9/26/2018
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Closing the Gaps: Improving the HCV Care Continuum in Hard‐to‐
Reach Patients
Jennifer Price, MD, PhD
Associated Professor of Medicine
Division of Gastroenterology/Liver Transplant
University of California, San Francisco
Disclosures
• Dr. Price has received research support grants from Gilead Sciences and Merck.
• Dr. Price’s spouse has ownership interest in AbbVie, Bristol‐Myers Squibb, Johnson and Johnson, and Merck.
Outline
• Epidemiology of HCV in 2018
• HCV care cascade
• UCSF and SF‐wide efforts to eliminate HCV‐related health disparities
Estimated 70 Million Persons Living With HCV Worldwide
Polaris Observatory HCV Collaborators. Lancet Gastroenterol Hepatol. 2017;2:161‐176.
USA 2015 Estimates:Viremic prevalence 0.9% (95% CI 0.7 to 1.2%)
Viremic population 2.9 million (95% CI 2.2 to 3.8 million)
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HCV Incidence is Rising in the US Related to the Opioid Epidemic
https://www.cdc.gov/hepatitis/hcv/statisticshcv.htm#section1
• Estimated 41,200 new HCV infections in the US in 2016
• 3‐fold increase since 2010
• 80% related to injection drug use
• Parallels rises in injection of prescription opioids and heroin
MaleFemale
Mostly baby boomers
Newly Rep
orted
HCV Cases (%) 5
0 10 20 30 40
Age (Yrs)
4
3
2
1
050 60 70 80 90 100
Newly Rep
orted
HCV Cases (%) 5
0 10 20 30 40
Age (Yrs)
4
3
2
1
050 60 70 80 90 100
MaleFemale
PWIDs: 20‐40 yrs of age
2007 (N = 41,037) 2015 (N = 33,454)
Changing Epidemiology of HCV in the US
Slide credit: clinicaloptions.com
California Department of Public Health. Chronic hepatitis C infections in California: cases newly reported through 2015. June 2017.
Pre‐All Oral DAA Hepatitis C Virus Care Cascade in the US
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
Pre‐All Oral DAA Hepatitis C Virus Care Cascade in the US
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
Increase SVR rates
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Real‐World SVR Rates Using Pangenotypic Regimens
96100
9097 9596 93
0
20
40
60
80
100
All Patients F4 OnlyGT1A GT1B G2 G3
Tsai N, et al EASL 2017. Abstract SAT-244
TRIO Network: Specialty pharmacies in U.S.
SVR12
GT1
N= 23/24. 5/5. 91/94. 66/68 9/10. 21/22. 14/15
97 100
0
10
20
30
40
50
60
70
80
90
100
Intent to Treat Per Protocol*
*2 patients stopped treatment prematurely; 1 lost to f/u
German Hepatitis C Registry
49% GT18% GT234% GT39% GT4
SOF/VEL GLE/PIB
Berg T, et al. EASL 2018. Abstract GS-007.
Most Patients Can Now Be Cured
Pan‐genotypic all oral regimens
Short duration of treatment
Highly effective and safe
Multiple options
High SVR Rates Are Not Enough If Treatment Initiation Does Not Improve
Thomas DL. Lancet 2010;376:1441‐1442.
Pre‐All Oral DAA Hepatitis C Virus Care Cascade in the US
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
Increase SVR rates
We must focus on the left side of the cascade
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Pre‐All Oral DAA Hepatitis C Virus Care Cascade in the US
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
Increase SVR rates
We must focus on the left side of the cascade
Improve HCV screening
HCV Screening
• PCP offices
– Birth cohort and risk‐based screening
• Hospitals
– ER, inpatient
• Prenatal clinics
• Prisons and jails
• Community‐based testing
– Homeless shelters
– Single room occupancy hotels
– OST clinics
– Syringe exchange programs
– Residential drug treatment
– STD clinic
Screening Initiatives Work!
