102606 Hepatitis Update

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Hepatitis A and B Vaccines : 

Hepatitis A and B Vaccines Sheila L. Palevsky, MD MPH Bureau of Immunization New York City Department of Health and Mental Hygiene October 26, 2006

Hepatitis B Virus: 

Hepatitis B Virus Epidemic jaundice described by Hippocrates in 5th century BCE Differentiated from Hepatitis A (infectious hepatitis) in the early 1940s Humans are only known host Resilient organism - may retain infectivity for at least 1 month at room temperature Hepadnaviridae family (DNA)

Slide3: 

HBsAg Antigenic determinant found on the surface of the virus Not infectious; only the complete virus (Dane particle) is infectious When HBsAg is present, complete virus is also present During replication, HBV produces HBsAg in excess of that needed for production of the Dane particles HBcAg Nucleocapsid protein core of the HBV Not detectable in serum by conventional techniques Found in liver tissue of persons with acute or chronic HBV infection HBeAg A soluble protein found in the core of HBV Found in serum of person with high virus titers Anti-HBs Develops during convalescence to acute HBV or after vaccination Anti-HBc Indicates infection with HBV at an undefined time in the past Anti-HBe Associated with low infectivity of serum

Hepatitis B Clinical Features: 

Hepatitis B Clinical Features Incubation period 60 -150 days (average 90 days) Nonspecific prodrome of fever, malaise, headache, myalgias At least 50% of infections asymptomatic Illness not specific for hepatitis B Most acute HBV infections in adults result in complete recovery with resultant immunity

Slide5: 

Risk of Chronic HBV Carriage by Age of Infection CDC

Slide6: 

Outcomes of Hepatitis B Infection Acute HBV Infection Recovery and Immunity Fulminant Hepatitis Chronic Infection [carrier] Chronic Active Hepatitis cirrhosis hepatocellular carcinoma Death 10% 25% 63-93% 1-2% CDC

Hepatitis B Virus Infection: 

Hepatitis B Virus Infection >300 million carriers worldwide Established cause of chronic hepatitis and cirrhosis Human carcinogen – an underlying cause of up to 80% of hepatocellular carcinomas

Hepatitis B Epidemiology: 

Hepatitis B Epidemiology Reservoir Human. Endemic Transmission Bloodborne Subclinical cases transmit Communicability 1-2 months before and after onset of symptoms Chronic carriers

Slide10: 

Hepatitis B—United States, 1978-2005* Hepatitis B vaccine licensed Year *2005 provisional total CDC Infant immunization recommended (1991) Adolescent immunization recommended (1996) Universal birth dose (2006)

Hepatitis B Virus Infection: 

Hepatitis B Virus Infection In the United States: ~78,000 new infections/year >5,000 new carriers/year >1 million chronically infected ~5,000 deaths/year CDC 2001 estimates

Modes of Hepatitis B Virus Transmission: 

Modes of Hepatitis B Virus Transmission Sexual Parenteral Perinatal

Body Fluid Concentrations of Hepatitis B Virus: 

Body Fluid Concentrations of Hepatitis B Virus High Moderate Low/Not Detectable blood semen urine serum vaginal fluid feces wound exudates saliva sweat tears breast milk

Transmission of Hepatitis B: 

Transmission of Hepatitis B Percutaneous: needlestick injury, IDU, body piercing, tattooing, inadequate sterilization Household transmission: shared objects – toothbrushes, razors, washcloths Person-to-person contact: biting, oozing lesions Institutionalized settings: biting, sexual contact Pre-chewing of food: traditional practices, chewing gum

High Risk Groups For Hepatitis B : 

High Risk Groups For Hepatitis B Immigrants / refugees from endemic areas Children born in US to those from endemic areas Household contacts / sexual partners of those with chronic HBV Men who have sex with men Heterosexuals with multiple sexual partners Persons diagnosed with an STD Persons who trade sex for money or survival Injection drug users Inmates of long-term correctional facilities Persons receiving dialysis Healthcare workers

Slide17: 

Risk Factors for Hepatitis B CDC Sentinel Sites. 2001 data. CDC

Hepatitis B Virus Infection by Duration of High-Risk Behavior: 

Hepatitis B Virus Infection by Duration of High-Risk Behavior 0 3 6 9 12 15 Years at Risk 0 20 40 60 80 100 Percent infected IV drug user MSM HCWs Heterosexual CDC

Slide19: 

Missed Opportunities for Immunization Against Hepatitis B Virus Infection ~33% have been previously treated for an STD ~25% have been previously incarcerated ~2% were incarcerated during the incubation period Of persons with acute hepatitis B:

Slide20: 

Prevention of Hepatocellular Carcinoma: Experience in Taiwan After introduction of Hepatitis B vaccine in 1984, the rate of hepatocellular carcinoma (HCC) among cohorts of children declined by > 50% Rates of HCC in older age groups and rates of other childhood cancers remained stable or increased during this time period Lee CL, Ko YC, Pediatrics 1997;99:351-353

Slide21: 

Liver cancer death rates among children in Taiwan, 1975 to 1993 From Vaccine, 4th ed. Plotkin, 2004; adapted from Lee CL, Ko YC.. Pediatrics 99:351–353, 1997.

