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Executive Director, Hepatitis C Support Project hcvadvocate hbvadvocate

Integrating Hepatitis C Care into a Primary Care Setting. Alan Franciscus. Executive Director, Hepatitis C Support Project www.hcvadvocate.org www.hbvadvocate.org www.hepatitistattoos.org. Your Logo. Integrating Chronic HCV into Medical Clinics – Test, Monitor and Treat. Objectives.

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Executive Director, Hepatitis C Support Project hcvadvocate hbvadvocate

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  1. Integrating Hepatitis C Care into a Primary Care Setting Alan Franciscus Executive Director, Hepatitis C Support Project www.hcvadvocate.org www.hbvadvocate.org www.hepatitistattoos.org Your Logo

  2. Integrating Chronic HCV into Medical Clinics – Test, Monitor and Treat Objectives • This is an example text. Go ahead and replace it Understand the need for more HCV medical providers ✓ Recognize the front line primary care provider as the critical link ✓ • Discuss how to integrate HCV into medical offices • Testing • Monitoring • Treating with HCV Protease Inhibitor combination ✓

  3. Reference publications: • Hepatitis B and C Guidelines – Colorado Clinical Guidelines Collaborative • HCSP: Management of Hepatitis C by the Primary Care Provider – Monitoring Guidelines

  4. The Need NHANES: 3.2 million persons chronically infected with hepatitis C • If 100 persons infected with HCV: • 75 to 85% will develop chronic infection • 20% will develop cirrhosis in 20 to 30 years • 1% to 5% will die of consequences of chronic infection (liver cancer or cirrhosis)

  5. Testing Current Risk Factor Testing Isn’t Working Risk Factor Assessment Templates • Sharing needles and drug preparation tools • Blood products & solid organ transplantation before 1992 • Clotting factors before inactivation in 1987 • Sexual transmission • Mother-to-child • Healthcare workers • Hemodialysis Age-Based Testing – Pilot Your Logo

  6. Total U.S. Population with HCV 3.2 million persons chronically infected with HCV 25% have been diagnosed = 800,000 persons 75% have NOT been diagnosed = 2,400,000 persons Your Logo

  7. Baby Boomers Account for the Majority of HCV Cases in United States Estimated Prevalence by Age Group 1.6 Number With Chronic HCV Infection (millions) 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0 1990+ 1980s <1920 1920s 1970s 1940s 1950s 1930s 1960s Birth Year Group Intregating HCV

  8. Baby Boomers Aging • Typically 10 to 40 years for serious HCV disease progression • Most HCV baby boomers have been infected ≥ 40 years

  9. Future Burden of Hepatitis C Current and projections • 2010: • 800,00 persons with HCV-related cirrhosis • 10,000 to 12,000 deaths • 2020 – 1 million persons with HCV-related cirrhosis • 2020-2029 = 283,378 deaths / ~14,000/yr

  10. Increased Diagnosis and Treatment The Beginning of a New Era: OraQuick HCV Antibody Test Age-Based Testing New Antivirals Templates . • .Test everyone of a certain age. Pilot programs are being planned in: • New York, • Detroit, MI, • Houston, TX, • Birmingham, AL • Finger Prick • Whole Blood Draw • Oral Swab • Results available within 20 minutes • More testing within clinics and mobile sites can lead to increased consultations about care, management and treatment • tNew HCV Treatments – • An HCV protease inhibitor combined with pegylated interferon, plus ribavirin will increase the cure rates up to 79% • Higher cure rates will mean more treatment- naive and prior non-responders will seek treatment 3 1 2 Your Logo

  11. Primary Care Providers and HCV 1 Percentage of US Population with HCV Average number of patients in PCP practice Number of patients with HCV per PCP practice 2 3 Your Logo

  12. The Primary Care Provider Office The Passion 1 3 Staff 2 4 The Team Approach Mechanics Your Logo

  13. Passion • Passion to provide services that will have a dramatic impact on the lives of people affected by HCV

  14. Staff A physician to provide and oversee patient care Physician Medical team to provide provide support to physican and patients Nurse Practicioner, Nurse, etc. Office staff – billing, reception – knowledgeable and able to provide support to medical team and patients. Office Your Logo

  15. Team Approach • Phsyican Office • -Working together to provide services • Patient • Part of the Team Process • -involvement with decision process • contract with provider Your Logo

  16. The Mechanics Diagnosis 1 Management 2 Treatment Your Logo

  17. Testing: Risk Factors • Injection Drug Use (illicit drugs, hormones, vitamins, steroids) – needles, cookers, cottons, water, ties, etc. – even just once • Persons with HIV • Received blood products, organ transplant, or transfusion before 1992 Your Logo

  18. Testing: Risk Factors – con’t • Children born to HCV-infected Mothers • Healthcare, emergency medical and public safety workers after a needle-stick injury or mucosal exposure to HCV-positive blood • Current sexual partners of HCV-positive person – although the risk is low Your Logo

