Upload
nguyentruc
View
218
Download
0
Embed Size (px)
Citation preview
Viral Hepatitis C Testing
Recommendations for Persons Born
1945-1965
Local Health Departments and Hepatitis C: Webcast 1.3
Presented by:
Claudia Vellozzi, M.D., M.P.H.
Chief, Prevention Branch, Division of Viral Hepatitis
Centers for Disease Control and Prevention (CDC)
Role of Public Health in HCV
Prevention
Public Health Core
Functions - Institute
of Medicine, 1988
Guided by
research…
• Assessment
• Policy Development
• Assurance
Outline
Assessment and policy development leading to
recommendations
Public health strategies to provide assurance in
implementing recommendations
3
Assessment and Policy Development for the Viral Hepatitis C Testing Recommendations for
Persons Born 1945-1965
4
Impact of Prevention Measures on Hepatitis C Virus (HCV) Infection in U.S.
Alter MJ JAMA 1990; Jagger J, J infect Dis Pub Health 2008; CDC.gov/hepatitis; 5
0
2
4
6
8
10
12
14
16
18
20
Anti-HCV test licensed
1992
1986 Indirect blood screening for HCV
and HIV prevention measures
Needle stick Safety
and Prevention Act
2001
Year
Discovery
of HCV
1989
22,000 new acute HCV cases reported in 2012
Prevalence of Current HCV Infection Among Persons in the United States
6
Prevalence
Civilian, Non-Institutionalized
Populations
(NHANES)
2.7 million
(2.2-3.2 million)
1.0% (0.8%-1.2%)
Estimated HCV Infection
Among Homeless and
Incarcerated Persons
(Not Included in NHANES)
360,000-840,000
22%-52%
Denniston M, Ann Int Med 2014. Chak E, Liver Int 2011.
Two of Three Americans Living with HCVWere Born During 1945-1965
Reflects historical high
HCV incidence before
viral discovery in 1989
Five-fold higher
prevalence than other
US adults (3.39% vs
0.55%)
81% of all HCV+ US adults
Of all HCV-related
mortality in US, 73% were
born in this cohort
Smith, AASLD Liver Meeting 2011. Armstrong, Ann Int Med 2006. Kramer, Hepatology 2011. Ly, Ann Int Med 2012. 7
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0
0 10 20 30 40 50 60 70
1910 1920 1930 1940 1950 1960 1970 1980 1990
Age at Time of Survey, y
Year of Birth
1988–1994
1999–2002
1988–1994
1999–2002
Pro
po
rtio
n A
nti
-HC
V-P
os
itiv
e,
%P
rop
ort
ion
An
ti-H
CV
-Po
sit
ive
, %
1945
Age 20-59
Characteristic Odds
Ratios
Age Categories
(20-39 referent)
Age 40-49 6.0 (3.2-11.1)
Age 50-59 9.5 (5.3-16.8)
Race-Ethnicity
(all others referent)
Non-Hispanic Black 1.6 (1.1-2.3)
High School Education
(high school or more referent)
Less than High School/GED 2.0 (1.2-3.3)
Family Income
(>2.0 times poverty level referent)
<2.0 times poverty level 3.7 (2.6-5.3)
Age ≥ 60
Characteristic Odds Ratios
Age Categories
(≥ 70 referent)
Age 60-69 6.0 (3.2-11.1)
Race-Ethnicity
(all others referent)
Non-Hispanic Black 10.0 (4.9-20.1)
Adjusted Odds Ratios for the Presence of
HCV RNA: NHANES 2003-2010
Denniston M, Ann Int Med 2014 8
The Growing Burden of Hepatitis C in the United States
Of 2.7 million HCV-infected persons in primary care
1.47 million will develop cirrhosis
350,000 will develop hepatocellular carcinoma (HCC)
897,000 will die from HCV-related complications
Rein D, Dig Liver Dis 2010.9
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
Num
ber
of
Indiv
iduals
Year
Deaths
DCC
HCC
0
1
2
3
4
5
6
Rat
e p
er
10
0,0
00
Pe
rso
ns
Year
Reported Deaths 19,368
Median age- 59 years
Increases in Hepatitis C Mortality
10
39%42%
34%
16%6%
0
20
40
60
80
100
IFN IFN/RBV PEG/
RBV
IFN IFN/
RBV
Peg-IFN
(PEG)
Adapted from Strader DB, et al. Hepatology. 2004;39:1147-71
1991 1999 2001 2002 2011 2014
Advances in HCV Therapy
11
54 – 56%
Peg/RBV
DAA
67-72%
>90%
All oral
DAA
HCV Deaths Averted with Birth Cohort Testing Using Different Treatments
12
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
NoTreatment
PR PRPI, PR PRS/SR SS/SR
De
ath
s A
ve
rte
d
Treatment Type
PR = Pegylated Interferon plus Ribavirin for all genotypes, PRPI; PR = PR plus a protease inhibitor for genotype 1, PR for genotypes 2/3;
PRS/SR = pegylated interferon, ribaviron, and sofosbuvir for genotype 1, and sofosbuvir plus ribavirin for genotypes 2 and 3;
SS/SR = Sofosbuvir and Simeprevir for genotype 1, and sofosbuvir and ribavirin for genotypes 2 and 3.
