The HRSA/SPNS Hepatitis C
Treatment Expansion Initiative:
Project Summary Webinar for
Demonstration Clinics
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
ONGOING HCV/HIV RESOURCES
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Resources - www.usfetac.com
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Tools & Forms
See ETAC website:
http://health.usf.edu/medicine/internalmedicine/infectio
us/etac/index.htm
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Web Based Resources
• http://aasld.org/PRACTICEGUIDELINES/Pages/guidelinelisting.aspx
– Hepatitis C, Guidance and Hepatitis C, management and treatment
• http://aasld.org/LiverLearning%C2%AE/Pages/HCVtalks2.aspx
– Learning site for special populations.
• http://aasld.org/LiverLearning%C2%AE/Pages/LiverProgramforPrim
aryCareProviders.aspx
– Modular training with free CME for Hepatitis B and Hepatitis C
• http://files.easl.eu/easl-recommendations-on-treatment-ofhepatitis-C.pdf
– EASL Recommendations on Treatment of Hepatitis 2014
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Web Based Resources
• www.medscape.com/hiv
– Requires registration. Search on this site for HIV/HCV
• https://www.clinicaloptions.com/Hepatitis or/HIV
– Both sites have slides and CME education related to the coinfected
patient
• 2014 - Optimal Management of HIV and Hepatitis: Clinical Conference XXII
– http://www.practicepointhepatitis.com/
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
ECHO/TELEHEALTH
• http://echo.unm.edu/
– Univ. of NM TeleECHO clinics offers HCV
monoinfection & HIV sessions
• http://fcaetc.org/echo
– USF Florida/Caribbean AETC ECHO offers HIV/HCV and
General HIV sessions
• http://depts.washington.edu/nwaetc/echo/index.
html
– NW AETC ECHO home offers HIV sessions
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
SUSTAINABILITY
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Program Components
•
•
•
•
Clinic Infrastructure
Personnel
Delivery Protocols
Resources
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Personnel
•
•
•
•
•
•
•
Experienced providers
Affiliated specialists
Dedicated case managers
Dedicated HCV nurses
Dedicated pharmacists
Mental health/ substance abuse specialists
Specific personnel in some sites
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Delivery Protocols
• Established treatment protocols
• Quality improvement activities
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Resources
•
•
•
•
•
•
Ryan White Care Act
Mixed payer source
New drug availability
Local public health authority
Patient assistance programs
Tele-Health activities
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
PROJECT FINDINGS
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Patient Gender
Female
Male
Transgender
Total
1370
3697
94
5161
% of patients 26.6%
71.6%
1.8%
Patients
treated
196
2
82.0%
.8%
HCV+
Patients at
baseline
41
% of patients 17.2%
treated
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
239
Patient Race/Ethnicity
African
America
n
2468
Asian
White
Other/
Total
Unknown
Hispanic
60
1367
1266
1224
% of
patients
Patients
treated
47.8%
1.2%
26.5%
24.5%
86
3
121
29
% of
patients
treated
36.0%
1.3%
50.6%
12.1%
HCV+
Patients
at
baseline
5161
23.7%
239
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
76
31.8
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Patients treated by model of care
model 1
model 2
model 3
model 4
Patients
treated
64
118
43
14
clinics
10
7
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%
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
7
7
5
patients/clinic
6.4
16.9
6.1
2.8
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Patients treated by study cohort
cohort 1
cohort 2
total
year 1
46
48
94
year 2
66
54
120
year 3
25
0
25
137
102
239
total
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Size Matters
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Genotype of patients treated
Genotype
Patients
1
191
2
18
3
21
4
Other/unknown
2
7
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Treatment for Genotype 1 patients
Treatment
Standard (Interferon + Ribavirin)
Telapravir (Incivek)
Boceprevir (Victrelis)
Experimental
Unknown
patients
74
84
22
9
2
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Patient Outcomes
Patients
Started treatment
Terminated early
Completed with viral suppression
Completed but relapsed
Unknown outcomes
Number
239
94
100
5
40
Treatment success rate
% of patients who started: 41.8%
% of patients with known outcomes: 50.2%
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Early Termination: When?
Time in treatment
First 12 weeks
12 – 24 weeks
24 – 48 weeks
Patients
51
30
13
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Early Termination: WHO?
0 -12
weeks
12-24
weeks
24-48
weeks
total
% of
treated
patients
36.2%
71
51.2%
21
male
38
23
10
female
12
6
3
1
1
0
2
100.0%
total
51
30
13
94
39.3%
afr amer
23
12
2
37
43.0%
white
21
13
10
44
36.4%
other
7
5
1
13
44.8%
total
51
30
13
94
39.5%
transgender
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
Other
33
9
Total early termination
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
94
Patients terminating treatment
early by genotype
Genotype 1
Genotype 2
Genotype 3
Genotype 4
Other/unknown
0 -12
weeks
12 – 24
weeks
24 – 48
weeks
total
44
2
3
1
1
24
2
3
0
1
10
2
1
0
0
78
6
7
1
2
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
% of
treated
patients
40.8%
33.3%
33.3%
50.0%
28.6%
Genotype 1 Patient outcomes
Treatment
# patients
SVR
Early
Relapse
termination
Unknown
Standard
74
35
34
2
3
Telaprivir
84
29
29
1
25
Boceprivir
22
6
13
0
3
Experimental
9
6
1
0
2
Unknown
2
1
1
0
0
191
77
78
3
33
Total
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Genotype 1 Patients: Termination
Reason by Treatment
Physical
adverse
effects
Standard
9
Telapravir
13
Boceprevir
5
Experimental
0
Unknown
1
Psychological Insufficient
adverse
treatment
effects
response
2
18
3
8
2
5
0
0
0
0
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Other
5
5
1
1
0
Early termination by model of care
0 -12
weeks
Model 1
Model 2
Model 3
Model 4
12-24
weeks
12
29
8
2
24-48
weeks
total
12
12
3
7
4
2
1
2
27
48
13
6
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
% of
treated
patients
43.2%
40.7%
30.2%
42.9%
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Barriers to treatment: Community
• Lack of highly skilled nursing and pharmacy
staff
• Lack of mental health treatment resources
• Lack of substance abuse treatment
resources
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Barriers to treatment: Poor
treatment options
• Clinician resistance
• Patient resistance
• Patients’ acute and chronic mental health
issues
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
FUTURE CHALLENGES
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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)?
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
Moving forward…
•
•
•
•
Change in reimbursement structure
Affordable Care Act
New HCV treatment guidelines
Newly approved DAAs
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014
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?
HEPATITIS C TREATMENT EXPANSION INITIATIVE
ETAC Project Summary Webinar
May 28, 2014