1. The HRSA/SPNS Hepatitis C Treatment Expansion Initiative: Project Summary Webinar for Demonstration Clinics

2. ONGOING HCV/HIV RESOURCES

3. Resources - www.usfetac.com

4. Tools & Forms See ETAC website:
Side bar link: Tools and Forms
Consent for Hepatitis C Treatment ISU
Decision flow chart ISU
HCV tracker for patients st mary
WashingtonUniv_H97HA19759_Appendix2-patient monitoring
UCSF_Protocol_for_Circle_of_care_5_18_12_final.pdf

5. Web Based Resources
Hepatitis C, Guidance and Hepatitis C, management and treatment
Learning site for special populations.
Modular training with free CME for Hepatitis B and Hepatitis C
EASL Recommendations on Treatment of Hepatitis 2014

6. Web Based Resources www.medscape.com/hiv
Requires registration. Search on this site for HIV/HCV
or/HIV
Both sites have slides and CME education related to the coinfected patient
Optimal Management of HIV and Hepatitis: Clinical Conference XXII

7. ECHO/TELEHEALTH http://echo.unm.edu/ http://fcaetc.org/echo
Univ. of NM TeleECHO clinics offers HCV monoinfection & HIV sessions
USF Florida/Caribbean AETC ECHO offers HIV/HCV and General HIV sessions
NW AETC ECHO home offers HIV sessions

8. SUSTAINABILITY

9. Program Components Clinic Infrastructure Personnel Delivery Protocols
Resources

10. Clinic Infrastructure
Established clinic with stable personnel
Diverse service availability
Organization leadership
340-B pharmacy
Availability of clinical trials
Access to specialists
Access to HCV rapid testing
Established outreach programs

11. Personnel Experienced providers Affiliated specialists
Dedicated case managers
Dedicated HCV nurses
Dedicated pharmacists
Mental health/ substance abuse specialists
Specific personnel in some sites

12. Delivery Protocols Established treatment protocols
Quality improvement activities

13. Resources Ryan White Care Act Mixed payer source New drug availability
Local public health authority
Patient assistance programs
Tele-Health activities

14. PROJECT FINDINGS

15. Patient Gender Female Male Transgender Total HCV+ Patients at baseline
Female
Male
Transgender
Total
HCV+ Patients at baseline
1370
3697 94
5161
% of patients
26.6%
71.6%
1.8%
Patients treated 41
196 2
239
% of patients treated
17.2%
82.0%
.8%

16. Patient Race/Ethnicity
African American
Asian
White
Other/
Unknown
Total
Hispanic
HCV+ Patients at baseline
2468 60
1367
1266
5161
1224
% of patients
47.8%
1.2%
26.5%
24.5%
23.7%
Patients treated 86 3
121 29
239 76
% of patients treated
36.0%
1.3%
50.6%
12.1%
31.8

17. Models of care Model 1: Integrated care – no clinic
Model 2: Integrated care with clinic
Model 3: Primary care – Expert Backup
Model 4: Co-located care with specialist

18. Patients treated by model of care
model 1
model 2
model 3
model 4
Patients treated 64
118 43 14
clinics 10 7 5
patients/clinic
6.4
16.9
6.1
2.8
HCV+ patients
2039
1996
736
390
Treated/HCV+
3.14%
5.92%
5.84%
3.59%
Total treated patients / Total HCV+ patients at baseline = 4.63%

19. Patients treated by model and year
model 1
model 2
model 3
model 4
year 1 24 48 16 6
year 2 37 53 23 7
year 3 3 17 4 1
patients 64
118 43 14
clinics 10 5
patients/clinic
6.4
16.9
6.1
2.8

20. Patients treated by study cohort
cohort 1
cohort 2
total
year 1 46 48 94
year 2 66 54
120
year 3 25
137
102
239

21. Size Matters Small (<1,000 HIV+ pts) Large (>1,000 HIV+ pts)
Small (<1,000 HIV+ pts)
Large (>1,000 HIV+ pts)
Patients treated 71
168
clinics 15 14
patients/clinic
4.73
12.00
HCV+ patients
1,032
4,129
Treated/HCV+
6.88
4.07

