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9/26/2018

1

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.


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%


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.


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%


Increase SVR rates

We must focus on the left side of the cascade

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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%


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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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%


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

9/26/2018

7

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

28

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


9/26/2018

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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


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


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Summary

• HCV is curable in individuals with DAAs

• Eliminating HCV in populations requires much more than medication

Summary



Identify and

Diagnose

•Educate providers on screening

•Scale up screening in high risk populations

•Rapid diagnostic and point‐of‐care confirmatory tests

Summary



Identify and

Diagnose




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



Identify and

Diagnose

Prevent New

Infections, Re‐infection




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

9/26/2018

10

•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%


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


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