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Veterans & Hepatitis C: Test, Treat, Cure November 10, 2016
VETERANS HEALTH ADMINISTRATION
Faculty Presenters
Lisa I. Backus MD PhD
Patient Care Services/Population Health
Department of Veterans Affairs
Rachel Gonzalez, MPH
Program Manager, National Hepatitis C Resource Center
Elizabeth Maguire, MSW
Communications Lead, HIV, Hepatitis, and Public Health Pathogens Program
Center for Healthcare Organization and Implementation Research (CHOIR)
Bedford VA Medical Center
2
VETERANS HEALTH ADMINISTRATION
VA Structure
ā¢ Organized into 18 regions called Veteran Integrated Service Networks (VISNs)
ā¢ 151 VA Medical Centers (VAMCs), with 6-8 per VISN
ā A VAMC generally consists of an acute care hospital, outpatient clinics, diagnostic facilities, and support services
ā¢ ~1000 community-based outpatient clinics (CBOCs), with 3-8 per VAMC
- provide primary care and mental health services
ā¢ HCV recognized as a priority by VA leadership
ā¢ VA is the largest single provider of HCV care in the United States
3
VETERANS HEALTH ADMINISTRATION
Cascade of HCV Care Veterans in VHA Care
4
250,000
200,000
150,000
100,000
50,000 220,605 65,742 174,027 161,955 47,919
(100%) (30%) (79%) (73%) (22%)
232,001 180,489 160,794 43,544 22,159 (100%) (78%) (69%) (19%) (10%) 0
Chronic HCV Diagnosed with Linked to HCV careā” Treated with HCV Achieved SVRā (estimated)* chronic HCVā antiviralsā
2014 2015
79% 93% 41% 73%
78% 89% 27% 51%
*Estimated from diagnosed+ratio of prevalence in sex, race/ethnicity, birth cohort strata in those tested in prior two years applied to those still untested ā Diagnosed with chronic HCV defined as ever had a detectable HCV RNA or genotype. ā”Linked to HCV care required an outpatient visit in 2014, entry in the VHAās HCV registry and HCV entered on the patient's medical record problem list. āTreated with HCV antivirals defined as ever received HCV antivirals from VHA as of 31 December 2014/2015. āAchieved SVR defined as undetectable HCV RNA on all tests after end of treatment including at least one test at least 12 weeks after the end of treatment with the SVR rate among those evaluable for SVR applied to those without definitive SVR status.
VETERANS HEALTH ADMINISTRATION
HCV Testing
5
Lisa I. Backus MD PhD Patient Care Services/Population Health Department of Veterans Affairs
VETERANS HEALTH ADMINISTRATION
Background
ā¢ Nationally an estimated 2.7 to 3.9 million Americans have chronic HCV infection
ā 45% to 85% do not know they are infected
ā Disproportionately high prevalence of HCV in those born 1945-1965
ā¢ CDC (2012) and USPSTF (2013) recommend one-time HCV screening for anyone born 1945-1965
6 Denniston et al, Ann Inter Med 2014;160:293-300 Armstrong et al, Ann Inter Med 2006;144:705-714
HCV Ab+ prevalence by birth year from two NHANES periods: 1988-1994 and 1999-2002
VETERANS HEALTH ADMINISTRATION
Background
