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Screening for Hepatitis C Virus Infection

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Title: Screening for Hepatitis C Virus Infection


1
Screening for Hepatitis C Virus Infection
  • Prepared for
  • Agency for Healthcare Research and Quality (AHRQ)
  • www.ahrq.gov

2
Outline of Material
  • Introduction to the epidemiology of and screening
    for hepatitis C virus (HCV) infection
  • Systematic review methods
  • The clinical questions addressed by the
    comparative effectiveness review
  • Results of studies and evidence-based conclusions
    about the benefits and adverse effects of
    screening for HCV infection
  • Updated recommendations from the U.S. Preventive
    Services Task Force and the Centers for Disease
    Control and Prevention for screening for HCV
    infection
  • What to discuss with patients and their caregivers
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

3
BackgroundPrevalence of Hepatitis C Virus
Infection
  • The hepatitis C virus (HCV) is the most common
    chronic blood-borne pathogen in the United
    States.
  • About 78 percent of individuals who test positive
    for anti-HCV antibody have detectable hepatitis C
    virus in their blood, indicating chronic
    infection.
  • The Centers for Disease Control and Prevention
    estimated that there were 16,000 new cases of
    acute HCV infection in the United States in 2009.
  • HCV infection was associated with an estimated
    15,000 deaths in 2007.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

4
BackgroundRisk Factors for Hepatitis C Virus
Infection
  • The strongest risk factor for infection with the
    hepatitis C virus (HCV) is injection drug use.
  • Transfusions received before 1992 are also a risk
    factor for HCV infection.
  • Blood transfusions are no longer an important
    source of infection because of the implementation
    of effective screening programs for donated
    blood.
  • People born between 1945 and 1965 are at
    particular risk.
  • About 75 percent of patients with HCV infection
    were born between the years 1945 and 1965, with
    the highest prevalence (4.3) in people 40 to 49
    years of age in 19992002.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

5
Background Clinical Consequences ofHepatitis C
Virus Infection
  • Infection with the hepatitis C virus (HCV) is a
    leading cause of complications from chronic liver
    disease including cirrhosis, hepatic failure,
    hepatocellular cancer, and death.
  • Although the incidence of HCV infection has been
    declining over the last two decades, the rates of
    cirrhosis, hepatic failure, and hepatocellular
    cancer are expected to rise in the next 10 to 20
    years.
  • This rise is expected because of the long lag
    time between infection with HCV and the
    development of complications.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

6
Background Importance of Screening for Hepatitis
C Virus Infection
  • Screening for hepatitis C virus (HCV) infection
    in asymptomatic adults without a history of liver
    disease or liver enzyme abnormalities may
    identify infected patients early, before they
    develop serious liver damage.
  • Data from the Centers for Disease Control and
    Prevention suggest that out of every 100 people
    infected with HCV
  • About 75 to 85 will develop chronic HCV infection
  • About 520 will develop cirrhosis over 2030
    years, with the rates increasing after 30 years
  • HCV antibody testing with subsequent polymerase
    chain reaction testing was found to be accurate
    for identifying patients with HCV infection.
  • Centers for Disease Control and Prevention.
    Available at www.cdc.gov. Accessed August 9,
    2013.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
  • U.S. Preventive Services Task Force. Ann Intern
    Med. 2004140(6)462-4. PMID 15023712.

7
BackgroundObjectives of This Systematic Review
  • The authors of this review aimed to evaluate the
    evidence regarding
  • The effects of screening for hepatitis C virus
    (HCV) infection on clinical outcomes in
    asymptomatic adults
  • The relative effectiveness of various screening
    strategies for HCV infection
  • The potential harms of screening for HCV
    infection
  • The effects of counseling interventions on
    clinical and intermediate outcomes in patients
    with HCV infection
  • The effects of labor-and-delivery practices and
    breastfeeding on mother-to-child transmission of
    HCV infection
  • This review has also been used by the U.S.
    Preventive Services Task Force to update its
    recommendations on HCV screening.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

