ongoing hcv/hiv resources
DESCRIPTION
The HRSA/SPNS Hepatitis C Treatment Expansion Initiative: Project Summary Webinar for Demonstration Clinics. ONGOING HCV/HIV RESOURCES. Resources - www.usfetac.com. Tools & Forms. See ETAC website: http://health.usf.edu/medicine/internalmedicine/infectious/etac/index.htm - PowerPoint PPT PresentationTRANSCRIPT
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
The HRSA/SPNS Hepatitis C Treatment Expansion Initiative:
Project Summary Webinar for Demonstration Clinics
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
ONGOING HCV/HIV RESOURCES
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Resources - www.usfetac.com
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Tools & Forms See ETAC website:http://health.usf.edu/medicine/internalmedicine/infectious/etac/index.htmSide 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 INITIATIVEETAC 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/LiverProgramforPrimaryCareProviders.aspx– Modular training with free CME for Hepatitis B and Hepatitis C
• http://files.easl.eu/easl-recommendations-on-treatment-of-hepatitis-C.pdf– EASL Recommendations on Treatment of Hepatitis 2014
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC Project Summary Webinar
May 28, 2014
SUSTAINABILITY
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Program Components
• Clinic Infrastructure• Personnel• Delivery Protocols• Resources
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC Project Summary Webinar
May 28, 2014
Delivery Protocols
• Established treatment protocols• Quality improvement activities
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 INITIATIVEETAC Project Summary Webinar
May 28, 2014
PROJECT FINDINGS
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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%
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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 INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC 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
total 137 102 239
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 INITIATIVEETAC Project Summary Webinar
May 28, 2014
Genotype of patients treated
Genotype Patients
1 191
2 18
3 21
4 2Other/unknown 7
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Treatment for Genotype 1 patients
Treatment patients
Standard (Interferon + Ribavirin) 74
Telapravir (Incivek) 84
Boceprevir (Victrelis) 22
Experimental 9
Unknown 2
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Patient OutcomesPatients NumberStarted 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%
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Early Termination: When?
Time in treatment PatientsFirst 12 weeks 5112 – 24 weeks 3024 – 48 weeks 13
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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%
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 33
Other 9
Total early termination 94
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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%
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
Genotype 1 Patient outcomesTreatment # patients SVR Early
terminationRelapse 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
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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%
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC Project Summary Webinar
May 28, 2014
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 INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC Project Summary Webinar
May 28, 2014
FUTURE CHALLENGES
HEPATITIS C TREATMENT EXPANSION INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC 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 INITIATIVEETAC 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?