Hepatitis B Vaccine: 

1965 Discovery of Australian antigen 1973 Successful HBV infection of chimpanzees 1981 Licensure of plasma-derived vaccine 1986 Licensure of recombinant vaccine 1991 Universal infant vaccination 1996 Universal adolescent vaccination Hepatitis B Vaccine

Hepatitis B Vaccine Intervals: 

Hepatitis B Vaccine Intervals 3 dose series: dose # 1 dose # 2 at least one month after the 1st dose dose #3 at least 4 months after the 1st dose and at least 2 months after the 2nd dose For infants, the final dose not before 24 weeks of age

Slide24: 

There is no need to ever start the hepatitis B vaccines series over again, no matter how long the interval between each dose!

Recommended Doses and Schedules of Hepatitis B Vaccines: 

Recommended Doses and Schedules of Hepatitis B Vaccines ‡ Two 1.0 ml doses given at one site in a four dose series 0,1,2,6 months

Immunogenicity and Vaccine Efficacy: 

Immunogenicity and Vaccine Efficacy Adequate antibody responses after three IM doses of Hep B vaccine >95% of those from birth to <19 years >90 of healthy adults <40 years ~90% of adults 40 <60 years 75% of adults >60 years

Vaccine Completion Rates and Seroconversion: 

Vaccine Completion Rates and Seroconversion Protective levels of antibodies in healthy adults <40 yrs of age: In 20-30% after one dose In 70-85% after two doses In >90% after three doses A full series of vaccine is recommended as there are no data on persistence of antibody after <3 doses of vaccine

Vaccine Completion Rates and Seroconversion: 

Vaccine Completion Rates and Seroconversion Factors that may play a role in lower seroconversion rates: Increased age (>40 years) Male gender Smoking Obesity Immune dysfunction ?

Persistence of Immunity: 

Persistence of Immunity Immunologic memory established following vaccination Exposure to HBV results in anamnestic anti-HBs response Chronic infection rarely documented among vaccine responders

Vaccine Administration: 

Vaccine Administration Vaccine must be administered IM – doses given subcutaneously should not be counted as valid and should be repeated

Hepatitis B Vaccine: 

Hepatitis B Vaccine Booster doses are NOT routinely recommended for any age group

Hepatitis B Adverse Reactions in Adults: 

Hepatitis B Adverse Reactions in Adults Pain at injection site: 13-29% Mild systemic complaints: 11-17% (fatigue, headache) Temperature >37.7° C: 1% Severe systemic reactions: rare

Hepatitis B Vaccine: 

Hepatitis B Vaccine Contraindications Severe allergic reaction to a vaccine component (hypersensitivity to Baker’s yeast) Severe allergic reaction following a previous dose Precaution Moderate or severe acute illness

Childhood/Adolescent Hepatitis B Vaccine Recommendations: 

Childhood/Adolescent Hepatitis B Vaccine Recommendations All newborns prior to hospital or birthing center discharge All children All adolescents NYS PHL§2164 requires a complete series of hepatitis B vaccines for attendance in daycare / preK / K-12

Adult Hepatitis B: Vaccine Candidates : 

Adult Hepatitis B: Vaccine Candidates Men who have sex with men Heterosexuals with multiple partners Persons diagnosed with an STD Persons who trade sex for money or survival Injection drug users Inmates of long-term correctional facilities Persons receiving dialysis Persons with chronic liver disease (not HBV) Healthcare workers

Adult Hepatitis B: Vaccine Candidates(cont’d): 

Adult Hepatitis B: Vaccine Candidates(cont’d) Staff of institutions for developmentally disabled Alaskan Natives, Pacific Islanders Immigrants/refugees* Adoptees, orphans, unaccompanied minors* Household members and sexual partners of HBV carriers Extended travel to areas of high endemicity Recipients of certain blood products *from countries of high or intermediate HBV endemnicity

Prevaccination Serologic Testing: 

Prevaccination Serologic Testing Not indicated before routine vaccination of infants or children May be considered in persons where there is a high rate of HBV infection Injection drug users MSM Sexual contacts of persons with HBV infection Family members of HBV carriers Immigrants/refugees from endemic areas Adoptees from HBV endemic countries Pacific Islanders, Alaskan Natives

Postvaccination Serologic Testing: 

Postvaccination Serologic Testing Not routinely recommended following vaccination of infants, children, adolescents, or most adults Recommended for: Infants born to HBsAg+ women Sexual partners of HBsAg+ persons Hemodialysis patients Immunodeficient persons Certain healthcare workers

Management of Non-response to Hepatitis B Vaccine: 

Management of Non-response to Hepatitis B Vaccine Complete a second series of three doses Should be given on the usual schedule of 0, 1 and 6 months Retest ~2 months after completing the second series

Persistent Non-response to Hepatitis B Vaccine: 

Persistent Non-response to Hepatitis B Vaccine <5% of vaccinees do not develop anti-HBs after 6 valid doses May be nonresponder or "hyporesponder" Check HBsAg status If exposed, treat as nonresponder with postexposure prophylaxis

