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Objectives of hepatitis C surveillance

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Title: Objectives of hepatitis C surveillance


1
Update on Viral Hepatitis
2009 COA Annual Conference Public Health
Epidemiology Adapting to a Changing World
R. Monina Klevens, DDS, MPH Epidemiology and
Surveillance Branch Division of Viral Hepatitis
2
Objectives
  • Current picture of public health burden
  • Biology
  • Treatment
  • Transmission in healthcare settings
  • Post-exposure guidance

3
Public Health Burden of Disease from Viral
Hepatitis in the United States
  • Estimated new infections in 2006
  • Hepatitis A 32,000
  • Hepatitis B 46,000
  • Hepatitis C 19,000
  • Estimated chronic infections
  • Hepatitis B 1 million (0.27)
  • Estimated annual deaths 1,000
  • Hepatitis C 3.2 million (1.3)
  • Estimated annual deaths 8,000

4
Healthcare Utilization of Patients With a Viral
Hepatitis Diagnosis, U.S. 2004
5
Objectives
  • Current picture of public health burden
  • Biology
  • Treatment
  • Transmission in healthcare settings
  • Post-exposure guidance

6

Viral Hepatitis Overview

7

Viral Hepatitis Overview

8
Features of HBV, HCV and HIV Relevant to
Healthcare Transmission
Blood, acute infection
9
Clinical Manifestations ofAcute Viral Hepatitis
Asymptomatic
Symptomatic
Fulminant liver failure and death
Typical Signs and Symptoms
  • Jaundice
  • Scleral icterus
  • Abdominal/RUQ pain
  • Hepatomegaly
  • Arthritis
  • Fever
  • Malaise
  • Anorexia
  • Nausea
  • Vomiting

10
  • Laboratory Findings in Acute Viral Hepatitis

Laboratory indicators of liver pathology
  • Elevated ALT (SGPT) and AST (SGOT)
  • Elevated bilirubin
  • Elevated alkaline phosphatase

Laboratory indicators of infection
  • Increased WBC

All non-specific with regard to making an
etiologic diagnosis
11
Immunologic Markers Used forSerologic Diagnosis
and Surveillance
  • Immune globulin of the M subclass (IgM)
  • Produced in early infection
  • Immune globulin of the G subclass (IgG)
  • Produced in later infection
  • Total immune globulin (Total Ig)
  • Combination of IgM and IgG

12
Objectives
  • Current picture of public health burden
  • Biology
  • Treatment
  • Transmission in healthcare settings
  • Post-exposure guidance

13
Hepatitis A Virus Infection
  • Illness weeks - months
  • more severe in adults than in children
  • children often asymptomatic
  • very rarely death may occur in the elderly or
    with the presence of pre-existing liver disease
  • Treatment supportive care only
  • Rest
  • Avoid dehydration
  • Pain relief (avoid liver toxins e.g.
    acetaminophen)

14
Hepatitis B Virus Infection
  • Acute disease supportive only (avoid alcohol,
    acetaminophen, liver toxicity)
  • Chronic infection
  • Therapeutic drugs include lamivudine,
    entecavir, adefovir, telbivudine, and
    interferon
  • Therapies require long term treatment - problems
    with rebound and resistance
  • AASLD Treatment Guidelines https//www.aasld.org/e
    web/docs/chronichep_B.pdf

Also active against HIV other HIV drugs active
(but not licensed) against HBV are emtricitabine
and tenofovir
15
Hepatitis C Virus Infection
  • Acute infection - supportive care only
  • (avoid alcohol, acetaminophen jury still out on
    whether early treatment will prevent chronic
    infection)
  • Chronic infection complex
  • Combination interferon-based (injection) and oral
    ribavirin
  • Multiple side effects
  • 48 weeks (for most 24 weeks for some
    non-genotype 1 or 4)
  • Counsel to reduce further harm to liver
  • Limit or abstain from alcohol
  • Vaccinate for hep A and B, if appropriate
  • AASLD Practice Guidelines
  • https//www.aasld.org/eweb/docs/hepatitisc.pdf

16
Objectives
  • Current picture of public health burden
  • Biology
  • Treatment
  • Transmission in healthcare settings
  • Post-exposure guidance