• Baby boomer screening in healthcare settings (104 testing sites, 21 US municipalities)1
– 24,966 tested 11.6% HCV Ab+
• Baby boomer screening in ER2
– 1,529 tested 11.1% HCV Ab+
• Baby boomer screening in safety net hospital3
– 4,582 tested 6.9% HCV Ab+
1Patel RC, et al. Public Health Rep. 2016;131(suppl 2):12‐19. 2Galbraith JW, et al. Hepatology. 2015;61:776‐782. 3Turner BJ, et al. Hepatology. 2015;62:1388‐1395.
Screening Isn’t Enough…
Identifying HCV Ab+ individuals
Drop‐off for confirmatory testing with HCV RNA
Very big drop‐off for linkage to care
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Pre‐All Oral DAA Hepatitis C Virus Care Cascade in the US
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
Increase SVR rates
Improve HCV screening
Linkage to care is a major challenge
Barriers to HCV Care
Patient Provider System
• Comorbidities• Active substance use• Unstable housing• Lack of transportation
• Competing priorities• Limited knowledge of HCV
• Lack of trust in traditional healthcare systems
• Perceived lack of value in treating some patients
• Concerns about adherence
• Medical contraindications
• Competing priorities
• Limited time
• Insurance access• Availability of HCV providers
• Payer restrictions for DAA approval
• Payer requirements prior to DAA approval
UCSF Hep C Extension for Community Health Outcomes (ECHO)
• To expand the community of HCV healthcare providers in CA, especially in non‐urban settings– Academic “hub” of experts supporting education and training of community PCPs (the “spokes”)
• Build PCP skill and confidence implementing HCV screening and treatment guidelines– Bimonthly videoconferences with didactics and case presentations by the spokes
– On‐demand CME webinars, sharing of best practices, e‐newsletters
– HCV “warm‐line”
– HCV 101 and HCV 102 conferences
– Longitudinal mentoring
UCSF HCV ECHO: Our Commitment
• Clinical mentorship and support of our HCV champions
– Access during and in between bimonthly HCV clinics
• Pharmacy expertise
– Resources for assessment of drug‐drug interactions
– Support and guidance on authorization, PAPs
• Assist with linkages for higher level care for patients with complications
– Cirrhosis, liver cancer
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Bimonthly didactics
Case presentations HCV 101 and HCV 102
HCV ECHO Spokes
Siskiyou
Shasta
4
Inyo
Tehama
3Lassen
Plumas
76
33
Modoc
2
1
15
29
Toulumne
13
Mono
5
14
27
8
35
31
12
36
11
19
32
9
16
17
26
25
2418
10
23
28
18
21
San Francisco
Tulare
20
22
1.Del Norte
2.Humboldt
3. Trinity
4. Mendocino
5. Glenn
6. Butte
7. Sierra
8. Lake
9. Colusa
10. Sutter
11. Yuba
12. Nevada
13. Sonoma
14. Napa
15. Yolo
16. Sacramento
17. Placer
18. El Dorado
19. Solano
20. Contra Costa
21. San Joaquin
22. Amador
23. Calaveras
24. Alpine
25. Alameda
26. San Mateo
27. Santa Cruz
28. Santa Clara
29. Stanislaus
30. Merced
31. Mariposa
32. San Benito
33. Monterey
34. Madera
35. Fresno
36. Kings
2 3
6
1
6
1
1
1
1
1
3
3
1
1
13
1
1
2
3
2
Rates of newly reported non‐incarcerated HCV cases in 2013 by county and number of UCSF HCV Project ECHO local Champions (red pins).