Hepatitis A: 

Hepatitis A Enteric viral infection – oral fecal spread Acute disease and asymptomatic infection; no chronic infection Incubation period 15-50 days Non-specific illness; usually self-limited Age-related clinical illness Young children generally asymptomatic Teens and adults symptomatic Fulminant hepatitis A results in ~100 deaths/yr

GEOGRAPHIC DISTRIBUTION OF HEPATITIS A VIRUS INFECTION: 

GEOGRAPHIC DISTRIBUTION OF HEPATITIS A VIRUS INFECTION CDC

Risk Factors Among Persons with Hepatitis A, Reported Cases, United States, 1990-2000: 

Risk Factors Among Persons with Hepatitis A, Reported Cases, United States, 1990-2000 Unknown Other Child care 2% 10% 6% International travel 5% 45% Common source outbreak 4% Child care contact CDC sentinel counties Illicit drug users 8% 6% MSM Household and sexual contact 14%

Hepatitis A, United States: 

Hepatitis A, United States Most disease occurs in the context of community-wide outbreaks Infection transmitted from person to person in households and extended family settings Some groups at increased risk No risk factor identified in ~50% of cases Asymptomatic pediatric travelers play a role in silent transmission Between 25-50% of adults with no clear risk factor have contact with asymptomatic child Consider travel to endemic region as a risk factor

Hepatitis A Vaccine Recommendations: 

Hepatitis A Vaccine Recommendations Universal vaccination at 12 - 23 months of age In NYC – vaccination of all children 12 – 59 months of age in certain communities Men who have sex with men Drug users Persons with chronic liver disease, including hepatitis C International travelers Recipients of clotting factors Persons with occupational risk

Hepatitis A Vaccine Recommendations: 

Hepatitis A Vaccine Recommendations Health care workers: not routinely recommended Day care centers: not routinely recommended Plumbers and sewer workers: not routinely recommended Food handlers: may be considered based on local circumstances

Hepatitis A Vaccine: 

Hepatitis A Vaccine Two brands of vaccines: HAVRIX (GlaxoSmithKline) VAQTA (Merck) Pediatric (12 months -18 years) and adult (>19 years) formulations Vaccine licensed for use in persons aged 12 months and older Vaccines are equivalent and interchangeable 2 dose series for all ages: A minimum of 6 months between doses

Duration of Protection: 

Duration of Protection Persistence of antibody At least 10 years for 95-100% of adult vaccinees At least 6 years for 99% of vaccinated children Mathematical models of antibody decline suggest protective antibody levels persist for minimum of 15-25 years

Efficacy of Hepatitis A Vaccine After Exposure to Hepatitis A Virus: 

Efficacy of Hepatitis A Vaccine After Exposure to Hepatitis A Virus Indirect evidence Animal models Efficacy studies No cases in vaccinees > 16 days after vaccination No cases in vaccinated children at 9 years of follow-up Randomized trial comparing vaccine to no intervention Hospitalized cases Household contacts vaccinated within 8 days 79% efficacy; 95% CI 7%-95% Randomized trial comparing vaccine to IG just completed

Hepatitis A Serologic Testing: 

Hepatitis A Serologic Testing Pre-vaccination Not routinely indicated for children Cost-effective for Persons born or lived in high endemic areas Adults in high prevalence groups Adults >40 years Post-vaccination Not routinely indicated or recommended Not all commercially available assays are sensitive enough to detect lower (protective) levels of vaccine-induced antibody

Safety of Hepatitis A Vaccine: 

Safety of Hepatitis A Vaccine Most common side effects related to injection site Reported by 20-50% of recipients No severe adverse reactions attributed to vaccine Safety in pregnancy not determined – risk likely low

Contraindications and Precautions: 

Contraindications and Precautions Contraindications Severe adverse reaction to previous dose Severe allergy to a vaccine component Precaution Moderate to severe illness

Twinrix® (GSK): 

Twinrix® (GSK) Combination hepatitis B (adult dose) and hepatitis A vaccine (pediatric dose) Schedule: 0, 1, 6-12 months Approved for persons >18 years

Mixed Schedules: Twinrix and Hep A: 

Mixed Schedules: Twinrix and Hep A Adult formulation single antigen HepA vaccine may be used to complete a schedule begun with Twinrix and vice versa Acceptable schedules 2 Twinrix and 1 hepatitis A (adult formulation 1 Twinrix and 2 hepatitis A (adult formulation) Maintain spacing recommended for Twinrix

The Citywide Immunization Registry (CIR): 

The Citywide Immunization Registry (CIR) The NYC DOHMH’s centralized, computerized database of immunization records Citywide implementation January 1, 1997 and extended August 18, 2005 Mandated reporting for NYC children <19 years Voluntary reporting for NYC adults >19 years (consent in their medical record) Access to the CIR for authorized health care providers, parents, legal guardians and custodians, and patients NYC Health Code sections 11.04 and (d)11.07 212-676-2323 www.nyc.gov/health/cir

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