17
HBV and HCV Transmission in Healthcare Settings
Patient to patient
Healthcare worker to patient
Patient to healthcare worker
See Clinical Infectious Diseases 2004 3815928
18
Patient to patient transmission HBV associated
with oral surgery
  • Index case 60 yo female, unvaccinated, no risk
    factors
  • Multiple extractions
  • Same morning as chronic case
  • Same staff (14/15 vaccinated)
  • Same operatory
  • Same IV medications, local anesthetic
  • Strain typing identical
  • Source highly infectious (HBeAg )

Source Redd JT JID 20071951311-1314
19
Patient to patient transmission HCV at an
endoscopy clinic
  • 3 reports of acute HCV infection in Jan 2008, NV
    health district
  • Case finding identified 6 cases dx 7-12/2007
  • No significant risk factors
  • gt99 genetic similarity

Source Fischer MMWR 200857(19)513-517
20
iv
x X x
21
Outbreaks of healthcare-associated HBV and HCV in
non-hospital settings
22
Objectives
  • Current picture of public health burden
  • Biology
  • Treatment
  • Transmission in healthcare settings
  • Post-exposure guidance

23
Post-Exposure Prophylaxis for HBV
Updated U.S. Public Health Service Guidelines for
the Management of Occupational Exposures to HBV,
HCV, and HIV and Recs for PEP MMWR 50 (RR11) -
6/29/01
24
Postexposure Management for HCV Needle sticks,
Sharps, Mucosal Exposures to Blood
  • Test source for anti-HCV
  • If source anti-HCV positive
  • Test worker for anti-HCV and ALT at baseline and
    4-6 months
  • For earlier diagnosis, HCV RNA at 4-6 weeks
  • Confirm all anti-HCV results with RIBA
  • Immune globulin and antivirals (e.g., interferon)
    not recommended prophylactically

Updated U.S. Public Health Service Guidelines for
the Management of Occupational Exposures to HBV,
HCV, and HIV and Recs for PEP MMWR 50 (RR11) -
6/29/01
25
Conclusions
  • Enormous public health burden
  • Biology
  • Hardy viruses
  • Treatment
  • Continues to improve for B and C
  • Transmission in healthcare settings
  • Most recently patient to patient in ambulatory
    care settings
  • Post-exposure guidance
  • Restrictions for B not for C

26
Resources
  • http//www.cdc.gov/hepatitis/index.htm
  • http//www.cdc.gov/NCIDOD/DISEASES/HEPATITIS/b/Bse
    rology.htm
  • http//www.hepatitis.va.gov/vahep?pagediag-tests-
    00
  • rmk2_at_cdc.gov

27
Backup slides
28
Hepatitis E, briefly
  • How is HEV transmitted?
  • First recognized in 1980, like HAV transmitted
    via fecal-oral route.
  • Often a waterborne disease, consumption of
    fecally contaminated drinking water has given
    rise to epidemics, and eating uncooked shellfish
    has been the source of sporadic cases in endemic
    areas.
  • There is a possibility of zoonotic spread of the
    virus, since several non-human primates, pigs,
    cows, sheep, goats and rodents are susceptible to
    infection.
  • Person-to-person transmission occurs but is
    uncommon. There is no evidence for transmission
    by transfusion, or sexual transmission except
    perhaps with oral-anal contact.

29
Hepatitis E, briefly
  • Where is HEV a problem?
  • Regions with low standards of sanitation recent
    outbreaks in refugee camps in Uganda, Chad,
    Sudan. Epidemics have been reported in Central
    and South-East Asia, North and West Africa, and
    in Mexico.
  • Sporadic cases of hepatitis E have been reported
    in the U.S. and Europe, and serological surveys
    suggest a global distribution of strains of
    hepatitis E of low pathogenicity.

30
Hepatitis E, briefly
  • When is a HEV infection life-threatening?
  • In general a self-limiting viral infection
    followed by full recovery. Occasionally, a
    fulminant form of hepatitis develops, with
    overall patient population mortality rates
    ranging between 0.5 - 4.0. Fulminant hepatitis
    occurs more frequently in pregnancy and regularly
    induces a mortality rate of 20 among pregnant
    women in the 3rd trimester.