ā¢ HCV disproportionately affects Veterans
ā HCV prevalence in veterans in VA care in 2011 was elevated at 6.2% compared to national estimate of 1.0%
ā HCV prevalence in veterans in VA care in 2011 was highest in the 1945-1965 birth cohort
ā¢ Born <1945 prevalence 1.7%
ā¢ Born 1945-1965 prevalence 10.3%
ā¢ Born >1965 prevalence 1.1%
ā¢ VA (2014) also recommends one-time HCV
screening for anyone born 1945-1965
ā¢ ~220,000 veterans with HCV in VA care
7 Backus et al, JAMA Inter Med 2013;173(16):1549-1552
20.0%18.4%
18.0%
16.0%
14.0%
12.0%
10.0%
8.0%
6.0%
3.8% 4.0%2.5%
2.0%
0.0%
VETERANS HEALTH ADMINISTRATION
VHA HCV Testing National
8
,000,000
2,753,017
,500,000
,000,000 1,924,778 (69.9%)
,500,0001,350,882
,000,000828,239 817,621 (30.1%)
500,000533,261 (39.5%)
02002 2004 2006 2008 2009 2010 2011 2012 2013 2014 2015
Born 1945-1965 in care in year HCV tested in VHA Need testing
1
1
2
2
3
VETERANS HEALTH ADMINISTRATION
HCV Testing of Female Veterans in Care in 2015
[VALUE] 72.9%
67.0% 72.1% 73.7% 71.5% 68.8%
51.2%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
National AmericanIndian/AlaskaNative
Asian Black Hispanic NativeHawaiian/
PacificIslander
White Mixed/Other/
Unknown
Born <1945 Born 1945-1965 Born > 1965Females
Population Health Services Data Source: CDW as of 7 January 2016
9
VETERANS HEALTH ADMINISTRATION
HCV Testing of Male Veterans in Care in 2015
70.0% 72.8%
66.9%
77.5% 76.2% 72.6%
69.0%
55.3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
National AmericanIndian/AlaskaNative
Asian Black Hispanic NativeHawaiian/
PacificIslander
White Mixed/Other/
Unknown
Born <1945 Born 1945-1965 Born > 1965Males
Population Health Services Data Source: CDW as of 7 January 2016
10
VETERANS HEALTH ADMINISTRATION
HCV Prevalence in Female Veterans in Care in 2015
3.9%
4.8%
1.5%
4.4%
3.3%
5.0%
3.7%
2.8%
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
Total American Indian/Alaska Native
Asian Black Hispanic Native Hawaiian/Pacific Islander
White Mixed/Other/
Unknown
Born <1945 Born 1945-1965 Born >1965
Population Health Services Data Source: CDW as of 7 January 2016
11
VETERANS HEALTH ADMINISTRATION
HCV Prevalence in Male Veterans in Care in 2015
Population Health Services Data Source: CDW as of 7 January 2016
8.4% 8.4%
2.2%
14.8%
8.6%
7.4% 6.6% 6.5%
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
National AmericanIndian/AlaskaNative
Asian Black Hispanic NativeHawaiian/
PacificIslander
White Mixed/Other/
Unknown
Born <1945 Born 1945-1965 Born >1965
12
VETERANS HEALTH ADMINISTRATION
Homeless Veterans ā¢ VA provides care to over 200,000 homeless veterans each year
ā HCV prevalence presumed elevated in homeless veterans
ā Prior prevalence estimates for HCV antibody positivity ranging from 6.6%-44.0%
13
Cheung et al, J Clin Gastro 2002;34(4):476-480; Desai et al, Soc Psych Pysch Epi 2003;38(7):396-401; Gish et al, Clin Gastro Hep 2005;3(4):311-318.
