OVERVIEW: PROTECTING US ADULTS AGAINST HEPATITIS B INFECTION
Despite the availability of highly effective hepatitis B vaccines, only one-quarter (24.8%) of US adults (aged ≥19 years) in high-risk groups for acquiring hepatitis B virus (HBV) get vaccinated as recommended by the Centers for Disease Control and Prevention (CDC) (Fig. 1).1,2 Those who remain unimmunized are at risk of acute HBV infection, which can progress to chronic infection, leading to liver cirrhosis, hepatocellular carcinoma (HCC), and liver-related death.3
In 1991, the United States adopted a public health strategy aimed at eliminating transmission of HBV.4 Nearly 30 years later, the goal remains the same and vaccination is still a critical component—including universal hepatitis B vaccination of children and hepatitis B vaccination of at-risk adults in the United States.2 In a pattern typical of vaccines recommended for both children and adults, hepatitis B vaccination coverage rates are far higher among children (>90%, 3-dose coverage in children aged 19–35 months)5 than among adults in the United States.
In 2017, a National Academy of Medicine report concluded that hepatitis B could be eliminated as a public health problem in the United States and that immunization, which can prevent 95% of infections, is the first key step.6 The report, which was supported by CDC, the US Department of Health and Human Services, American Association for the Study of Liver Diseases, Infectious Diseases Society of America, and National Viral Hepatitis Roundtable, acknowledged that “eliminating the public health problem of hepatitis B will take more time and require considerable public will, resources, and attention to [vaccination] barriers.”6
The National Foundation for Infectious Diseases (NFID) supports a comprehensive effort to raise awareness of the burden of HBV infection and the benefits of hepatitis B vaccination in an effort to improve immunization rates for all recommended adults in the United States. The authors of this article led a multidisciplinary roundtable convened by NFID to address the problem and discuss potential solutions for overcoming vaccination barriers.
EPIDEMIOLOGY OF ACUTE AND CHRONIC HBV INFECTION
The rate of reported cases of acute HBV infection in the United States declined nearly 90% after widespread uptake of hepatitis B vaccine in infants and children but has leveled off in recent years (Fig. 2).7,8 In 2016, there were 3218 acute HBV infections reported in the United States; however, many acute infections are asymptomatic and consequently unreported. The CDC estimates that 21,000 US infections occur annually.9
The burden of acute HBV infection in the United States is mainly in adults, with the highest incidence in those aged 30 to 59 years.8 Lower incidence in adults 20 to 29 years old reflects higher hepatitis B immunization rates in this age group, as they were born after infant and childhood vaccination recommendations were widely adopted in the United States. However, efforts should be made to ensure that young adults who were not vaccinated as infants and who missed catch-up vaccination as adolescents are protected through vaccination.
However, it is important to note that patients may either not recognize or acknowledge high-risk behaviors that put them at increased risk of HBV infection. More than half of US adults with acute HBV infection (52%) reported no risk behaviors for infection during the previous 6 weeks to 6 months.2 Among those who report risk factors, injection drug users (IDUs) and multiple sex partners are the most commonly reported sources of HBV acquisition.8
Although the incidence of acute HBV infection has been stable nationwide, certain regions of the United States are experiencing significant increases. One study conducted in Kentucky, Tennessee, and West Virginia found a 114% increase in acute hepatitis B cases between 2009 and 2013,10 which has been attributed to a combination of increasing rates of IDU fueled by the US opioid epidemic as well as low rates of hepatitis B vaccination coverage among adults. The largest increases in HBV infections were seen in rural areas, which mirror the increase in hepatitis C virus (HCV) infections noted in these 3 states and Virginia. As the opioid crisis continues to worsen across the United States, concerns have been raised about the impact of IDU on increasing rates of HBV, HCV, HIV, and other sexually transmitted infections (STIs).
Acute HBV infection will progress to chronic infection in approximately 1 in 20 adults overall11 and is more likely in individuals with immunosuppression (eg, with HIV or on hemodialysis) or diabetes.12,13 There are as many as 2.2 million individuals living with chronic hepatitis B in the United States,14 and two-thirds (67%) are not aware that they are infected,6,15 contributing to ongoing transmission.