31
HCW to Patient Transmission of HCV
  • Overall quite rare (14 reports worldwide)
  • Most often Anesthetists and surgeons/techs
  • Majority of cases linked to HCW substance abuse
  • Reuse of needles or sharing patient narcotics
    used for self-injection
  • HCW acutely infected in several episodes

32
Patient to HCW Transmission of viral hepatitis
  • Hepatitis C
  • 1.8 (0-7) after sharps injury with HCV blood
  • Primarily related to needlesticks (unlike HBV)
  • Not vaccine-preventable
  • No post-exposure prophylaxis
  • Note prevalence of HCV among health care workers
    1, lower than adults in the general population

33
Prevention of HBV Transmission from Infected HCWs
  • Adhere to standard precautions
  • Appropriate use of protective barriers, hand
    washing, and care in use and disposal of needles
    and other sharps
  • (i.e., keep their blood out of the patient care
    environment)
  • No restriction of practice activities except for
    exposure-prone invasive procedures
  • Know HBeAg status
  • HBeAg positive HCWs should seek counsel from an
    expert review panel to determine under what
    circumstances (if any) to continue to perform
    these procedures

34
Recommendations for HCV-Positive Health Care
Workers United States
  • Refer for medical evaluation and management
  • Follow strict aseptic technique and standard
    precautions
  • Hand hygiene
  • Protective barriers
  • Care in use and disposal of needles / sharps
  • No restrictions routinely recommended absent
    evidence of transmission

MMWR 199847 (No. RR-19)
35
Etiology of Chronic Liver Disease Among Newly
Diagnosed Patients in Gastroenterology Practices,
1999 -2001 (n 1040)
Bell et al Am J Gastroenterol 20081032727-2736
36
Acute Viral Hepatitis, United States, 2001-2004
56
34
9
Hepatitis A
Hepatitis B
Hepatitis C
Non-ABCDE
1
Source Sentinel Counties Study, CDC
37
Viral Hepatitis
  • Hepatitis, general term meaning inflammation of
    the liver
  • may be viral, or toxicity often a cause-- e.g.
    acetaminophen overdose, medication adverse effect
  • Viral hepatitis can be caused by a variety of
    different viruses such as hepatitis A, B, C, D
    and E.
  • Since the development of jaundice is a
    characteristic feature of liver disease, a
    correct diagnosis can only be made by testing
    patients' sera for the presence of specific viral
    antigens and/or anti-viral antibodies.
  • yellowing of the skin and eyes caused by too
    much bilirubin in the blood

38
Concentration of HBV in Various Body Fluids

39
  • Transmission of hepatitis B infection may take
    place with as few as 100 viral particles with
    blood carrying up to 12 trillion viral particles
    per cc, very small amounts of contamination are
    required for successful transmission.
  • Active hepatitis B viral particles may persist
    for up to a week on contaminated environmental
    surfaces (ond WW, Favero MS, Peterson NJ, et al.
    Survival of hepatitis B virus and drying and
    storage for one week. Lancet 1981i550-551
    ttp//www.biomedcentral.com/1471-2334/6/130/)

40
  • Hepatitis B
  • gt30 after sharps injury with HBV (e-Ag) blood
  • Transmission can occur with cutaneous,
    non-parenteral exposure to blood/body fluids
  • VACCINE-preventable!
  • Post-exposure
  • immune globulin (HBIG) for unvaccinated
  • evaluation of the hepatitis B surface antigen
    status of the source and the vaccination and
    vaccine-response status of the exposed person
    http//www.cdc.gov/MMWR/preview/MMWRhtml/rr5011a1.
    htm

41
HCW to Patient Transmission of HCV
  • Rare, most appear related to HCW substance abuse
  • Reuse of needles or sharing narcotics used for
    self-injection
  • Reported mechanism for transmission of other
    bloodborne pathogens from anesthesiologists
  • No restrictions recommended

42
Natural History of HBV Infection
43
Chronic hepatitis B
  • Chronic hepatitis B represents a major health
    problem for the United States.
  • While the incidence of acute hepatitis B has
    declined markedly since 1990,
  • an estimated 1.25 million Americans remain
    chronically infected, with an
  • estimated 3,000-5,000 chronic hepatitis B virus
    related deaths per year.
  • Asian/Pacific Islanders represent only 4 of the
    U.S. population but gt50 of those with chronic
    hepatitis B infection.