Homeless veterans in VA care in 2015, N=242,740
Non-homeless veterans in VA care in 2015, N=5,424,685
Female Male
26,966 (11.1%) 215,774 (88.9)
408,481 (7.5%) 5,016,204 (92.5%)
American Indian/Alaskan Native Asian Black Native Hawaiian/Pacific Islander Hispanic White Mixed/Other/Unknown
3,465 (1.4%) 1,653 (0.7%)
94,166 (38.8%) 2,058 (0.8%)
16,601 (6.8%) 112,137 (46.2%)
12,660 (5.2%)
45,599 (0.8%) 54,000 (1.0%)
824,828 (15.2%) 47,095 (0.9%)
316,125 (5.8%) 3,655,678 (67.4%)
481,360 (8.9%)
Born <1945 Born 1945-1965 Born >1965
11,200 (4.6%) 143,617 (59.2%) 87,923 (36.2%)
1,659,796 (30.6%) 2,609,717 (48.1%) 1,155,172 (21.3%)
Backus LI, APHA Oct 2016
VETERANS HEALTH ADMINISTRATION
HCV Testing in Homeless Veterans in VA Care in 2015
59.5%
44.0%
69.2% 60.0%
78.1%
64.9%
83.6%
70.7%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Total Born <1945 Born 1945-1965
Born>1965
Non-homeless Homeless
189,508 242,740
3,277,550 5,424,685
7,264 11,200
729,840 1,659,796
1,804,687 2,609,717
693,023 1,155,172
62,153 87,923
120,091 143,617
14
Backus LI, APHA Oct 2016
VETERANS HEALTH ADMINISTRATION
HCV Prevalence in Homeless Veterans in VA Care in 2015
4.5%
1.3%
7.2%
0.9%
15.4%
8.4%
21.4%
4.6%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Total Born <1945 Born 1945-1965
Born>1965
Non-homeless Homeless
29,063 188,581
144,964 3,216,967
610 7,228
9,696 727,309
129,163 1,797,664
6,105 691,972
2,876 62,045
25,577 119,308
15
Backus LI, APHA Oct 2016
VETERANS HEALTH ADMINISTRATION
HCV Testing - Strategies
ā¢ National electronic Clinical Reminder for providers
ā āpop-upā that notifies provider that patient is in 1945-1965 birth cohort
ā HCV RNA reflex testing for positive antibody
ā¢ Automated invitation letter for at-risk veterans to get tested ā automation of result notification
ā¢ Focus on at-risk groups by educating and partnering with providers in MH, SUD
ā¢ Partner with homeless stand-downs and HUD/VASH programs
ā¢ Performance measure for VISN Network Directors
ā Increase in screening rates by 7-8% nationwide in FY15+FY16 (vs. 1% in years prior)
ā¢ Social Marketing
ā Multimedia
ā Stimulate patients to ask for the test
16
VETERANS HEALTH ADMINISTRATION
VA Electronic HCV Testing Reminders
ā¢ Birth Cohort testing: Born 1945-1965
ā¢ Documented HCV risk factor
ā¢ If a patient has a positive anti-HCV antibody but no HCV RNA result in the local VISTA system, the reminder will provide options for ordering HCV RNA or recording outside HCV RNA results
ā IDU ā Blood transfusion or organ transplantation
prior to 1992 ā Hemodialysis ā Vietnam-era service (1964-1975) ā Tattoos or body piercing ā Intranasal drug use ā 20+ lifetime sexual partners ā Sexual exposure to HCV-infected persons
ā HIV infection ā Hemophilia and received clotting factors
prior to 1987 ā Unexplained liver disease or abnormal liver
function test ā Alcoholic hepatitis ā Alcohol abuse/dependence ā Born to mother with HCV ā Incarceration
17
VETERANS HEALTH ADMINISTRATION
HCV Treatment & Cure
18
Lisa I. Backus MD PhD Patient Care Services/Population Health Department of Veterans Affairs
VETERANS HEALTH ADMINISTRATION
Treatment of HCV-Infected Veterans in VA
70,000
io
nt 60,000
ipcr
es 50,000
pr
tfi
