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Eliminating HCV Among PWIDs:

Part 2, Integrate the Tools Into Care Models


That Work in Your Setting
In partnership with:

This activity is supported by independent educational grants


from AbbVie and Gilead Sciences
About These Slides
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Slide credit: clinicaloptions.com

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Faculty and Disclosures
Stacey Trooskin, MD, PhD
Clinical Assistant Professor of Medicine
Division of Infectious Diseases
Perelman School of Medicine
University of Pennsylvania
Director of Viral Hepatitis Program
Philadelphia FIGHT Community Health Centers
Philadelphia, Pennsylvania

Stacey Trooskin, MD, PhD, has disclosed that she has received funds for
research support from Gilead Sciences.
Outline
 HCV Elimination Among PWID
 Models of Linkage to HCV Care for PWID
 Models of HCV Treatment and Cure
‒ Supporting Providers
‒ Supporting Patients
HCV Elimination Among PWID
Global Call for HCV Elimination
 WHO vision[1]: “Eliminate viral  US HBV/HCV Elimination Strategy
hepatitis as a major global public (National Academies of Sciences,
health threat by 2030” Engineering, and Medicine)[2]
‒ “Elimination” = 90% reduction in
2030 Targets incidence by 2030
90% Diagnosed  HCV elimination in US not feasible
80% Treated without engaging, treating PWID
65% Reduced mortality ‒ 30.5% of all HCV infections in
North America are among people
with recent IDU[3]

1. WHO. Global Health Sector Strategy on Viral Hepatitis, 2016-2021. 2. NASEM. A national strategy for the elimination of
hepatitis B and C. Washington, DC: The National Academies Press; 2017. 3. Grebely. Addiction. 2019;114:150. Slide credit: clinicaloptions.com
The Challenge: HCV Care Cascade Among PWID
100
90
Number of People (Thousands)

80
70
60
50
40
30
20
10
0
PWID Screened HCV Confirmatory HCV Treated Cured (SVR)
for HCV Antibody HCV RNA or Specialist
Antibody Positive GT Test Assessment
Grebely. Nat Rev Gastroenterol Hepatol. 2017;14:641. Iversen. Int J Drug Policy. 2017;47:77. Slide credit: clinicaloptions.com
The Barriers

Patient Provider System


• Comorbidities • Perceived lack of • Insurance access
• Competing priorities value in treating • Availability of
• Unstable housing some patients HCV providers
• Lack of • Concerns about • Payer restrictions
transportation adherence for DAA approval
• Limited knowledge • Medical • Payer
of HCV contraindications requirements
• Stigma around HCV • Competing prior to DAA
• Prior negative priorities approval
experiences in • Limited time
healthcare settings
Adapted from Jennifer Price, May 2019 AASLD Hepatitis C Special Interest Group Webinar. HCV Treatment in Patients with IDU. Slide credit: clinicaloptions.com
Operational Interventions to Reduce Gaps/Barriers
Along the HCV and HBV Care Continuum
People living
with chronic Diagnosed by
viral hepatitis serology Visited
provider for Initiated
hepatitis care, treatment Completed
assessment of HCV treatment Cure (HCV)
treatment or or viral
eligibility maintained on suppression
HBV treatment (HBV)
Testing Linkage to care Treatment Treatment Viral suppression
uptake adherence

Improve testing Facilitated referral Education about Coordinated Coordinated


access treatment treatment for treatment for
Programs to help hepatitis & other hepatitis & other
Education about patients meet Mental health comorbidities comorbidities
testing treatment services
eligibility criteria Education about Education about
Prompts to Resources for PCPs treatment treatment
increase testing by Colocated testing to manage
providers and care services treatment DOT DOT
Zhou. Lancet Infect Dis. 2016;16:1409. Slide credit: clinicaloptions.com
Models of Linkage to HCV Care for PWID
“Street Outreach”: Bring Services to the Patients
 Do One Thing: community-based HCV screening and linkage program in medically
underserved Philadelphia neighborhood with high HCV rate
 Provides comprehensive screening and patient navigation services