22. Genotype of patients treated1
191 2 18 3 21 4
Other/unknown 7

23. Treatment for Genotype 1 patients
Standard (Interferon + Ribavirin) 74
Telapravir (Incivek) 84
Boceprevir (Victrelis) 22
Experimental 9
Unknown 2

24. Patient Outcomes Patients Number Started treatment 239
Terminated early 94
Completed with viral suppression
100
Completed but relapsed 5
Unknown outcomes 40
Treatment success rate
% of patients who started: 41.8%
% of patients with known outcomes: 50.2%

25. Early Termination: When?
Time in treatment
Patients
First 12 weeks 51
12 – 24 weeks 30
24 – 48 weeks 13

26. Early Termination: WHO?
0 -12 weeks
12-24 weeks
24-48 weeks
total
% of treated patients
male 38 23 10 71
36.2%
female 12 6 3 21
51.2%
transgender 1 2
100.0% 51 30 13 94
39.3%
afr amer 37
43.0%
white 44
36.4%
other 7 5
44.8%
39.5%

27. Early Termination: Why?
Reason 
 Patients
Physical adverse effects 36
Psychological adverse effects 7
Patient request 4
Patient lost 3
Alcohol use 2
Insufficient treatment response 33
Other 9
Total early termination
 94

28. Patients terminating treatment early by genotype
0 -12 weeks
12 – 24 weeks
24 – 48 weeks
total
% of treated patients
Genotype 1 44 24 10 78
40.8%
Genotype 2 2 6
33.3%
Genotype 3 3 1 7
Genotype 4
50.0%
Other/unknown
28.6%

29. Genotype 1 Patient outcomes
Treatment
# patients
SVR
Early termination
Relapse
Unknown
Standard 74 35 34 2 3
Telaprivir 84 29 1 25
Boceprivir 22 6 13
Experimental 9
Total
191 77 78 33

30. Genotype 1 Patients: Termination Reason by Treatment
Physical adverse effects
Psychological adverse effects
Insufficient treatment response
Other
Standard 9 2 18 5
Telapravir 13 3 8
Boceprevir 1
Experimental
Unknown

31. Early termination by model of care
0 -12 weeks
12-24 weeks
24-48 weeks
total
% of treated patients
Model 1 12 3 27
43.2%
Model 2 29 7 48
40.7%
Model 3 8 4 1 13
30.2%
Model 4 2 6
42.9%

32. Barriers to treatment: Administrative/Financial
Changing leadership means persuading new people
Changing staff means training new people
Scheduling challenges
Extra paperwork – prior authorizations
Inadequate insurance coverage for procedures

33. Barriers to treatment: Community
Lack of highly skilled nursing and pharmacy staff
Lack of mental health treatment resources
Lack of substance abuse treatment resources

34. Barriers to treatment: Patient resistance
Patients have many complex and competing priorities
Many patients have heard negative stories about the side effects
Patient refusal was more often due to timing than unwillingness

35. Barriers to treatment: Poor treatment options
Clinician resistance
Patient resistance
Patients’ acute and chronic mental health issues

36. FUTURE CHALLENGES

37. Clinic Infrastructure/Personnel
How much of each clinics’ HCV treatment program was designed to address challenges with interferon based therapy?
Workforce realignment: Can personnel who were working to address a high toxicity/low efficacy paradigm (high patient needs) shift to address a low toxicity/high efficacy era (high patient volume)?

38. Moving forward… Change in reimbursement structure Affordable Care Act
New HCV treatment guidelines
Newly approved DAAs

39. Changes in Reimbursement/Drug Funding
New limitations on DAAs based on liver disease severity
Some drugs limited to only fibrosis grades 3 or above
Role of consultants in an ACO
Clinic-based treatment decisions at provider level versus higher volume review by a dedicated specialist

40. New HCV/HIV Treatment Guidelines
Each newly released direct acting antiviral must be evaluated and proper role in treatment established
Efficacy is now high across multiple classes
New Questions?
Timing – how to stratify multiple eligible patients for treatment now or later
Cost
Drug Interactions

41. Timing of Therapy
Quickly entering an interferon and ribavirin free era of HCV treatment
Who truly needs treatment now and who can wait for better, more tolerable therapies?
Are current therapies good enough so that clinicians can stop waiting and can proceed with patient treatment?