One hundred times more infectious than HIV,1 the hepatitis B virus (HBV) – which is the leading cause of cirrhosis and liver cancer – can be a silent killer.2
Symptoms of chronic hepatitis B can take up to 30 years to manifest, leaving most people unaware of their infection, and therefore may unknowingly be spread to others. Left unmanaged, HBV can slowly damage the liver and ultimately cause death in one in four chronically infected individuals. Currently, there are an estimated 2.2 million people in the U.S. with chronic hepatitis B.3 Despite tremendous progress towards eliminating this vaccine-preventable disease, the decline in hepatitis B rates has plateaued and more work is required to achieve the goal of hepatitis B elimination by 2030. The recent recommendation from the Centers for Disease Control and Prevention (CDC) expanding the number of adults who are recommended for immunization against hepatitis B is an important and bold step towards achieving the goal of elimination of hepatitis B.
From a “risk-based” to a “universal” adult immunization strategy
The expanded ACIP recommendation builds upon the highly-successful infant vaccination program for hepatitis B that was implemented in 1991. This program led to a decline in the incidence of acute hepatitis B by ~80% between 1987 and 20044 and most individuals born after 1991 have been immunized against hepatitis B. Historically, the adult immunization strategy has been risk-based, focusing on those at highest risk of becoming infected. This strategy has left many adults born before 1991 unprotected for two reasons: 1) it excludes most of the population and 2) coverage rates of individuals at high risk of HBV remains low due to the challenges of implementing strategies targeting this group.
The expansion of the current risk-based adult ACIP recommendation to include all adults 59 years of age and younger should help achieve the goal of hepatitis B elimination by 2030.* Hepatitis B would become the fifth vaccine routinely recommended for adult immunization (alongside Influenza, Tdap, Shingles and Pneumococcal). This should reduce hepatitis B transmission by making it easier to understand who should be immunized and increasing access to the vaccine.
Implementation Considerations
For adults to achieve the lifetime protection conferred by hepatitis B vaccines, they must achieve immune responses considered to be seroprotective. Completion of the vaccine series is critical to ensure seroprotection. Given the importance of series completion at both the individual and population level, implementation considerations for universal hepatitis B vaccination should consider strategies to maximize adherence. Historically, adult hepatitis B vaccines required at least three doses administered over six-months and series completion has proven challenging. Numerous studies have documented this challenge in the real world. For example, a study published in 2020 by Kaiser Permanente, showed only 26% of adults completed all three doses of the traditional hepatitis B vaccine.5
The availability of HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], the first and only, two-dose in one-month adult vaccine approved for adults >18 years of age, can help address the challenge of achieving seroprotection through improved adherence. In the Kaiser Permanente study, 45% of adults completed the two-dose vaccine series (almost twice as much as those with the three-dose series).5
The ACIP universal recommendation for adults is a significant step forward, but its impact requires effective implementation, which includes awareness, access, and series completion. Efforts to optimize access and series completion, including choice of vaccine, will be critical to help achieve our common goal of eliminating this deadly disease.
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Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.
IMPORTANT SAFETY INFORMATION
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%).
For full Prescribing Information for HEPLISAV-B, click here.
* The ACIP also voted to recommend that all adults 60 years of age and older with risk factors for hepatitis B should be vaccinated and adults 60 years of age and older without risk factors for hepatitis B may be vaccinated.
1. Walayat S, Ahmed Z, Martin D, Puli S, Cashman M, Dhillon S. Recent advances in vaccination of non-responders to standard dose hepatitis B virus vaccine. World J Hepatol. 2015;7(24):2503-2509.
2. Kim W. R. (2009). Epidemiology of hepatitis B in the United States. Hepatology (Baltimore, Md.), 49(5 Suppl), S28–S34. https://doi.org/10.1002/hep.22975.
3. Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology. 2012;56(2):422-433.
5. Association of Number of Doses With Hepatitis B Vaccine Series Completion in US Adults. JAMA Network Open. Available at Association of Number of Doses With Hepatitis B Vaccine Series Completion in US Adults | Infectious Diseases | JAMA Network Open | JAMA Network.
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Kelvin McKoy, MD, Senior Regional Medical Director, Dynavax Technologies Corporation