 Social marketing campaign


 Door-to-door outreach Uninsured: navigator facilitates
 Rapid screening via mobile medical unit appt with clinical social worker
 Patient navigator to provide counseling
and insurance assessment Insured with no known PCP:
 Facilitate referrals from PCPs navigator facilitates PCP acquisition
 Facilitate linkage to specialist

Trooskin. J Gen Intern Med. 2015;30:950. Slide credit: clinicaloptions.com


“Do One Thing” Campaign: HCV Care Cascade
 Of 1301 persons screened, 48 anti-HCV positive and not engaged in care
60

50 48 48
42
Participants, n

40 36 35
32 58%
30 29
23 21
20 17
12
10
0
Anti-HCV Accepted HCV RNA HCV RNA Received Had or Had or Obtained Linked to Retained in Initiated
positive HCV RNA test positive HCV RNA obtained obtained referral to sub- sub- HCV
test performed test results insurance PCP sub- specialty specialty therapy
specialist care care
Trooskin. J Gen Intern Med. 2015;30:950. Slide credit: clinicaloptions.com
Linkage to Care at Philadelphia FIGHT
 Patient Navigation Model
‒ Obtain detailed contact information
‒ Cross disciplinary and multicenter weekly “HCV Huddle”
‒ Open scheduling/walk-in hours
‒ Mobile FibroScan
‒ FQHC: no insurance or referral required
‒ Free transportation, food, blankets, shoes
‒ Modified DOT model, nurse-led but patient-driven
‒ Blood draws in the community
Slide credit: clinicaloptions.com
Philadelphia FIGHT: The C a Difference Testing and
Linkage to Care Program

CURE COMMUNITY BASED TESTING


The Jonathan Lax Treatment Center Drug Treatment Programs
The John Bell Health Center Homeless shelters
Broad Street Ministries Medication Assisted Treatment
The Youth Health Empowerment Project

Slide credit: clinicaloptions.com


C a Difference Testing at In-patient and Out-patient
Drug Treatment Sites: Jan 2017 – Mar 2019
Patient navigation model
1200
1080 1065 Evolving data with
linkage rate of
1000 46%
805
800
Individuals, n

600

371
400
219
200
65
0
HCV Ab+ HCV RNA test HCV RNA+ Linked to Care Initiated Documented
performed Treatment SVR
Courtesy of Stacey Trooskin. Slide credit: clinicaloptions.com
Facilitated Linkage to Care Model in North Carolina

 Durham County Department of Public Health federally funded HCV testing and
linkage to care program in Durham, North Carolina
 HCV antibody testing with reflex HCV RNA offered through STI clinic, county jail,
community testing sites (including residential substance abuse recovery program),
homeless clinic
 Linkage to care facilitated by HCV bridge counselor: education, incentives,
transportation, appointment scheduling with HCV specialists at nearby academic
centers and on-site clinics
 Dec 2012 – Feb 2014: 2004 HCV tests; 326 (16.3%) HCV Ab+; 241 (12.0%) HCV RNA+
‒ Rate of linkage to care: 51% (123/241)

Seña. Public Health Rep. 2016;131(Suppl 2):57. Slide credit: clinicaloptions.com


Patient Navigators: NYC DOH Check Hep C Patient
Navigation Program
 HCV services provided at 2 clinical care sites and 2 sites that linked patients to off-site care
 Multidisciplinary team included patient navigators to provide risk assessment, health
education, treatment readiness counseling, medication adherence counseling, medication
coordination
‒ Patient navigator supervisors provided oversight, program management, communication,
meetings, and site visits

 March 2014 - January 2015: N = 388


‒ Initiated treatment: 33% (129/388)
‒ SVR: 91% (119/129)

 Odds of treatment initiation higher for participants receiving on-site clinical care vs
participants linked to off-site care in bivariate analysis: 46% vs 25% (P < .0001)