  19. Diagnosis Antibody, viral load test

  20. Management: Counseling Patients Prevent transmission, encourage lifestyle changes

  21. Management: Counseling Patients Secondary Prevention Primary Prevention • Lifestyle Changes: • Avoid Alcohol • Exercise • Diet • Advise on Herbs, Vitamins & Supplements • Avoid Raw or Undercooked Shellfish • HCV is spread by blood-to-blood contact with HCV infected blood: • Do not share anything used to inject drugs for recreational use, hormones, vitamins, etc. • Do not share razors or toothbrushes • Stable monogamous relationship –no barriers unless worried about potential risk • Safer sex outside of stable monogamous relationship • Safer Tattoos & Piercings Your Logo

  22. Management: Test & Vaccinate Vaccinate against HAV & HBV

  23. Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy. Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level). Clinical Assessment 1 Physical exam for evidence of liver damage 4 2 Blood work – CBC, CMP, INR, TSH, ANA, HIV. 3 Ferritin % Saturation Hep A ab total, Hep B Surface Ab/Ag, Hep B Core Ab total Your Logo

  24. Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy. Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level). Clinical Assessment Hep C gentoype, Hep C viral load 5 HOMA Score 6 Hep A & Hep B vaccination series if needed 7 Influenza and pneumococcal vaccinations 8 Pregnancy Test 5 Your Logo

  25. Monitor: • Annual physical (6-12 months) • Complete Blood Panel • Hepatic Function Panel (HFP) • Liver biopsy (3-5 yrs) Monitor & Consideration of Treatment May consider Treatment

  26. Monitor: • Annual physical (6-12 months) • Complete Blood Panel • HFP • Liver biopsy (3-5 yrs) Monitor & Consideration of Treatment Consider treatment

  27. Monitor: • Annual physical (6-12 months) • Complete Blood Panel • HFP • Liver biopsy (3-5 yrs) • Ultra Sound (every 6 months) Monitor & Consideration of Treatment Should be treated

  28. Monitor & Consideration of Treatment • Monitor: • Annual physical (6-12 months) • Complete Blood Panel • HFP • Liver biopsy (3-5 yrs) • Ultra-sound & AFP every 6 mos) • Compensated: • Treat (with liver specialist)

  29. Refer to Specialist HIV Specialist Liver Specialist

  30. HCV Treatment: Goals 1 HCV Eradication – Viral Cure 2 3 Improve health & reduce complications and death from HCV Improve Histology . Your Logo

  31. Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy. Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level). Evaluation: Absolute Contraindications Pregnancy or patients unwilling or unable to practice two forms of birth control 1 Poorly controlled psychiatric disease 2 Poorly controlled coronary disease 3 Kidney or heart transplant 4 Renal failure or insufficiency 5 Your Logo

  32. Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy. Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level). Evaluation: Relative Contraindications History of severe depression – evaluate and treat depression 1 Minor or on-going depression 2 Decompensated cirrhosis 3 Autoimmune disease 4 History of coronary heart disease 5 Blood deficiencies (anemia, neutropenia and thrombocytopenia 6 Your Logo

  33. Test for HCV genotype. Consider doing a liver biopsy to assess the severity of the underlying hepatitis and need for current therapy. Genotype 1: Test for HCV RNA level immediately before starting therapy (baseline level). Evaluation: Patient Criteria Willing to start treatment 1 Stable work/life environment 2 Support Network – support group 3 Willingness to be evaluated for depression 4 Willingness to keep appointments and lab work 5 Team approach with medical team 6 Your Logo

  34. HCV Medical Treatments – Advances Approval expected Mid-2011 Mid-2011 Your Logo

  35. Telaprevir, Pegylated Interferon plus ribavirin • Telaprevir (every 8 hrs) • Treatment naïve: Telaprevir, PegIFN/RBV 12 weeks followed by 12 weeks of PegIFN/RBV • Treatment experienced patients: Telaprevir, PegIFN/RBV 24 weeks followed by 24 weeks of PegIFN/RBV Your Logo

  36. Boceprevir, Pegylated Interferon plus ribavirin • Boceprevir (three times a day) – 4 week lead-in: PegIFN/RBV • Treatment naïve: Boceprevir, PegIFN/RBV for 28 or 48 weeks • Treatment experienced: Boceprevir, PegIFN/RBV for 48 weeks Your Logo

  37. Laboratory Monitoring

  38. Response Guided Therapy • Treatment duration will be dictated by response at certain time points during therapy (RVR – eRVR – EVR) • A consideration to stopping therapy if patient is HCV positive during certain time points to prevent drug exposure and resistance

  39. Interferon Side-effects Ribavirin • Physical • fatigue, muscle/joint pain, headaches, dry skin, insomnia, • Anxiety, depression, mania • Neutropenia (Low white blood cells) • Thrombocytopenia (Low platelets) • Anemia, rash, dry cough • Black box warning: • Women of childbearing age, their partners and female partners of male patients taking ribavirin must practice two forms of effective contraception during to 6 months post-treatment • Anemia (Low red blood cells)

  40. Boceprevir Side-effects Telaprevir • Increased anemia • Metal taste • Slight increase in anemia • Body rash

  41. THANK YOU! Questions? Your Logo

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