rs 40,000
h
wit
s 30,000
ane
rte 20,000
Ve
ivta 10,000
Cu
mu
l
01/1/14 1/1/15 1/1/16
SOF (Jan 2014) n=7892
SOF+SMV (Jan 2014) n=3697
LDV/SOF (Nov 2014) n=46,000
OPrD (Jan 2015) n=8174
DAC+SOF (Aug 2015) n=1406
OPr (Aug 2015) n=35
ELB/GRZ (Feb 2016) n=4493
Uptake of HCV Antiviral Regimens in VA in 2014/2015/2016
VEL/SOF (Jul 2016) n=1987
Population Health Services Release dates through 9/30/2016
Regimen (first available) n Cumulative Veterans n=71,586
FY15 29,129 FY14 5,445 FY16 37,012
19
VETERANS HEALTH ADMINISTRATION
Number of Veterans with HCV in VA care Requiring Anti-viral Treatment
168,708
71,811
0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
10/1/2013 10/1/2014 10/1/2015 10/1/2016
Vet
era
ns
awai
tin
g tr
eat
me
nt
Population Health Services Data Source: CCR as of 7 October 2016
20
VETERANS HEALTH ADMINISTRATION
Demographics of HCV-Infected Veterans in VA care in 2015
21
Veterans with HCV in VA care in 2015
Female Male
3.5% 96.5%
American Indian/Alaskan Native Asian Black Native Hawaiian/Pacific Islander Hispanic White Mixed/Other/Unknown
1.0% 0.2%
35.2% 0.8% 6.0%
52.2% 4.6%
Born <1945 Born 1945-1965 Born >1965
5.9% 88.9% 5.2%
Population Health Services Data Source: CCR as of 27 March 2016
VETERANS HEALTH ADMINISTRATION
Characteristics of 21,142 Genotype 1 Veterans Initiating HCV Treatment in VA
Age (years)
< 55
55-64
ā„ 65
61.7Ā±6.4 (23.4-90.8)
2,040 (9.6%)
12,841 (60.5%)
6,361 (29.9%)
Sex Male 20,529 (96.6%)
Race/ethnicity
African-American
Caucasian
Hispanic
Other/multiple
8,276 (39.0%)
10,447 (49.2%)
1,143 (5.4%)
1,376 (6.5%)
Diabetes 6,883 (32.4%)
HIV co-infected 1,092 (5.1%)
Mental health diagnosis, ever 15,102 (71.1%)
Mental health diagnosis, ever
Anxiety
Bipolar
Depression
PTSD
Schizophrenia
9,529 (44.9%)
2,708 (12.7%)
13,338 (62.8%)
6,740 (31.7%)
1,968 (9.3%)
Mental health diagnosis in the past year
Anxiety
Bipolar
Depression
PTSD
Schizophrenia
3,632 (17.1%)
1,115 (5.2%)
7,379 (34.7%)
4,351 (20.5%)
838 (3.9%)
Population Health Services Backus et al, AASLD 2016 poster 2011
22
VETERANS HEALTH ADMINISTRATION
SVR Rates Among GT-1 HCV-infected Veterans
Population Health Service Backus et al, AASLD 2016 poster 2011
% (n/N)
Overall SVR 90.3 (17,609/19,504)
Age < 55
55-64
ā„ 65
90.8 (1,634/1,800)
90.1 (10,620/11,782)
90.4 (5,355/5,922)
Sex: Male
Female
90.2 (16,996/18,848)
93.4 (613/656)
Race/ethnicity
African-American
Caucasian
Hispanic
Other/multiple/unknown
89.6 (6,789/7,575)
91.0 (8,730/9,595)
89.7 (9,54/1,063)
89.4 (1,136/1,271)
HIV coinfection: No
Yes
90.3 (16,701/18,495)
90.0 (908/1,009)
FIB-4: ā¤3.25
>3.25
91.7 (12,372/13,488)
87.1 (5,187/5,952)
HCV subtype: 1a
1b
89.6 (12,589/14,047)
92.0 (5,020/5,457)
23
VETERANS HEALTH ADMINISTRATION
SVR Rates Among GT-1 HCV-infected Veterans: Impact of Mental Health
Population Health Services Backus et al, AASLD 2016 poster 2011
24
% n/N
Mental health diagnosis
No
Yes
91.6 (5,201/5,679)
89.8 (12,408/13,825)
Mental health diagnosis, ever
Anxiety
Bipolar
Depression
PTSD
Schizophrenia
89.6 (7,787/8,695)
89.6 (2,182/2,434)
89.7 (10,959/12,216)
89.7 (5,522/6,158)
89.7 (1,606/1,791)
Mental health diagnosis in past year
Anxiety
Bipolar
Depression
PTSD
Schizophrenia
90.3 (2,983/3,305)