8
Agency for Healthcare Research and Quality (AHRQ)
Comparative Effectiveness Review (CER) Development
  • Topics are nominated through a public process,
    which includes submissions from health care
    professionals, professional organizations, the
    private sector, policymakers, members of the
    public, and others.
  • A systematic review of all relevant clinical
    studies is conducted by independent researchers,
    funded by AHRQ, to synthesize the evidence in a
    report summarizing what is known and not known
    about the select clinical issue. The research
    questions and the results of the report are
    subject to expert input, peer review, and public
    comment.
  • The results of these reviews are summarized into
    Clinician Research Summaries and Consumer
    Research Summaries for use in decisionmaking and
    in discussions with patients.
  • The Research Summaries and the full report, with
    references for included and excluded studies, are
    available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at http//www.effectivehealthcare.ahrq.g
    ov/hepatitis-c-screening.cfm.

9
Clinical Questions Addressed by This Comparative
Effectiveness Review (1 of 4)
  • Key Question 1a. Does screening for hepatitis C
    virus (HCV) infection in nonpregnant adults
    without known abnormal liver enzymes reduce
    mortality and morbidity due to HCV infection
    affect quality of life or reduce incidence of HCV
    infection?
  • Key Question 1b. Does screening for HCV infection
    during pregnancy reduce vertical transmission of
    HCV or improve mortality or morbidity for the
    mother or child?
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

10
Clinical Questions Addressed by This Comparative
Effectiveness Review (2 of 4)
  • Key Question 2a. What is the effectiveness of
    different risk-based or prevalence-based methods
    for screening for HCV infection in improving
    clinical outcomes?
  • Key Question 2b. What is the sensitivity and
    number needed to screen to identify one case of
    HCV infection of different risk-based or
    prevalence-based methods for screening for HCV
    infection?
  • Key Question 3. What are the harms associated
    with screening for HCV infection, including
    adverse effects such as anxiety, labeling, and
    impact on relationships?
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

11
Clinical Questions Addressed by This Comparative
Effectiveness Review (3 of 4)
  • Key Question 4a. What are the comparative
    effectiveness and comparative diagnostic accuracy
    of various tests and strategies for the workup to
    guide treatment decisions in patients who test
    positive for HCV infection?
  • Key Question 4b. What proportion of patients with
    screen-detected HCV infection receives treatment?
  • Key Question 5. What are the harms associated
    with the workup for guiding treatment decisions?
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

12
Clinical Questions Addressed by This Comparative
Effectiveness Review (4 of 4)
  • Key Question 6a. How effective is counseling or
    immunization of patients with hepatitis C virus
    (HCV) infection at improving health outcomes or
    reducing the spread of HCV?
  • Key Question 6b. Does becoming aware of a
    positive serostatus for HCV infection decrease
    high-risk behaviors?
  • Key Question 6c. How effective is counseling or
    immunization of patients with HCV infection at
    improving intermediate outcomes, including change
    in high-risk behaviors?
  • Key Question 7. Do any interventions decrease or
    increase the risk of vertical transmission of HCV
    during delivery or in the perinatal period?
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

13
Rating the Strength of Evidence From the
Comparative Effectiveness Review
  • The strength of evidence was classified into four
    broad categories

High Further research is very unlikely to change the confidence in the estimate of effect.
Moderate Further research may change the confidence in the estimate of effect and may change the estimate.
Low Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate.
Insufficient Evidence either is unavailable or does not permit estimation of an effect.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

14
Evidence for the Clinical Benefits and Harms of
HCVScreening in Nonpregnant and Pregnant
Asymptomatic Adults
  • There was no direct evidence of clinical benefits
    and limited evidence on harms associated with
    screening for hepatitis C virus infection, when
    compared with no screening or between different
    screening approaches, in nonpregnant and pregnant
    adults.
  • Strength of Evidence Insufficient
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

15
Sensitivity of Different Strategies for
Hepatitis C Virus Screening
  • Targeted screening strategies based on multiple
    risk factors were associated with sensitivities
    of more than 90 percent and with numbers needed
    to screen to identify one case of hepatitis C
    virus infection of less than 20.
  • Strength of Evidence Low
  • The more narrowly targeted screening strategies
    were associated with numbers needed to screen of
    less than two but with the trade-off of missing
    up to two-thirds of infected patients.
  • Strength of Evidence Low
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

