Hepatitis A. Case Investigation and Public Health Response
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1 Hepatitis A Case Investigation and Public Health Response Presented by: Ellen Rudowski, RN,C APN,C Training Goals Enhance working knowledge of viral hepatitis A (HAV) epidemiology Foster communicable disease staff case investigation competency Reinforce public health response interventions to control and prevent further spread of illness Promote public health partner collaboration 1
2 Training Objectives Provide a comprehensive overview of HAV epidemiology Review HAV immunology and laboratory testing interpretation Present the REVISED NJDHSS reporting criteria and HAV case definition Address controlling the spread of illness Discuss special situation management Reinforce prevention measures Hepatitis A A highly contagious viral disease Self limiting infection of the liver Acute disease or asymptomatic infection No chronic infection Protective antibodies develop in response to infection conferring lifelong immunity 2
3 HAV Pathogen RNA Picornavirus Single serotype worldwide Resistant to heat, solvents, and acid Grows slowly in living cells Major site of replication is the liver, excreted in bile, and shed in the stool HAV Symptom Severity Hepatitis A virus attacks the liver and leads to varying degree of illness Asymptomatic Young children are usually asymptomatic, yet infectious Typical course of illness is < 2 months Prolonged/relapsing illness in % of the cases Symptoms severity increases with age 3
4 HEPATITIS A Clinical Features Incubation period: Range days Average days Jaundice by <6 yrs <10% age group: 6-14 yrs 40%-50% >14yrs 70%-80% Rare complications: Chronic sequelae: Relapsing hepatitis Fulminant hepatitis Cholestatic hepatitis None Hepatitis A Virus Transmission Person to - person transmission Fecal oral route Close personal contact Household contacts, extended families, sexual partners Young children are often the source of infection Asymptomatic illness Lower standards of hygiene Foodborne and waterborne contamination ready to eat or uncooked foods prepared by an infected foodhandler with poor hygiene consuming raw shellfish harvested from sewage contaminated water, drinking contaminated water or ice Blood exposure (rare) but can occur during the viremic phase of the disease injecting drug use, transfusion 4
5 Population at Increased Risk Travel to countries with high or intermediate endemicity of infection MSM Illicit drug users Persons with occupational risk Chronic liver disease GEOGRAPHIC DISTRIBUTION OF HEPATITIS A VIRUS INFECTION Source: CDC 5
6 Hepatitis A in the United States Nationally reportable communicable disease Two periods referenced: Before and after implementation of national recommendation for hepatitis A vaccine Most disease occurs in the context of community-wide outbreaks Persist for years and are difficult to control Infection transmitted from person to person in households and extended family settings Facilitated by asymptomatic infection among children Children and young adults account for % of reported case No risk factor identified for 40%-50% of cases RISK FACTORS ASSOCIATED WITH REPORTED HEPATITIS A, , UNITED STATES Unknown 46% Sexual or Household Contact 14% International travel 5% Men who have sex with men 10% Injection drug use 6% Other Contact 8% Source: NNDSS/VHSP Contact of daycare child/employee 6% Food- or waterborne outbreak 4% Child/employee in day-care 2% 6
7 Hepatitis A in New Jersey NJAC 8:57 Hepatitis A is a reportable disease Institutional cases of hepatitis A are immediately reportable NJDHSS is in the process of upgrading all suspect and positive cases of hepatitis A to immediately reportable status Hepatitis A Reports New Jersey, 2005 Total cases reported = 309 Confirmed cases = 158 Not A Case = 151 Clusters = 12 Outbreaks = 0 HAV (+) IGM and NOT A CASE = 61 7