90.3 (908/1,006)
89.8 (6,046/6,734)
89.3 (3,558/3,985)
89.7 (689/768)
HCV Care Cascade in Homeless and Non-homeless Veterans in VHA Care in 2015
100.0%
77.0% 72.4%
31.0%
22.8%
100.0%
89.6%
79.5%
22.9%
15.5%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Chronic HCV(estimated)*
n=188,156|32,449
Diagnosed with chronic HCVā
n=144,964 |29,063
Linked to HCV careā” n=136,169|25,786
Treated with HCV antiviralsā
n=58,321|7,421
Achieved SVRā
n=42,878|5,041
% o
f to
tal c
hro
nic
HC
V p
op
ula
tio
n
Non-homeless Homeless
77.0% 93.9% 42.8% 73.5%
89.6% 88.7% 28.8% 67.9%
4,012 homeless Ve terans received all-oral regimens in 2015
Noska A, et al. Pub Health Rep , in press
25
VETERANS HEALTH ADMINISTRATION 26
Data Reports to Identify Patients Locally
VETERANS HEALTH ADMINISTRATION
VA Strategies to Address HCV
Timothy Morgan MD Chief of Hepatology, VA Long Beach Director, National Hepatitis C Resource Center
27
VETERANS HEALTH ADMINISTRATION
VA National Strategy for Curing HCV
ā¢ Active identification and outreach (registry, dashboards)
ā¢ Data analysis and feedback to track and monitor continuum of caremetrics, outcomes, and cost
ā¢ Increase capacity ā make it easy for patients to get treated
ā Midlevel providers (PharmDās, NPās, PAās to treat), SCAN-ECHO, telehealth,shared medical appointments
ā¢ Integrated care ā case management, psychosocial support, primary care,pharmacy
ā¢ Targeted Outreach to patients ā multimedia, letters, Veteran ServiceOrganizations
ā¢ Regional HCV Innovation Teams (HITs)- education and dissemination ofbest practices, redesign care based on local process and clinical outcomes
28
National Hepatitis C Resource Center/VISN HCV Innovation Team (HIT) Collaborative
National Hepatitis C Resource Center
ā¢ Provider and Patient Educationā¢ Regional (VISN) Innovation Teamsā¢ System Redesignā¢ Monitoring and Evaluation of HCV care
Collaborating within VISNs and across VISNs HIT Collaborative
ā¢ Multi-disciplinary teams guided by Lean/process improvement methods Physicians, nursing, pharmacy, psychology, case management Lean experts, Population Health, IT
ā¢ Make-up of teams and activities guided by local needs
VETERANS HEALTH ADMINISTRATION 29
VETERANS HEALTH ADMINISTRATION
System Redesign Definition and Process
30
ā¢ Improving care by redesigning the processes of care
delivery
ā¢ Assess how we deliver care now (current state map)
ā¢ Identify problems with care delivery (problem statement)
ā¢ Propose solutions (future state map)
ā¢ Measure change in care (monitoring and evaluation)
ā Assess improvements
VETERANS HEALTH ADMINISTRATION
Linkage to Care - Strategies
ā¢ Active outreach vs. dependency on passive referral
ā¢ Treatment offered to all ā emphasis on patients with most severe liver disease
ā¢ Optimizing use of electronic health records to create electronic population health management tools for hep c (registry, dashboards)
ā¢ Multi-disciplinary team coordinators
ā¢ Patient education classes
31
VETERANS HEALTH ADMINISTRATION
Evaluation and Treatment
ā¢ Ongoing Provider education ā vaww.hepatitis.va.gov, educational materials
ā Teleconferences, webinars, clinical updates, email communication to providers