Ford. Clin Infect Dis. 2017;64:685. Slide credit: clinicaloptions.com


Models of HCV Treatment and Cure:
Supporting Providers
Task Shifting to Address Barrier of Lack of Access to
Specialists
 Many different types of providers can deliver HCV treatment:
‒ PCPs, addiction medicine specialists, PAs, NPs
‒ Specialists can contribute by facilitating mentorship, education, training
 Many different settings can deliver HCV treatment
‒ FQHCs, drug treatment centers, prisons, mental health clinics
‒ Utilize embedded models of care
 Hepatologists/other subspecialists are only needed for select cases
(advanced liver disease, other complicating comorbidities)
Kattakuzhy. Ann Intern Med. 2017;167:311. Arora. N Engl J Med. 2011;364:2199. Rossaro. Dig Dis Sci. 2013;58:3620. Miller. J
Natl Med Assoc. 2012;104:244. Slide credit: clinicaloptions.com
Prescriber Restrictions
2014 2018

No restrictions
By or in consultation with a specialist
Specialist must prescribe
Restrictions unknown
CHLPI and NVHR at https://stateofhepc.org/. Slide credit: clinicaloptions.com
Strategies to Address Barrier of Payer Restrictions on
Type of Provider
 Utilize models that involve close collaboration between PCPs and
subspecialists
‒ Telemedicine
‒ Knowledge networks
 Also overcomes geographic distances to specialist access
 Good option for drug treatment and correctional settings

Arora. N Engl J Med. 2011;364:2199. Rossaro. Dig Dis Sci. 2013;58:3620. Miller. J Natl Med Assoc. 2012;104:244. Slide credit: clinicaloptions.com
Project ECHO: Extension for Community Healthcare
Outcomes
 Addresses critical gap in availability of specialty care for patients with complex
health conditions in rural and underserved settings

Learning Loop Trained PCPs


Community- deliver Patients receive
Expert team based primary specialty care specialty care
constitutes Hub provides care teams are services where
the “hub” training in the “spokes” they need them
specialty care

https://echo.unm.edu/about-echo/. Arora. NEJM. 2011;364:2207.


Rattay. Gastroenterology. 2017;153:1531. Slide credit: clinicaloptions.com
Veterans Affairs-ECHO: Promote PCP-Based HCV
Treatment With Video-Enabled Specialist Support
 4173 PCPs at 152 sites caring for Time to HCV Treatment by VA-ECHO Exposure
38,753 patients with HCV Exposed/Individual case review
0.8 Exposed/No individual case review
‒ n = 6431 with PCP in VA-ECHO Unexposed

Unadjusted Proportion Treated


‒ n = 32,322 with “unexposed” PCP 0.6

‒ Exposure = PCP participation in ≥ 1


VA-ECHO session 0.4

 Exposed patients had higher HCV


treatment rate vs unexposed patients 0.2

‒ aHR: 1.20 (95% CI: 1.10-1.32; P < .01)


0.0
 Adjusted SVR rates similar for exposed 0 1 2 3 4 5
vs unexposed PCPs (P = .32) Yrs Post-Baseline
Beste. Am J Med. 2017;130:432. Slide credit: clinicaloptions.com
Models of HCV Treatment and Cure:
Supporting Patients
Decrease HCV- and PWID-Related Stigma
 Goal: Everyone can access culturally appropriate stigma-free HCV
prevention, care, and treatment
 Training for health care providers and peer groups:
‒ Increase knowledge in different settings including drug use, addiction,
and other STIs
 Policy-level strategies, eg, decriminalization of drug possession for
personal use

Slide credit: clinicaloptions.com


Coordinating Care for PWID: Mental Health, Substance
Use Disorder, and Hepatitis Treatment
 Meta-analysis of 56 studies, 41 with outcomes on HCV care continuum
 5 studies evaluated coordinated mental health, substance use disorder,
and hepatitis treatment services
 Results showed improved HCV treatment uptake, treatment
completion, and cure vs usual care
HCV Outcome OR/RR (95% CI)
Treatment uptake (3 studies) 3.03 (1.24-7.37)
Treatment adherence (4 studies) 1.22 (95% CI: 1.05-1.41)
SVR (5 studies) 1.21 (95% CI: 1.07-1.38)

