ONGOING HCV/HIV RESOURCES

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


May 28, 2014

ONGOING HCV/HIV RESOURCES


May 28, 2014


May 28, 2014

Resources - www.usfetac.com


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


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


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/


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


May 28, 2014

SUSTAINABILITY


May 28, 2014

Program Components

• Clinic Infrastructure• Personnel• Delivery Protocols• Resources


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


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


May 28, 2014

Delivery Protocols

• Established treatment protocols• Quality improvement activities


May 28, 2014

Resources

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


May 28, 2014

PROJECT FINDINGS


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%


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


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


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%


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


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


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


May 28, 2014

Genotype of patients treated

Genotype Patients

1 191

2 18

3 21

4 2Other/unknown 7


May 28, 2014

Treatment for Genotype 1 patients

Treatment patients

Standard (Interferon + Ribavirin) 74

Telapravir (Incivek) 84

Boceprevir (Victrelis) 22

Experimental 9

Unknown 2


May 28, 2014


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%


May 28, 2014

Early Termination: When?

Time in treatment PatientsFirst 12 weeks 5112 – 24 weeks 3024 – 48 weeks 13


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%


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


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%


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


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


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%


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


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


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


May 28, 2014

Barriers to treatment: Poor treatment options

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

issues


May 28, 2014

FUTURE CHALLENGES


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)?


May 28, 2014

Moving forward…

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


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


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


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?

ONGOING HCV/HIV RESOURCES

Documents

Transcript of ONGOING HCV/HIV RESOURCES