8 2005 HAV (+) IGM NOT A CASE Statistics Age Group Asymptomatic Not Clinically Compatible Renal Disease Vaccination Multi System Failure GI Disease Liver Disease Medication Out of State Insufficient Documentation TOTAL = y/o (15, 44 y/o) 4 14 > 50 y/o (84 y/o) - 47 NJ HAV 2005 Select Demographics (N=158) Male = 97 (61%) Female = 61 (39 %) White = 72 (46%) Black = 10 ( 6%) Asian Pacific = 10 (6%) Unknown/Other = 66 (42%) Hispanic = 45 (28%) Non- Hispanic = 50 (31%) Other/Unknown = 64 (41%) 8
9 HAV Exposure Risk Factors NJ 2005 (N=158) 10% (n=16) Travel to Endemic Areas 11% 11% (n=17) 44% (n=69) Unknown 35% 35% (n=56) (n=56) Sexual or Household Contact Contaminated Food or Water Not Identified: Child/Employee in Daycare Contact of Child Employee in Daycare MSN Injection Drug Use Other Contact Prevalance of Jaundice by Age Group, USA and NJ Age group CDC NJDHSS (N=158) <6 yrs <10% 60% 6-14 yrs 40%-50% 81% >14yrs 70%-80% 72% 9
10 Rate of HAV Hospitalization, NJ 2005 (N=158) 23.4% of 2005 HAV cases hospitalized < 6 y/o = y/o = y/o = 18 > 50 y/o = 7 MMWR 5/19/06 national HAV surveillance data: 11 22% cases are hospitalized Average work loss for adults Hospitalized 32 days Non hospitalized patient is 15.5 days CDRSS Documented 2005 HAV Contact Post Exposure Prophylaxis Contact Post exposure prophylaxis (PEP): # cases with documented PEP = 52 (33%) # contacts received IG = 403 # doses of IG and Hepatitis A vaccine = 17 # doses of Hepatitis A vaccine = 92 Exclusions - prolonged 13 for 28 days (restaurant foodhandlers) 1 for 32 days (cafeteria foodhandler) 4 for 1 week (healthcare workers ) 10
11 Hepatitis A Case Investigation And Public Health Response Case Investigation and Public Health Response Review laboratory results and validate additional testing Enter case into CDRSS Conduct interviews to determine clinical features Establish Onset of Jaundice or Elevated Liver Enzymes Identify contacts Facilitate Immune Globulin (IG) post exposure prophylaxis contacts within 14 days of last exposure. 11
12 Case Investigation and Public Health Response Identify Risk Factor Exposure Determine public health risk. Is the case a source of infection for others? Foodhandler Childcare worker or attendee Healthcare worker or patient care provider Residential facility NJDHSS HAV Resource CD Hepatitis A Information PowerPoint Presentation Resource Articles Investigation Forms NJDHSS HAV Worksheet Line lists Population Specific Symptom Line List Public Health Response Sample Time Line Work Exclusion Notification HAV Notification Letters Case Outbreak Immune Globulin Distributor List Fact sheet Waiver Release Hepatitis A Vaccine VIS 12
13 Hepatitis A Immunology HAV Total Antibodies HAV IgG HAV IgM Previous illness Immunity due to vaccination Acute illness (within 6 months) Recent HAV vaccination (rarely) 13
14 EVENTS IN HEPATITIS A VIRUS INFECTION Clinical illness Infection ALT Response Viremia HAV in stool IgM IgG Week Concentration of Hepatitis A Virus in Various Body Fluids Feces Body Fluids Serum Saliva Urine Infectious Doses per ml Source: Viral Hepatitis and Liver Disease 1984; 9-22 J Infect Dis 1989;160:
15 NJDHSS HAV Case Definition Confirmed: Clinical criteria An acute illness with: discrete onset of symptoms (e.g. fatigue, abdominal pain, loss of appetite, intermittent nausea, vomiting), and jaundice or elevated serum aminotransferase levels AND Laboratory criteria IgM antibody to hepatitis A virus (anti-hav) positive OR a case that meets the clinical case definition and occurs in a person p who has an epidemiologic link with a person who has laboratory-confirmed hepatitis A (i.e., household or sexual contact with an infected person during g the days before the onset of symptoms) Probable: Clinical Criteria NJDHSS HAV Case Definition None Laboratory Criteria IgM antibody to hepatitis A virus (anti-hav) positive AND Other Criteria The patient is epidemiologically linked to a confirmed case of acute hepatitis A. An epidemiological link is defined as a household or sexual contact, or sharing the same exposure as that which is thought to be the cause of a common source hepatitis A outbreak (e.g. dining at a restaurant where an infected food handler was working). 15
