ONGOING HCV/HIV RESOURCES

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: http://health.usf.edu/medicine/internalmedicine/infectious/etac/index.htm Side bar link: Tools and Forms • Consent for Hepatitis C Treatment ISU • Decision flow chart ISU • HCV tracker for patients stmary • WashingtonUniv_H97HA19759_Appendix2-patient monitoring • UCSF_Protocol_for_Circle_of_care_5_18_12_final.pdf

5. 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

6. 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/

7. 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

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

16. Patient Race/Ethnicity

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 Total treated patients / Total HCV+ patients at baseline = 4.63%

19. Patients treated by model and year

20. Patients treated by study cohort

21. Size Matters

22. Genotype of patients treated

23. Treatment for Genotype 1 patients

24. PatientOutcomes Treatment success rate % of patients who started: 41.8% % of patients with known outcomes: 50.2%

25. Early Termination: When?

26. Early Termination: WHO?

27. Early Termination: Why?

28. Patients terminating treatment early by genotype

29. Genotype 1 Patient outcomes

30. Genotype 1 Patients: Termination Reason by Treatment

31. Early termination by model of care

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?