Press, 2010. Cancer: A National Strategy for Prevention and Control of 9 Ibid. Hepatitis B and C. Institute of Medicine. Washington, D.C.: The National Academies Press, 2010. 10 The Hepatitis Research Foundation. “Hepatitis C Virus.” http://www.heprf.org/hcv.htm (accessed 2 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver July 26, 2010). Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Institute of Medicine. Washington, 11 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver D.C.: The National Academies Press, 2010. Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Institute of Medicine. Washing- 3 American Association for the Study of Liver Diseases ton, D.C.: The National Academies Press, 2010. And and Colvin, H.M. and A.E. Mitchell. Hepatitis and Minimo, AM, Heron, MP, and Murphy, SI, et al. Liver Cancer: A National Strategy for Prevention and Con- “Deaths: Final Data for 2004.” Natl Vital Stat Rep. trol of Hepatitis B and C. Institute of Medicine. Wash- 2007 August 21: 55(19):1-119. And Punpapong, S, ington, D.C.: The National Academies Press, 2010. Kim WR, and Poterucha JJ. “Natural History of Hep- 4 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver atitis B Infection: An Update for Clinicians.” Mayo Cancer: A National Strategy for Prevention and Control of Clin Proc 2007; August; 82 (8):967-075. Hepatitis B and C. Institute of Medicine. Washing- 12 The Hepatitis Research Foundation. “Hepatitis C ton, D.C.: The National Academies Press, 2010. Virus.” http://www.heprf.org/hcv.htm (accessed 5 Pyenson, B., K. Fitch, and K. Iwasaki. Consequences of July 26, 2010). Hepatitis C (HCV): Costs of a Baby Boomer Epidemic of 13 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver Liver Disease. Milliman Report. May 2009. Commis- Cancer: A National Strategy for Prevention and Control of sioned by Vertex Pharmaceuticals Incorporated. Hepatitis B and C. Institute of Medicine. Washing- 6 U.S. Centers for Disease Control and Prevention. ton, D.C.: The National Academies Press, 2010. Viral Hepatitis http://www.cdc.gov/hepatitis/ 14 Pyenson, B., K. Fitch, and K. Iwasaki. Consequences of index.htm (accessed April 17, 2010). Hepatitis C (HCV): Costs of a Baby Boomer Epidemic of 7 TFAH interview April, 2010 with John Ward, MD, of Liver Disease. Milliman Report. May 2009. Commis- the U.S. Centers for Disease Control and Prevention. sioned by Vertex Pharmaceuticals Incorporated. 36 15 Wong, J.B. “Hepatitis C: Cost of Illness and Consider- 29 Ibid. ations for the Economic Evaluation of Antiviral Ther- 30 World Health Organization, “Hepatitis B.” Depart- apies.” Pharmacoeconomics. 2006: 24 (7): 661.-672. ment of Communicable Diseases and Response, Note: Article references $33,407 (year 2003 values) to 2002, http://www.who.int/csr/disease/hepatitis/ 25,500 pounds in Germany (year 2000 values). HepatitisB_whocdscsrlyo2002_2.pdf (accessed April 16 Pyenson, B., K. Fitch, and K. Iwasaki. Consequences of 24, 2010). Citing Hollinger FB, Liang TJ, Hepatitis B Hepatitis C (HCV): Costs of a Baby Boomer Epidemic of Virus In: Knipe DL et al., eds. Fields Virology, 4rth ed. Liver Disease. Milliman Report. May 2009. Commis- Philadelphia, Lippincott, Williams and Wilkins, sioned by Vertex Pharmaceuticals Incorporated. 2001:2971-3036. 17 U.S. Census Bureau. “2006-2008 American Commu- 31 The C. Everett Koop Institute. “Hepatitis C: Worldwide nity Survey.” http://factfinder.census.gov/servlet/ Prevalence.” http://www.epidemic.org/theFacts/the DTTable?_bm=y&-geo_id=01000US&-ds_name= Epidemic/worldPrevalence/ (accessed April 17, 2010). ACS_2008_3YR_G00_&-redoLog=false&-mt_name= 32 World Health Organization, “Hepatitis C -- an Intro- ACS_2008_3YR_G2000_B02001 (accessed June 16, duction.” http://www.who.int/csr/disease/hepatitis/ 2010); and Fleckenstein, J. “Chronic hepatitis C in whocdscsrlyo2003/en/index1.html (accessed April African Americans and other minority group.” 