UCSF HCV ECHO Champions Sep 2016
Not available<50*50‐99*100‐149*≥150*
*per 100,000
53 HCV Champions(36 Active)
Siskiyou
Shasta
4
Inyo
Tehama
3Lassen
Plumas
76
33
Modoc
2
1
15
29
Toulumne
13
Mono
5
14
27
8
35
31
12
36
11
19
32
9
16
17
26
25
2418
10
23
28
18
21
San Francisco
Tulare
20
22
1.Del Norte
2.Humboldt
3. Trinity
4. Mendocino
5. Glenn
6. Butte
7. Sierra
8. Lake
9. Colusa
10. Sutter
11. Yuba
12. Nevada
13. Sonoma
14. Napa
15. Yolo
16. Sacramento
17. Placer
18. El Dorado
19. Solano
20. Contra Costa
21. San Joaquin
22. Amador
23. Calaveras
24. Alpine
25. Alameda
26. San Mateo
27. Santa Cruz
28. Santa Clara
29. Stanislaus
30. Merced
31. Mariposa
32. San Benito
33. Monterey
34. Madera
35. Fresno
36. Kings
Not available<50*50‐99*100‐149*≥150*
*per 100,000
4
5
2
1
35
1
1
1
1
1
6
3
2
16
2
2
4
1
Rates of newly reported non‐incarcerated HCV cases in 2013 by county and number of UCSF HCV Project ECHO local Champions (red pins).
UCSF HCV ECHO Champions Sep 20184
1
3
11
Los Angeles (2), Santa Barbara (2), San Bernadino (7)
107 HCV Champions(90 Active)
Barriers to HCV Care
Patient Provider System
• Comorbidities• Active substance use• Unstable housing• Lack of transportation
• Competing priorities• Limited knowledge of HCV
• Lack of trust in traditional healthcare systems
• Perceived lack of value in treating some patients
• Concerns about adherence
• Medical contraindications
• Competing priorities
• Limited time
• Insurance access• Availability of HCV providers
• Payer restrictions for DAA approval
• Payer requirements prior to DAA approval
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Improving HCV Screening and Linkage to Care
Mission: To improve liver health for all by providing mobile liver health screenings and linkage to care
Procedures Offered
OraQuick® HCV Rapid Antibody Test
If HCV antibody positive venipuncture for confirmatory HCV RNA testing and genotype
Liver fibrosis staging with portable FibroScan® 430 Mini+
HCV counseling
Linkage to care with DeLIVERteam facilitating appointment scheduling
27
VISION STATEMENT: End Hep C SF envisions a San Francisco where HCV is no longer a public health threat, and HCV‐related health inequities have been eliminated.
Slide credit: K Burk/End Hep C SF
End Hep C SF Design and Work Group Functions
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Coordinating Committee
•Manage Finances
• Ensure Alignment of activities and plans
Research and Surveillance
• Discuss HCV research opportunities
• Prevalence, care cascades
Prevention Testing Linkage
• Explore testing, linkage strategies
• Lead community engagement events
Treatment Access
• Identify treatment access opportunities
• Develop capacity of treating providers
Executive Advisory
Committee
Consumer Advocates
Problem‐solve, advise
Participate, lead, share stories
Slide credit: K Burk/End Hep C SF
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End Hep C SF Overall Accomplishments—Evaluation
• Year Two Evaluation Highlights
40 people representing 20 organizations regularly participate in monthly meetings
52% increase in community‐based rapid testing from 2016‐2017
15 new HCV treatment sites added in 2017
28% increase in citywide treatment access from 2016 to 2017
29Slide credit: K Burk/End Hep C SF
Prevention Testing Linkage Success: Community Engagement
Get Cured, Stay Cured meeting 3.8.18, Testing Day Rally 5.18.18
30Slide credit: K Burk/End Hep C SF
Increase in Community‐Based Screening
31
0
100
200
300
400
500
600
700
800
900
1000
2015 Q1 2015 Q2 2015 Q3 2015 Q4 2016 Q1 2016 Q2 2016 Q3 2016 Q4 2017 Q1 2017 Q2 2017 Q3 2017 Q4
Rapid Antibody HCV Testing, 1/1/15‐12/31/17San Francisco Department of Public Health
Reactive Total Tests Linear (Total Tests)
Overall 2017 Antibody Reactivity
Rate 18.4%
Focus on: PWIDs, People who smoke stimulants, Trans women, MSM on PrEP
Slide credit: K Burk/End Hep C SF
What’s next?
