Hepatitis B Virus: Who Is at Risk, and What Can We Do?

The hepatitis B virus (HBV) is spread through contact with infected blood or bodily fluids. The virus usually passes into a host via damaged skin (eg, lesions, needlesticks) or mucous membranes, such as the eyes or genitalia. HBV is viable for at least 7 days outside a host; therefore, the virus can be spread for days in areas visited by an infected individual. HBV can incubate for 40 to 90 days before signs and symptoms are detected.¹ With a lack of early and specific symptomology, many cases of HBV infection go undetected until severe liver damage has occurred.² Because of these factors, vaccination for HBV is critical for almost everyone, especially anyone working or living in a high-risk environment such as a health care setting, or among household contacts or sexual partners who are infected with HBV.^1,3

The most commonly reported risk factors for HBV infections are injection-drug use and having multiple sex partners.¹ In addition to living in a high-risk environment or having a sexual partner who is hepatitis B surface antigen (HBsAg)-positive, other risk factors include being treated for a sexually transmitted infection, and traveling to areas with high rates of HBV infection. Specific populations at risk for infection include men who have sex with men, victims of sexual assault or abuse, health care personnel or others working in areas where blood or bodily fluids may be present, residents and staff of correctional facilities or homes for developmentally disabled persons; and persons with chronic liver disease, kidney disease, HIV infection, or diabetes.³

Vaccines for HBV were first introduced in the mid-1980s.⁴ Successful vaccination and reliable serologic response to vaccinations have been recognized as lead initiatives responsible for a decline in acute viral hepatitis B infections in the United States since the early 1990s.² After a significant decline in infections, rates of acute infection have been relatively stable since 2009; however, reported numbers may be lower than actual infections because of the infection’s nonspecific symptoms and lack of testing.⁵

AVAILABLE HEPATITIS B VACCINES

Five FDA-approved hepatitis B vaccines (HepB) are available. They differ in their antigen composition (single or multiple), dosing guidelines, and approved patient populations.⁶

Three recombinant HBsAg vaccines are on the market. Engerix-B (GlaxoSmithKline Biologicals) and Recombivax HB (Merck & Co, Inc) are used for vaccination against HBV infection starting at birth. They are normally administered in a series of 3 doses at 0, 1, and 6 months of age.^1,4,7 Adolescents aged 11 to 15 years may receive a 2-dose series of the adult formulation (1 mL) of Recombivax HB separated by at least 4 months.^4,8 Heplisav-B (Dynavax Technologies Corporation) is approved to prevent HBV infection in adults 18 years and older.⁹

Two combination products with various antigens are also available. Pediarix (GlaxoSmithKline Biologicals) is used for the vaccination of children aged 6 weeks to 6 years and contains recombinant HBsAg, diphtheria and tetanus toxoids and acellular pertussis adsorbed, and inactivated poliovirus. Twinrix (GlaxoSmithKline Biologicals), used for the vaccination of adults 18 years and older, contains recombinant HBsAg and inactivated hepatitis A virus.¹

The most recent addition is the Heplisav-B (HepB-CpG) vaccine, which is a single-antigen formulation manufactured without aluminum.^9,10 Several studies comparing Heplisav-B with Engerix-B found a higher seroprotective response rate and similar adverse reactions in patients who received a 2-dose series of Heplisav-B compared with those who received a 3-dose series of Engerix-B.⁶ A 2-dose versus 3-dose series can mean significant differences to patients in terms of adverse reactions, and likelihood of completing the vaccine course.⁹ Two doses of Heplisav-B are given intramuscularly (IM) 1 month apart.⁹

TARGET PATIENT POPULATION

Health care professionals should screen patients at risk of HBV infection and verify that a complete HepB series has been documented.¹¹ If a complete HepB series has not been given, the series should be completed. The Advisory Committee on Immunization Practices (ACIP) recommends that all adults at risk of HBV infection and anyone who wants to be protected from HBV receive the vaccine.³ Some populations, such as patients with chronic kidney disease or those on hemodialysis, may require revaccination because of an inability to seroconvert. Populations at risk for reduced HBV protection should be tested for hepatitis B surface antibodies before revaccination.¹² As with many vaccines, a lower percentage of the older population will seroconvert after a complete series of HepB, but routinely revaccinating this group is not recommended.⁹