16 HAV Immunology Total HAV Abs Positive Why was this test ordered? Was IgM ordered? Results? Will IgM be ordered? Total HAV Abs HAV IgM Positive Negative NOT A CASE Total HAV Abs HAV IgM Positive Positive Laboratory criteria met HAV IgM Positive Laboratory criteria met HAV Liver Studies Jaundice: Elevated Bilirubin, Total Bilirubin, Direct Elevated Liver Enzymes: Serum aminotransferase levels are elevated in acute HAV Alanine Transaminase ALT (SGPT) range value 9-50 U/L Aspartate Transaminase AST (SGOT) range value U/L 16
17 ABRUPT Onset of Symptoms Fever Malaise Anorexia Nausea Abdominal pain Diarrhea Dark urine Clay colored stools Jaundice- yellowing skin Icteric- yellowing sclera Those infected may have all, some or none of these symptoms. A laboratory test is required to diagnose hepatitis A infection 17
18 18
19 Risk Assessment Assess exposure history: Contact with a confirmed hepatitis A case Consumption of contaminated food or water Travel to area with high incidence of hepatitis A What country? Dates of travel? Exposure to contaminated food or water? Assess if other individuals that traveled with the case meet the definition of close contact? 19
20 Period of Communicability Most infectious 2 weeks prior onset of jaundice or elevated liver enzymes Until one week after jaundice Viral shedding in stool is greatest during two week period prior to jaundice and greatly decreases with the onset of jaundice Identifying jaundice or elevated liver enzymes onset date is the most crucial piece of the case investigation If onset date of jaundice or elevated liver enzymes is unknown then onset of dark urine Calculating Period of Infectivity Jaundice Onset Date or Elevated Liver Enzyme Date Infectious Period Two weeks prior to jaundice / liver enzymes to One week after jaundice / liver enzymes 20
21 Defining HAV Case Contacts Definition of contact, all unvaccinated: Household members Sexual contacts Anyone who shared illicit drugs w/case Anyone who shared food or eating or drinking utensils w/case Anyone consuming ready-to to-eat foods prepared by an infectious food handler experiencing diarrhea 21
22 Identified Case Contacts Name Address Contact numbers Date of birth Age Weight in pounds Date of last exposure Date is IG required by Date IG administered Return to work date Contact surveillance: Contacts should be monitored for 50 days for hepatitis A symptomology Utilize HAV sample line list to capture contacts and public health response 22
23 23
24 Controlling Further Spread Minimum Period of Isolation of Patient Until end of the febrile period or one week after onset of jaundice. Minimum Period of Quarantine of Contacts Applies only to foodhandling facility employees A food handler is any person directly preparing or handling food. This can include a healthcare, patient care or child care provider. Excluded from work for 28 days unless they receive IG within 14 days of exposure May return to work immediately upon receiving IG Exclusion exception: Able to produce documentation of HAV vaccination Able to produce documentation of serologic immunity 24
25 Is case a source of infection for others? BE CONSISTENT Immune Globulin Immune globulin is a sterilized solution obtained from pooled human blood plasma, which contains the immunoglobulin (or antibodies) to protect against infectious agents that cause diseases. Immune globulins are sometimes called gamma globulins or immune serum globulins. Each unit is tested for evidence of HIV, HBC, HCV and many other bloodborne pathogens. In addition to testing, several chemical processes are used to sterilize the product and eliminate other disease causing germs. 25
26 Immune Globulin Post exposure prophylaxis (PEP) with IG for contacts of case during their infectious period Provides passive protection against HAV 80-90% effective in preventing HAV if administered within 14 days of exposure Greater efficacy if administered early in the incubation period vs. later Administer IG ASAP after exposure. Sources of Immune Globulin for Intramuscular Administration (IMIG) 24-hour telephone numbers as follows: FFF Enterprises: Physicians & Health Departments can order single vial of IG Henry Schein Medical Physicians call Health Departments call Amerisource ASD: Biomed Plus: NSS Cardinal Health: Talecris: : then prompt 2 (One week credit approval) All require credit account application completion (24 to 48 to process p credit approval) 26