44
Natural History of HCV Infection
100 People
Time
15
85
Resolve (15)
Chronic (85)
80
20
Stable (68)
Cirrhosis (17)
75
25
Stable (13)
Mortality (4)
Leading Indication for Liver Transplant
45
Chronic hepatitis C
  • The incidence of acute hepatitis C declined
    during the 1990s but has plateaued in recent
    years
  • Approximately 3.2 million Americans are
    chronically infected with hepatitis C virus
  • In the US, African-Americans are
    disproportionately affected by chronic hepatitis
    C virus infection, representing 12 of the U.S.
    population but approximately 22 of those with
    the disease.

46
Acute hepatitis panel
  • IgM hepatitis A antibody (IgM anti-HAV)
  • Hepatitis B surface antigen (HBsAg)
  • IgM hepatitis B core antibody (IgM anti-HBc)
  • Antibody to hepatitis C virus (anti-HCV)

47
Viral hepatitis B/C panel
  • Some labs may also offer a viral hepatitis B/C
    panel, excluding hepatitis A
  • Hepatitis B surface Antigen - HBs Ag
  • Hepatitis B core Antibody, Total - HBc Ab
  • Hepatitis C virus Antibody - HCV Ab

48
Hepatitis Serology
  • Hepatitis Serology training
  • http//www.cdc.gov/ncidod/diseases/hepatitis/serol
    ogy/training.htmone
  • Serology
  • Hepaitits A
  • Complex serology of Hepatitis B
  • -chronic vs acute
  • -immune compromise, other factors such as
    timing may make results unclear
  • Serology of positive C
  • -differentiate chronic vs acute?

49
Hepatitis Reporting Requirements
  • Reporting generally done by laboratory upon
    positive result on acute hepatitis panel. For GA
    forms, requirements see http//health.state.ga.us
    /epi/disease/report.asp
  • Hep A required to report immediately prevention
    counseling, contact notificiation, report within
    24 hours to health dept
  • Hepatitis C, past or present, report within 7
    days
  • Hepatitis B, past or present, report within 7
    days
  • Acute Hepatitis B
  • HBsAg pregnant women
  • newly identified HBsAg carriers

50
Hepatitis Reporting Requirements
  • When you identify
  • New acute cases of Hep A, B, or C,
  • Hepatitis B in pregnancy, or
  • Newly identified HBsAg carriers
  • office call local health dept to offer additional
    information

51
Hepatitis B Clinical Features
  • Incubation period Average 60-90 days
  • Range 45-180 days
  • Clinical illness (jaundice) lt5 yrs,
    lt10 gt5 yrs, 30-50
  • Acute case-fatality rate 0.5-1
  • Chronic infection lt5 yrs, 30-90 gt5 yrs,
    2-10
  • Premature mortality fromchronic liver
    disease 15-25

52
Hepatitis C Clinical Features
  • Incubation period Average 6 - 7 wks
  • Range 2 - 26 wks
  • Clinical illness (jaundice) 30 - 40 (20 -
    30)
  • Chronic hepatitis 70
  • Persistent infection 85 - 100
  • Immunity No protective antibody
    response identified

53
Medical Evaluation and Management
  • Assess for biochemical evidence of chronic liver
    dz
  • Assess for severity of disease and possible
    treatment, according to current practice
    guidelines
  • 30-70 sustained response to antiviral
    combination therapy (interferon alpha,
    ribavirin) genotype 1 least successful
  • Vaccinate against hepatitis A
  • Counsel to reduce further harm to liver
  • Limit or abstain from alcohol

54
NEW 2007 guidelines for HAV post-exposure
prophylaxis
  • For healthy persons aged 12 months--40 years,
    vaccine at the age-appropriate dose is preferred
    to IG because of vaccine advantages that include
    long-term protection and ease of administration.
  • IG should be used for children aged lt12 months,
    immunocompromised persons, persons who have had
    chronic liver disease diagnosed, and persons for
    whom vaccine is contraindicated. For persons aged
    gt40 years, IG is preferred because of the absence
    of information regarding vaccine performance and
    the more severe manifestations of hepatitis A in
    this age group vaccine can be used if IG cannot
    be obtained.
  • The magnitude of the risk for HAV transmission
    from the exposure should be considered in
    decisions to use IG or vaccine.