2004. 24, 2010). Citing Viral Hepatitis Prevention Board. Current Gastroenterology Reports. Feb: 6(1):66-70. “Hepatitis A, B & C: defining workers at risk.” Viral 18 U.S. Census Bureau. “2006-2008 American Commu- Hepatitis, 1995, 3. nity Survey.” http://factfinder.census.gov/servlet/ 33 TFAH interview April, 2010 with John Ward, MD, of DTTable?_bm=y&-geo_id=01000US&-ds_name= the U.S. Centers for Disease Control and Prevention. ACS_2008_3YR_G00_&-redoLog=false&-mt_name= ACS_2008_3YR_G2000_B02001 (accessed June 16, 34 National Viral Hepatitis Roundtable. “Rep. John- 2010); and U.S. Centers for Disease Control and son’s Statement on Hepatitis C.” Press Release, De- Prevention. “Notice to Readers: National Hepatitis cember 7, 2009. http://www.nvhr.org/news/press- B Initiative for Asian Americans/Native Hawaiian 12-07-09.htm (accessed May 6 2010). and Other Pacific Islanders.” MMWR, 58(18): 503, 35 Testimony. Dr. John Ward, CDC. June 17, 2010. 2009. http://www.cdc.gov/mmwr/preview/mmwr HGO Committee Hearing: “The Secret Epidemic.” html/mm5818a6.htm (accessed June 16, 2010). 36 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver 19 U.S. Department of Health and Human Services. Cancer: A National Strategy for Prevention and Control of “Minority Women’s Health: Hepatitis B.” Hepatitis B and C. Institute of Medicine. Washington, www.womenshealth.gov/minority/asianamerican/ D.C.: The National Academies Press, 2010. hepatitis-B.cfm (accessed June 15, 2010). 37 Ibid. 20 U.S. Centers for Disease Control and Prevention. 38 Centers for Medicare and Medicaid Services. “Medicare “Viral Hepatitis: Information for Gay and Bisexual and Medicaid Programs; Electronic Health Record In- Men.” http://www.cdc.gov/hepatitis/Populations/ centive Program.” 42 CFR Parts 412, 413, 422, and 495; PDFs/HepGay-FactSheet.pdf. CMS-0033-F; RIN 0938-AP78 http://www.ofr.gov/ (accessed August 18, 2010). OFRUpload/OFRData/2010-17207_PI.pdf. 21 U.S. Centers for Disease Control and Prevention. 39 TFAH interview with Daniel Church, MPH (Epidemiol- “Congressional Budget Justification, FY 2011.” ogist/Viral Hepatitis Coordinator, MDPH) May 21, 2010. http://www.cdc.gov/fmo/topic/Budget%20Infor- mation/appropriations_budget_form_pdf/FY2011_ 40 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver CDC_CJ_Final.pdf (accessed July 26, 2010). Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. Institute of Medicine. Washing- 22 U.S. Centers for Disease Control and Prevention. “Viral ton, D.C.: The National Academies Press, 2010. Hepatitis: Information for Gay and Bisexual Men.” http://www.cdc.gov/hepatitis/Populations/PDFs/Hep- 41 Pyenson, B., K. Fitch, and K. Iwasaki. Consequences of Gay-FactSheet.pdf. (accessed August 18, 2010). Hepatitis C (HCV): Costs of a Baby Boomer Epidemic of Liver Disease. Milliman Report. May 2009. Commis- 23 Thompson ND et al. “Nonhospital Health Care-Asso- sioned by Vertex Pharmaceuticals Incorporated. ciated Hepatitis B and C Virus Transmission: United States, 1998-2008.” Ann Intern Med. 2009;150:33-39. 42 Clinical Infectious Diseases Jan 1, 2006;42:82-91 Brian L. Pearlman Center for Hepatitis C, Atlanta Med- 24 National Institutes of Health. “Panel Advocates Im- ical Center, Medical College of Georgia, and Emory proved Understanding of Hepatitis B and Screening University School of Medicine, Atlanta, Georgia. of High-Risk Populations.” Press Release, Oct. 22, 2008. http://www.nih.gov/news/health/oct2008/ 43 U.S. Department of Health and Human Services. od-22.htm (accessed July 26, 2010). “Minority Women’s Health: Hepatitis B.” www.wom- enshealth.gov/minority/asianamerican/hepatitis- 25 Wasley, A, S. Grytdal, and K. Gallagher. “Surveillance B.cfm (accessed June 15, 2010). for Acute Viral Hepatitis -- United States, 2006.” MMWR Surveillance Summaries. 