16
Evidence for the Clinical Benefits and Adverse
Effects Associated With Detection of Hepatitis C
Virus Infection
  • Biopsy-related adverse effects appeared to be
    small, with a risk of death of less than 0.2
    percent and a risk of serious complications
    (primarily bleeding and severe pain) of about 1
    percent.
  • Strength of Evidence Moderate
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

17
Evidence for the Clinical Benefits and Adverse
Effects Associated With Treatment of HCV
Infection (1 of 2)
  • From 15 to 33 percent of patients with
    screen-detected chronic hepatitis C virus (HCV)
    infection received treatment however, this
    varied according to the population assessed and
    the treatment eligibility criteria used.
  • Strength of Evidence Moderate
  • Treatment of HCV genotype 1 infection with triple
    and dual antiviral therapy regimens resulted in
    sustained virologic response (SVR) rates of 66 to
    80 percent and 43 to 52 percent, respectively.
  • Strength of Evidence Moderate
  • Evidence from cohort studies and meta-analyses
    suggested that achieving an SVR after antiviral
    therapy was associated with a lower risk of
    all-cause mortality, hepatocellular carcinoma,
    and cirrhosis when compared with not achieving an
    SVR.
  • Strength of Evidence Moderate

For information on the effectiveness of
antiviral regimens in patients infected with HCV
of other genotypes, please refer to the
complementary review on treatment of HCV
infection referenced below.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
  • Chou R, Hartung D, Rahman B, et al. AHRQ
    Comparative Effectiveness Review No. 76.
  • Available at www.effectivehealthcare.ahrq.gov/hepc
    treatment.cfm.

18
Evidence for the Clinical Benefits and Adverse
Effects Associated With Treatment of HCV
Infection (2 of 2)
  • Dual and triple antiviral therapy regimens for
    hepatitis C virus (HCV) infection have been shown
    to be associated with adverse effects such as
    fatigue, headache, flu-like symptoms, hematologic
    events, and rash.
  • Strength of Evidence Moderate
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
  • Chou R, Hartung D, Rahman B, et al. AHRQ
    Comparative Effectiveness Review No. 76.
  • Available at www.effectivehealthcare.ahrq.gov/hepc
    treatment.cfm.

19
Impact of Awareness of HCV Serostatus and
Counseling on Health Outcomes and Reduction in
the Spread of HCV Infection or High-Risk
Behaviors in HCV-Positive Patients
  • Knowledge of hepatitis C virus (HCV) serostatus
    may reduce alcohol use in the short term, but the
    evidence indicates that any such behavior is not
    lasting.
  • Strength of Evidence Low
  • Evidence on the effects of counseling or
    immunizations for the hepatitis A and B viruses
    on health outcomes, reduction in the spread of
    HCV, or decrease in high-risk behaviors was
    limited.
  • Strength of Evidence Insufficient
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

20
Risk of Vertical Transmission of Hepatitis C
Virus During Delivery or the Perinatal Period
  • The risk of vertical transmission of hepatitis C
    virus (HCV) infection did not differ
    significantly between cesarean (elective or
    emergent) delivery and vaginal delivery.
  • Strength of Evidence Moderate
  • Prolonged labor (gt6 hours based on one study)
    after membrane rupture was associated with
    increased risk of vertical transmission of HCV
    infection.
  • Strength of Evidence Low
  • No significant association was found between
    breastfeeding and risk of transmitting HCV
    infection.
  • Strength of Evidence Moderate
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

21
Additional Information
  • New oral antiviral agents, some of which do not
    require interferon in the treatment regimen, are
    under development and have obtained fast-track
    status for review in the next few years by the
    U.S. Food and Drug Administration.
  • Preliminary studies suggest that these agents may
    be more tolerable than currently available
    therapies.
  • Clinical practice has evolved toward less routine
    use of biopsy. However, this comparative
    effectiveness review found no studies reporting
    the proportion of patients who undergo biopsy
    before treatment.
  • Noninvasive diagnostic tests are being developed
    for the diagnosis of fibrosis and cirrhosis and
    for guiding treatment decisions in HCV-positive
    patients (see the full report).
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

