Hepatitis C in California: The Role of the Primary Care Provider

1. Hepatitis C in California:The Role of the Primary Care Provider Sponsored by the California Academy of Family Physicians, National Viral Hepatitis Roundtable and CalHEP/Project Inform This webinar is also supported by an unrestricted educational grant from Quest Laboratories.

2. Our Faculty • Stacey Trooskin, MD, PhD, Assistant Professor in the Division of Infectious Diseases and HIV Medicine at Drexel University College of Medicine, and co-chair, Hepatitis C Allies of Philadelphia (HepCAP. Dr. Trooskin completed her medical degree at UMDNJ-Robert Wood Johnson School of Medicine, her PhD in Public Health at UMDNJ School of Public Health, and her MPH at the Yale University School of Epidemiology and Public Health. She specializes in infectious diseases, HIV medicine, HIV/HCV co-infection and internal medicine. • Rachel McLean, MPH, Coordinator, Adult Viral Hepatitis Prevention, California Department of Public Health. Ms. McLeancompleted her MPH at Johns Hopkins University. Previously, she worked on policies affecting incarcerated youth and their families at the Ella Baker Center for Human Rights in California and on issues affecting people released from prisons and jails at the Council of State Governments Justice Center in New York. She also founded the Drug Overdose Prevention and Education Project in San Francisco. • Marshall Kubota, MD, regional medical director for Partnership Health Plan, in Sonoma County. Dr. Kubota completed his medical degree at St. Louis University School of Medicine and did his residency at Sutter Medical Center of Santa Rosa.  Dr. Kubota has served as residency director at the program and medical director for both the North Coast Area AIDS Education and Training Center and Public Health Clinical Services for Sonoma Department of Health Services. He is the founder of the Sonoma County Center for HIV Prevention and Care.

3. Disclosure of Interest The CAFP Committee on Continuing Professional Development is responsible for management and resolution of conflict for any individual who may have influence on content, who have served as faculty, or who may produce CME/CPD content for the CAFP. It is the policy of CAFP to ensure independence, balance, objectivity, scientific rigor, and integrity in all of their continuing education activities. The CCPD has reviewed the COI statements for this activity and has managed/resolved the interest declared by Dr. Kubota. Our faculty does not intend to discuss off-label uses of drugs, mechanical devices, biologics, or diagnostics approved OR investigational drugs, mechanical devices, biologics, or diagnostics not approved by the FDA for use in the United States. DrTrooskin, Mss. McLean, Broder, Rodrigues declares that neither they nor members of their immediate families have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation Dr. Kubota declares that he has received speaker honoraria from Gilead.

4. By the end of the webinar, participants will be able to: Describe the epidemiology of hepatitis C in California; Articulate the US Preventive Services Task Force recommendations for who should be screened for hepatitis C; Explain the testing algorithm to diagnose Hepatitis C; Describe new treatment options for HCV infected patients; Implement connections for HCV follow-up care with local health care providers. Explain the primary care provider’s role in hepatitis C screening and care; and Describe at least one example of a primary care hepatitis C screening protocol. Today’s program

5. Hepatitis C In California RACHEL McLEAN, MPH ADULT VIRAL HEPATITIS PREVENTION COORDINATOR CALIFORNIA DEPARTMENT OF PUBLIC HEALTH SACRAMENTO, CA

6. Hepatitis C Infection in the United States • Leading cause of liver disease, liver cancer, and liver transplantations • 3-5 million living with hepatitis C infection ~ 600,000-750,000 in California • 45-65% unaware of their infection • More deaths each year due to hepatitis C than 60 other reportable diseases combined

7. Incidence of Acute HCV in the United States 1982-2008 New Infections per 100,000 population

8. Sources of New HCV Infection 1% 4% 1995-2000 * In a medical setting; healthcare work, perinatal

9. Incidence of Acute Hepatitis C by Age — U.S. 2000–2013 Source: CDC. Surveillance for Viral Hepatitis – United States, 2013.

10. HCV-related Mortality On the Rise Source: NCHS Multiple-Cause-of-Death, 1999-2010.

11. Hepatitis-Related Hospitalizations Among HCV and HBV/HCV-Infected Patients by Birth Cohort, California 2002-2011 2002 2011 Data source: OSHPD

12. Cumulative Chronic Hepatitis C Cases: California 1994-2013 Persons unaware of their infection? Preliminary data. Prepared by California Department of Public Health. Note: It is unknown how many of these cases are currently living—need to match with death records.

