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Should all adults be vaccinated against HBV?
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In the United States, universal hepatitis B vaccination is recommended for all infants beginning within 24 hours of birth and any unvaccinated children aged younger than 19 years. Vaccination is recommended only for certain adult populations at an increased risk for infection.
In light of the vaccine’s effectiveness and its importance in the national plan to eliminate HBV, Infectious Disease News asked Robert G. Gish, MD, scientific and medical advisor to the Hepatitis B Foundation andprinciple of Robert G. Gish Consulting LLC, if all adults should be vaccinated against HBV.
Gish: As part of the current goal to eliminate viral hepatitis worldwide, we believe that all adults should be tested for and, if not immune, vaccinated against HBV, excluding those who have been exposed to the virus. U.S. prevalence is approximately 0.3% to 0.5%, and testing all adults is cost-effective down to a prevalence of 0.3%. To accurately identify who needs to be vaccinated, it will be crucial to properly interpret tests. The Hepatitis B Foundation supports an action plan that is based on the following:
1. Test all adults for HBV with the test panel that includes:
All adults in whom these tests are negative should be offered HBV vaccination.
2. If a person has received three vaccinations, there is no need to test for surface antibody and no need to do boosting except in the case of people who are HIV positive or on kidney dialysis.
3. There is a new potent vaccine called Heplisav-B (Dynavax) that is very effective with only two doses, yielding a much better antibody response, especially in people who typically have a low response to being vaccinated, such as older age individuals, diabetics and dialysis patients.
Disclosure: Gish reports numerous ties to industry. His relevant financial disclosures can found at RobertGish.com.
Brosgart: Despite licensure of HBV vaccines since the 1990s, HBV remains a major preventable health crisis in the U.S. Up to 2.2 million individuals have chronic HBV. Anyone who is not immune is at risk for HBV. Children and adolescents are recommended to receive the currently licensed HBV vaccines in three doses over 6 months. Approximately 75% of adults have not been immunized. Annually, over 20,000 new acute HBV infections occur in the U.S., mostly in adults. Around 95% of these new cases are unvaccinated adults with risk factors, including behavioral factors (IDU, unsafe sexual activity), medical procedures (diabetics, dialysis) or occupational factors. With the raging opioid epidemic, we have been seeing an increase of acute HBV infections among adults.
Once infected, adults may become chronically infected. Approximately 25% with chronic HBV die prematurely of cirrhosis or liver cancer. HBV accounts for around 5,000 U.S. deaths annually. If an adult with another chronic liver disease (i.e., alcoholic steatohepatitis or nonalcoholic steatohepatitis, a burgeoning epidemic both domestically and globally that currently affects up to 15 to 20 million in the U.S.) acquires acute HBV, there is a significant risk for morbidity and mortality from the acute-on-chronic liver disease.
Despite HBV vaccine availability, it has primarily been used in children. Infants, seen frequently over the first year for well-baby care, can complete the three-dose series HBV vaccine; healthy adults are generally not seen in the medical setting more than once a year. The current vaccine schedule of three doses over 6 months leaves adult patients inadequately protected against infection until series completion. In a managed care organization study, only 54% completed the three-vaccine series within 1 year of initiation. Completion rates were markedly lower in the STD clinic setting, where approximately 32% completed the series within 1 year. In addition, with the three-dose series, efficacy diminishes in adults with age, comorbidities (diabetes, obesity, chronic kidney disease, etc.) and in men. The poor compliance with the three-dose series and the poor immune response in the presence of increasing age and comorbidities poses a major unmet medical need.
To eliminate HBV transmission, high vaccine coverage rates must be sustained among infants, children and adolescents, and programs to vaccinate adults at high-risk for HBV infection must be expanded. In 2017, the National Academies of Science, Engineering and Medicine outlined a strategy for eliminating viral hepatitis as a public health problem by 2030 in the U.S. Because there is no available, licensed cure for HBV, disease prevention through effective vaccination is critical.
Professionals in public health, infectious diseases and liver diseases are thrilled to welcome an advance in our ability to prevent HBV infection in adults, with the recent FDA approval of a new HBV vaccine, Heplisav-B (Dynavax). The public health benefit that Heplisav-B offers as a vaccine regimen of two doses over 1 month is substantial. In addition to the expected improved compliance, the efficacy, at each time point and in all adult populations studied (healthy, aged 18 to 75 years, male, female, diabetics, obese), is superior with Heplisav-B.
With Heplisav-B, we have a new tool to achieve HBV immunity, prevent significant morbidity and mortality and put us on the path towards HBV elimination in the U.S. By immunizing all susceptible adults over age 18 years, we could stop new HBV infections.
Disclosure: Brosgart reports being a member of the board at Galmed, a former member of the board at Tobira, a consultant for Allergan, chair of the scientific advisory committee and consultant for Contravir and a consultant for Dynavax, Assembly, Cirius, Frazier and 3v-Biosciences. Gish’s financial disclosures are available at RobertGish.com.