HBV TRANSMISSION AND CLINICAL PRESENTATION IN ADULTS
Hepatitis B virus is transmitted through infectious blood and bodily fluids and is 50 to 100 times more infectious than HIV.16 The virus remains infectious outside the body for at least 7 days and can be transmitted in the absence of visible blood.17–19 The primary routes of transmission among US adults are percutaneous exposure to blood (eg, by IDU) and through sexual contact.2
At least half of adults with an acute HBV infection will be asymptomatic.12,20,21 The 30% to 50% of adults who have symptoms may present with nausea, vomiting, abdominal pain, fever, dark urine, changes in stool color, hepatomegaly, splenomegaly, and jaundice. There is no specific treatment of acute HBV infection.
The liver is the primary site of virus replication, which can continue asymptomatically for decades among those for whom the infection becomes chronic. Chronic hepatitis B is frequently referred to as a “silent killer” because most people are not aware that they are infected until the virus has caused serious liver damage.22 Chronic hepatitis B cannot be cured, but antiviral therapy may reduce the risk of progression to cirrhosis, HCC, and/or liver-related death.23
MORBIDITY, MORTALITY, AND SOCIETAL BURDEN OF CHRONIC HEPATITIS B
Between 15% and 40% of those with chronic hepatitis B will develop cirrhosis, HCC, or liver failure, and 25% will die prematurely from these complications.3,24,25 Many studies have shown a sharply increased risk of HCC among people with chronic hepatitis B.3 In a study that screened nearly 23,000 male railway workers in Taiwan, those with chronic hepatitis B were 233% more likely to develop HCC than those without chronic infection.26 In addition, several studies have shown a possible association between HBV infection and increased risk of pancreatic cancer.27–29
In its hepatitis B best-practice statements,30 the High Value Care Task Force cites an estimate of $1 billion annually for direct and indirect costs due to complications of chronic hepatitis B31–33 and declares that hepatitis B vaccination is cost saving.30 Costs for treatment of decompensated liver disease range from $38,932 to $153,1000 in the first year alone, whereas liver transplantation costs are estimated at $343,241 to $541,862 in the first year.
In addition to immunization, screening and linkage to care are essential tools in the strategy to eliminate HBV in the United States.6,34 Two-thirds of individuals with chronic hepatitis B do not know they are infected,6,15 and only 10% to 15% of those eligible are being treated.35 Identifying individuals with chronic infection also allows them to take steps to reduce virus transmission to others and allows for identification and vaccination of their close contacts. Table 1 includes a summary of risk screening recommendations for chronic hepatitis B based on guidelines from the US Preventive Services Task Force, CDC, and American Association for the Study of Liver Disease.2,36,37
CDC RECOMMENDATIONS FOR HEPATITIS B VACCINATION IN US ADULTS
Hepatitis B vaccination coverage (≥3 doses) is 24.8% for adults 19 years or older, with minor variations among specific risk groups (from a high of 31.1% in travelers to a low of 26.2% in adults <60 years old with diabetes). Coverage in health care professionals (HCPs) is higher (61.4%) but still not optimal (Fig. 1).1 Better adoption of hepatitis B immunization recommendations is essential to achieve the goal of eliminating transmission of HBV in the United States.
Hepatitis B vaccination is recommended for any adult seeking protection from HBV infection.2 Health care professionals should provide vaccination even in the absence of patient acknowledgement of having a specific risk factor or engaging in a specific risk behavior.