2008: 57(SS02);1-24. 44 U.S. Census Bureau. “2006-2008 American Commu- nity Survey.” http://factfinder.census.gov/servlet/ 26 Ibid. DTTable?_bm=y&-geo_id=01000US&-ds_name= ACS_ 27 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver Can- 2008_3YR_G00_&-redoLog=false&-mt_name= ACS_ cer: A National Strategy for Prevention and Control of Hepati- 2008_3YR_G2000_B02001 (accessed June 16, 2010); tis B and C. Institute of Medicine. Washington, D.C.: and U.S. Centers for Disease Control and Prevention. The National Academies Press, 2010; citing Lavanchy, “Notice to Readers: National Hepatitis B Initiative for D. Chronic viral hepatitis as a public health issue in the Asian Americans/Native Hawaiian and Other Pacific world. Best Pract Res Clin Gastroenterol 2008;22(6):991- Islanders.” MMWR, 58(18): 503, 2009. 1008 and World Health Organization (WHO) 2009. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm Hepatitis B fact sheet no. 204. http://www.who.int/ 5818a6.htm (accessed June 16, 2010). mediacentre/factsheets/fs204/en/. 45 U.S. Centers for Disease Control and Prevention. “Viral 28 World Health Organization, “Hepatitis B.” Hepatitis: Information for Gay and Bisexual Men.” http://www.who.int/mediacentre/factsheets/fs204 http://www.cdc.gov/hepatitis/Populations/PDFs/ /en/index.html (accessed April 17, 2010). HepGay-FactSheet.pdf. (accessed August 18, 2010). 37 46 Boutwell, A. E., S. A. Allen, and J. D. Rich..“Oppor- 66 Mast E et al. “ A comprehensive Immunization Strat- tunities to address the hepatitis C epidemic in the egy to Eliminate Transmission of Hepatitis B Virus correctional setting.” Clinical Infectious Diseases Infection in the United States.” MMWR Recomm Re- 2005;40(s5):S367-S372. ports, Dec 8, 2006/55(RR16);1-25. 47 Hunt, D. R., and S. Saab. 2009. “Viral hepatitis in in- 67 Willis, B.C, et. al. “Gaps in Hospital Policies and carcerated adults: A medical and public health con- Practices to Prevent Perinatal Transmission of Hepa- cern.” American Journal of Gastroenterology, 2009 titis B Virus.” Pediatrics. Apr 2010: 125(4):704-11. Apr;104(4):1024-31. 68 www.cdc.gov/hepatitis/Partners/PeriHepBCoord.htm 48 Rich, J.D. “Hepatitis C infection and incarcerated 69 U.S. Centers for Disease Control and Prevention. populations.” International Journal of Drug Policy “HIV: Pregnancy and Childbirth.” October 2007. 2004;15(2):103-114 http://www.cdc.gov/hiv/topics/perinatal/index.htm 49 U.S. Centers for Disease Control and Prevention. (accessed August 2010) “Prevention and Control of Infections with Hepatitis 70 Thompson ND et al. “Nonhospital Health Care-Asso- Viruses in Correctional Settings.” MMWR, ciated Hepatitis B and C Virus Transmission: United 52(RR01):1-33, 2003. States, 1998-2008.” Ann Intern Med. 2009;150:33-39. 50 U.S. Centers for Disease Control and Prevention. 71 National Institutes of Health. “Panel Advocates Im- “Prevention and Control of Infections with Hepatitis proved Understanding of Hepatitis B and Screening Viruses in Correctional Settings.” MMWR, of High-Risk Populations.” Press Release, Oct. 22, 52(RR01):1-33, 2003. 2008. http://www.nih.gov/news/health/oct2008/ 51 U.S. Centers for Disease Control and Prevention. od-22.htm (accessed July 26, 2010). “HIV prevalence estimates -- United States, 2006.” 