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

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The HRSA/SPNS Hepatitis C Treatment Expansion
InitiativeProject Summary Webinar for
Demonstration Clinics
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ONGOING HCV/HIV RESOURCES
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Resources - www.usfetac.com
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Tools Forms

• See ETAC website
• http//health.usf.edu/medicine/internalmedicine/in
  fectious/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

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Web Based Resources

• http//aasld.org/PRACTICEGUIDELINES/Pages/guidelin
  elisting.aspx
• Hepatitis C, Guidance and Hepatitis C, management
  and treatment
• http//aasld.org/LiverLearningC2AE/Pages/HCVtalk
  s2.aspx
• Learning site for special populations.
• http//aasld.org/LiverLearningC2AE/Pages/LiverPr
  ogramforPrimaryCareProviders.aspx
• Modular training with free CME for Hepatitis B
  and Hepatitis C
• http//files.easl.eu/easl-recommendations-on-treat
  ment-of-hepatitis-C.pdf
• EASL Recommendations on Treatment of Hepatitis
  2014

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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/

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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

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SUSTAINABILITY
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Program Components

• Clinic Infrastructure
• Personnel
• Delivery Protocols
• Resources

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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

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Personnel

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

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Delivery Protocols

• Established treatment protocols
• Quality improvement activities

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Resources

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

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PROJECT FINDINGS
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Patient Gender
  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  
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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
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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

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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
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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
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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
total 137 102 239
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Size Matters
  Small (lt1,000 HIV pts) Large (gt1,000 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
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Genotype of patients treated
Genotype Patients
1 191
2 18
3 21
4 2
Other/unknown 7
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Treatment for Genotype 1 patients
Treatment patients
Standard (Interferon Ribavirin) 74
Telapravir (Incivek) 84
Boceprevir (Victrelis) 22
Experimental 9
Unknown 2
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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
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Early Termination When?
Time in treatment Patients
First 12 weeks 51
12 24 weeks 30
24 48 weeks 13
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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 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
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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
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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 2 2 6 33.3
Genotype 3 3 3 1 7 33.3
Genotype 4 1 0 0 1 50.0
Other/unknown 1 1 0 2 28.6
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Genotype 1 Patient outcomes
Treatment patients SVR Early termination Relapse 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
Total 191 77 78 3 33
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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 5
Boceprevir 5 2 5 1
Experimental 0 0 0 1
Unknown 1 0 0 0
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Early termination by model of care
  0 -12 weeks 12-24 weeks 24-48 weeks total of treated patients
Model 1 12 12 3 27 43.2
Model 2 29 12 7 48 40.7
Model 3 8 4 1 13 30.2
Model 4 2 2 2 6 42.9
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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

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Barriers to treatment Community

• Lack of highly skilled nursing and pharmacy staff
• Lack of mental health treatment resources
• Lack of substance abuse treatment resources

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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

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Barriers to treatment Poor treatment options

• Clinician resistance
• Patient resistance
• Patients acute and chronic mental health issues

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FUTURE CHALLENGES
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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)?

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Moving forward

• Change in reimbursement structure
• Affordable Care Act
• New HCV treatment guidelines
• Newly approved DAAs

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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

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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

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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?