Spotlight on hepatitis B vaccination

The Advisory Committee on Immunization Practices released new recommendations, a CDC-funded study examined vaccination rates among patients who have HIV infection, and the FDA approved a new vaccine.

The latest on hepatitis B vaccination includes new recommendations from the Advisory Committee on Immunization Practices (ACIP), as well as a study of vaccination rates among HIV patients.

The ACIP recommendations include several new and updated items, such as universal hepatitis B vaccination within 24 hours of birth for medically stable infants weighing at least 2,000 g. The committee also removed permissive language for delaying the birth dose until after hospital discharge. The full recommendations were published in the Jan. 12 Morbidity and Mortality Weekly Report.

The ACIP now also recommends vaccinating for hepatitis B in those with chronic liver disease, including hepatitis C virus infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase or aspartate aminotransferase level more than twice the upper limit of normal.

Other new recommendations include testing for hepatitis B virus DNA in pregnant women with the hepatitis B surface antigen and treating those whose levels of hepatitis B virus DNA exceed 200,000 IU/mL with antiviral agents at 28 to 32 weeks' gestation, conducting postvaccination serologic testing in infants born to mothers whose antigen status remains unknown indefinitely, and conducting single-dose revaccination in infants born to women with the antigen who do not respond to the initial vaccine series.

One subgroup in need of increasing hepatitis B vaccination rates may be those living with HIV infection, according to results from a CDC-funded study published online on Dec. 26, 2017, by Annals of Internal Medicine.

Researchers estimated hepatitis B vaccination prevalence using records of 18,089 U.S. adults with HIV who participated in the Medical Monitoring Project between 2009 and 2012. Primary outcomes were the prevalence of 1) no documentation of vaccination, immunity, or infection (i.e., candidates to initiate vaccination) and 2) vaccination initiation among candidates over a one-year period of HIV care.

At the start of the surveillance period, 44.2% (95% CI, 42.2% to 46.2%) of patients were candidates to initiate vaccination. By the end of surveillance, 9.6% (CI, 8.4% to 10.8%) of candidates were vaccinated, 7.5% (95% CI, 6.4% to 8.6%) had undocumented vaccination but documented infection or immunity, and 82.9% (95% CI, 81.1% to 84.7%) remained candidates for vaccination.

During the surveillance period, patients at facilities funded by the Ryan White HIV/AIDS Program (RWHAP) had higher rates of vaccination: 12.5% (95% CI, 11.1% to 13.9%) versus 3.7% (95% CI, 2.6% to 4.7%) among patients at facilities not funded by RWHAP (P<0.001).

The study authors noted limitations, such as underrepresentation of patients receiving less frequent medical care and the incomplete availability of medical records from outside facilities, which may have resulted in participant misclassification.

“Meeting goals for hepatitis B elimination will require a multifaceted approach to increasing vaccination of HIV patients,” they concluded. “Particular attention should be focused on increasing vaccination of patients who receive care in private practices or at facilities that are not funded by RWHAP.”

Also of note, in November 2017 the FDA approved a new vaccine for hepatitis B virus. The recombinant adjuvanted vaccine, which will be marketed under the brand name HEPLISAV-B by Dynavax Technologies, is intended to protect against hepatitis B virus infection in adults 18 years of age and older. It is administered by intramuscular injection in two doses given one month apart, a shorter time frame than that required for other available hepatitis B vaccines, which involve three shots over a period of six months, according to a press release from the manufacturer.

Because of concerns about cardiovascular risk, the FDA is requiring the manufacturer to conduct a large postmarketing observational study to evaluate risk for acute myocardial infarction in patients who receive the new vaccine versus another hepatitis B vaccine. More information about the approval is available on the FDA's website.