Hepatitis B vaccination recommendations in adults are categorized in several groups: individuals at risk from sexual exposure, those at risk from percutaneous or mucosal exposure to contaminated blood, and individuals based on their existing health condition, living situation, or travel plans.2 The rationale for vaccination in selected groups is provided hereinafter, and a complete list of adults recommended to receive hepatitis B vaccination is included in Table 2.2
Injection drug use is an increasingly important driver of HBV acquisition. An estimated 11.8% (range, 3.5%–20%) of individuals with a history of IDU have chronic hepatitis B, and another 23% have evidence of past infection.38 Three-quarters of new HBV infections in Kentucky, Tennessee, and West Virginia—3 states with higher-than-average age-adjusted opioid death rates39—are among people with a history of IDU.10
All men who have sex with men as well as all sexually active persons who are not in a long-term, mutually monogamous relationship (eg, those with ≥2 sex partners in the previous 6 months) should be vaccinated. Among those with acute HBV infection, 26% report having 2 or more sexual partners in the previous 6 months, 3% report sexual contact with an HBV-infected person, and 12% of men report having sex with another man.8 When making hepatitis B vaccination recommendations based on patient-provided sexual history, HCPs should consider that patients may not be comfortable sharing information on their sexual history, partners, and practices, or may not be completely forthright.40
To overcome some of these challenges, every adult who seeks evaluation or treatment of an STI should be vaccinated.2 Four in 10 adults with acute HBV infection were previously screened or sought care for an STI, representing missed opportunities for vaccination.41
Adults with diabetes have a 60% higher prevalence of past or present HBV infection and twice the odds of acquiring HBV compared with nondiabetic adults.2 Although chronic infection is the larger concern, there are data indicating a higher mortality rate from acute HBV infection among adults with diabetes compared with nondiabetic adults.42
Household contacts of individuals with chronic hepatitis B are at high risk of acquiring HBV. An estimated 30% have serologic evidence of past infection, and 14% have evidence of current infection.43 Improved screening (Table 1) is an important first step in identifying people with chronic hepatitis B so that household and other contacts can be appropriately vaccinated.30
Additional groups at risk of infection by percutaneous or mucosal exposure to contaminated blood and consequently recommended for hepatitis B vaccination include residents and staff of facilities for developmentally disabled persons, HCPs, and public safety personnel who may be at risk of exposure, as well as hemodialysis, predialysis, peritoneal dialysis, and home dialysis patients.
Other adults who are recommended for hepatitis B vaccination include the following: incarcerated persons as the prevalence of HBV is higher among prison inmates than the general population,44,45 persons with chronic liver disease as concurrent HBV infection may increase the risk of progressive chronic liver disease,46 persons with HIV as concurrent HBV infection increases the risk of cirrhosis and liver-related mortality,47 travelers to countries with intermediate- or high-HBV endemicity (prevalence of ≥5%), and persons with HCV infection as those who already have another liver disease are at increased risk of more severe outcomes.
IMMUNOGENICITY AND DOSING SCHEDULES FOR HEPATITIS B VACCINES
Three single-antigen hepatitis B vaccines are licensed in the United States for use in adults: 2 long-standing vaccines, Engerix-B (GlaxoSmithKline) and Recombivax HB (Merck & Co, Inc), and one newer vaccine recently licensed in November 2017, Heplisav-B (Dynavax Technologies Corporation). One combination of hepatitis A and hepatitis B vaccine, Twinrix (GlaxoSmithKline), is licensed for use in US adults.48–51
Heplisav-B is administered as a 2-dose series. Standard dosing for all other vaccines (Engerix-B, Recombivax HB, and Twinrix) is a 3-dose series, with each having alternate dosing schedules and/or special formulations for specific patient groups and for accelerated dosing (Table 3).45–48
An HBV surface antigen antibody level of 10 mIU/mL or higher 1 to 2 months after vaccination is considered a surrogate of clinical protection (ie, seroprotective).2,52 Vaccination with any of the 3-dose vaccine series is seroprotective in more than 90% of adults younger than 40 years and in 75% of adults 60 years and older.53 Seroprotection with a 2-dose series of Heplisav-B does not decrease with age; in clinical trials, vaccination was seroprotective in more than 90% of adults aged 18 to 70 years, remaining more than 90% even in the oldest group (91.6% in subjects aged 60–70 years).54
A systematic literature review by Schillie and colleagues55 reported lower seroprotection from 3-dose vaccines in adults with diabetes (88%), hemodialysis/chronic kidney disease (CKD) patients without diabetes (75%), and hemodialysis/CKD patients with diabetes (60%). Lower immunogenicity has also been noted in immunocompromised adults.53 Higher vaccine doses are recommended for end-stage renal disease patients and may be considered for immunocompromised patients (Table 3). Because their subsequent clinical management depends on their immune status, postvaccination serological testing is recommended for hemodialysis patients, as well as HIV-infected adults, other immunocompromised adults, sex partners of HBV-infected adults, and health care and public safety workers at risk of blood or body fluid exposure.2
Vaccination with the newer 2-dose series led to similar seroprotection rates in adults with CKD with and without diabetes (89.5% vs 90.5%, respectively).56 Seroprotection rates with the 2-dose series were lower for patients on dialysis compared with the overall population but were significantly higher than seroprotection rates for the 3-dose comparator vaccine (86.4% vs 74.1%). Seroprotection with the 2-dose series was also more than 90% in populations where hyporesponsiveness to 3-dose vaccines has been noted (people with diabetes, smokers, obese persons, and men).54,57 However, CDC does not recommend any hepatitis B vaccine preferentially.