Zhou. Lancet Infect Dis. 2016;16:1409. Slide credit: clinicaloptions.com


ANCHOR: Pilot Study of HCV Treatment at Drop-in Harm
Reduction Organization in Washington, DC
 Single-center study
‒ 76% men, 93% black, 33% cirrhotic, 58% injected drugs at least daily, 33%
receiving medication-assisted therapy for drug use
Wk 12

Patients with chronic HCV infection, opioid use


disorder, and opioid injection in last 3 mos; no SOF/VEL* QD
decompensated cirrhosis or contraindicated DDIs
Concurrent buprenorphine and
(N = 100)
HIV PrEP offered as indicated
*Dispensed in 28-day increments at Day 1,
Wk 4, Wk 8 (ie, 3 bottles).

 Primary endpoint: SVR12


Kattakuzhy. AASLD 2018. Abstr 18. Slide credit: clinicaloptions.com
ANCHOR: HCV Treatment at Harm Reduction
Organization
 93 patients in ITT analysis Adherence Measure in ITT P
SVR12, %
Population Value
‒ Lost to follow-up: n = 8
Wk 4 HCV RNA  Yes (n = 80) 86
‒ Deceased: n = 3 .0005
< 200 IU/mL  No (n = 8) 25
‒ Virologic failure: n = 9 No treatment  Yes (n = 76) 86
.22
interruptions  No (n = 12) 67
‒ SVR12: n = 73 (78%) Completed 2 or 3
 Yes (n = 87) 84
of 3 SOF/VEL .0001
 Per protocol SVR12: 89% (73/82)  No (n = 6) 0
bottles
 Virologic success unaffected by Finished SOF/VEL  Yes (n = 20) 95
.65
baseline demographics such as drug on time (vs late)  No (n = 43) 88
use frequency, housing stability,
medication-assisted therapy

Kattakuzhy. AASLD 2018. Abstr 18. Slide credit: clinicaloptions.com


Colocalized Drug and HCV Treatment: Buprenorphine
Treatment Retention May Improve Cascade of HCV Care
P < .01
70 Retained in buprenorphine treatment > 6 mos
63
Not retained in buprenorphine treatment
60
P < .05
50
Clients, %

41
40 34
P < .05
30
21 22
20
9 9
10 6

0
Referred for Evaluated for Offered HCV Initiated HCV
HCV Care HCV Care Treatment Treatment
Norton. J Subst Abuse Treat. 2017;75:38. Slide credit: clinicaloptions.com
HCV Services at Syringe Service Program (SSP):
Contingency Management
 New York Harm Reduction Educators
 39 clients positive for HCV antibody by rapid testing
‒ 19 enrolled in contingency management arm
‒ 20 enrolled in control arm
 Contingency management:
‒ $20/visit for 2 evaluation visits and Wk 4, 8, and 12 visits
‒ $50 if HCV RNA undetectable at Wk 4

Norton. Int J Drug Policy. 2019;69:1. Slide credit: clinicaloptions.com


Linkage to HCV Care for PWID: Contingency
Management May Improve Cascade of HCV Care
20
20 19
Contingency management
P = .01 Control
15 14
12
Clients, n

10 9 9

6
5 4
3
1
0
Enrolled Attended Chronic Initiated SVR12
Baseline Visit HCV Treatment
Norton. Int J Drug Policy. 2019;69:1. Slide credit: clinicaloptions.com
PREVAIL: Intensive Models of HCV Care for PWID With
GT1 HCV Infection
 Randomized, controlled trial conducted Oct 2013 - Apr 2017 in Bronx, NY
Individual Treatment: self-administer all HCV medications
(n = 53)
Patients with GT1 HCV
infection willing to receive Group Treatment: attend weekly treatment group
HCV therapy on site at 3 (n = 52)
OAT programs
(N = 158) DOT: receive observed oral doses by nursing staff
at same time as receiving methadone or buprenorphine
(n = 53)