Rein, D. B., The Cost-effectiveness, Health Benefits, and Financial Costs of New Antiviral Treatments for Hepatitis C Virus CID 2015
Risk-based Recommendations for HCV Screening
Since 1998, CDC recommendations included risk-
based screening
Injection drug use
Blood transfusion before 1992 and other blood exposures
HIV infected persons
45%-85% of infected persons remained unidentified
Barriers to testing
Lack of clinician awareness of HCV testing guidelines
Clinician reluctance to ask about risks
Patient reluctance to disclose or failure to recall risks
13MMWR 1998;47 (No. RR-19); Roblin, et al.. Am J Man Care 2011. Spradling, et al., Hepatology, 2012. Southern, et al., J Viral Hepat,. Shehab TM, et
al. Hepatology, 1999.; Shehab TM. J Viral Hepat, 2001.;Shehab TM, et al. Am J Gastroenterol, 2002.; Serrante JM, et al. Fam Med, 2008.
Broader HCV Testing Recommendation in 2012One time Test for Persons Born 1945 –1965
Prevalence ~6 times higher
than other ages (3.29% vs
0.55%)
Represent 81% of adult
chronic infections and 73%
HCV deaths
Benefit of treatment, with
SVR reducing
Liver cancer risk: 70%
All-cause mortality: 50%
No reported risk factors:
44%
14
Combined Birth-cohort and Risk-based Testing Effectively Identify HCV-infected Patients
0
10
20
30
40
50
60
70
80
90
100
Birth cohort testing Risk based only Birth cohort + risk based
68 %
27%
77%
Indications for Testing for Persons Reported with HCV
15Mahajan R, Am J Pub Health 2013 Aug
CDC and USPSTF Updated Recommendations for HCV Testing
One time screening test for persons born 1945-1965
Major risk
Past or present injection drug use
Other risks
Received blood/organs prior to June 1992
Received blood products made prior to 1987
Ever on chronic hemodialysis
Infants born to HCV infected mothers
Intranasal drug use
Unregulated tattoo
History of incarceration
Medical
Persistently elevated ALT
HIV (annual testing)
MMWR Aug 2012. Moyer VA, Ann Int Med 2013. http://www.hcvguidelines.org 16
HCV Testing Linked to Care and Treatment Yields Health Benefits
The goal of HCV therapy is a sustained virologic
response (SVR)
SVR is the suppression of HCV to undetectable
levels in the blood usually determined 12 weeks after
the end of treatment
SVR represents a cure of HCV infection
Reduces risks of liver cancer and mortality
70% reduction in hepatocellular carcinoma
90% reduction in liver related mortality
50% reduction in all cause mortality
Rein D, Ann Int Med 2012, Eckman , CID, 2013,;McEwan, Hepatology2013,;McGarry, Hepatology 2012, Liu S, Plos One 2013
18
HCV Test, Care, and Cure Continuum, United States
19
1.6 M
(50%) 1.2 M
(38%)750,000
(23%) 360,000
(11%)200,000
(6%)
Holmberg S, et al, NEJM, 2013
Educate Communities:Know More Hepatitis
National Multi-Media Campaign
Goals:
Increase awareness of hepatitis C
Encourage testing of those born 1945-1965
Campaign Implementation:
Phase I – August 2012
Phase II – January 2015
Audiences:
Primary Care Providers
Consumers (Born from 1945 to 1965)
20
Know More Hepatitis
National Multi-Media Campaign Strategies
• Help with dissemination from state and local partners
• Primarily donated time and space
21
Campaign materials & how to use them
to help implement Know More Hepatitis
• Website
• Fact sheets
• Infographics
• Posters
• Video PSAs
• Live read radio scripts
• Buttons & Badges
• Shareable digital content
• Resources for providers
• Personalized recommendations based on
CDC’s hepatitis testing and vaccination
guidelines
Online Viral Hepatitis Risk Assessment
23
Testing Algorithm for Identifying Current Hepatitis C Virus (HCV) Infection (2013)
CDC. Testing for HCV infection: An update of guidance for clinicians and laboratorians. MMWR. 2013;62(18).24
* For persons who might have been exposed to HCV within the past 6 months, testing for HCV RNA or follow-up testing for HCV antibody is
recommended. For persons who are immunocompromised, testing for HCV RNA can be considered.
† To differentiate past, resolved HCV infection from biologic false positivity for HCV antibody, testing with another HCV antibody assay can be
considered. Repeat HCV RNA testing if the person tested is suspected to have had HCV exposure within the past 6 months or has clinical
evidence of HCV disease, or if there is concern regarding the handling or storage of the test specimen.