55
Universal Infant ImmunizationRationale
  • 16,000 US children infected each year
    postnatally before universal infant B vaccination
    implemented
  • Vaccination of all infants needed to prevent
    these infections because 50 of early childhood
    cases were in children born to HBsAg-negative
    mothers
  • Birth dose for all infants is a safety net to
    prevent perinatal HBV infections
  • Assures protection for infants born to mothers
    with unknown HBsAg status
  • Prevents infections in infants born to
    HBsAg-positive mothers if there are errors in
    tracking these infants
  • Immunization of infants provides long-term
    protection

56
Estimated Hepatitis B Vaccination Coverage
19-35 Months of AgeUnited States, 1992-2004
HP 2010 Target90
Routine infant vaccination recommended
Source National Immunization Survey, CDC
57
Reported HepB Coverage Among Adults Aged 18-49
Years, 2004
All adults
Adults at risk
Vaccine Coverage,
Source National Health Interview Survey, MMWR
2006 55(18)509-511
58
Hepatitis B Vaccination ACIP Recommendations -
Summary
  • Routine infant
  • All children up through 18 years
  • Over 18 high risk
  • Behavioral risk
  • Occupational risk
  • Medical risk
  • Venue-based all
  • STD clinic clients
  • Correctional settings
  • HIV care
  • Drug treatment
  • Institution for developmental disability
  • Prevaccination testing if cost effective
  • Post-vaccination testing 1-2 months after last
    shot, if establishing response critical (HCW)

59
Hepatitis B Prevention Strategy
  • Primary prevention Eliminate HBV Transmission
  • Prevent perinatal HBV transmission
  • Universal infant vaccination
  • Catch-up vaccination of all children/adolescents
    lt19 yrs
  • Catch-up vaccination of adults in high risk
    groups
  • Secondary prevention Reduce risk of liver
    disease in persons with chronic infection
  • Identify and test persons at risk for chronic HBV
    infection
  • Counseling, medical evaluation, management of
    infected persons

60
HCV Testing Routinely Recommended(Based on Risk
for Infection)
  • Persons who ever injected illegal drugs
  • Persons with selected medical conditions
  • received clotting factor concentrates produced
    before 1987
  • ever on chronic hemodialysis
  • evidence of liver disease
  • Prior recipients of transfusion/organs
  • before July 1992
  • notified that donor later tested positive

61
HCV Testing Routinely Recommended (Based on
Recognized Exposure)
  • Healthcare, emergency medical, and public safety
    workers after needle sticks, sharps, or mucosal
    exposures to HCV- positive blood
  • Children born to HCV-positive women

62
Routine HCV Testing Not Recommended(Unless Risk
Factor Identified)
  • Health-care, emergency medical, and public safety
    workers
  • Pregnant women
  • Household (non-sexual) contacts of HCV-positive
    persons
  • General population

63
Preventing HCV Transmission to Others
Avoid Direct Exposure to Blood
  • Do not donate blood, body organs, other tissue or
    semen
  • Do not share items that might have blood on them
  • personal care (e.g., razor, toothbrush)
  • home therapy (e.g., needles)
  • Cover cuts and sores on the skin

64
Post-exposure Follow-up of Workers For HCV
Infection
  • Baseline testing of source for anti-HCV
  • Person exposed to HCV-positive source, baseline
    and follow-up testing anti-HCV and ALT, again at
    4-6 months (or test for HCV RNA at 4-6 weeks)
  • Confirmation by supplemental anti-HCV testing of
    all positive by enzyme immunoassay
  • IG not recommended studies ongoing of early
    treatment of positives

65
Standard Precautions (SP) and Protection from
Bloodborne Pathogens
  • Information on infection control practices
    http//www.cdc.gov/ncidod/dhqp/injectionsafety.htm
    l
  • http//www.cdc.gov/ncidod/diseases/hepatitis/spotl
    ights/glucose.htm
  • http//www.cdc.gov/ncidod/dhqp/gl_isolation_standa
    rd.html
  • recent CDC training for healthcare providers A
    Never Event Unsafe Injection Practices
    http//www.emergency.cdc.gov/coca/ppt/UnsafeInject
    ionPractices032708.ppt262,1,A
  • DHQP Inquiries (inquiries about safe injection
    practices) 1-800-311-3435, option 1 -or-email us
    at hip_at_cdc.gov

