Executive Director, Hepatitis C Support Project hcvadvocate hbvadvocate

Executive Director, Hepatitis C Support Projectwww.hcvadvocate.orgwww.hbvadvocate.orgwww.hepatitistattoos.org

Alan Franciscus

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Integrating Hepatitis C Care into a Primary Care Setting

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

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Understand the need for more HCV medical providers

Recognize the front line primary care provider as the critical link

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✓ 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

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•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 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

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Total U.S. Population with HCV

Estimated Prevalence by Age Group

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Birth Year Group

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

1990+1980s1970s1960s1950s1940s1930s1920s<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

• 2020-2029 = 283,378 deaths / ~14,000/yr

Future Burden of Hepatitis C Current and projections

Increased Diagnosis and Treatment

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OraQuick HCV Antibody TestOraQuick 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

TemplatesAge-Based TestingAge-Based Testing

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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

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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

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Primary Care Providers and HCV

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The Primary Care Provider Office

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The Passion

Staff

The Team Approach

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Mechanics Mechanics

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

Passion

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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.

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•Phsyican Office -Working together to provide services

•Patient Part of the Team Process

-involvement with decision process contract with provider

Team Approach

The Mechanics

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Diagnosis

Management

Treatment

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2

Testing: Risk Factors

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• 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

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• 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

Management: Counseling Patients Prevent transmission, encourage lifestyle changes

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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 & VaccinateVaccinate against HAV & HBV

Ferritin % SaturationFerritin % Saturation

Blood work – CBC, CMP, INR, TSH, ANA, HIV.Blood work – CBC, CMP, INR, TSH, ANA, HIV.

Physical exam for evidence of liver damage

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Clinical Assessment

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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

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Clinical Assessment

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66

77

88

55

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 loadHep C gentoype, Hep C viral load

Monitor & Consideration of Treatment

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

Monitor:

• Annual physical (6-12 months)

•Complete Blood Panel

•HFP

•Liver biopsy (3-5 yrs)

Consider treatment

Monitor & Consideration of Treatment

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

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

Liver Specialist

HIV Specialist

Improve health & reduce complications and death from HCV Improve health & reduce complications and death from HCV

HCV Eradication – Viral Cure

Improve Histology

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HCV Treatment: Goals

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Renal failure or insufficiency

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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 Pregnancy or patients unwilling or unable to practice two forms of birth control

Evaluation: Absolute Contraindications

History of coronary heart disease

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33

44

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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 History of severe depression – evaluate and treat depression

Evaluation: Relative Contraindications

Blood deficiencies (anemia, neutropenia and thrombocytopenia

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Willingness to keep appointments and lab work

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44

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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 Willing to start treatment

Evaluation: Patient Criteria

66 Team approach with medical team

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HCV Medical Treatments – Advances

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Mono INF INF + Riba Peg-Intron + Riba Pegasys + Riba Peg INF + Riba + PI

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Gentotype

HCV Medical Treatments

Genotype 1

Genotype 2, 3

Approval expected Mid-2011 Mid-2011

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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

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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?

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