March 8, 2006 New ACIP Hepatitis B Recommendations and Their Impact on Vaccination of Adults at Risk March 8, 2006

Background Hepatitis B vaccine Hepatitis B infection and disease Licensed in 1982 Standard three dose regimen >90% recipients have protective antibody response Hepatitis B infection and disease Transmission- perinatal, sexual, parenteral Risk of chronic disease is age dependent 90% of infants 5% of persons >5 yrs 15-25% die from cirrhosis or cancer

Advisory Committee on Immunization Practices Strategy to Eliminate HBV Transmission Adults at high risk (1982) Prevent perinatal HBV transmission (1984-88) Maternal screening Newborn vaccination Universal infant vaccination (1991) Catch –up vaccination adolescents 11-12 years (1995) all persons <19 years (1999) Universal birth dose (2005)

Hepatitis B Vaccine Coverage, Children Aged 19-35 Months, by Race/Ethnicity, U.S. Asian-Pacific Islander HP 2010 target Black Hispanic White Immunization of infants of all racial groups has increased over the last 10 years, and in 2000 reached the HP2010 target of 90% coverage with 3 doses of hepatitis B vaccine by age 35 months. Coverage levels vary somewhat by race/ethnicity, with Asian children having the highest coverage and black children having the lowest, but all races now have rates right around 90%. Source: National Immunization Survey

Acute Hepatitis B by Age, Unites States, 1990-2004

Adult Hepatitis B Vaccine Coverage, 2002 Vaccination of 0-18 yrs recommended 60 50 40 Vaccine coverage, % 30 20 10 19-20 21-25 26-30 31-40 41-50 51-65 65+ Age group, yrs National Health Interview Survey

Hepatitis B Vaccine Coverage Among High Risk Adults Risk Group Coverage Estimate (year, site) Occupationally-exposed workers 75% (2002-2003, national) Dialysis patients 56% (2002, national) Men who have sex with men (MSM) HIV+ persons in care 9% (1996-98, multi-city) 14% (1998-2001, multi-city) Injection drug users STD clinic clients 4%-29% (1998-2001, multi-city) 10% (1998-2001, San Diego)

Rate per 100,000 persons (n=60,000 cases) Reported Acute Hepatitis B Incidence, By Age and Sex, United States, 2004 <5 0.1 0.1 Female Male 5-9 0.0 0.0 10-14 0.1 0.1 15-19 1.1 0.7 20-24 3.1 3.9 25-29 4.2 6.2 30-34 4.0 6.3 Age group 35-39 4.4 6.0 40-44 3.6 6.2 45-49 2.7 5.1 50-54 2.0 3.8 55-59 1.3 2.6 60+ 0.8 1.7 Rate per 100,000 persons (n=60,000 cases)

Revision of ACIP Adult Hepatitis B Recommendations Goals Assure coverage of those at highest risk Recommend strategies to increase coverage Process Oct 2004: Convene ACIP working group Jan-Mar, 2005: Invite public comment Feb 2005: ACIP review May 2005: Consultation with external partners June 2005: ACIP review Summer 2005: CDC convened work groups October 2005: ACIP approved recommendations

Barriers to Hepatitis B Vaccination in Adults Financial Cost of vaccine Reimbursement for supply and delivery Provider practices Awareness/priority Time constraints Patient acceptance Preventive service Acknowledgement of risk Three dose schedule

Hepatitis B Vaccination In High-Prevalence Settings Demonstration projects in STD and other high prevalence settings established: High patient acceptance of first dose ( 75-85%) Feasibility of vaccinating as part of routine services Funding is a major barrier Local champions are key

Hepatitis B Vaccination In Primary Care Settings Settings care for many high risk adults Report 40% of STDs Risk-targeted vaccination is most efficient ~15-20% of all adults report risk factors for infection Risk identification is recommended (e.g. USPSTF) Many patients are reluctant to report risks Few evaluations conducted Models of successful implementation in this setting

Revised ACIP Recommendations for Adult Hepatitis B Vaccination

Revised ACIP Recommendations for Adult Hepatitis B Vaccination Adults recommended to receive vaccine Sexual Parenteral Other (travelers) All persons seeking protection from HBV Recommended implementation strategies by setting

HIV/STD treatment centers Drug abuse treatment facilities 2005 ACIP Recommendations Care Settings Where All Adults Should Receive Hepatitis B Vaccine HIV/STD treatment centers Drug abuse treatment facilities HIV/AIDS testing facilities Facilities serving MSM Correctional facilities When feasible, administer vaccine in outreach settings

Risk based (opt-in strategy) Most efficient 2005 ACIP Recommendations Primary Care Settings: Tailor Strategy to Fit Practice Setting Risk based (opt-in strategy) Most efficient Basis to provide other prevention services Age-based (opt-out) Vaccinate low risk persons Less stigmatizing Routinely inform patients of the value of HBV vaccination Vaccinate all persons seeking protection from HBV

Barriers and Strategies: Fiscal Recommendations Cost of vaccine supply and delivery Use of multiple resources (state, federal) Implement cost recovery mechanisms (i.e., billing) Facilitate bulk purchase

Barriers and Strategies: Providers Recommendation Risk ascertainment intrusive and time-consuming Simplify risk assessment Adopt alternative strategies Vaccination not a priority/Lack of time Inform and remind providers about hepatitis B and vaccination Implement standing orders

Barriers and Strategies: Patients Recommendation Lack of awareness Create demand through outreach to risk populations Perceived stigma of risk behaviors Risk factor acknowledgement not required for vaccination Don’t return to complete vaccine series Tracking and reminder systems needed Concerns about series completion should not preclude series initiation

Impact of ACIP Recommendations on Hepatitis B Vaccination Coverage Impact is dependent on implementation of the recommendations. ACIP statement provides a framework for action Follow through by CDC and partner organizations will determine success

Key Factors for Success Commitment of CDC and immunization partners Establish as priority for new CDC organization Craft guidance for STD/ HIV/VH programs Develop marketing, training, and education Support state/local coordinators for adult Hep B program Resources for adult Hep B vaccination purchase/delivery Monitoring of progress by ACIP