27 Immune Globulin Single- use (2ml) Multi dose (10ml) Formulated without preservatives IM route of administration Peak levels ~ 2 days Half life ~ days Immune Globulin (IG) PEP can provide passive immunity for < 3 months Hyperimmune Globulin Therapy Source: Talecris Biotherapeutics Hyperimmune Globulin 27
28 Who should receive IG? Identified contacts within two weeks of exposure to an acute HAV case during his/her infectious period. Travelers to areas with high rates of hepatitis A: Known allergy to a hepatitis A vaccine component or If travel departure is <4 weeks, one should receive IG, if they do/do not receive hepatitis A vaccine. Is it safe to receive IG when pregnant? Yes. Pregnant women can get IG and it should be considered for pregnant women at risk for exposure of hepatitis A infection or after exposure to hepatitis A infection, if they have not received the hepatitis A vaccine. 28
29 Reactions to IG Pain and tenderness at the site Itching, hives and swelling Severe allergic reactions are rare and associated with: Inadvertent IV administration Patients with immunoglobulin A (IgG) deficiency Emphasize proper injection technique to assure IM delivery and avoid inadvertent IV administration. IG Interaction With Live Attenuated Vaccines IG can interfere with the response of other live vaccines: MMR (measles, mumps, rubella) S/B delayed > 3 months after IG Varicella vaccine S/B delayed > 5 months after IG If IG is administered: < 2 weeks after administration of MMR or < 3 weeks after varicella vaccine The person should be revaccinated: 3 months after IG for MMR 5 months after for varicella vaccine 29
30 Recommendations for Hepatitis A Post Exposure Prophylaxis Time Since Exposure < 2 weeks < 2 weeks Future Exposure Likely or Other Indication for Vaccination* NO YES Recommended Prophyaxis IG 0.02 ml/kg IG 0.02 ml/kg and Initiate hepatitis A vaccine series > 2 weeks > 2 weeks NO YES Children <1 years of age (for whom vaccine is not licensed) and persons with a contraindication to vaccination should receive immune globulin (IG) every 5 months during extended exposure. Source: Mandel, Infectious Diseases and Etiologic Agents NONE Initiate hepatitis A vaccine series Is case a source of infection for others? BE CONSISTENT 30
31 Managing Hepatitis A in a Child Care Setting Strictly enforce hand hygiene policies. Parent and staff notification to include HAV symptoms. Reinforce with all parents and staff to notify the center if a household h contact develops HAV symptomology. HAV education includes advising parents not to withdraw child from the center or enroll child at another site. Strictly enforce disinfection of objects and environmental surfaces with appropriate bleach solutions. Investigation includes identification child/staff population. Is space, activities, equipment, and objects shared? Determine disinfecting routine for such supplies. Staff assignments, do staff switch or share classrooms? Food preparation: where, by whom any illness? Confirmed Case of HAV in Child Care Setting with a Toilet Trained Population Parent and staff notification. HAV education includes advising parents not to withdraw child from center or enroll child at another site. HAV (+) IgM employee or child in center with population >2 y/0 and toilet trained. IG is recommended for employees and classroom contacts of an index case. Hepatitis A vaccine may be administered at the same time as IG PEP for child care center attendees 31
