Executive Director, Hepatitis C Support Project Alan Franciscus Your Logo Integrating Hepatitis C Care into a Primary Care Setting

Integrating Chronic HCV into Medical Clinics – Test, Monitor and Treat ✓ 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 Objectives

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

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)

Current Risk Factor Testing Isn’t Working Testing Templates Risk Factor Assessment Your Logo 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

1.3.2 million persons chronically infected with HCV 2.25% have been diagnosed = 800,000 persons 3.75% have NOT been diagnosed = 2,400,000 persons Your Logo Total U.S. Population with HCV 3.2 Million 2,400,000 Undiagnosed 800,000 Diagnosed

Estimated Prevalence by Age Group 0 Number With Chronic HCVInfection(millions) Birth Year Group s 1970s 1960s 1950s1940s 1930s 1920s <1920 Baby Boomers Account for the Majority of HCV Cases in United States Intregating HCV

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

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

Increased Diagnosis and Treatment Your Logo OraQuick HCV Antibody Test 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 Templates Age-Based Testing.. 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 New Antivirals.Test everyone of a certain age. Pilot programs are being planned in: New York, Detroit, MI, Houston, TX, Birmingham, AL The Beginning of a New Era:

1.Percentage of US Population with HCV 2.Average number of patients in PCP practice 3.Number of patients with HCV per PCP practice Your Logo Primary Care Providers and HCV 1.6% of U. S. Population 2000 Patients 32 HCV Patients

The Primary Care Provider Office Your Logo The Passion Staff The Team Approach Mechanics

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

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

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

The Mechanics Your Logo Diagnosis Management Treatment 1 2

Testing: Risk Factors Your Logo 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

Testing: Risk Factors – con’t Your Logo 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

Diagnosis Antibody, viral load test HCV Antibody HCV RNA

Management: Counseling Patients Prevent transmission, encourage lifestyle changes Primary Prevention Secondary Prevention

Your Logo Lifestyle Changes: Avoid Alcohol Exercise Diet Advise on Herbs, Vitamins & Supplements Avoid Raw or Undercooked Shellfish Secondary Prevention Primary Prevention 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 Management: Counseling Patients

Management: Test & Vaccinate Vaccinate against HAV & HBV Test for HAV, HBV Vaccinate if unprotected

Ferritin % Saturation Blood work – CBC, CMP, INR, TSH, ANA, HIV. Physical exam for evidence of liver damage Your Logo Clinical Assessment 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). 44 Hep A ab total, Hep B Surface Ab/Ag, Hep B Core Ab total Hep A ab total, Hep B Surface Ab/Ag, Hep B Core Ab total

Pregnancy Test Your Logo Clinical Assessment 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). HOMA Score Hep A & Hep B vaccination series if needed Influenza and pneumococcal vaccinations Hep C gentoype, Hep C viral load

Monitor & Consideration of Treatment Stage 0 – 1 Fibrosis Monitor: Annual physical (6-12 months) Complete Blood Panel Hepatic Function Panel (HFP) Liver biopsy (3-5 yrs) May consider Treatment

Monitor & Consideration of Treatment Stage 2 Fibrosis Monitor: Annual physical (6-12 months) Complete Blood Panel HFP Liver biopsy (3-5 yrs) Consider treatment

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

Monitor & Consideration of Treatment Stage 4 Cirrhosis 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)

Refer to Specialist CirrhoticHIV/HCV Coinfection Liver Specialist HIV Specialist

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

Renal failure or insufficiency Your Logo 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). Poorly controlled psychiatric disease Poorly controlled coronary disease Kidney or heart transplant Pregnancy or patients unwilling or unable to practice two forms of birth control Evaluation: Absolute Contraindications

History of coronary heart disease Your Logo 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). Minor or on-going depression Decompensated cirrhosis Autoimmune disease History of severe depression – evaluate and treat depression Evaluation: Relative Contraindications Blood deficiencies (anemia, neutropenia and thrombocytopenia 6

Willingness to keep appointments and lab work Your Logo 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). Stable work/life environment Support Network – support group Willingness to be evaluated for depression Willing to start treatment Evaluation: Patient Criteria 6 6 Team approach with medical team

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

Your Logo 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 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

Laboratory Monitoring

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 Response Guided Therapy

Physical –fatigue, muscle/joint pain, headaches, dry skin, insomnia, –Anxiety, depression, mania Neutropenia (Low white blood cells) Thrombocytopenia (Low platelets) Side-effects Ribavirin Interferon 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)

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

THANK YOU! Questions? Your Logo