San Francisco Health Plan: approximately 4000 members with HCV, 23% have been treated since 2014
San Francisco Health Network: 560 patients treated though primary care since tracking in 2016, out of an estimated total of 2400 with active HCV (23%)
Estimated 4000‐5000 patients treated citywide since 2014 – approximately 20% of active HCV infections re: End Hep C SF point‐in time estimate
Treatment Access Success:Increased Treatment Access Citywide
Treating HCV Beyond the 4‐Wall Clinic
HCV treatment DOT in methadone clinics
Testing and Treatment in shelters
Street Medicine team actively treating patients
SFAF treating folks at Magnet and 6th St. Harm Reduction Center
Slide credit: K Burk/End Hep C SF
9/26/2018
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Summary
• HCV is curable in individuals with DAAs
• Eliminating HCV in populations requires much more than medication
Summary
• HCV is curable in individuals with DAAs
• Eliminating HCV in populations requires much more than medication
Identify and
Diagnose
•Educate providers on screening
•Scale up screening in high risk populations
•Rapid diagnostic and point‐of‐care confirmatory tests
Summary
• HCV is curable in individuals with DAAs
• Eliminating HCV in populations requires much more than medication
Identify and
Diagnose
•Educate providers on screening
•Scale up screening in high risk populations
•Rapid diagnostic and point‐of‐care confirmatory tests
Link to HCV
Treatment
•Linkage navigators
•Expand network of treaters
•Remove payer restrictions
•Bring treatment to patients, beyond traditional 4‐wall clinics
•Develop long‐acting/injectable treatment?
Summary
• HCV is curable in individuals with DAAs
• Eliminating HCV in populations requires much more than medication
Identify and
Diagnose
Prevent New
Infections, Re‐infection
•Educate providers on screening
•Scale up screening in high risk populations
•Rapid diagnostic and point‐of‐care confirmatory tests
Link to HCV
Treatment
•Linkage navigators
•Expand network of treaters
•Remove payer restrictions
•Bring treatment to patients, beyond traditional 4‐wall clinics
•Develop long‐acting/injectable treatment?
•Scale up treatment in transmission networks
•Educate patients on transmission prevention
•Provide harm reduction services
•Develop HCV vaccine
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•Keri Gailloux, Project Coordinator•Norah Terrault MD, Hepatologist• Jennifer Price MD, Hepatologist• John Chamberlain MD, Psychiatrist•Lisa Catalli NP• Jeff McKinney NP•Eliana Agudelo PA•David Quan, Pharmacist•Aileen Chi, Pharmacist•Max Fasbinder, IT• Jennifer Slepin RN, Outreach Liason
Rachel KannerProject Manager
•Angel Okoro, CHORI Intern•Tajii Thomas, CHORI Intern
Yesenia LaguardiaField Coordinator
Emily ValadaoResearch Coordinator
Funding•Gilead•Merck
•San Francisco Health Plan•Echosens
HCV Care Cascade
Pts (%)
n = 3,500,000 1,743,000 1,514,667 952,726 581,632 555,883 326,859
0
20
40
60
80
100
ChronicHCV
Infected
Diagnosedand Aware
Access to Care
HCV RNAConfirmed
Liver Biopsy
Prescribed HCV
Treatment
AchievedSVR
100%
50%
43%
27%
17% 16%9%
Yehia BR, et al. PLoS One. 2014;9:e101554.
OraQuick® HCV Rapid Antibody Test
Blood drawn and sent for HCV RNA and genotype,Liver fibrosis staging with portable FibroScan® 430 Mini+
Facilitate linkage to HCV provider
San Francisco by the Numbers
40
22,500 PWIDs
• 12,000 Active HCV Cases
• 68% of active cases among PWIDs
22,000 people HCV Seropositive
• 6% PWID
• 15% MSM‐PWID
16,010 people living with HIV
• Driven by both HBV and HCV
Highest Rate of Liver Cancer in US
Chen, Y.H., McFarland, W. Raymond, H.F. (2015). Estimated number of people who inject drugs in San Francisco, 2005‐2012. AIDS and Behavior.
www.endhepcsf.org
HIV Epidemiology Annual Report 2016. The San Francisco Department of Public Health. Population Health Division, HIV Epidemiology Section
Slide credit: K Burk/End Hep C SF