32 Confirmed Case of HAV in Child Care Setting with a Diapered Population One or more cases of HAV in enrolled children or employees or HAV in two or more households of center attendees IG is recommended for all employees and enrolled children Administer IG to all new employees and new attendees for 6 weeks after the last case is identified. Hepatitis A vaccine may be administered at the same time as IG PEP for child care center attendees Outbreak: Child Care Center Outbreak Management Hepatitis A cases in three or more families IG also should be considered for members of households that have children (center attendees) in diapers. Hepatitis A vaccine may be administered at the same time as IG PEP for child care center attendees. 32
33 Exclusion Criteria with HAV IgM Positive Childcare Household Contacts Confirmed HAV childcare setting household contact: child or staff living with case should be tested. If test results are negative administer IG to prevent illness. If tests results are HAV IgM positive exclude as below: Exclude symptomatic child or staff. Exclude people exposed within last 2 weeks unless they received IG or can produce documented HAV immunity. People excluded can return 6 weeks after last identified case. People sick with HAV may return to program no less than one week after onset of illness, if fever and jaundice are gone. HAV in Kindergarten or Preschool Class Strictly enforce hand hygiene policies Ensure all bathrooms are properly supplied with soap, paper towels, and toilet paper Identification of contacts Investigate classroom activities i.e., no bake cooking Parent/staff notification including HAV symptoms. Reinforce with all parents and staff to notify the center and/or local health department if a household contact develops HAV symptomology. 33
34 Managing HAV in the School Setting Usually does not pose a significant risk of transmission and IG is usually not indicated. IG may be given to identified close contacts (sharing food or eating and drinking utensils with a case). Community Residential Programs Handled on case-by by-case basis. Level of case hygiene and type of facility is pivotal. Roommates sharing food or eating or drinking utensils are considered close contacts and are given IG within 14 days of exposure (+) HAV staff are considered foodhandlers, evaluate responsibilities e.g. feeding, distribute medication, food preparation or perform dental procedures 2 weeks prior to jaundice onset 34
35 Infected Foodhandler Assess whether case prepares/serves/or handles food. If yes Ready to eat foods? Compile list of all foods prepared/served/ or handled. Did case have bare hand contact with foods or medications? Any time when protective gloves were not worn or serving utensils s used? Inquire about personal hygiene habits During the period of infectivity, did the case have diarrhea while working? Obtain work schedule for case and coworkers. Inspect food establishment for sanitation status and infection control c protocols/practices. Infected Foodhandler Coworkers and public are assessed for risk Foodhandling coworkers are excluded from work for 28 days unless they receive IG within 14 days of exposure May return to work immediately upon receiving IG Exclusion exception: Able to produce documentation of HAV vaccination Able to produce documentation of serologic immunity 35
36 Case Contact Line List Cases onset of illness date is 06/09/2006 Contact Name Address Contact Number Date of Birth Age Weight In Pounds Exposure Date IG Due By: Date IG Given Return To Work Date Jane Doe 133 Grace St Jersey City (111) /02/ /10/06 06/24/06 06/13/06 06/13/06 John Doe 133 Grace St Jersey City (111) /21/ /30/06 Exempt N/A 06/29/06 Mary Smith James Brown ** Weight in pounds divided by 2.2 equals weight in kilograms (KG) ** Example: 165 lbs. / 2.2 = 75kg then 75kg X 0.02 IG dose = 1.5mL of IMIG Public Notification Criteria Common source of transmission to patrons is unlikely, IG administration is recommended only if during infectious period: The foodhandler handled foods, served uncooked or foods after cooking Had diarrhea or poor hygiene practices And patrons can be identified, and treated within 2 weeks after the exposure 36
