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 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

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

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/

ECHO/TELEHEALTH http://echo.unm.edu/ http://fcaetc.org/echo 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

SUSTAINABILITY

Program Components Clinic Infrastructure Personnel Delivery Protocols Resources

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

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

Delivery Protocols Established treatment protocols Quality improvement activities

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

PROJECT FINDINGS

Patient Gender Female Male Transgender Total HCV+ Patients at baseline   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%

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

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

Patients treated by model of care   model 1 model 2 model 3 model 4 Patients treated 64 118 43 14 clinics 10 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%

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 5 patients/clinic 6.4 16.9 6.1 2.8

Patients treated by study cohort   cohort 1 cohort 2 total year 1 46 48 94 year 2 66 54 120 year 3 25 137 102 239

Size Matters Small (<1,000 HIV+ pts) Large (>1,000 HIV+ pts)   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

Genotype of patients treated 1 191 2 18 3 21 4 Other/unknown 7

Treatment for Genotype 1 patients Standard (Interferon + Ribavirin) 74 Telapravir (Incivek) 84 Boceprevir (Victrelis) 22 Experimental 9 Unknown 2

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%

Early Termination: When? Time in treatment Patients First 12 weeks 51 12 – 24 weeks 30 24 – 48 weeks 13

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 2 100.0% 51 30 13 94 39.3% afr amer 37 43.0% white 44 36.4% other 7 5 44.8% 39.5%

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

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 6 33.3% Genotype 3 3 1 7 Genotype 4 50.0% Other/unknown 28.6%

Genotype 1 Patient outcomes Treatment # patients SVR Early termination Relapse Unknown Standard 74 35 34 2 3 Telaprivir 84 29 1 25 Boceprivir 22 6 13 Experimental 9 Total 191 77 78 33

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 Boceprevir 1 Experimental Unknown

Early termination by model of care   0 -12 weeks 12-24 weeks 24-48 weeks total % of treated patients Model 1 12 3 27 43.2% Model 2 29 7 48 40.7% Model 3 8 4 1 13 30.2% Model 4 2 6 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

Barriers to treatment: Community Lack of highly skilled nursing and pharmacy staff Lack of mental health treatment resources Lack of substance abuse treatment resources

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

Barriers to treatment: Poor treatment options Clinician resistance Patient resistance Patients’ acute and chronic mental health issues

FUTURE CHALLENGES

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)?

Moving forward… Change in reimbursement structure Affordable Care Act New HCV treatment guidelines Newly approved DAAs

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

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

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?