ATLANTA – Hepatitis B vaccination of adults with diabetes could potentially prevent more than 5,000 hepatitis B infections, according to data presented at the June 23 meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

CDC data from 2009-2010 showed an overall incidence of hepatitis B in adults with diabetes of 2.1 per 100,000, compared with 1.1 per 100,000 for adults without diabetes, and this difference was statistically significant, said Meredith Reilly of the CDC’s Division of Viral Hepatitis.

Vaccinating adults who have diabetes against hepatitis B could prevent more than 5,000 such infections, according to the CDC's Advisory Committee on Immunization Practices.

Documentation of multiple hepatitis B outbreaks among adults with diabetes, mostly in long-term care facilities, prompted the ACIP hepatitis working group to consider the issue, noted Dr. Mark Sawyer of the University of California, San Diego, who chaired the working group.

Two potential options for ACIP recommendations for hepatitis B vaccination of adults with diabetes were presented, in anticipation of a possible vote on the matter at the October ACIP meeting.

The two recommendations include two categories, explained Dr. Trudy Murphy of the CDC, who presented the options. Category A applies to all persons in an age or risk group, and uses words such as "should," she said. Category B recommendations encourage individual clinical decision making and include words such as "may."

The proposed Option 1/Category A recommendation calls for the hepatitis B vaccination for all unvaccinated adults with diabetes who are younger than 60 years, and the hepatitis B vaccine series should be completed as soon as feasible after a diagnosis of diabetes. The proposed Option 1/Category B recommendation states that decisions to vaccinate adults with diabetes who are aged 60 years and older should be made based on the clinical judgment of the health care provider, considering the various risks and benefits.

"Option 1 was preferred by a majority of the working group," said Dr. Murphy. However, a minority still preferred Option 2.

The proposed Option 2/Category A recommendation calls for the hepatitis B vaccination of all unvaccinated adults with diabetes regardless of age, and the series should be completed as soon as feasible after a diabetes diagnosis.

The proposed Option 2/Category B recommendation has several elements. First, it calls for individual clinical decision making on the value of vaccinating frail, elderly adults who have diabetes. In addition, the proposed category B recommendation states that "revaccination with three additional doses of hepatitis B vaccine generally increases the proportion of [nonresponding] adults who achieve a protective level of antibody to hepatitis B surface antigen." And, for adults who might have a reduced response to the initial vaccine series, revaccination would be medically appropriate. However, "if revaccination is planned when a protective level is not achieved, testing for anti-HBs [surface antigen] is recommended 1-2 months after completion of the initial hepatitis B series," according to the proposed Category B recommendation for Option 2.

Dr. Murphy added that final recommendations could potentially contain "remarks," with language stating that available data do not confirm an advantage to any specific hepatitis B vaccine, dosage, or approved schedule for adults with diabetes, and that no additional hepatitis B vaccination is currently recommended for adults with diabetes who received a complete series of hepatitis B vaccine at any time in the past.

Option 1 was preferred by a majority of the working group, in part because it recommends vaccination for the age groups that could achieve the highest rates of protection, Dr. Murphy said. However, a minority of the working group favored Option 2, in part because of its simplicity.

Simplicity was appealing to several ACIP liaisons who commented during a discussion period.

Dr. William Schaffner of the National Foundation for Infectious Diseases was emphatically in favor of Option 2 because it would simplify the vaccination process for clinicians. "If you want to immunize diabetics, immunize them," rather than make distinctions based on age, he said. He also noted that Option 1 would eliminate many older patients in nursing homes from vaccination.

Dr. Sandra Fryhofer of the American College of Physicians added her support for Option 2. "The reason why we are talking about this is outbreaks in the nursing home," she said.

Both recommendation options were based in part on cost-effectiveness data presented by Thomas Hoerger, Ph.D., of RTI International. Dr. Hoerger and colleagues worked with the CDC to develop a cost-effectiveness model for hepatitis B vaccination of adults with diabetes. Dr. Hoerger presented data showing that vaccination does provide protection against hepatitis B in adults with diabetes, although the efficacy declines with age. The cost per QALY (quality-adjusted life year) for vaccination of adults aged 20-59 years was $58, 762, and the cost per QALY for vaccination of all adults with diabetes aged 20 years and older was $159, 633.

The working group plans to present additional data at the October 2011 ACIP meeting, Dr. Murphy said.

None of the presenters had any relevant financial disclosures.

ACIP Considers Hepatitis B Vaccine for Adults with Diabetes