37 Hospitals Administration of IG to healthcare workers: Only recommended in an outbreak situation. If hospital worker is considered a foodhandler then foodhandler guidelines are followed. Hepatitis A Prevention Measures Meticulous hand hygiene is the single most important protective measure. Passive Immunization - Immune Globulin Active Immunization - Vaccination New ACIP recommendations as of 10/2005 Adequate sanitation systems Avoidance of contaminated food Boiling or cooking food and beverage items for 1 minute to 185 degrees inactivates the virus boil it, cook it, peel it, or forget it 37
38 Hepatitis A Prevention Measures Safe sexual practices Dispose of feces in a sanitary manner. Traveling to HAV endemic regions: Do not drink fluids (with or without) ice of unknown purity Do not eat uncooked shellfish Do not eat uncooked fruits and vegetables that are not peeled or prepared by you personally Advisory Committee on Immunization Practices (ACIP) Recommendation Routine hepatitis A vaccination of children aged > 1 year nationwide Persons who are at increased risk for infection Any person wishing to obtain immunity Reinforce existing vaccination programs Expand protection against HAV nationwide Create the foundation for eventual consideration of elimination of indigenous HAV transmission 38
39 Short Term < 3 months 3 5 months > 5months Recommendations for Hepatitis A Pre Exposure Travel Prophylaxis Hepatitis A Pre Exposure Travel Prophylaxis Duration of Exposure Short term or long term Recommended Prophylaxis IG 0.02mL/kg IG 0.06mL/kg IG 0.6mL/kg every 5 months Hepatitis A Vaccine departure in 4 weeks Hepatitis A vaccine and IG (0.02mL/kg) if travel departure is less than weeks Substitute IG as above if vaccine is contraindicated or refused ** Weight in pounds divided by 2.2 equals weight in kilograms (KG) ** Example: 162 lbs. / 2.2 = 75kg then 75kg X 0.02 IG dose = 1.5mL of IMIG Recommended Dosages of Hepatitis A Vaccines Age Volume 2-Dose Schedule Vaccine (yrs) Dose (ml) (mos) HAVRIX # (EL.U.*) 0.5 0, 6-12 >18 1, , 6-12 VAQTA ## (U**) 0.5 0, 6-18 > , 6-18 * EL.U. Enzyme-linked immunosorbent assay (ELISA) units ** Units # has 2-phenoxyethanol as a preservative ## has no preservative 39
40 Hepatitis A Vaccination Immunogenicity Protective antibody level : Adult 94% - 100% one month after dose one 100% after second dose Children and adolescents ( 2-18) 97% - 100% of one month after dose one 100% after second dose Infants < 2 Available data indicates inactivated hepatitis A vaccines are immunogenic Source: MMWR Prevention of Hepatitis A Through Active or Passive Immunization, 5/19/06 Long Term Protection Through Vaccination Studies reflect protective anti-hav levels: Adults years (HAVRIX) Children years (VAQTA) Persistence of antibody derived form kinetic models of antibody decline indicate protective levels of anti HAV in: Adults - > 25 years Children - > years 40
41 Hepatitis A Vaccination Refer to manufacturer s s insert Most common side effects Soreness/tenderness at injection site Headache Malaise Safety in pregnancy not determined risk likely low Contraindications - severe adverse reaction to previous dose or allergy to a vaccine component Including neomycin for HAVRIX Warning: DRY NATURAL LATEX VAQTA vial stopper & syringe plunger stopper HAVRIX tip cap & rubber plunger of needleless prefilled syringes No special precautions for immunocompromised persons Twinrix Combined Hepatitis A and Hepatitis B Vaccine Approved by the FDA in U.S. for persons >18 y/o Contains 720 EL.U. hepatitis A antigen and 20 µg. HBsAg Vaccination schedule: 0,1,6 months Immunogenicity similar to single-antigen vaccines given separately Can be used in persons > 18 y/o who need vaccination against both hepatitis A and B Formulation for children available in many other countries 41
42 Resources CDC Division of Viral Hepatitis: N.J.A.C. 8:57 NJDHSS Communicable Disease Manual Chapters NJDHSS Communicable Disease Case Definitions: NJDHSS CDS Vaccine Preventable Disease Program NJDHSS Contact Information NJDHSS Communicable Disease Service (609) Request to speak with clinical staff regarding Hepatitis A After hours (609) Ellen Rudowski RN,C; APN,C Ellen.Rudowski@doh.state.nj.us Food and Drug Safety Program - (609)
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