72 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver MMWR 2008; 57(39):1073-76. Cancer: A National Strategy for Prevention and Control of 52 U.S. Centers for Disease Control and Prevention. Hepatitis B and C. Institute of Medicine. Washing- “Screening for Chronic Hepatitis B Among Asian/ ton, D.C.: The National Academies Press, 2010. Pacific Islander Populations - New York City, 2005.”, 73 National Institutes of Health. “Panel Advocates Im- MMWR, May 12, 2006. proved Understanding of Hepatitis B and Screening 53 Wand, S., et al. “The Dawn of a new era: Transform- of High-Risk Populations.” Press Release, Oct. 22, ing our domestic response to hepatitis B and C.” 2008. http://www.nih.gov/news/health/oct2008/ Journal of Family Practice, April 2010. 59(4):S59-S64. od-22.htm (accessed July 26, 2010). 54 TFAH interview April, 2010 with John Ward, MD, of 74 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver the U.S. Centers for Disease Control and Prevention. Cancer: A National Strategy for Prevention and Control of 55 Wong, J.B. “Hepatitis C: Cost of Illness and Consider- Hepatitis B and C. Institute of Medicine. Washing- ations for the Economic Evaluation of Antiviral Ther- ton, D.C.: The National Academies Press, 2010. apies.” Pharmacoeconomics. 2006: 24 (7): 661.-672. 75 U.S. Centers for Disease Control and Prevention, Note: Article references $33,407 (year 2003 values) to MMWR, May 7, 2010 / 59(17);514-516. 25,500 pounds in Germany (year 2000 values). 76 Mast, E.E., C.M. Weinbaum, A.E. Fiore Et al. “A 56 Pyenson, B., K. Fitch, and K. Iwasaki. Consequences of Comprehensive Immunization Strategy to Eliminate Hepatitis C (HCV): Costs of a Baby Boomer Epidemic of Transmission of Hepatitis B Virus Infection in the Liver Disease. Milliman Report. May 2009. Commis- United States: Recommendations of the Advisory sioned by Vertex Pharmaceuticals Incorporated. Committee on Immunization Practices (ACIP) part 57 Ibid. ii: Immunization of Adults.” MMWR Recomm Rep 2006;55(RR-16):1-33; quiz CE31-34. 58 Ibid. 77 U.S. Centers for Disease Control and Prevention. 59 “Hepatitis Responds Best of Combo of Ribavirin and Viral Hepatitis http://www.cdc.gov/hepatitis/ Interferon, Study Concludes.” Medical News Today, index.htm (accessed April 17, 2010). July 21, 2005 http://www.medicalnewstoday.com/ articles/27745.php (accessed July 26, 2010). 78 U.S. Centers for Disease Control and Prevention. “HIV-Associated Behaviors Among Injecting-Drug 60 Itman I. “Hepatitis C: The Importance of Screen- Users -- 23 Cities, United States, May 2005--February ing for this Silent Disease.” HHS Office of Minority 2006.” Morbidity and Mortality Weekly Report 58, (April Health. http://minorityhealth.hhs.gov/templates/ 2009): 329-332 content.aspx?ID=5116 (accessed June 18, 2010). 79 Hagan, H., et. al. “Sharing of Drug Preparation 61 U.S. Department of Health and Human Services. Equipment as a Risk Factor for Hepatitis C,” Ameri- “Estimates of Funding for Various Research, Condi- can Journal of Public Health. 91 (2001) 1: 42-46. tion, and Disease Categories (RCDC), Research Portfolio Online Reporting Tools.” 80 Colvin, H.M. and A.E. Mitchell. Hepatitis and Liver http://report.nih.gov/rcdc/categories/#bpopup Cancer: A National Strategy for Prevention and Control of (accessed May 3, 2010, link no longer active). Hepatitis B and C. Institute of Medicine. Washing- ton, D.C.: The National Academies Press, 2010. 62 Itman I. “Hepatitis C: The Importance of Screen- ing for this Silent Disease.” HHS Office of Minority 81 Bluthenthal, R., R. Anderson, N. Flynn, and A. Kral. Health. http://minorityhealth.hhs.gov/templates/ “Higher Syringe Coverage is Associated with Lower content.aspx?ID=5116 (accessed June 18, 2010). Odds of HIV Risk and Does Not Increase Unsafe Sy- ringe Disposal among Syringe Exchange Program 63 Institute of Medicine, Initial National Priorities for Clients.” Drug and Alcohol Dependence 89;(2007): 214-222. Comparative Effectiveness Research. Washington, D.C.: The National Academies Press, 2009, p. 115. 