ā¢ System-wide guidelines and VA treatment considerations for evaluation for treatment
ā¢ Primary care providers, mid-level and specialty care providers engaged in evaluation and treatment
ā¢ Group treatment clinics
32
VETERANS HEALTH ADMINISTRATION
Increasing Capacity
ā¢ Expanding role of mid-level providers
ā PharmD, NP, PA as treaters and to conduct monitoring and follow-up
ā¢ Engage Primary Care
ā Testing
ā Identification of HCV patients
ā Co-management / Treatment
ā¢ SCAN-ECHO
ā¢ Telehealth
ā¢ Mental Health / Substance Use Disorder integration
ā¢ Education
ā Produce high-quality providers
ā Mini-sabbaticals, train-the-trainer, Bootcamps
33
VETERANS HEALTH ADMINISTRATION
Integrated Care
34
ā¢ Integrated multi-disciplinary
HCV care: use of PharmD,
NP, PA as ātreatersā
ā¢ Screening protocols for
psychiatric, alcohol use, and
substance use disorders
ā¢ Motivational interviewing to
reduce alcohol use and allow
anti-viral treatment of HCV
patients
ā¢ Liver tumor boards to
coordinate HCC care
Liver
Specialty
Social
Work
Pharmacy Substance Use
Disorder Therapy
Mental
Health Care
Coordination
Primary
Care
VETERANS HEALTH ADMINISTRATION
Barriers
ā¢ Patient Level ā Unable or unwilling to receive HCV treatment
ā Other comorbidities (Mental health, substance use)
ā Extensive, multi-pronged outreach approaches necessary
ā¢ System Level ā Funding
ā Efficient linkage to care
ā Geographic location / convenience
ā Provider knowledge / experience / comfort
ā Infrastructure
ā¢ Lab resources, case management, psychosocial support
35
VETERANS HEALTH ADMINISTRATION
Patient-level Barriers to Treatment
36
Source: Based on VA data collected from VISNs 3, 7, 8, 17, 19, 21, 22, & 23; July 2016
Deceased 3%
Psychosocial Needs 16%
Unstable Comorbidity
31%
Patient Determinant
50%
Deceased
Psychosocial Needs
Unstable Comorbidity
Patient Determinant
VETERANS HEALTH ADMINISTRATION
Outreach and Education
Elizabeth Maguire, MSW Communications Lead, HIV, Hepatitis, and Public Health Pathogens Program Center for Healthcare Organization and Implementation Research (CHOIR) Bedford VA Medical Center
37
VETERANS HEALTH ADMINISTRATION
Veteran Outreach
ā¢ Awareness campaigns, including social media
ā¢ Advertising campaigns
ā¢ Partnerships with Veteran Service Organizations (VSOs)
ā¢ Direct outreach to Veterans
38
VETERANS HEALTH ADMINISTRATION
Promotional Campaign with Veterans Cured of Hepatitis C
39
VETERANS HEALTH ADMINISTRATION
Provider Resources
ā AUDIT-C scoring cards
ā Hepatitis A/B immunization
ā Hepatitis C Support Groups
ā Liver Telehealth Guide
ā Brief Alcohol Intervention Teaching Guide
ā¢ Web
ā LiveMeeting Webcasts on HCV
ā¢ Conferences
ā SCAN/ECHO
ā Clinical Pharmacist HCV Boot Camps
ā Hot Topics in Liver Disease at AASLD
ā HCV Protease inhibitor training
ā Liver Disease for Primary Care Physicians
ā Mini-sabbaticals/mini-residencies
ā¢ Published guidelines
ā VA HCV Treatment Considerations
ā HCV Testing
Patient Resources ā¢ Patient Guides
ā Cirrhosis
ā Liver Cancer
ā New HCV Drugs āTaking Your Therapyā
ā Liver Transplant
ā Alcohol
ā Managing Treatment Side-effects
ā¢ Patient tools
ā Drinking diaries
ā Triple therapy workbooks
ā Education classes
40
Training and Education www.hepatitis.va.gov