BARRIERS TO HEPATITIS B VACCINATION IN US ADULTS
General and vaccine-specific (eg, influenza and human papillomavirus) barriers to adult vaccination as well as recommendations to overcome them have been well characterized in the literature.58–62 The barriers to adult vaccination detailed in these reports are applicable and relevant to hepatitis B vaccination: limited access to care; low consumer awareness of vaccines and the risk of the diseases they prevent along, as well as incorrect beliefs about vaccine safety and efficacy; complexity of recommendations and ability of HCPs to implement complex vaccine recommendations; competing priorities during health care visits; lack of systems to remind providers to vaccinate; lack of strong HCP recommendations; and logistical challenges with ordering and stocking vaccines.
In addition to common barriers to adult vaccination, barriers of concern for hepatitis B vaccines include the following:
- ▪ Hepatitis B vaccine recommendations include more than a dozen target populations, complicating identification of patients who may need vaccination.
- ▪ The need for multiple doses over time may also be a barrier to completing the vaccine series.
- ▪ Patients may not readily admit to the 2 leading risk factors for HBV acquisition: sexual exposure and IDU.
- ▪ HCPs may also face logistical and financial challenges in stocking hepatitis B vaccines, especially because many have difficulty predicting how quickly doses will be used, which may be easier to do for influenza vaccine and other vaccines with age-based recommendations.
- ▪ Health insurance coverage for hepatitis B vaccines is complicated despite the CDC recommendation that vaccination be given to anyone who requests it even if no risk factor is obvious to the HCP.
- ○ The vaccine is covered under Medicare Part B (medical coverage) for individuals that Medicare defines as at medium or high risk of hepatitis B, such as those with diabetes, hemophilia, or end-stage renal disease; health care workers who have frequent contact with blood or bodily fluids; and people who live with someone who has hepatitis B.63 For other Medicare recipients, hepatitis B vaccines are covered under Part D (pharmacy/drug coverage), with exact coverage varying by plan.64
- ○ Many insurers, both private and public, require prior authorization for hepatitis B vaccines that may include requirements to list the risk factor; however, as discussed previously, patients do not always disclose risk factors. A patient's desire for privacy should not limit access to vaccination.
- ○ Not all HCPs or health care settings (eg, pharmacies) are covered or reimbursed adequately for hepatitis B vaccine administration.
SUMMARY AND CALL TO ACTION
Achieving high hepatitis B vaccination coverage in US adults is a complex undertaking that requires active participation and coordination by a range of immunization stakeholders. All HCPs (physicians, nurses, nurse practitioners, physician assistants, pharmacists, medical assistants, etc.), professional societies, patient and health advocacy groups, state and local public health departments, policy makers, and payers should invest in assessing current vaccination programs to evaluate and implement best practices to improve vaccine delivery and uptake.
Because of the complexity of hepatitis B vaccine recommendations in US adults, an important first step is to provide ongoing education and awareness among all frontline HCPs about which adults are indicated for hepatitis B vaccination, why they are at risk, and the burden of chronic hepatitis B.