82 Normand, J., et. al. Preventing HIV Transmission: The Role of Sterile Needles and Bleach. Washington, DC: Na- 64 Hepatitis B Foundation. “Hepatitis B Fast Facts.” tional Academies Press, 1995. http://www.hepb.org/pdf/hepb_fast_facts.pdf (ac- cessed July 26, 2010). 83 Interview with TFAH with Daniel Church, MPH (Epidemiologist/Viral Hepatitis Coordinator, 65 National Center for Health Statistics. MDPH) May 21, 2010. http://www.cdc.gov/nchs/. 38 84 U.S. Centers for Disease Control and Prevention. 87 Weinbaum, C., et. al. “Recommendations for Identi- “Use of Enhanced Surveillance for Hepatitis C Virus fication and Public Health Management of Persons Infection to Detect a Cluster Among Young Injec- with Chronic Hepatitis B Virus Infection.” MMWR. tion-Drug Users -- New York, November 2004-April September 19, 2008 / 57(RR08);1-20. 2007.” MMWR May 16, 2008. 57(19);517-521. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr 85 Interview with Daniel Church, MPH (Epidemiologist/ 5708a1.htm (accessed August 2010). Viral Hepatitis Coordinator, MDPH) May 21, 2010. 88 Institute of Medicine, Initial National Priorities for 86 Quote provided by Arun J. Sanyal, M.D., President Comparative Effectiveness Research. Washington, D.C.: of AASLD and Professor of Medicine and Chair- The National Academies Press, 2009, p. 115. man, Division of Gastroenterology, Virginia Com- monwealth University Medical Center ACKNOWLEDGEMENTS TRUST FOR AMERICA’S HEALTH IS A NON-PROFIT, NON-PARTISAN ORGANIZATION DEDICATED TO SAVING LIVES AND MAKING DISEASE PREVENTION A NATIONAL PRIORITY. The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease and whose vision is to prevent and cure liver disease through its mission to advance the science and practice of Hepatology, Liver Transplantation and Hepatobiliary Surgery, thereby promoting liver health and optimal care of patients with liver and biliary tract diseases. TFAH would like to thank the AASLD for their generous support of this issue brief. REPORT AUTHORS TFAH BOARD OF DIRECTORS Jeffrey Levi, PhD. Lowell Weicker, Jr. Executive Director President Trust for America’s Health and Former three-term U.S. Senator and Governor of Connecticut Professor of Health Policy Cynthia M. Harris, PhD, DABT The George Washington University School of Public Vice President Health and Health Services Director and Associate Professor Courtney Pastorfield, PHN Institute of Public Health, Florida A & M University Policy Development Manager Robert T. Harris, MD Trust for America’s Health Secretary Laura M. Segal, MA Former Chief Medical Officer and Senior Vice President for Director of Public Affairs Healthcare Trust for America’s Health BlueCross BlueShield of North Carolina Marlene Cimons, PhD. John W. Everets Medical Writer Treasurer Gail Christopher, DN CONTRIBUTORS Vice President for Health Hannah Graff, MPhil WK Kellogg Foundation Policy Development Associate David Fleming, MD Trust for America’s Health Director of Public Health Karen Hendricks, JD Seattle King County, Washington Policy Development Director Arthur Garson, Jr., MD, MPH Trust for America’s Health Executive Vice President and Provost and the Robert C. Rebecca St. Laurent, JD Taylor Professor of Health Science and Public Policy Health Policy Research Associate University of Virginia Trust for America’s Health Alonzo Plough, MA, MPH, PhD Serena Vinter, MHS Director, Emergency Preparedness and Response Program Senior Research Associate Los Angeles County Department of Public Health Trust for America’s Health Jane Silver, MPH President Irene Diamond Fund Theodore Spencer Senior Advocate, Climate Center Natural Resources Defense Council 39 PEER REVIEWERS AND EXPERTS CONSULTED TFAH and AASLD thank the reviewers for their time, Trudy Murphy, MD expertise, and insights. The opinions expressed in this Division of Viral Hepatitis; National Center for report do not necessarily represent the