HCV
RNANot detected Detected+-
No current HCV infectionNo HCV antibody detected Current HCV infection
Link to careAdditional testing as appropriate†
STOP*
+-
Early Identification and Linkage to Care Capacity Building
Hepatitis C virus testing and linkage to care: 24 sites
funded 9/2012–9/2014
PWID (10)
Community Health Centers (7)
Settings to strengthen care and treatment (2): Project ECHO
Other: HIV/STD clinic, liver clinics, emergency departments
Community based programs to improve healthcare
capacity to test and cure hepatitis C: 3 sites funded
9/2014–9/2018
Improve primary care capacity to test and cure
Leverage Affordable Care Act
Build surveillance capacity to monitor outcomes and impact
25
1945-1965 Birth Cohort Testing* & Linkage to Care
Oct 2012 - Sept 2014
No. Tested = 43,068
3694
2848
2020
1646
1198
0
500
1000
1500
2000
2500
3000
3500
4000
HCV Ab Reactive RNA Tested from AbPositive
Persons RNA Positive Referred to Medical Care Attended 1st Medical Appt
9%
77%
71%
81%
73%
26
*Venues Include: Health Departments; Hospitals; Corrections; SheltersPrevention and Public Health Funding and Secretary's Discretionary Funding
Extension for Community Health care
Outcomes (ECHO)
Expand PCP capacity in
HCV management
Rural and underserved
populations
Use videoconferencing
Share “best practices”
Case based learning
Similar SVR achieved
as those in HCV clinics
28N Engl J Med 2011;364:2199-207.
During 9/2012 –2/2014
Trained 66 PCP predominantly from rural settings
Most PCP (93%) with no experience in HCV care
Of 280 patients, 129 (46%) received treatment
• More than twice that observed in other CDC studies
29
Community-based Programs to Test and Cure Hepatitis C: 9/2014 –9/2018
Goal: develop package of services to improve
healthcare capacity to test and cure
Identify and educate target population
Incorporate HCV testing in primary care practices
Implement regular consultation of primary care provider with
HCV specialists
Case management
Monitor outcome and community impact via data system
Leverage Affordable Care Act: free testing, insurance
enrollment, and improve quality of care through use of EMR
30CDC RFA- PS 14-1413
Health Care ReformImpact on Viral Hepatitis Prevention
Insurance coverage for those with preexisting,
chronic disease
Testing covered as a non-copay preventive service
Incentive for adoption of health information
technology to care for patients
Emphasis on quality of provider care: use of
performance measures
31
American Medical Association Performance Measures Updated
Screening
One-time screening: patients at risk (injection drug use ever, blood
transfused prior to 1992, or born during 1945–1965)
Annual HCV screening: patients who are active injection Drug Users
Care and treatment
Referral to treatment for patients identified with HCV Infection
Sustained Virologic Response (SVR)
Confirmation of Hepatitis C viremia
Hepatitis C RNA and genotype testing before initiating treatment
HCV RNA testing between 4-12 weeks after treatment start
Discontinuation of antiviral therapy if inadequate response
Screening for HCC in patients with Hepatitis C Cirrhosis
Additional performance measures on prevention (vaccination,
alcohol consumption counseling, HCC screening)
Yellow= newly developed performance measures
Summary: U.S. Strategies to Enhance HCV Testing and Care
Broader testing recommendations, risk based and
birth-cohort
Multiple efforts to increase uptake
Education, capacity building , performance measures
Community based programs to improve healthcare
capacity to test and cure hepatitis C
Better linkage to care crucial to realize full potential of advances
in treatment
Challenges: under-diagnosis, access to care, and
cost of medications
33
Local Strategies to Enhance HCV
Testing and Care
• Gather community data to guide service delivery and inform policy
• Improve reporting
• Update professional training/ public awareness
• Assist in the expansion of HCV testing
• Target providers and health systems with interventions to promote
delivery of HCV testing and care
– Promote development of clinical decision tools and performance
measures
• Use to monitor and report back to providers and health systems
• Convene stakeholders
– Meetings with Medicaid, other payers,
– Presentations to providers, public health officials, others
• Participate in policy development
• Work in conjunction with the state Viral Hepatitis Prevention
Coordinator
34
Webcast 1.1 Hepatitis C: Where Are We Now?
Webcast 1.2 The National Viral Hepatitis Action Plan
Webcast 1.3 Viral Hepatitis C Testing Recommendations for
Persons Born 1945-1965
Webcast 1.4 Leveraging Partnerships to Address Hepatitis C:
Philadelphia’s Model
All materials available at www.naccho.org/hepatitisc
Local Health Departments and Hepatitis C NACCHO Educational Series
NACCHO’s educational series is supported by an educational grant from Janssen Therapeutics,
Division of Janssen Products, LP and funding from Gilead Sciences, Inc.