The ACIP recommends the HepB series as a routine vaccination for children from birth to age 19 years. All medically stable infants weighing at least 2000 g should receive the first vaccine of the HepB series within 24 hours of birth or within 12 hours if the mother was HBsAg-positive or has an unknown status.¹ Infants should receive a total of 3 doses of the pediatric formulation Engerix-B or Recombivax HB, at 0, 1, and 6 months.⁸

HBV vaccines have not been prospectively studied in pregnant women; however, Recombivax HB and Engerix-B have not been shown to increase risk for miscarriage or birth defects in postapproval data.^4,7 Heplisav-B has not been studied in pregnant women, so it should not be given during gestation. Pregnant women who are given a dose of Heplisav-B are encouraged to contact the Heplisav-B pregnancy registry.⁹

COUNSELING TIPS

HBV vaccines are well tolerated, with most adverse reactions being mild and localized to the injection site. The most common reactions are pain and redness at the site of injection.³ For specific adverse reactions, review the package insert for the vaccine being administered.^4,7,9 All vaccine adverse reactions should be reported to the Vaccine Adverse Event Reporting System website (or call 800-822-7967).³ HBV vaccines should be given IM in the deltoid muscle or anterolateral portion of the thigh in patients younger than 1 year of age.^4,7,9 Recombivax HB can be given subcutaneously in patients with hemophilia who are at risk of hemorrhage.⁴ Giving HBV vaccines at the same time as other vaccines has not been shown to create additional risks or decrease efficacy.³ Patients with a severe yeast allergy may be allergic to HepB because all vaccines are manufactured using yeast.^4,7,9 Patients who are allergic to any component of the vaccine or are moderately sick should not receive the vaccine.³ Patients should be encouraged to complete the entire series to ensure the highest response possible. For dosing instructions on specific populations, consult the CDC’s immunization schedules.^8,13

Michelle Sahr, PharmD, is an assistant professor of pharmacy practice in the Pharmaceutical Sciences Department at Ferris State University College of Pharmacy in Big Rapids, Michigan.

REFERENCES

• Schillie S, Vellozzi C, Reingold A, et al. Prevention of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(1):1-31. doi: 10.15585/ mmwr.rr6701a1.
• Surveillance for viral hepatitis — United States, 2014. CDC website. cdc.gov/hepatitis/statistics/2014surveillance/commentary.htm. Reviewed May 17, 2016. Accessed April 30, 2019.
• Hepatitis B VIS. CDC website.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html. Updated April 5, 2019. Accessed April 30, 2019.
• Recombivax HB [prescribing information]. Whitehouse, NJ: Merck Sharp & Dohme Corp; 2018. merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf. Accessed April 25, 2019.
• Surveillance for viral hepatitis — United States, 2016. CDC website. cdc.gov/hepatitis/statistics/2016surveillance/commentary.htm. Reviewed April 16, 2018. 2019. Accessed April 30, 2019.
• Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for use of a hepatitis B vaccine with a novel adjuvant. MMWR Morb Mortal Wkly Rep. 2018;67(15):455-458. doi:10.15585/mmwr.mm6715a5.
• Engerix-B [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2018. gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Engerix-B/pdf/ENGERIX-B.PDF. Accessed April 25, 2019.
• Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2019. CDC website. cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html. Reviewed February 5, 2019. Accessed May 2, 2019.
• Heplisav-B. FDA website. www.fda.gov/vaccines-blood-biologics/vaccines/heplisav-b. Updated April 24, 2019. Accessed April 30, 2019.
• Hepatitis B. National Foundation for Infectious Diseases website. adultvaccination.org/hepatitis_b_vaccine_vaccination_adult_immunizations.htm. Accessed April 30, 2019.
• Hepatitis B - vaccination of adults. CDC website. cdc.gov/hepatitis/hbv/vaccadults.htm. Published February 5, 2019. Accessed April 8, 2019.
• Janssen RS, Mangoo-Karim R, Pergola PE, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013;31(46):5306-5313. doi: 10.1016/j.vaccine.2013.05.067.
• Recommended adult immunization schedule for ages 19 years or older, United States, 2019. CDC website. cdc.gov/vaccines/schedules/hcp/imz/adult.html. Updated February 5, 2019. Accessed May 6, 2019.