In addition to targeted education and awareness building, strategies to improve hepatitis B vaccination coverage in adults include the following:
- ▪ Do not miss any vaccination opportunity. Although HCPs working with high prevalence populations (eg, immigrants from Southeast Asia and Sub-Saharan Africa) may choose to screen patients to help identify patients in need of treatment, screening is not required before administering hepatitis B vaccination. Likewise, pregnancy is not a contraindication to hepatitis B vaccination. Pregnant women at risk of hepatitis B infection should be vaccinated during pregnancy. Vaccination should be provided to all adults requesting protection from hepatitis B infection.
- ▪ Implement standing orders, which are among the most effective strategies to improve vaccination rates in adults.65–68 Sample standing orders, including for hepatitis B vaccination in adults, are freely available from many resources.
- ▪ Develop and implement a process to track doses and ensure patients return for follow-up doses (eg, schedule follow-up appointments for next dose(s), set up transportation if needed, have the patient self-address a recall reminder that can be mailed before the follow-up appointment, etc).
- ▪ Consider alternative locations to HCP offices for follow-up hepatitis B vaccination doses. Some patients may find it more convenient to receive additional doses at their local pharmacy or other nontraditional settings.
- ▪ Ensure hepatitis B vaccinations are part of best-practice guidelines for relevant patient populations, for example, patients with diabetes, to be sure vaccination becomes a part of their routine care.
- ▪ Integrate hepatitis B vaccination into nontraditional settings, such as
- ○ community events at local community centers and/or churches,
- ○ syringe service and substance abuse treatment programs that work with and treat persons who inject drugs,
- ○ primary care practices with HCPs who are approved to prescribe buprenorphine for treatment for patients with opioid use disorder, and
- ○ STI clinics and screening events.
- ▪ Capitalize on and enhance existing disease surveillance information from state and local public health departments that
- ○ dentifies pregnant women and women at childbearing age who may have chronic HBV infection (in an effort to reduce perinatal HBV transmission) and use it to identify household and other close contacts who may require vaccination,
- ○ tracks and identifies local outbreak activities that can target groups and geographic areas for increased hepatitis B vaccination efforts and assess impact, and
- ○ allows HCPs and public health groups to use regional outbreaks as an opportunity to engage and educate the community about the burden of hepatitis and benefits of vaccination.
- ▪ Partner with facilities and professionals that see and serve individuals with opioid addiction to integrate hepatitis B vaccination into their care.
- ○ End stigmatization against individuals living with or at risk of viral hepatitis. Educate HCPs about engaging patients in comfortable and frank conversations about risk behaviors.
- ▪ Engage with the correctional system to identify opportunities to vaccinate all incarcerated individuals because of their high risk of HBV infection and ability to spread infection once reintegrated into society.
- ▪ Educate the next generation of HCPs about the importance of adult vaccines. Although it seems that there are no recent data or surveys quantifying the depth of the adult vaccine curriculum, experts agreed that most learning on the topic occurs in the clinic, not in the classroom, which leads to inconsistent levels of knowledge among future HCPs.
- ▪ HCPs should lead by example and, in addition to ensuring that they are up-to-date on their hepatitis B vaccines, should make a strong recommendation to at-risk patients for optimal protection.
Based on the NFID roundtable discussions, all relevant stakeholder groups should implement strategies and evidence-based best practices to increase vaccination among at-risk populations. Raising awareness about the burden of hepatitis B in US adults and the link to cirrhosis, liver failure, and liver cancer is an important first step to eliminating hepatitis B as a public health problem in the United States.
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A minimum assessment score of 80% is required.
- What proportion of hepatitis B infections could be eliminated by vaccination?
- Which age group has the highest incidence of new HBV infection in the United States?
- Children (≤19 years of age)
- Young adults (20 to ≤29 years of age)
- Adults (30 to 59 years of age)
- Older adults (60≥ years of age)
- Approximately what proportion of patients with newly diagnosed HBV infection report risk behaviors for infection in the period immediately preceding infection?
- Chronic hepatitis B infection has been connected to increased risk of:
- Liver cirrhosis and liver cancer
- Pancreatic cancer
- Premature death
- A and C
- All of the above
- Which adults are recommended to receive hepatitis B vaccination?
- Persons seeking evaluation for sexually transmitted infections
- Persons with diabetes
- Persons with chronic liver disease
- Anyone seeking protection from HBV infection
- All of the above
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