 Primary endpoint: adherence by electronic blister packs


 Secondary endpoints: HCV treatment completion and SVR 12

Akiyama. Ann Intern Med. 2019;[Epub]. Slide credit: clinicaloptions.com


PREVAIL: Outcomes for Intensive Models of HCV Care
for PWID

Individual Group
DOT
Outcome, % Treatment Treatment P Value
(n = 51)
(n = 51) (n = 48)
Overall adherence
 Electronic blister pack 74.4 77.5 82.8 .007 (DOT vs individual)
 Self report 94.2 95.5 94.8 .85
Completed HCV
96.1* 95.8* 98.0 .81
treatment
SVR12 90 94 98 .24
*1 patient in each of these groups died during study.

Akiyama. Ann Intern Med. 2019;[Epub]. Slide credit: clinicaloptions.com


Patient-Centered Model of HCV Care for PWID:
Hepatitis C Real Options (HERO) Study
 On-site HCV treatment at community health centers or methadone
treatment programs (16 sites in 8 states)
‒ Treatment: 12 wks SOF/VEL
Modified Directly Observed Therapy (mDOT)
(methadone maintenance program: n = 150;
Patients with any GT HCV
community health center: n = 150)*
infection, IDU in previous 3 mos,
± current OAT, DAA naive,
± HIV coinfection Standardized Intervention: Patient Navigation
(N = 600) (methadone maintenance program: n = 150;
community health center: n = 150)
*Patients in mDOT arm treated at methadone maintenance programs receive SOF/VEL daily with
daily methadone and those treated in community health centers video record themselves taking
SOF/VEL each day using app on their mobile device.
Taylor. INHSU 2018. Abstr. Slide credit: clinicaloptions.com
Key Take-Home Messages
 Ideal scenario to optimize care for PWID with HCV is integration of drug use
treatment, HCV therapy, harm reduction, and social services via collocated
multidisciplinary team
 In environments where that extent of colocalized care is not feasible, there are
advantages to comprehensive patient navigation services
‒ Consider the needs of your specific population
 Primary care providers do and will continue to play an integral role in achieving
HCV elimination targets for all populations, including PWID
‒ Telemedicine is an effective way to support nonspecialist treaters

 Call to Action: community and provider mobilization is needed to advocate


for removing barriers to HCV elimination
Go Online for More CCO
Coverage of HCV Elimination!
Case-based interactive multimedia modules on important considerations and strategies for
reaching HCV elimination goals among principle populations
Downloadable slidesets to use, update, and share in your noncommercial presentations to
colleagues or patients
ClinicalThought Commentaries in which expert faculty provide
key insights from their own clinical practice experience for
overcoming barriers to HCV elimination in key populations

clinicaloptions.com/hepatitis
Partnership Information

 The ASAM Fundamentals of Addiction Medicine 40-Hour CME Program


is an innovative educational program empowering primary care and
other providers to diagnose and treat patients at risk for or with
addiction.
 For more information, go to https://www.asam.org/education/live-
online-cme/fundamentals-program
Partnership Information

 International Network on Hepatitis in Substance Users (INHSU) has collaborated


with the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine
(ASHM) and the Kirby Institute at the University of New South Wales (UNSW) to
develop and deliver hepatitis C education, globally.
 The Hepatitis C in Primary Care and Drug and Alcohol Settings Education Program
provides healthcare practitioners with the knowledge and skills to expand hepatitis
C (HCV) care beyond hospital settings.
 For more information, go to http://inhsu.org/education-program/
Partnership Information

 HealthHCV designs and implements medical and consumer education and


training programs to improve the ability of organizations, professionals, and
individuals to address the needs of people living with viral hepatitis.
HealthHCV recently designed a new HealthHIV’s HCV Training & Certificate
Program, which will be launched in the coming months.
 For more information, go to http://healthhiv.org/certificate-
programs/coming-soon-hcv-training-and-certificate-program/

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