executive director, hepatitis c support project alan franciscus your logo integrating
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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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Nu
mb
er W
ith
Ch
ron
ic H
CV
In
fect
ion
(mil
lio
ns)
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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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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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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22
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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).
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
Per
cen
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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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