1. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 The HRSA/SPNS Hepatitis C Treatment Expansion Initiative: Project Summary Webinar for Demonstration Clinics

2. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 ONGOING HCV/HIV RESOURCES

3. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Resources - www.usfetac.com

4. 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

5. 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 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-of- hepatitis-C.pdf http://files.easl.eu/easl-recommendations-on-treatment-of- hepatitis-C.pdf – EASL Recommendations on Treatment of Hepatitis 2014

6. 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 https://www.clinicaloptions.com/Hepatitis – 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/ http://www.practicepointhepatitis.com/

7. 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 http://depts.washington.edu/nwaetc/echo/index. html – NW AETC ECHO home offers HIV sessions

8. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 SUSTAINABILITY

9. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Program Components Clinic Infrastructure Personnel Delivery Protocols Resources

10. 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

11. 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

12. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Delivery Protocols Established treatment protocols Quality improvement activities

13. 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

14. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 PROJECT FINDINGS

15. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patient Gender FemaleMaleTransgenderTotal HCV+ Patients at baseline 13703697945161 % of patients26.6%71.6%1.8% Patients treated 411962239 % of patients treated 17.2%82.0%.8%

16. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patient Race/Ethnicity African America n AsianWhiteOther/ Unknown TotalHispanic HCV+ Patients at baseline 2468601367126651611224 % of patients 47.8%1.2%26.5%24.5% 23.7% Patients treated 8631212923976 % of patients treated 36.0%1.3%50.6%12.1% 31.8

17. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC 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

18. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patients treated by model of care model 1model 2 model 3 model 4 Patients treated641184314 clinics10775 patients/clinic6.416.96.12.8 HCV+ patients20391996736390 Treated/HCV+3.14%5.92%5.84%3.59% Total treated patients / Total HCV+ patients at baseline = 4.63%

19. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patients treated by model and year model 1model 2 model 3 model 4 year 12448166 year 23753237 year 331741 patients641184314 clinics10775 patients/clinic6.416.96.12.8

20. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patients treated by study cohort cohort 1cohort 2total year 1464894 year 26654120 year 3250 total137102239

21. 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 treated71168 clinics 1514 patients/clinic 4.7312.00 HCV+ patients 1,0324,129 Treated/HCV+ 6.884.07

22. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Genotype of patients treated GenotypePatients 1191 218 321 42 Other/unknown7

23. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Treatment for Genotype 1 patients Treatmentpatients Standard (Interferon + Ribavirin)74 Telapravir (Incivek)84 Boceprevir (Victrelis)22 Experimental9 Unknown2

24. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Patient Outcomes PatientsNumber Started treatment239 Terminated early94 Completed with viral suppression100 Completed but relapsed5 Unknown outcomes40 Treatment success rate % of patients who started: 41.8% % of patients with known outcomes: 50.2%

25. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Early Termination: When? Time in treatmentPatients First 12 weeks51 12 – 24 weeks30 24 – 48 weeks13

26. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Early Termination: WHO? 0 -12 weeks 12-24 weeks 24-48 weekstotal % of treated patients male 382310 71 36.2% female12 63 21 51.2% transgender1102 100.0% total51301394 39.3% afr amer 23122 37 43.0% white 211310 44 36.4% other75113 44.8% total51301394 39.5%

27. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Early Termination: Why? Reason Patients Physical adverse effects36 Psychological adverse effects7 Patient request4 Patient lost3 Alcohol use2 Insufficient treatment response33 Other9 Total early termination 94

28. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC 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 14424107840.8% Genotype 2222633.3% Genotype 3331733.3% Genotype 4100150.0% Other/unknown110228.6%

29. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Genotype 1 Patient outcomes Treatment# patientsSVREarly termination RelapseUnknown Standard74353423 Telaprivir8429 125 Boceprivir2261303 Experimental96102 Unknown21100 Total1917778333

30. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Genotype 1 Patients: Termination Reason by Treatment Physical adverse effects Psychological adverse effects Insufficient treatment response Other Standard92185 Telapravir13385 Boceprevir5251 Experimental0001 Unknown1000

31. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 Early termination by model of care 0 -12 weeks 12-24 weeks 24-48 weekstotal % of treated patients Model 1 12 3 2743.2% Model 229 127 4840.7% Model 38411330.2% Model 4222642.9%

32. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC 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

33. 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

34. 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

35. 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

36. HEPATITIS C TREATMENT EXPANSION INITIATIVE ETAC Project Summary Webinar May 28, 2014 FUTURE CHALLENGES

37. 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)?

38. 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

39. 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

40. 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

41. 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?