14. * * * Hepatitis C Cases in 2013 American Indian/Alaska Native: 1.8% African American: 12.2% White: 58.5% California Population in 2013 American Indian/Alaska Native: 0.5% African American: 6.0% White: 40.3%

17. Rates increased 26% among 18-24 year old males in State prisons from 2009-2013

18. State Role in Addressing Hepatitis C: Educating the Public, Providers, and Policymakers http://www.cdph.ca.gov/programs/Documents/HepatitisBandCScreeningToolkitforPrimaryCare.pdf Norah Terrault, MD, MPH

19. The Role of Primary Care Providers in Hepatitis C Screening, Diagnosis, and Care MARSHALL KUBOTA, MD REGIONAL MEDICAL DIRECTOR PARTNERSHIP HEALTH PLAN SONOMA, CA

20. Sources of Testing Guidelines • Centers for Disease Control and Prevention (CDC) • Viral Hepatitis – Hepatitis C Information • 2015 STD Treatment Guidelines • American Association for the Study of Liver Diseases (AASLD) • Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected With Hepatitis C Virus

21. CDC Testing Recommendationsfor HCV Infection October 2015 • Testing for HCV antibodies – followed by confirmatory testing • Serum testing for antibodies • Rapid point of service, CLIA waved blood test available - fingerstick • Confirmatory testing for HCV RNA to distinguish between current and resolved HCV infection – reflexive or subsequent submission • 8-9 week window period for antibody formation • 6 month outside risk (>97% seroconversion)

22. Baby BoomersRecommend to Test • ALL baby boomers – adults born from 1945 to 1965 (included in guidelines all professional guidelines) • The last baby boomer turned 50 on Dec 31, 2015 • Should be tested once without ascertainment of risk factors

23. Figure 2. Treatment Cascade for People with Chronic Hepatitis C Virus (HCV) Infection, Prevalence Estimates with 95% Confidence Intervals. Yehia BR, Schranz AJ, Umscheid CA, Lo Re V III (2014) The Treatment Cascade for Chronic Hepatitis C Virus Infection in the United States: A Systematic Review and Meta-Analysis. PLoS ONE 9(7): e101554. doi:10.1371/journal.pone.0101554 http://journals.plos.org/plosone/article?id=info:doi/10.1371/journal.pone.0101554

24. Baby Boomer Testing • For these individuals risk ascertainment is not necessary • Unknown risk • Undivulged risk • Misconceptions about prior testing • Testing not routinely available until 1992 (blood banking) • Silent infection • Work flow integration • No special consent (unlike HIV • EHR integration • Notification process – important • Made easier with success of treatment

25. Targeted Testing

26. HCV Testing is Recommended • Current IDU (annually) or Any past history of IDU • Medical conditions • Clotting factor concentrates before 1987 • Long-term hemodialysis • Persistently elevated ALT • HIV infection • Can be considered annually if high risk sexual (traumatic, GUD, STD proctitis) • Combined screening • Prior transfusion or organ transplant recipients • On notification of exposure • Prior to July 1992

27. HCV Testing on Recognized Exposure HCWs, public safety, first responders on percutaneous or mucosal exposure to HCV infected blood Children born to HCV-positive women

28. Uncertain Testing Cases *Recommended by AASLD • Recipients of transplanted tissues • Sperm, ova, cornea, skin, musculoskeletal • Intranasal cocaine or other non-injection drug users* • History of tattoos, piercings*unregulated • History of multiple sexual partners, STDs • Long-term steady sexual partners of HCV-positive persons

29. Routine Testing is Not Recommended HCWs, emergency medical and public safety workers Pregnant women Household contacts (non-sexual) of HCV-positive persons General population (not otherwise indicated)

30. Other Considerations (not in guidelines) Reduce the first steep step off in the HCV treatment cascade by testing Baby Boomers Low threshold for testing Build into EHR, alerts and workflow

31. Care and Management of Persons with Current HCV Infection

32. Care and Management of Persons with Current HCV Infection • Program of Care and Treatment • Screen – Diagnose – Advise - Baseline • Refer • Treat • Uncomplicated • Complex • Post-consultation / treatment care