views of these HIV/AIDS, Viral Hepatitis, STD, and TB Prevention individuals or their organizations. Centers for Disease Control and Prevention Jeffrey Caballero, MPH Michael Ninburg Executive Director, Association of Asian Pacific Executive Director, Hepatitis Education Project Community Health Organizations Robert Perrillo, MD Lisa Jacques-Carroll, MSW Director of Transplant Heptology Fellowship Program National Center for Immunization and Respiratory Baylor School of Medicine Diseases; Centers for Disease Control and Prevention Andrea E. Reid, MD Laura Cheever, MD Program Director, Gastroenterology Training Deputy Associate Director, Health Resources and Services Veterans Affairs Medical Center Administration HIV/AIDS Dan Riedford, MD Francis (Frank) Chisari, MD Associate Director for Policy, Planning and External Relations Professor of Immunology and Microbial Science, Scripps National Center for HIV/AIDS, Viral Hepatitis, STD, Research Institute and TB Prevention Hari S. Conjeevaram, MD Centers for Disease Control and Prevention Division of Gastroenterology, A. Alfred Taubman Lorren Sandt Health Care Center, University of Michigan Executive Director; Caring Ambassadors Program and Michael R. Craig, MPP Chair, National Viral Hepatitis Roundtable Program Analyst, Centers for Disease Control and Arun J. Sanyal, MD Prevention President of American Association for the Study of Liver James Curran, MD, MPH Diseases, Professor of Medicine and Chairman, Division of Dean, Rollins School of Public Health Gastroenterology, Virginia Commonwealth University Woodruff Health Sciences Center; Emory University Medical Center Daniel Church, MPH Douglas L. Senecal, PA-C State Viral Hepatitis Coordinator, Massachusetts Clinical Manager; Bayer Health Care Pharmaceutical Co. Department of Public Health Robert T. Schooley, MD Brian R. Edlin, MD Professor of Medicine; Chief, Division of Infectious Diseases, Professor of Medicine, SUNY Downstate College of Medicine University of California, San Diego School of Medicine Leslye D. Johnson, PHD Samuel K. So, MD Chief, Enteric and Hepatic Diseases Branch Director, Asian Liver Center; Professor of Surgery, Division of Microbiology and Infectious Diseases Stanford University School of Medicine National Institute of Allergy and Infectious Diseases Chris Taylor National Institutes of Health Senior Manager, Viral Hepatitis, National Alliance of W. Ray Kim, MD State and Territorial AIDS Directors Mayo Clinic Transplant Center, Minnesota Ronald Valdiserri, MD, MPH Theodore C. M. Li, MD, FACP Deputy Assistant Secretary for Health, Infectious Diseases Internist, Foxhall Internal Medicine PC and Office of Public Health and Science Emeritus Director, American Board of Internal Medicine U.S. Department of Health and Human Services T. Jake Liang, MD Su H. Wang, MD Senior Investigator, National Institute DDK Charles B. Wang Community Health Center National Institutes of Health John W. Ward, MD Robert Lubran, MD Director, Division of Viral Hepatitis; National Center for Director, Division of Pharmacological Treatment HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Center for Substance Abuse Treatment, Substance Centers for Disease Control and Prevention Abuse and Mental Health Services Administration Lester N. Wright, MD, MPH Bill McColl Deputy Commissioner and Chief Medical Officer, Political Director, AIDS Action New York State Department of Correctional Services Lynne Mercedes Special thanks to Gregory K. Folkers, MS, MPH, Chief State Viral Hepatitis Coordinator of Staff, Immediate Office of the Director at the National Institute of Allergy and Infectious Diseases (NIAID), for his important contributions to this report. 1730 M Street, NW, Suite 900 • Washington, DC 20036 • (t) 202-223-9870 • (f) 202-223-9871 40