22
U.S. Preventive Services Task Force 2013
Recommendations for HCV Infection Screening
  • The USPSTF recommends screening for hepatitis C
    virus (HCV) infection in adults at high risk,
    including those with any history of intravenous
    drug use or blood transfusions before 1992.
  • The USPSTF recommends that clinicians offer
    screening for HCV infection in adults born
    between 1945 and 1965.
  • Grade B Recommendation

The USPSTF recommends this service. There is
moderate certainty that the net benefit is
moderate.
  • U.S. Preventative Services Task Force. Available
    at www.uspreventiveservicestaskforce.org.
    Accessed June 26, 2013.

23
The Centers for Disease Control and Prevention
2012 Testing Recommendation for Chronic HCV
Infection
  • In addition to the 1998 guidelines for testing
    for chronic HCV infection, the Centers for
    Disease Control and Prevention published the
    following recommendation in August 2012.
  • People who should be tested once in their
    lifetime for hepatitis C virus (HCV) infection
    without ascertaining their risk factors include
  • Adults born in the years 1945 through 1965
  • The Centers for Disease Control and Prevention.
    Available at www.cdc.gov/hepatitis/hcv/guidelinesc
    .htm. Accessed August 9, 2013.

24
Conclusions (1 of 2)
  • No direct evidence comparing clinical outcomes in
    patients screened with those not screened was
    available.
  • However, several studies provided indirect
    evidence regarding the potential benefits of
    screening.
  • Screening tests (hepatitis C virus HCV antibody
    testing with subsequent polymerase chain reaction
    testing) can accurately identify adults with
    chronic HCV infection.
  • Targeted screening strategies resulted in numbers
    needed to screen to identify one case of HCV
    infection of less than 20 however, they missed a
    significant number of infected patients.
  • In HCV-positive patients, treatment with
    antiviral regimens resulted in sustained
    virologic response rates of 4380 percent, which
    was associated with a reduction in hepatocellular
    carcinoma and mortality.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
  • Chou R, Hartung D, Rahman B, et al. AHRQ
    Comparative Effectiveness Review No. 76.
  • Available at www.effectivehealthcare.ahrq.gov/hepc
    treatment.cfm.
  • U.S. Preventive Services Task Force. Ann Intern
    Med. 2004140(6)462-4. PMID 15023712.

25
Conclusions (2 of 2)
  • The evidence was insufficient to determine the
    effectiveness of counseling in patients who were
    positive for hepatitis C virus or the
    effectiveness of immunizations for the hepatitis
    A and B viruses on clinical outcomes.
  • Limited evidence suggests that for some patients,
    knowledge of hepatitis C status may be associated
    with reduction in high-risk behaviors such as
    alcohol use in the short term.
  • Additional research is needed to understand
    effective interventions for preventing vertical
    transmission.
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

26
What To Discuss With Your Patients andTheir
Caregivers (1 of 2)
  • The patients risk status for hepatitis C virus
    (HCV) infection
  • That HCV infection is potentially curable
  • ??The U.S. Preventive Services Task Force
    recommendations about screening for HCV infection
  • The available diagnostic tests for HCV infection
    and their accuracy
  • The potential emotional and social impact of
    being screened for HCV infection
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.

27
What To Discuss With Your Patients andTheir
Caregivers (2 of 2)
  • The potential benefits and harms of diagnostic
    tests for hepatitis C virus (HCV) infection
  • If the patient tests positive for HCV infection,
    the possibility that he/she might be referred to
    a liver specialist
  • For HCV-positive patients
  • The available tests and workup strategies to
    guide treatment decisions and the accuracy of the
    various tests
  • The importance of monitoring for fibrosis,
    cirrhosis, and hepatocellular carcinoma
  • The impact of various interventions in preventing
    vertical transmission of HCV during delivery or
    in the perinatal period
  • Chou R, Barth Cottrell EB, Wasson N, et al. AHRQ
    Comparative Effectiveness Review No. 69.
  • Available at www.effectivehealthcare.ahrq.gov/hepa
    titis-c-screening.cfm.
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