33. Current Treatments: Upside • Development of highly curative regimens • No AASLD recommended regimens contain interferon • Some with ribavirin • Low side effect profile, low pill counts (as little as one pill daily) • Pangenotypic option • Greater than 90% cure rates with 8-12 weeks of treatment • With some exceptions for previously treated, advanced cirrhosis, transplants, viral resistance • Public health benefit to reduce community viral burden and transmission

34. Current Treatments: Downside • Currently recommended treatments are costly • The cost is trending downwards but remains a high cost item to payers and the healthcare system • Common twelve-week regimens run from $65,000 to $176,000 • The highest single pill cost is $1,350

35. Relative Simplicity of Treatment vs High Cost • Results in a high degree of clinical responsibility • Patient selection - by payers • State Medi-Cal – expanded eligibility for treatment • Stage II liver fibrosis or higher • Complications or co-existing conditions • No Medi-Cal restrictions regarding active drug use, alcohol • Do restrict with limited life expectancy • Private Insurers / other states – variable • Patient selection – by clinicians • Prepared for treatment • Ethical decisions • Treatment selection • May be affected by cost vs preference

36. Consequences of Poor Treatment Decisions • Treatment failure • May result in viral resistance and more difficult or reduced future treatment options • Cost of futile treatment • Logistic failure • Poor management / instruction in treatment • Pharmaceutical errors - gaps • Lost medications • Drug interactions leading to failure

37. Common Barriers to HCV Treatment and Potential Strategies -- AASLD http://www.hcvguidelines.org/node/64

38. Screen, Diagnose, Advise, Baseline and Refer for Curative Treatment • Diagnose • Complete confirmatory testing of a positive HCV antibody test with a HCV RNA (viral load testing) • Advise • Chronic, latent infection – highly treatable • Healthy living – liver and otherwise • Transmission and testing of others • IDU treatment • Medication review / advice

39. Baseline • HCV viral quantitation and genotype • US of liver • CBC, chem panel, INR, UA • Test of fibrosis • FIB-4, APRI, US, Biochemical algorithms, elastometry, biopsy • Degree of fibrosis if cirrhosis – CTP score • Testing for HIV, HBV, HAV serostatus • Immunizations – ACIP plus HAV, HBV if needed • Medication review • Specialized tests may be needed – or left to the referral • Up to date preventive care • Birth control / pregnancy testing • Transmission • Ribavirin use • Detailed past HCV treatment history • IFN treatment failure consists of relapse, rebound, null response (not failure to complete) • Advance Directive

40. Choosing to Treat • Commitment to the development of a team • Clinician and team education – Project ECHO • Protocols • Education • Reminders • Follow up • Fixing problems in supply • Lots of treatment authorization work • Post care (may be returned to Family Physician) • Familiarity with AASLD HCV treatment guidelines • Amenable to telemedicine • Know your limitations • This is not prescribe and forget

41. Post Treatment Care Sustained virologic response testing Continued healthy choices – liver Completion of immunizations Prevention of reinfection Cirrhosis care Prescription contraindications

42. Family Physician Care of HCV • Simplified and effective regimens • Patient preparation and readiness for treatment • Highly rewarding • For clinician, team, patients

43. STACEY B TROOSKIN, MD PHD ASSISTANT PROFESSOR OF MEDICINE DREXEL UNIVERSITY COLLEGE OF MEDICINE PHILADELPHIA, PA

44. Primary Care Testing Program • Integrate CDC recommendations for birth cohort hepatitis C testing into standard workflow • Encourage reflexive confirmatory testing • EMR modifications, provider education, feedback • Provide linkage to subspecialty care for patients chronically infected with hepatitis C

45. Recommended testing sequence for identifying HCV infection CDC. MMWR 2013; 62(18)

46. AllScripts EMR • Limited access to duplicate testing options • Removed all orders for non-preferred tests

48. Preferred Tests • Preferred HCV Screening Test • HCV antibody with reflex to RNA PCR confirmatory testing (Quest #8472; LabCorp #144045) • Use for anyone who has not recently been screened for HCV • Requires one blood draw, most effective—provides viral load if patient is positive • Preferred HCV Confirmatory Test • HCV PCR Quantitative Test (Quest #37273; LabCorp #550080) • HCV PCR Qualitative Test (LabCorp #550713) • Use for anyone who has a recent antibody test but no confirmatory test to confirm chronic infection • Provides a baseline viral load

50. Percentage of Eligible Baby Boomers Tested Before and After Prompts Went Live