66
All healthcare providers are urged to carefully
review their infection control practices and the
practices of all staff under their
supervision In particular, providers
should Never administer medications from the
same syringe to more than one patient, even if
the needle is changed Never enter a vial with a
syringe or needle that has been used for a
patient if the same medication vial might be used
for another patient
67
What is aseptic technique? Handling,
preparation, and storage of medications and all
supplies used for injections and infusionse.g.,
syringes, needles, intravenous (IV) tubingin a
manner that prevents microbial contamination Medi
cations should be drawn up in a designated
clean medication preparation area In general,
any item that could have come in contact with
blood or body fluids should be kept separate
68
  • Safe handling of parenteral medications
  • Always use a new sterile syringe and needle to
    draw up medications
  • Proper hand hygiene should be performed before
    handling medications
  • Parenteral medications and injection equipment
    should be accessed in an aseptic manner
  • Maintaining sterility of vials
  • A new sterile needle and syringe should be used
    for each injection
  • Medications should be discarded upon expiration
    or any time there are concerns regarding the
    sterility of the medication
  • Leftover parenteral medications should never be
    pooled for later administration
  • A needle should never be left inserted into a
    medication vial septum for multiple uses
  • This provides a direct route for microorganisms
    to enter the vial and contaminate the fluid

69
  • Minimizing the use of shared medications reduces
    patient risk.
  • Single-use medications vials (e.g., propofol)
    should never be used for more than one patient
  • Assign multi-dose vials to a single patient
    whenever possible
  • Do not use bags or bottles of intravenous
    solution as a common source of supply for more
    than one patient
  • Absolute adherence to proper infection control
    practices
  • Absolute adherence to proper infection control
    practices must be maintained during the
    preparation and administration of injected
    medications

70
Q How can healthcare providers ensure that
injections are performed correctly? A To help
ensure that staff understand and adhere to safe
injection practices, consider the following -
Designate someone to provide ongoing oversight
for infection control issues - Develop written
infection control policies - Provide training
- Conduct quality assurance assessments
71
  • Q If I used a syringe only to infuse medications
    into an IV tubing port that is several feet away
    from the patients IV catheter site, is it OK to
    use the same syringe for another patient?
  • A NO. Everything from the medication bag to the
    patients catheter is a single interconnected
    unit
  • - Separation from the patients IV by distance,
    gravity and/or positive infusion pressure does
    not ensure that small amounts of blood are not
    present in these supplies
  • - A syringe that intersects through ports in the
    IV tubing or bags also becomes contaminated and
    cannot be used for another patient

72
Overview of 30 Outbreaks in Non-Hospital
Healthcare Settings, US, 1998-2008
73
Hepatitis B or C transmission, Outpatient
Healthcare
  • infection control breach
  • syringe reuse in many cases, sometimes resulting
    in contamination of multidose vials,
  • handling of injection equipment and preparation
    of injections in a contaminated environment,
  • needle-syringe reuse in heparin locks
  • contamination of shared saline bags or multidose
    vials (should not share multidose vials or saline
    bags between patients)
  • poor hand hygiene and poor glove use

74
Common Themes and Findings
  • Investigations were resource-intensive,
    disruptive
  • Notification, testing, and counseling of hundreds
    of patients
  • Delayed recognition and missed opportunities
  • Prolonged transmission
  • Growing reservoirs of infected patients
  • IC programs lacking or responsibilities unclear
  • Clinic space rented from a hospital (NE)
  • Contractors (NYC and OK)
  • Entirely preventable
  • Standard precautions aseptic technique

MMWR 2003 52901-6 / CID 2004 3815928
75
Hepatitis B or C transmission in non-hospital
healthcare
  • These recognized viral hepatitis outbreaks,
    caused by failures to adhere to fundamental
    infection control precautions and aseptic
    technique,
  • probably represent only an index of a much wider
    problem, as complex and invasive procedures are
    increasingly performed in non-hospital healthcare
    settings, where routine infection control
    training and oversight are often inadequate.

76
Treatment
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